If you missed 1 tablet of yarina. Yarina: clear instructions

Latest update of the description by the manufacturer 23.09.2015

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Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

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Compound

Description of the dosage form

The film-coated tablets are light yellow in color and have a hexagon engraved on one side with the letters “DO” inside.

pharmachologic effect

pharmachologic effect- contraceptive, estrogen-gestagenic.

Pharmacodynamics

Yarina ® is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

The contraceptive effect of Yarina ® is mainly achieved by suppressing ovulation and increasing the viscosity of cervical mucus.

The incidence of venous thromboembolism (VTE) in women with or without risk factors for VTE using ethinyl estradiol/drospirenone-containing oral contraceptives at a dose of 0.03 mg/3 mg is the same as in women using levonorgestrel-containing combined oral contraceptives or other combined oral contraceptives . This was confirmed in a prospective controlled database study that compared women using oral contraceptives at a dose of 0.03 mg ethinyl estradiol/3 mg drospirenone with women using other combined oral contraceptives. Data analysis revealed a similar risk of VTE among the sample.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstrual-like bleeding is less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduced risk of endometrial and ovarian cancer.

Drospirenone contained in Yarin ® has an antimineralocorticoid effect and is able to prevent weight gain and the appearance of other symptoms (for example, edema) associated with estrogen-dependent fluid retention. Drospirenone also has antiandrogenic activity and helps reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to the effect of natural progesterone produced by the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

Pharmacokinetics

Drospirenone

When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral dose, Cmax of drospirenone in serum equal to 37 ng/ml is achieved after 1-2 hours. Bioavailability ranges from 76 to 85%. Food intake does not affect the bioavailability of drospirenone.

Drospirenone binds to serum albumin (0.5-0.7%) and does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG). Only 3-5% of the total concentration in the blood serum is found in free form. The increase in SHBG induced by ethinyl estradiol does not affect the binding of drospirenone to plasma proteins.

After oral administration, drospirenone is completely metabolized.

Most metabolites in plasma are represented by acidic forms of drospirenone, which are formed without the involvement of cytochrome P450.

The concentration of drospirenone in blood plasma decreases in 2 phases. Drospirenone is not excreted unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines in a ratio of approximately 1.2-1.4. T1/2 for excretion of metabolites in urine and feces is approximately 40 hours.

During cyclic treatment, the maximum steady-state serum concentration of drospirenone is achieved in the second half of the cycle.

A further increase in the serum concentration of drosperinone is observed after 1-6 cycles of administration, after which no increase in concentration is observed.

In women with moderate liver dysfunction (class B on the Child-Pugh scale), AUC is comparable to the corresponding indicator in healthy women with similar Cmax values ​​​​in the absorption and distribution phases. T1/2 of drospirenone in patients with moderate liver dysfunction was 1.8 times higher than in healthy volunteers with intact liver function.

In patients with moderate liver dysfunction, a 50% decrease in the clearance of drospirenone was observed compared with women with preserved liver function, while there were no differences in the concentration of potassium in the blood plasma in the studied groups. When diabetes mellitus is detected and concomitant use of spironolactone (both conditions are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma has not been established.

It should be concluded that drospirenone is well tolerated in women with mild to moderate liver dysfunction (Child-Pugh class B).

The concentration of drospirenone in the blood plasma when reaching a steady state was comparable in women with mild renal impairment (Cl creatinine - 50-80 ml/min) and in women with preserved renal function (Cl creatinine - > 80 ml/min). However, in women with moderate renal impairment (Cl creatinine - 30-50 ml/min), the average concentration of drospirenone in the blood plasma was 37% higher than in patients with preserved renal function. Drospirenone was well tolerated by all groups of patients. There were no changes in the concentration of potassium in the blood plasma when using drospirenone.

Ethinyl estradiol

After oral administration, ethinyl estradiol is rapidly and completely absorbed. C max in blood plasma, equal to approximately 54-100 pg/ml, is achieved in 1-2 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in its bioavailability when taken orally, on average, about 45%.

Ethinyl estradiol is almost completely (approximately 98%), although nonspecifically, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG.

Ethinyl estradiol undergoes presystemic conjugation, both in the mucous membrane of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation.

The decrease in the concentration of ethinyl estradiol in the blood plasma is biphasic. It is not excreted from the body unchanged. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6 with T1/2 of about 24 hours.

C ss is achieved during the second half of the cycle.

Indications of the drug Yarina ®

Contraception (prevention of unwanted pregnancy).

Contraindications

Yarina ® should not be used if you have any of the conditions/diseases listed below:

thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders;

conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history;

migraine with focal neurological symptoms currently or in history;

diabetes mellitus with vascular complications;

multiple or severe risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years;

pancreatitis with severe hypertriglyceridemia currently or in history;

liver failure and severe liver diseases (until normalization of liver tests);

liver tumors (benign or malignant) currently or in history;

severe and/or acute renal failure;

identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them;

bleeding from the vagina of unknown origin;

pregnancy or suspicion of it;

breastfeeding period;

hypersensitivity to any of the components of the drug Yarina ®.

If any of these conditions develop for the first time while taking Yarina, the drug should be discontinued immediately.

CAREFULLY

The potential risks and expected benefits of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors:

risk factors for the development of thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve defects, prolonged immobilization, major surgical interventions, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in anyone - or one of the closest relatives);

other diseases in which peripheral circulatory disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia), phlebitis of the superficial veins;

hereditary angioedema;

hypertriglyceridemia;

liver diseases;

diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice and/or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, pregnancy herpes, Sydenham's chorea);

postpartum period.

Use during pregnancy and breastfeeding

The drug is not prescribed during pregnancy and breastfeeding. If pregnancy is detected while taking Yarina ®, it should be discontinued immediately. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or teratogenic effects in cases of inadvertent use of sex hormones in early pregnancy. At the same time, data on the results of taking the drug Yarina ® during pregnancy are limited, which does not allow us to draw any conclusions about the negative impact of the drug on pregnancy, the health of the newborn and the fetus. Currently, no significant epidemiological data are available.

Taking combined oral contraceptives may reduce the amount of breast milk and change its composition, so their use is not recommended until you stop breastfeeding. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

Side effects

The most commonly reported adverse reactions to Yarina ® include nausea and breast pain. They occurred in more than 6% of women using this drug.

Serious adverse reactions include arterial and venous thromboembolism.

The table below shows the frequency of adverse reactions. which were reported during clinical trials of the drug Yarina ® (N=4897). Within each group, allocated depending on the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency they are divided into frequent (≥1/100 and<1/10), нечастые (≥1/1000 и <1/100) и редкие (≥1/10000 и <1/1000). Для дополнительных нежелательных реакций, выявленных только в процессе постмаркетинговых исследований, и для которых оценку частоты возникновения провести не представлялось возможным, указано «частота неизвестна» (см. табл. 1).

Table 1

System-organ classes (MedDRA version)	Often	Infrequently	Frequency unknown
Mental disorders	Mood swings, depression, depressed mood, decreased or loss of libido
Nervous system	Migraine
Vascular disorders		Venous or arterial thromboembolism*
Gastrointestinal tract	Nausea
Skin and subcutaneous tissues			Erythema multiforme
Reproductive system and mammary glands	Pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin

Adverse events during clinical trials were codified using the MedDRA dictionary (Medical Dictionary for Regulatory Activities, version 12.1). Different MedDRA terms reflecting the same symptom were grouped together and presented as a single adverse reaction to avoid diluting or diluting the true effect.

* - Approximate frequency based on the results of epidemiological studies covering the group of combined oral contraceptives. The frequency bordered on very rare.

Venous or arterial thromboembolism includes the following entities: peripheral deep vein occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not defined as hemorrhagic.

For venous and arterial thromboembolism, migraine, see also “Contraindications” and “Special instructions”.

Additional Information

Listed below are adverse reactions with a very rare incidence or with delayed symptoms, which are believed to be associated with taking drugs from the group of combined oral contraceptives (see also “Contraindications” and “Special instructions”).

Tumors:

The incidence of breast cancer diagnosis in women taking combined oral contraceptives is slightly increased. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in women taking combined oral contraceptives is small relative to the overall risk of breast cancer.

Liver tumors (benign and malignant).

Other states:

Erythema nodosum;

Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);

Increased blood pressure;

Conditions that develop or worsen while taking combined oral contraceptives, but their relationship with the drug has not been proven (jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham's chorea ; herpes of pregnant women; hearing loss associated with otosclerosis);

In women with hereditary angioedema, estrogen may cause or worsen symptoms;

Liver dysfunction;

Impaired glucose tolerance or effects on insulin resistance;

Crohn's disease, ulcerative colitis;

Chloasma;

Hypersensitivity (including symptoms such as rash, urticaria).

Interaction. The interaction of combined oral contraceptives with other drugs (inducers of microsomal liver enzymes, some antibiotics) can lead to breakthrough bleeding and/or a decrease in contraceptive effectiveness (see “Interaction”).

Interaction

Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to Yarina ®, or choose another method of contraception.

The following types of interactions have been reported in the literature.

Effect on hepatic metabolism. The use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or reduced contraceptive reliability. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

HIV protease inhibitors(eg ritonavir) and non-nucleoside reverse transcriptase inhibitors(eg nevirapine) and their combinations can also potentially affect hepatic metabolism.

Effect on enterohepatic circulation. According to individual studies, some antibiotics (for example, penicillins and tetracyclines) may reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

During your appointment drugs affecting microsomal enzymes, and within 28 days after their cancellation, a barrier method of contraception should be additionally used.

During your appointment antibiotics(such as penicillins and tetracyclines) and for 7 days after their discontinuation, a barrier method of contraception should be additionally used. If during these 7 days of the barrier method of contraception the tablets in the current package run out, then you should start taking tablets from the next package of Yarina ® without the usual break in taking the tablets.

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.

Oral combination contraceptives may affect the metabolism of other drugs, leading to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their plasma and tissue concentrations.

Based on interaction studies in vitro, as well as research in vivo Using female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone 3 mg on the metabolism of other medicinal substances is unlikely.

There is a theoretical possibility of increased serum potassium levels in women receiving Yarina ® concomitantly with other drugs that may increase serum potassium levels. These drugs include angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference in serum potassium concentrations compared with placebo.

Directions for use and doses

Inside, in the order indicated on the package, every day at approximately the same time, with a small amount of water.

Take one tablet per day continuously for 21 days. Taking tablets from the next package begins after a 7-day break, during which menstrual-like bleeding usually develops (withdrawal bleeding). As a rule, it begins on the 2-3rd day after taking the last pill and may not end until you start taking pills from a new package.

How to start taking Yarina ®

If you have not taken any hormonal contraceptives in the previous month

Taking Yarina ® begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is possible to start taking it on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

When switching from other combined oral contraceptives, vaginal ring or contraceptive patch

It is preferable to start taking Yarina ® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing containing 28 tablets per package). Taking Yarina ® should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.

When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant), or from a gestagen-releasing intrauterine contraceptive (Mirena)

You can switch from the “mini-pill” to Yarina ® on any day (without a break), from an implant or intrauterine contraceptive with gestagen - on the day of its removal, from the injection form - from the day when the next injection is due. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

You can start taking the drug immediately, on the day of the abortion. If this condition is met, the woman does not need additional contraception.

After childbirth or abortion in the second trimester of pregnancy

You should start taking the drug no earlier than 21-28 days after childbirth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already been sexually active, pregnancy should be excluded before starting to take Yarina ® or she must wait until her first menstruation.

Taking missed pills

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, and the next one should be taken at the usual time.

If the delay in taking the pills is more than 12 hours, contraceptive protection is reduced. The more pills are missed and the closer the missed pill is to the 7-day break in taking pills, the greater the likelihood of pregnancy.

In this case, you can be guided by the following two basic rules:

The drug should never be interrupted for more than 7 days;

To achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous tablet use are required.

Accordingly, the following advice can be given if the delay in taking tablets exceeds 12 hours (the interval since the last tablet was taken is more than 36 hours).

First week of taking the drug

The last missed pill should be taken as soon as possible, as soon as the woman remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) should be used for the next 7 days. If sexual intercourse took place within a week before missing the pill, the possibility of pregnancy must be taken into account.

Second week of taking the drug

The last missed pill should be taken as soon as possible, as soon as the woman remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Provided that the woman has taken the pills correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, or if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of pregnancy increases due to the upcoming break in taking the pills. A woman must strictly adhere to one of the two options below. However, if during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this means taking two pills at the same time). The next tablets are taken at the usual time until the tablets in the current pack are gone. You should start taking the tablets from the next package immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

2. You can stop taking tablets from the current package, thus starting a 7-day break (including the day you skipped tablets), and then start taking tablets from a new package.

If a woman misses taking pills and then does not have withdrawal bleeding during the break, pregnancy must be ruled out.

If vomiting or diarrhea occurs within 4 hours of taking the tablets, absorption may not be complete and additional measures should be taken to protect against unwanted pregnancy. In such cases, you should follow the above recommendations when skipping pills.

Changing the day of the onset of menstrual bleeding

In order to delay the onset of menstrual-like bleeding, it is necessary to continue taking tablets from the new package of Yarina ® without a 7-day break. Tablets from the new package can be taken for as long as necessary, incl. until the tablets in the package run out. While taking the drug from the second package, spotting from the vagina or breakthrough uterine bleeding are possible. You should resume taking Yarina ® from the next package after the usual 7-day break.

In order to move the day of the onset of menstrual bleeding to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and will subsequently experience spotting and breakthrough bleeding while taking the second pack (just as if she would like to delay the onset of menstrual-like bleeding).

Additional information for special categories of patients

Children and teenagers. The drug Yarina is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.

Elderly patients. Not applicable. The drug Yarina ® is not indicated after menopause.

Patients with liver disorders. Yarina ® is contraindicated in women with severe liver disease until liver function tests return to normal (see also “Contraindications” and “Pharmacokinetics”).

Patients with kidney disorders. The drug Yarina ® is contraindicated in women with severe renal failure or acute renal failure (see also “Contraindications” and “Pharmacokinetics”).

Overdose

Symptoms(identified based on cumulative experience with oral contraceptives): nausea, vomiting, spotting or metrorrhagia.

Treatment: symptomatic. There is no specific antidote.

No serious adverse events have been reported following overdose.

special instructions

If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking drug. In case of worsening, intensification or first manifestation of any of these conditions, diseases or increase in risk factors, the woman should consult with her doctor, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare. The risk of developing VTE is greatest in the first year of taking such drugs. An increased risk is present after initial use of combined oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients indicate that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (ethinyl estradiol content less than 50 mcg) is 2-3 times higher than in non-pregnant patients who do not take combined oral contraceptives, however, this risk remains lower compared to with the risk of VTE during pregnancy and childbirth. VTE can be life-threatening or fatal (in 1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any combined oral contraceptives.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels (for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels) occurs. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when upright or when walking, localized warmth in the affected leg, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism (PE) include: difficulty or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg shortness of breath, cough) are non-specific and may be misinterpreted as signs of other more or less serious events (eg respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of feeling in the face, arm or leg, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, acute abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or chest; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be fatal. The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:

With age;

For smokers (the risk increases with increasing number of cigarettes or increasing age, especially in women over 35 years of age).

In the presence of:

Obesity (body mass index more than 30 kg/m2);

Family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;

Prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least 4 weeks before it) and not resume use for 2 weeks after the end of immobilization;

Dyslipoproteinemia;

Arterial hypertension;

Migraine;

Heart valve diseases;

Atrial fibrillation.

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. The increased risk of thromboembolism in the postpartum period should be taken into account.

Poor peripheral circulation may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. An increase in the frequency and severity of migraine during use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (ethinyl estradiol content - 0.05 mg).

Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives. However, the connection with the use of combined oral contraceptives has not been proven. The possibility of interrelating these data with disease screening is discussed. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior (lower use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies found that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk - 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in women currently or recently taking combined oral contraceptives is small relative to the overall risk of breast cancer. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of careful monitoring and earlier diagnosis of breast cancer in women using combined oral contraceptives. Women who have ever used combined oral contraceptives are diagnosed with earlier stages of breast cancer than women who have never used them.

In rare cases, during the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors, which sometimes led to life-threatening intra-abdominal bleeding, was observed. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis. Malignant tumors can be life-threatening or fatal.

Other states

Clinical studies have shown no effect of drospirenone on plasma potassium concentrations in patients with mild to moderate renal failure. However, in patients with impaired renal function and an initial potassium concentration at the ULN level, the risk of developing hyperkalemia while taking drugs that lead to potassium retention in the body cannot be excluded.

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking combined oral contraceptives.

Although slight increases in blood pressure have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking the drug, these drugs should be discontinued and treatment of arterial hypertension should be initiated. The drug can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy. The following conditions have been reported to develop or worsen both during pregnancy and while taking combined oral contraceptives (but have not been shown to be associated with combined oral contraceptives): jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives. In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Acute or chronic liver dysfunction may require discontinuation of the drug until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of the drug. Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (ethinyl estradiol content less than 0.05 mg). However, women with diabetes should be closely monitored while taking this drug.

Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma while taking Yarina ® should avoid prolonged exposure to the sun and exposure to UV radiation.

Preclinical safety data

Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Laboratory tests

Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, blood coagulation and fibrinolysis. Changes usually do not go beyond normal values. Drospirenone increases plasma renin activity and plasma aldosterone levels, which is associated with its antimineralocorticoid effect.

Reduced efficiency

The effectiveness of Yarina ® may be reduced in the following cases: when taking tablets, vomiting and diarrhea (see “Taking missed tablets”) or as a result of drug interactions.

Insufficient control of the menstrual cycle

While taking Yarina ® , irregular (acyclic) spotting/bleeding from the vagina (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular menstrual-like bleeding should be carried out after an adaptation period of approximately 3 cycles. If irregular menstrual-like bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignancy or pregnancy.

Some women may not develop withdrawal bleeding during a pill-free break. If Yarina ® was taken as recommended, it is unlikely that the woman is pregnant. However, if the drug is not used regularly and there are no two consecutive menstrual-like bleedings, the drug cannot be continued until pregnancy has been ruled out.

Medical examinations

Before starting or resuming the use of the drug Yarina ®, it is necessary to familiarize yourself with the woman’s life history and family history, conduct a thorough general medical and gynecological examination, and exclude pregnancy. The scope of research and the frequency of follow-up examinations should be based on existing standards of medical practice, with the necessary consideration of the individual characteristics of each patient. As a rule, blood pressure, heart rate are measured, body mass index is determined, the condition of the mammary glands, abdominal cavity and pelvic organs is checked, including a cytological examination of the cervical epithelium (Papanicolaou test). Typically, follow-up examinations should be carried out at least once every 6 months.

Among the most common and effective oral contraceptives of the new generation, birth control pills Yarina can be noted. This drug is a monophasic combination drug with a low content of hormones (drospirenone (3 mg) and ethinyl estradiol (0.03 mg) - synthetic analogues of female sex hormones), which has antiandrogenic and antimineralocorticoid effects. Antiandrogenic properties are expressed in reducing the secretion of the sebaceous glands, and antimineralocorticoid properties in preventing weight gain, as well as the appearance of edema due to fluid retention.

Efficacy and mechanism of action of the drug Yarina.
The daily intake of the hormonal drug Yarina is designed to “deceive” the female body and make it work as if the ovulation process has already occurred. As a result of this, the maturation and release of the egg from the ovary does not occur. The contraceptive effect of the drug Yarina is due to the action of the active substances it contains, aimed at inhibiting the ovulation process, increasing the viscosity of cervical mucus, which prevents the penetration of sperm from the vagina into the uterus. In addition, the hormones present in the drug change the endometrium, as a result of which, even if fertilization has occurred, the likelihood of implantation of the fertilized egg is minimized. It should also be noted that in addition to effectively preventing the onset of unwanted pregnancy, Yarina birth control pills are prescribed for the treatment of acne and seborrhea in women.

As a result of regular use of this oral contraceptive, women's cycle normalizes, becomes regular, pain during menstruation disappears, menstrual bleeding becomes less heavy, as a result of which the risk of developing iron deficiency anemia is minimized. That is why Yarina is often prescribed to women for the treatment of painful menstruation and various menstrual disorders. There is also evidence that the drug helps reduce the risk of occurrence and development of ovarian and endometrial cancer.

When a contraceptive is used correctly, the Pearl index (the number of pregnancies per 100 women using this contraceptive throughout the year) is less than 1.

Method of administration and dose.
Each package of Yarina contains twenty-one active tablets, which should be taken one daily with plenty of water, preferably at the same time, according to the order indicated on the package. After twenty-one days, a week-long break is taken, during which (usually on the second or third day after taking the last pill) withdrawal bleeding (or menstrual-like bleeding) occurs. This bleeding may not stop before you start taking a new bottle of birth control.

Start taking the drug Yarina.
If you did not take other hormonal contraceptives in the previous month, then taking Yarina should start on the first day of the cycle or on the first day of menstruation. It is allowed to take it on the second to fifth day of the cycle, but during the next seven days of taking the pills it is recommended to additionally use barrier means of protection against the onset of unplanned pregnancy (condom).

When switching to Yarina from other oral contraceptives, it should be taken the next day after taking the last (twenty-first) tablet from the previous package. Taking Yarina when switching from a vaginal ring or contraceptive patch should be taken on the day the vaginal ring or patch is removed, but no later than the day on which a new ring should be inserted or a new patch should be applied.

The transition to the drug Yarina from the “mini-pill” can be carried out on any day (without a break), from a hormonal implant or intrauterine contraceptive with gestagen - on the day of its removal, from injections - from the day on which a new injection should be given. In all cases, additional contraception is required during the first week of taking the drug.

After an abortion in the first trimester of pregnancy, the drug should be started immediately on the day of the abortion, and no additional protection is required.

After childbirth or abortion in the second trimester of pregnancy, the drug should be started 21-28 days after childbirth (if the woman is not breastfeeding) or abortion. If you start taking the contraceptive Yarina later, you must use additional contraceptives during the week of taking the drug. It should be noted that if a woman had sexual intercourse before starting to take Yarina, it is necessary to exclude the possibility of pregnancy, and it is advisable to wait until the start of menstruation.

Skipping a drug dose.
If the pill was missed for less than twelve hours, the contraceptive protection of the drug is maintained. In this case, it is necessary to take the missed pill as quickly as possible, and then take it according to the schedule. If the delay in taking the drug is more than twelve hours, then the effectiveness of the drug is sharply reduced. The more pills you miss, the higher the chance of pregnancy, especially in the period close to a week's break. In this case, there are several options for what a woman can do if she misses taking the drug for more than twelve hours.

So, if a missed dose was missed in the first week of the cycle (taking the drug), the woman should immediately take the missed pill, even if it is time to take the next pill after the missed one. It is allowed to take two tablets at once, and then the usual dosage regimen. But at the same time, over the next week it is necessary to use a condom as an additional measure of protection. If a woman had sexual intercourse within a week before missing the drug, there is a possibility of pregnancy.

If you miss Yarina in the second week of taking it, you must take this pill as soon as possible. If it is time to take the next pill after the missed one, you are allowed to take two pills at once. The next tablet should be taken as usual. If the drug was taken correctly during the first week before skipping it, then additional barrier methods of contraception are not required, the contraceptive effect is maintained. Otherwise, or if a woman has missed more than two tablets, she should use an additional condom for a week.

In the third week of taking the drug, if the drug is missed, the risk of pregnancy increases against the background of the upcoming seven-day break. There are some rules to consider here. If during the week preceding the first missed pill the drug was taken correctly without interruptions, then there is no need to additionally use other contraceptives. Otherwise, you need to take the missed pill as soon as possible, and if necessary (if it is time to take the next pill), take two at once. Take the following tablets as usual. However, a new package of the drug should be started without interruption. In this case, bleeding is unlikely to occur until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

If a woman does not experience withdrawal bleeding when she skips pills during a break, it is necessary to rule out possible pregnancy.

Contraindications for taking Yarina.

• presence of severe liver disease;
• renal failure in severe and acute forms;
• thrombosis and conditions preceding it (transient cerebrovascular accidents, angina pectoris);
• migraine;
• diabetes mellitus with vascular complications;
• presence of risk factors for venous and arterial thrombosis;
• pancreatitis;
• liver diseases and liver failure;
• liver tumors of benign and malignant nature;
• hormone-dependent malignant diseases;
• vaginal bleeding of unknown origin;
• pregnancy or suspicion of it;
• breastfeeding period;
• individual intolerance to the components of the drug.

If any of the above diseases occur, you should stop taking the drug.

Use during pregnancy and lactation.
If pregnancy occurs while taking Yarina, you must urgently stop taking the drug and consult a gynecologist. It is also not recommended to take the drug during lactation, since the substances it contains can change the composition and properties of breast milk, as well as negatively affect its quantity.

Side effects:

• irregular bleeding from the vagina during the first three months of taking the drug;
• tenderness, engorgement or discharge from the mammary glands;
• mood swings;
• vaginal discharge;
• headache, migraine;
• intolerance to contact lenses;
• change in libido;
• hives, rash;
• nausea, abdominal pain, rarely vomiting or diarrhea;
• weight gain or loss;
• swelling;
• erythema nodosum;
• thrombosis or thromboembolism.

If a woman experiences vomiting or diarrhea while taking the drug (up to 4 hours after taking it), it is necessary to additionally use contraceptives, since in this case the absorption of the drug may not be complete, which can lead to pregnancy. In this case, the situation should be regarded as a missed pill and be guided based on the recommendations described above.

Overdose.
Symptoms of a drug overdose are nausea, vomiting, bleeding in the form of spotting or metrorrhagia. If signs of overdose appear, you should consult a specialist. Treatment is aimed at eliminating symptoms.

Thank you

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!

Composition and release form

A drug Yarina Available in the form of film-coated tablets. The active substances included in the drug are ethinyl estradiol at a dosage of 30 mg and drospirenone at a dosage of 3 mg. One package of the drug contains 21 tablets.

How does Yarina work?

Yarina is a combined remedy, as it contains two sex hormones - estrogen and gestagen. In addition, the product is low-dose (low doses of hormones) and monophasic (all tablets contain the same amount of hormones).

Yarina’s ability to protect against pregnancy is based on two mechanisms - suppression of ovulation (ovulation maturation) and a change in the properties of the secretion (mucus) located in the cervix. Thick cervical mucus becomes an obstacle to sperm penetration.

In addition, taking Yarina helps to regulate the menstrual cycle (if it is irregular). Pain during menstruation decreases, bleeding becomes less intense (this fact reduces the risk of developing iron deficiency anemia).

Other beneficial effects of Yarina are antimineralocorticoid and antiandrogenic effects. The hormone drospirenone has this effect - it reduces fluid retention in the body, reduces swelling, so that body weight does not increase. The antiandrogenic effect is the ability of the drug to reduce the symptoms of acne (acne) and regulate the production of sebum in the skin and hair (reduces seborrhea).

Indications for use

The main indication for the use of tablets is to prevent unwanted pregnancy.

Contraindications

Yarina should not be used for the following diseases or conditions:
1. Thrombosis of veins or arteries, and thromboembolism (blockage of blood vessels with blood clots), cerebral circulatory disorders.
2. Conditions that can lead to thrombosis are angina pectoris, transient cerebrovascular accidents, uncontrolled high blood pressure, major surgical operations with prolonged bed rest.
3. Migraine, which has appeared ever before, or currently, accompanied by focal neurological symptoms (visual disturbances, sensitivity, speech).
4. Diabetes mellitus, accompanied by vascular complications.
5. Smoking if the woman is over 35 years old.
6. Pancreatitis (inflammation of the pancreas), accompanied by an increase in triglycerides in the blood (currently or previously).
7. Severe liver disease or liver failure, liver tumors.
8. Renal failure - severe or acute.
9. Hormone-dependent malignant diseases of various organs, including genitals, currently present or suspected.
10. Bleeding from the vagina, the cause of which is unknown.
11. Pregnancy, breastfeeding or suspected pregnancy.
12. Hypersensitivity to substances included in the composition birth control pills.

Conditions for which caution should be taken

There are conditions and diseases during which Yarina should be taken with caution. In such cases, the risks and expected benefits of taking the medication are carefully weighed for each patient. These diseases must be reported to your doctor before prescribing the drug. These include:

• Diseases of the cardiovascular system (risk of thrombosis and thromboembolism).
• Angioedema.
• Liver diseases.
• Increased levels of triglycerides (such as cholesterol) in the blood.
• Postpartum period.
• Diseases associated with circulatory disorders (diabetes mellitus, systemic lupus erythematosus, sickle cell anemia, Crohn's disease, etc.).
• Diseases that occurred during pregnancy or during a previous appointment hormonal contraceptives.

Use during pregnancy and lactation

During pregnancy and lactation, Yarina is contraindicated. If pregnancy is detected while taking the drug, you should cancel the course and immediately consult a doctor. It is not recommended to take the medicine during breastfeeding, since its components can change the composition and properties of breast milk, as well as reduce its quantity.

Side effects

• The most common side effect when taking oral contraceptives is the occurrence of irregular bleeding from the vagina. They may appear as spotting or breakthrough bleeding. Most often they occur during the first three months.
• Other side effects associated with taking Yarina may include soreness, breast tenderness or discharge, and vaginal discharge.
• On the part of the nervous system, there may be changes such as headache, mood swings or depression, decreased or increased libido, migraine.
  Digestive disorders may manifest as nausea, abdominal pain, and less commonly, vomiting or diarrhea.
• Sometimes when taking Yarina, intolerance to contact lenses appears, and unpleasant sensations occur while wearing them.
• Metabolic disorders are manifested by changes in body weight – more often by an increase, less often by a decrease, and fluid retention in the body.
• Skin manifestations of hypersensitivity to the drug are represented by urticaria, rash, and less commonly the appearance of erythema nodosum.
• Like others contraception with a hormonal composition, in rare cases, when taking Yarina, the development of thrombosis or thromboembolism is possible.

Overdose

The most common symptoms of an overdose of Yarina may be nausea, vomiting, uterine bleeding in the form of spotting or metrorrhagia. In case of an overdose of the drug and its signs appear, you should immediately consult a doctor. Treatment is usually symptomatic.

How to take Yarina?

You need to take the drug once a day, at the same time each time, with a small amount of water. For convenience, each tablet is marked with the day of the week on which it must be taken. The tablets should be taken in the order indicated by the arrow. When all the tablets have been taken, you need to take a break of 7 days. During these 7 days (most often on days 2-3), menstruation (or withdrawal bleeding) begins. After a 7-day break, begin taking the next package of the drug. Thus, each package will begin on the same day of the week.

Yarina's first package

1. In cases where no contraceptive containing hormones was used in the previous month, it is best to start taking Yarina on the first day of menstruation. From the package you need to select a tablet marked with the corresponding day of the week. Next, you should drink them in the order indicated by the arrow. It is also possible to start taking it on days 2-5 of the cycle; in this case, during the first 7 days of taking the pills, you should use additional methods of contraception (for example, a condom).

2. If it is necessary to switch to taking Yarina from other combined oral contraceptives, the first tablet is taken without interruption. Thus, if the previous remedy contained 28 tablets, taking Yarina begins after the last active tablet is taken, but no later than the day the last inactive tablet is taken. If the product contained 21 tablets, take Yarina no later than the next day after a 7-day break.

3. In the case of using a vaginal ring or hormonal patch, taking Yarina begins on the day they were removed, but not later than the day the next ring is inserted or the patch is applied.

4. If before taking Yarina you used products containing only gestagen (mini-pills), you can stop taking them any day and start drinking Yarina. In this case, it is necessary to use a barrier method of protection during the first week.

5. When switching to Yarina from injections, an implant or an intrauterine device Mirena, the pills should be taken on the day when the next injection was supposed to be done, the implant or intrauterine device should be removed. After this, for 7 days, in addition to Yarina, barrier methods of contraception are used.

In case of liver dysfunction, the drug should not be taken until indicators characterizing liver function (liver tests) return to normal.

If kidney function is impaired, caution should be exercised, since the medicine is contraindicated in acute or severe renal failure.

Interaction with other drugs

There are a number of medications that can reduce the effectiveness of Yarina. These drugs include:

• for the treatment of epilepsy (such as phenytoin, barbiturates, topiramate, carbamazepine and others);
• for the treatment of tuberculosis (rifampicin);
• for the treatment of HIV infection (for example, nevirapine, ritonavir);
• antibiotics (tetracyclines, penicillin, griseofulvin);
• St. John's wort preparations (used to treat low mood).

In turn, taking Yarina may affect the metabolism of other drugs (in particular lamotrigine, cyclosporine).

You should always tell the doctor who prescribed Yarina what medications you are already taking. In addition, you should inform other doctors (including dentists) who prescribe other medications about taking Yarina. In addition, you must tell the pharmacist who sells the medications at the pharmacy about this.

In some cases, it may be necessary to use additional barrier agents to protect against unwanted pregnancy.

Special instructions for use

1. Before you start taking Yarina, you must undergo a medical examination to identify contraindications and restrictions on use. The examination must include a general medical examination with measurement of blood pressure, pulse, determination of body mass index, gynecological examination, examination of the mammary glands, Papanicolaou test (examination of scraping of the cervical mucosa). The doctor may also prescribe other additional tests.

2. It is important to remember that when taking combined oral contraceptives, the risk of thrombosis and thromboembolism increases. Therefore, before taking the drug, it is necessary to weigh the expected risk and possible benefits.

3. There is also evidence of increased detection of cervical and breast cancer with long-term use of combined oral contraceptives. This may be due to more thorough and regular examination of women taking them.

5. With angioedema of a hereditary nature, the substances included in Yarina can worsen the symptoms of this disease.

6. The effectiveness of Yarina may decrease in three cases - if you miss a pill, have digestive disorders, or as a result of interaction with other medications.

7. It should be remembered that Yarina is not a means of protecting against infection with AIDS (HIV infection) and other sexually transmitted diseases.

Menstruation while taking Yarina

Menstruation occurs during a week-long break, most often on the 2-3rd day, approximately on the same day of the week (provided that it is taken correctly). If desired, it is possible to change the day of menstruation. To delay the onset of menstruation, you do not need to take a 7-day break, but start taking the next pack of pills after the end of the current one. You can take the tablets until the package runs out or, if desired, stop taking them on any day (then menstruation begins). While taking tablets from the second package, spotting or bleeding may occur. The next package of Yarina is taken after a break of 7 days, as usual.

To change the day your period starts, you need to shorten the 7-day break from taking it. Thus, menstruation will begin earlier. If the break is less than 3 days, menstruation may not begin, but instead bleeding or spotting may appear when taking the next package of Yarina.

Spotting or bleeding during treatment - what to do?

Very often, when taking Yarina, spotting or breakthrough bleeding may occur. Such bleeding or discharge is irregular and is not associated with a break in taking Yarina. Most often, discharge occurs during the first three menstrual cycles, and is a sign of the body's adaptation to the contraceptive. Therefore, you should continue taking Yarina using personal hygiene products. If the discharge does not stop after 3 months, becomes profuse, or appears again after stopping, you should consult a doctor for an examination.

When should you see a doctor?

When taking Yarina, you must visit your doctor regularly - at least once a year - for preventive examinations.

You should visit a doctor as soon as possible if the following situations arise:
1. For any health changes, especially conditions for which the drug is used with caution, or for which it is contraindicated.
2. If a limited lump appears in the mammary gland.
3. If necessary, take other medications.
4. If there is a long period of immobility, bed rest - for example, as in the case of a plaster cast or surgery.
5. If you experience vaginal bleeding that is heavier or heavier than usual.
6. If you miss a pill in the first week of taking it, if you have had sexual intercourse in the previous 7 days.
7. If menstruation does not occur 2 times in a row, or there is a suspicion of pregnancy.

Film-coated tablets in blister packs, two types:

• Active tablets are orange, round, biconvex, on one side with “Y+” embossed in a regular hexagon (21 pieces in a blister). Active ingredient: 1 tablet contains ethinyl estradiol (micronized, in the form of betadex clathrate) - 30 mcg, drospirenone (micronized) - 3 mg, calcium levomefolate (micronized) - 451 mcg. Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hyprolose, magnesium stearate.
• Auxiliary (vitamin) tablets are light orange in color, round, biconvex, on one side with “M+” embossed in a regular hexagon (7 pieces in a blister). Active ingredient: 1 tablet contains calcium levomefolate (micronized) - 451 mg. Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hyprolose, magnesium stearate.

Pharmacological action

Yarina Plus is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug, including active tablets and auxiliary vitamin tablets containing calcium levomefolate. The contraceptive effect of Yarina Plus is mainly achieved by suppressing ovulation and increasing the viscosity of cervical mucus.

In women taking combined oral contraceptives (COCs), the cycle becomes more regular, the pain, intensity and duration of menstrual bleeding decrease, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduced risk of endometrial and ovarian cancer.

Drospirenone, contained in Yarina Plus, has an antimineralocorticoid effect and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a reduction in the likelihood of peripheral edema. Drospirenone also has antiandrogenic activity and helps reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to the effect of natural progesterone produced in the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

The acid form of calcium levomefolate is structurally identical to naturally occurring L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average concentration in the blood plasma of people who do not consume foods fortified with folic acid is about 15 nmol/l. Levomefolate, unlike folic acid, is a biologically active form of folate. Thanks to this, it is absorbed better than folic acid. Levomefolate is indicated to meet the increased need and ensure the necessary folate content in a woman’s body during pregnancy and lactation. The addition of levomefolate calcium to an oral contraceptive reduces the risk of developing a neural tube defect if a woman becomes unexpectedly pregnant immediately after stopping contraception (or, in very rare cases, when using oral contraception).

Indications for use

• contraception (primarily for women with symptoms of hormone-dependent fluid retention in the body);
• contraception and treatment of moderate acne (acne vulgaris);
• contraception in women with folate deficiency.

Directions for use and doses

Take the tablets at approximately the same time every day, with water if necessary. Follow the direction of the arrows until you have taken all 28 tablets. As a rule, menstruation begins 2-3 days after taking the last active tablet of Yarina Plus (i.e. during the period when you take the last 7 tablets from the last row of the package). Do not take a break between packs, i.e. Start taking pills from a new pack the day after you finish your current pack, even if you have not yet finished your menstrual-like bleeding (withdrawal bleeding). This means that you will always start a new pack on the same day of the week, and that the withdrawal bleed will occur around the same dates each month.

Start taking the drug

• When no hormonal contraceptive was used in the previous month
  Start taking Yarin Plus on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the pill that is marked with the appropriate day of the week. Then take the pills in order. Yarina Plus begins to act immediately, so there is no need to use additional barrier methods of contraception. Consult your doctor if you are not sure when exactly to start taking the drug.
• When switching from other combined oral contraceptives
  You can start taking Yarin Plus the next day after you take the last pill from the current package of hormonal contraceptives (this means that there will be no break in taking the pills). If your previous contraceptive also contains tablets without active substances, you can start taking Yarin Plus the day after taking the last active tablet (if you have doubts, ask your doctor about this). You can start taking it later, but no later than the day that follows the planned 7-day break in taking the contraceptives you are currently using (or no later than the next day after taking the last inactive pill from the package of the contraceptives you are using).
• When switching from a vaginal ring or contraceptive patch
  If you have previously used a vaginal ring or transdermal patch, it is preferable to start taking it on the day the ring/patch was removed, but no later than the day on which the ring/patch was scheduled to be replaced. If you follow these rules, additional contraception is not necessary.
• When switching from oral contraceptives containing only gestagen (mini-pills)
  You can stop taking the mini-pill on any day and start taking Yarin Plus the next day at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception (for example, a condom).
• When switching from an injectable contraceptive, an implant, or from a progestogen-releasing intrauterine contraceptive (Mirena)
  Start taking Yarin Plus on the day when the next injection is due or on the day the implant or intrauterine contraceptive is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
• After childbirth
  If you have just given birth, your doctor may recommend that you wait until the end of your first normal menstrual cycle before starting to take Yarina Plus. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.
• After spontaneous miscarriage or abortion in the first trimester of pregnancy
  Consult your doctor. It is usually recommended to start taking it immediately.

Stop taking Yarina Plus

You can stop taking Yarina Plus at any time. If you are not planning a pregnancy, ask your doctor about other methods of contraception. If you want to become pregnant, stop taking Yarina Plus and wait until your menstrual bleeding occurs naturally before trying to become pregnant. This will help you calculate your baby's expected due date.

Taking missed pills

If the delay in taking the next pill is less than 12 hours, the contraceptive effect of Yarina Plus is maintained. Take the pill as soon as you remember. Take the next tablet at your usual time. If the delay in taking the pills is more than 12 hours, contraceptive protection may be reduced. The more pills in a row are missed, and the closer this missed dose is to the start or end of the dose, the higher the risk of pregnancy. In this case, you can be guided by the following rules:

More than one tablet from the package was forgotten
Consult your doctor.

One tablet missed in the first week of taking the drug
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). Take the next tablet at your usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before missing the pill, the possibility of pregnancy must be taken into account. Consult your doctor immediately (see also Regimen for taking missed pills).

One tablet was missed in the second week of taking the drug
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). Take the next tablet at your usual time. If you have taken your pills correctly during the 7 days preceding the first missed pill, the contraceptive effect of Yarina Plus is maintained and you do not need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception for 7 days.

One tablet was missed in the third week of taking the drug
If all tablets have been taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods. You can follow either of the following two options without the need for additional contraceptive measures.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). Take the next tablet at your usual time. Start the next pack immediately after finishing the current pack, so there is no break between packs. Withdrawal bleeding is unlikely until the second pack of tablets is gone, but spotting or breakthrough bleeding may occur on the days you take the drug.
2. Stop taking the pills in your current pack, take a break of 7 days or less (including the day you missed the pills), and then start a new pack. Using this regimen, you can always start taking the next pack on the day of the week when you usually do it. If after a break in taking the pills there is no expected menstrual bleeding, you may be pregnant. Consult your doctor before starting a new pack.

In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 4 hours after taking an active tablet, the recommendations regarding missed tablets apply, which are listed in the section “Taking missed tablets.” If you do not want to change your usual dosing regimen, you will need to take additional tablet(s) from a different package.

Delay in the onset of menstrual bleeding

You can delay the onset of menstrual bleeding if you start taking the next package of Yarina Plus immediately after finishing the current package. You can continue taking the tablets from this pack for as long as you wish or until the pack runs out. If you want menstrual-like bleeding to begin, stop taking the pills. While taking Yarina from the second package, spotting or bleeding may occur on the days of taking the pills. Start the next pack after the usual 7-day break.

Changing the day of the onset of menstrual bleeding

If you take the tablets as recommended, you will have menstrual bleeding on about the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the period of time you are free from taking pills. For example, if your cycle usually starts on Friday, but in the future you want it to start on Tuesday (3 days earlier), the next pack should start 3 days earlier than usual. If your pill-free break is very short (for example, 3 days or less), menstrual-like bleeding may not occur during the break. In this case, bleeding or spotting may occur while taking the tablets from the next package.

Side effect

When taking the drug Yarina Plus, like any other medicines, adverse reactions may occur, although their occurrence is not necessary in all patients. See sections "With caution" and "Special instructions". Please read these sections carefully and if you experience any adverse reactions, including serious ones, consult your doctor.

Below is the frequency of adverse reactions reported during clinical trials of Yarina. These adverse reactions can also be attributed to the drug Yarina Plus.

Frequent adverse reactions (more than 1/100 and less than 1/10):

• depressed mood
• headache
• migraine
• nausea
• pain in the mammary glands
• vaginal candidiasis
• cycle disorder
• acyclic bleeding

Uncommon adverse reactions (more than 1/1000 and less than 1/100):

• change in body weight
• fluid retention
• libido change
• increased blood pressure (BP)
• decrease in blood pressure
• vomit
• eczema
• vaginitis

Rare adverse reactions (more than 1/10000 and less than 1/1000):

• hypoacusis
• thromboembolism
• bronchial asthma
• discharge from the mammary glands

Adverse reactions that were reported during use of Yarina Plus, but the frequency of which could not be assessed: hypersensitivity reaction, mood swings, contact lens intolerance, abdominal pain, diarrhea, rash, urticaria, erythema nodosum, erythema multiforme, breast enlargement iron

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema. If any of the side effects become serious or if you notice any side effects not listed in the instructions, please tell your doctor.

Contraindications for use

Yarina Plus is contraindicated in the presence of any of the conditions/diseases listed below. If any of these conditions/diseases develop for the first time while taking the drug, the drug should be discontinued immediately.

• Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
• Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.
• The presence of multiple or severe risk factors for venous or arterial thrombosis.
• Migraine with focal neurological symptoms currently or in history.
• Diabetes mellitus with vascular complications.
• Liver failure and severe liver diseases (until liver tests normalize).
• Severe and/or acute renal failure.
• Liver tumors (benign or malignant) currently or in history.
• Identified hormone-dependent malignant neoplasms (including genital organs or mammary glands) or suspicion of them.
• Bleeding from the vagina of unknown origin.
• Pregnancy or suspicion of it.
• Breastfeeding period.
• Hypersensitivity or intolerance to any of the components of the drug Yarina Plus.
• Yarina Plus contains lactose and is therefore contraindicated in patients with rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully

The potential risk and expected benefit of using the drug Yarina Plus should be assessed in each individual case in the presence of the following diseases/conditions and risk factors:

• Risk factors for the development of thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in someone close to relatives);
• Other diseases in which peripheral circulatory disorders may occur: diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of the superficial veins;
• Hereditary angioedema;
• Hypertriglyceridemia;
• Liver diseases that are not contraindications (see “Contraindications”);
• Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice and/or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, pregnancy herpes, Sydenham's chorea);
• Postpartum period.

Use of the drug Yarina during pregnancy and breastfeeding

The drug is contraindicated during pregnancy. If pregnancy is detected while taking Yarina Plus, the drug should be discontinued immediately. Data on the results of taking the drug Yarina Plus during pregnancy are limited and do not allow us to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and newborn child. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took COCs before pregnancy or teratogenic effects in cases of inadvertent use of COCs in early pregnancy. Specific epidemiological studies have not been conducted on the drug Yarina Plus.

The drug is contraindicated during breastfeeding. Taking COCs can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. Small amounts of sex hormones and/or their metabolites may be excreted in milk, but there is no evidence of their negative effects on the health of the child.

Use for liver and kidney dysfunctions

• The use of the drug is contraindicated in the presence or history of severe forms of liver disease (until the liver test results are normalized), the current presence or history of benign or malignant liver tumors;
• The drug is contraindicated for use in women with severe renal impairment and acute renal failure.

special instructions

If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of using Yarina Plus should be carefully weighed in each individual case and discussed with the woman before she decides to start taking this drug. drug.

For disorders of the cardiovascular system

There is epidemiological evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) when taking COCs. These diseases are rarely observed. The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. An increased risk is present after initial use of combined oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients suggest that this increased risk is predominantly present during the first 3 months.

Overall risk of VTE in patients taking low-dose combined oral contraceptives (Data from a large prospective study of 3 patient groups shows that in women with or without risk factors for VTE using ethinyl estradiol/drospirenone containing contraceptives at a dosage of 0.03 mg/3 mg, respectively , the incidence of VTE is the same as with the use of levonorgestrel-containing oral contraceptives.VTE can be fatal (in 1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any combined oral contraceptives.

It is extremely rare that when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.

Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing up or when walking, localized warmth in the affected leg, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism (PE) include: difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more or less severe events (eg, respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of feeling in the face, arm or leg, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, acute abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or chest; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.

Arterial thromboembolism can be fatal.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases in the presence of:

• obesity (body mass index more than 30 kg/m2);
• family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Yarina Plus;
• prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using the drug Yarina Plus (in the case of a planned operation, at least four weeks before it) and not resume taking it for two weeks after the end of immobilization;
• dyslipoproteinemia;
• arterial hypertension;
• migraine;
• heart valve diseases;
• atrial fibrillation;
• with age;
• in smokers (with increasing number of cigarettes or increasing age, the risk increases, especially in women over 35 years of age);

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

The increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraines during use of Yarina Plus (which may precede cerebrovascular events) may be grounds for immediate discontinuation of this drug.

Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives ( Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with taking COCs has not been proven. The possibility of the relationship of these data with screening for cervical diseases and with characteristics of sexual behavior (less frequent use of barrier methods of contraception) is discussed. A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24).

The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in current or recent COC users is small relative to the overall risk of breast cancer. Its connection with COC use has not been proven. The observed increased risk may be a consequence of careful monitoring and earlier diagnosis of breast cancer in women using COCs. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.

In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors was observed, which in some patients led to life-threatening intra-abdominal bleeding. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis

Other states

Clinical studies have shown no effect of drospirenone on plasma potassium concentrations in patients with mild to moderate renal failure. However, in patients with impaired renal function and an initial potassium concentration at the upper limit of normal, the risk of developing hyperkalemia cannot be excluded while taking medications that lead to potassium retention in the body.

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking COCs. Although slight increases in blood pressure have been described in many women taking COCs, clinically significant increases have rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking Yarina Plus, this drug should be discontinued and treatment of arterial hypertension should be started. The drug can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Acute or chronic liver dysfunction may require discontinuation of Yarina Plus until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of the drug Yarina Plus.

Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using Yarina Plus. However, women with diabetes should be closely monitored while taking this drug.

Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma while taking Yarina Plus should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Folates may mask vitamin B12 deficiency.

Laboratory tests

Taking Yarina Plus may affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal function, the concentration of transport proteins in plasma, indicators of carbohydrate metabolism, parameters of blood coagulation and fibrinolysis. Changes usually do not go beyond normal values. Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.

There is a theoretical possibility of increasing the concentration of potassium in the blood plasma in women receiving Yarina Plus simultaneously with other drugs that can increase the content of potassium in the blood plasma. These drugs include angiotensin II receptor antagonists, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with angiotensin-converting enzyme (ACE) inhibitors or indomethacin, there was no significant difference in plasma potassium concentrations compared with placebo.

Reduced efficiency

The effectiveness of Yarina Plus may be reduced in the following cases: if tablets are missed, with vomiting and diarrhea, or as a result of drug interactions.

Frequency and severity of menstrual-like bleeding

While taking the drug Yarina Plus, during the first few months, irregular (acyclic) bleeding from the vagina (spotting or “breakthrough” uterine bleeding) may be observed. Use hygiene products and continue taking your pills as usual. Irregular bleeding usually stops as your body adapts to the drug (usually after 3 cycles of taking the tablets). If they continue, increase in intensity, or return after stopping, consult a doctor.

No regular menstrual bleeding

If you took all the pills correctly and did not vomit while taking the pills or taking other medications at the same time, then the likelihood of pregnancy is low. Continue taking Yarina Plus as usual. If there are no 2 menstrual bleeding in a row, consult a doctor immediately. Do not start taking the next package until your doctor rules out pregnancy.

When to consult a doctor

Regular checkups

If you are taking Yarina Plus, your doctor will tell you about the need for regular examinations, at least once every 6 months.

Consult your doctor as soon as possible

• If there are any changes in your health, especially any of the conditions listed in these instructions (see also “Contraindications” and “Use with caution”);
• With local compaction in the mammary gland;
• If you are going to use other medications (see also “Interactions with other medications”);
• If prolonged immobility is expected (for example, the leg is in a cast), hospitalization or surgery is planned (consult with your doctor at least 3-4 weeks before the proposed surgery);
• If you experience unusually heavy bleeding from the vagina;
• If you forgot to take a pill in the first week of taking the pack and had sexual intercourse seven days or less before;
• You have not had regular menstrual bleeding twice in a row or you suspect that you are pregnant (do not start taking the next package until you have consulted your doctor).

Stop taking the tablets and consult your doctor immediately if you notice possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe leg pain or sudden swelling of either leg.

Yarina Plus does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Impact on the ability to drive vehicles and machinery

There have been no reported cases of adverse effects of the drug Yarina Plus on the speed of psychomotor reactions; No studies have been conducted to study the effect of the drug on the speed of psychomotor reactions.

Overdose

There have been no reported cases of overdose of Yarina Plus. Symptoms that may occur in case of overdose: nausea, vomiting, spotting vaginal discharge or metrorrhagia (more often in young women). There is no specific antidote; symptomatic treatment should be carried out.

Calcium levomefolate and its metabolites are identical to folates found in food products, the daily consumption of which does not harm the body. Taking levomefolate calcium at a dose of 17 mg/day (a dose 37 times higher than that contained in 1 tablet of Yarina Plus) for 12 weeks was well tolerated.

Drug interactions

Interaction of oral contraceptives with other drugs may lead to breakthrough uterine bleeding and/or decreased contraceptive reliability.

Interactions leading to a decrease in the effectiveness of the drug Yarina Plus

Effect on hepatic metabolism: the use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort. HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.

Effect on enterohepatic recirculation: According to individual studies, some antibiotics (for example, penicillins and tetracyclines) may reduce the enterohepatic recirculation of estrogens, thereby reducing the concentration of ethinyl estradiol.

While taking medications that affect liver microsomal enzymes, and for 28 days after their discontinuation, a barrier method of contraception should be additionally used.

While taking antibiotics (except for rifampicin and griseofulvin) and for 7 days after their discontinuation, a barrier method of contraception should be additionally used. If the period of use of the barrier method of contraception ends later than the hormone-containing orange tablets in the package, you should skip taking the remaining auxiliary light orange tablets and start taking Yarina Plus from a new package without interruption in taking the tablets.

Interactions that reduce the effectiveness of calcium levomefolate

Effect on folate metabolism: Some drugs reduce blood folate concentrations or reduce the effectiveness of levomefolate calcium by inhibiting the enzyme dihydrofolate reductase (eg, methotrexate, trimethoprim, sulfasalazine, and triamterene) or by reducing folate absorption (eg, cholestyramine) or through unknown mechanisms ( for example, antiepileptic drugs: carbamazepine, phenytoin, phenobarbital, primidone and valproic acid).

Effect on metabolism of COCs (enzyme inhibitors)

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.

Effect of COCs or calcium levomefolate on the activity of other drugs

COCs may affect the metabolism of other drugs, leading to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their plasma and tissue concentrations.

Based on interaction studies, as well as studies in female volunteers taking omeprazole, simvastatin and midazolam as test substrates, it can be concluded that the effect of drospirenone 3 mg on the metabolism of other drugs is unlikely.

Folates may alter the pharmacokinetics or pharmacodynamics of some drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, which may be accompanied by a decrease (mostly reversible, provided the dose of the drug affecting folate metabolism is increased) of their therapeutic effect. The administration of folate during treatment with such drugs is recommended mainly to reduce the toxicity of the latter.

Yarina is a monophasic oral contraceptive. This means that all tablets in the package contain the same dose of hormones. One tablet of Yarina contains 30 mcg (0.03 mg) of ethinyl estradiol and 3 mg of Drospirenone.

One package contains one blister (plate) of Yarina for use for one month.

ATTENTION: The drug has contraindications. Do not start using this drug without first consulting your doctor.

Analogs

Preparations Midiana and Yarina Plus contain the same dose of hormones as Yarina.

Advantages of Yarina

Oral contraceptives (OC) Yarina have an antiandrogenic effect. This means that they block the action of male sex hormones (androgens) in a woman’s body. It is known that androgens are a common cause of oily facial skin and acne. Therefore, Yarina can have a cosmetic effect - eliminate or at least weaken acne (blackheads).

In addition, Yarina helps relieve pain during menstruation, as well as reduce the manifestations of premenstrual syndrome (PMS). Yarin tablets do not retain water in the body, so taking them does not increase a woman’s weight.

Yarina can be used as a treatment for endometriosis, adenomyosis, uterine fibroids, polycystic ovary syndrome and some other gynecological diseases.

Rules for receiving Yarina

• If you are taking Yarina for the first time: the first tablet should be taken on the first day of menstruation (this day is considered the first day of the menstrual cycle). Your period may stop when you start taking the pills due to the effects of hormones. It's not scary.
• You can start taking the pills on the 3-5th day of your period, but in this case you need to use additional contraception (for example, a condom) for another week after starting to take the pills.
• It is advisable to take the tablets at approximately the same hour every day.
• It is recommended to take the tablets in the order indicated on the blister. But, if you mixed something up and started taking the tablets out of order, then nothing bad will happen, since all Yarin tablets contain the same dose of hormones.
• After finishing the blister (when you have finished 21 tablets), you should take a 7-day break, during which you do not need to take tablets. During the 7-day break, you may begin to menstruate.
• Taking the first tablet from the next blister should be started on the 8th day after a 7-day break, regardless of menstruation (even if it has not yet begun or has not yet ended).

Do I need to use protection during the 7-day break?

During the week-long break between packs, there is no need to use additional contraceptives, since the contraceptive effect remains at a high level.

But this is only true for those cases when the woman took the pills from the previous package without skipping and according to the rules. If you missed one or more tablets in the third week of taking Yarina, or if the effect of the tablets could be reduced for another reason (vomiting, diarrhea, taking medications, etc.), then it is recommended not to take a 7-day break at all.

How to switch to Yarina from other birth control pills?

If you have been taking other birth control pills and now want to switch to Yarina, follow these rules:

• If the blister of previous birth control pills contained 28 tablets, then taking the first Yarin tablet should be started the day after the end of 28 tablets of the previous OC.
• If the package of previous OCs contained 21 tablets, then taking the first Yarin tablet can be started the day after the blister of previous birth control pills ends, or on the 8th day after a seven-day break.

How to switch to OK Yarina from a vaginal ring or hormonal patch?

The first Yarin tablet should be taken on the day when you remove the vaginal ring or remove the hormonal patch, or on the day when you need to attach a new patch, or put the vaginal ring back on.

How to switch to Yarin from an intrauterine device (IUD)?

When switching to Yarina birth control pills from an intrauterine device, take the first pill on the day the device is removed. For 7 days after starting to take Yarin, use additional contraception (for example, condoms).

How to start taking Yarin after an abortion?

If the pregnancy was terminated at less than 12 weeks, the first Yarin tablet can be taken on the day of the abortion.

If you are more than 12 weeks pregnant, then you can start taking Yarina 21-28 days after the abortion. To avoid unwanted pregnancy, in this case, use a condom for another week after you start taking birth control pills. If you had unprotected sexual intercourse before starting to take OK, then you should not take Yarina until you are sure that you are not pregnant.

How to start taking Yarina after childbirth?

You can start taking Yarina 21 or 28 days after birth. If you start taking the pills later, you need to take additional protection for another 7 days. If you had unprotected sex before starting to take birth control pills, you can start taking the pills only after you have ruled out a possible pregnancy.

Can I take Yarina if I am breastfeeding?

What should I do if I missed Yarina’s pill?

If the delay in taking the Yarin tablet is less than 12 hours (that is, less than 36 hours have passed since taking the last tablet), then the contraceptive effect of the tablets is not reduced. Take the missed pill as soon as you remember. In this case, there is no need to take additional protection.

If the delay in taking the dose was more than 12 hours, then look at which tablet was missed:

• From 1 to 7 tablets: you need to take the missed tablet as soon as you remember, even if this means taking 2 tablets at the same time. Use additional contraception (such as a condom) for the next 7 days.
• From 8 to 14 tablets: you need to take the missed tablet as soon as you remember, even if this means taking 2 tablets at the same time. If you took the pills according to the rules for the previous 7 days (before skipping), you don’t have to use additional contraception. In any other case, it is recommended to take additional protection for another week after release.
• From 15 to 21 tablets: take the missed Yarina tablet as soon as you remember, even if this means taking 2 tablets at the same time. After this, continue taking the tablets as usual, and after finishing the blister, immediately start the next blister (without taking a 7-day break). If you took all your pills on time for the previous 7 days before missing the pill, then there is no need for additional contraception. Otherwise, use protection for another 7 days after missing it.

What should I do if I missed several Yarina tablets?

If you missed 2 Yarina tablets in a row, pay attention to which tablets you missed. If these are tablets of the first or second week of taking (from 1 to 14), then take 2 tablets as soon as you remember about the omission and 2 more tablets the next day. Then take one tablet per day as usual until the pack runs out. Use additional contraception for another 7 days after resuming taking the pills.

If you missed two tablets in a row in the 3rd week of taking it (from 15 to 21), then there are two options: 1. continue taking Yarina, one tablet per day until the package runs out and then, without taking a 7-day break, start new packaging. At the same time, use additional contraception for another 7 days after the missed period. 2. throw away the current (unfinished) package and start taking a new package with the first tablet (one tablet per day, as usual). In this case, you need to use additional contraception for another 7 days after the missed date.

If you miss 3 Yarina tablets in a row, throw away the current pack of tablets and start a new pack with the first tablet. Use additional contraception for another 7 days. You will have an increased risk of pregnancy, so if your period does not come during the next break, contact your gynecologist.

If you are not sure what to do in your situation, use additional contraception until you talk to your doctor. In any case, if you miss two or more tablets, be sure to use additional protection (using condoms) for at least 7 days.

1-2 days after missing the pills, you may experience spotting or breakthrough bleeding, similar to your period. This is not dangerous and is associated with Yarina’s passes. Continue taking the pills according to the instructions and the discharge will stop.

Bloody discharge when taking Yarina

Some women experience spotting brown discharge while taking Yarina. Such discharge is normal if you started taking Yarina several months ago, if the discharge appears in the middle of the package or continues for several days after the end of menstrual-like bleeding.

However, in some situations, spotting may indicate a decrease in the effect of Yarina and even some diseases. You can read more about this in the article: About spotting while taking OK.

What reduces the contraceptive effect of Yarina?

The contraceptive effect of Yarina can be reduced by vomiting, diarrhea, taking large doses of alcohol, or taking certain medications. Read more about this here:

How to delay menstruation with the help of Yarin?

If you need to delay your period, then after finishing one package of Yarin, start a new blister the next day without taking a 7-day break. In this case, menstruation will be delayed by 2-4 weeks, but slight spotting may appear approximately in the middle of the next package.

Please note: you can postpone your period only if you took Yarin at least one month before unwanted menstruation.

Do I need to take long breaks from taking Yarina?

If you have been taking Yarina for more than 6-12 months, you may be wondering if you should take a break for a few months. You can read about how useful such breaks are by following the link: Is it necessary to take long breaks from taking birth control pills?

What to do if you don’t have your period during a 7-day break from taking Yarin?

Carefully remember whether you took all the pills correctly last month.

If you followed the basic rules for taking Yarin tablets, did not skip or were more than 12 hours late in taking them, then do not worry. After completing the 7-day break, you can start taking a new blister. If you don’t have your period during the next 7-day break, then contact your gynecologist to rule out a possible pregnancy. For other possible reasons for a delay, read the article 10 reasons for a delay in menstruation.

If in the past month you had errors in taking pills (missing, being late), then stop taking Yarina pills until you are sure that you are not pregnant.

What should I do if I become pregnant while taking Yarina?

Pregnancy when taking Yarin tablets correctly is extremely rare. It is more likely that pregnancy occurred as a result of mistakes that you made in the previous month.

So, what to do if the test unexpectedly shows 2 stripes? First of all, stop taking the pills and contact your gynecologist.

Taking Yarina in the early stages of pregnancy cannot harm the health of your unborn child, so you can leave the pregnancy without fear. In this case, start taking folic acid as soon as possible.

Yarina's appointment before surgery

If you are undergoing a planned operation, then taking Yarin tablets should be stopped a month (4 weeks) before surgery. This will reduce the risk of blood clots in the vessels. If the operation is required urgently, be sure to tell the surgeon that you are taking birth control pills. In this case, the doctor will take additional measures to prevent blood clots (with the help of medications).

You will be able to start taking Yarin 2 weeks after you are able to walk independently after surgery.

How often should you visit a gynecologist while taking Yarin?

Even if nothing bothers you, you need to visit a gynecologist for preventative care at least once a year.

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• Применяется как лечебное SЃСЂРµРґСЃС‚РІРѕ РїСЂРё R°РґРµРЅРѕРјРёРѕР·Рµ .

RљР°Рє принмать РЇСЂРёРЅСѓ?

Рсли предстоит прием РЇСЂРёРЅС‹ впервые, то первую S‚аблетку начинают принимать СЃ первого РґРЅСЏ нач ала менструации. Можно начать прием таблеток РґРѕ 5-РіРѕ РґРЅСЏ RјРµРЅСЃС‚руальРSРѕРіРѕ С†Рекла, РЅРѕ тогда необ S…РѕРґРёРјРѕ РІ теченое RїРѕСЃР»РµРґСѓСЋС‰РµР№ недели дополнительнРѕ предохраняться барьерной контрацепцией. Таблетки обязательно принимать RµР¶РµРґРЅРµРІРЅРѕ РІ РѕРґРЅРѕ Рё С‚ Рѕ же время SЃСѓС‚РѕРє. RR»РёС‚ельность приема 21 день, затем делается 7-РґРЅРµРІРЅС ‹Р№ перерыв Рё РЅР° 8-Рµ сутки РЅР° S‡РёРЅР°СЋС‚ прием РЅРѕРІРѕР№ конвалюты. R' SЌS‚РѕС‚ 7-дневный период RїСЂРѕР№РґРµС‚ RјРµРЅСЃС‚руация. Прием РЅРѕРІРѕР№ конвалюты необходимо RїСЂРёРЅРёРјР°С‚СЊ строгРѕ СЃ 8 РґРЅСЏ после 7-дневного перерыва, даже если RјРµРЅСЃС‚СЂСѓ R° S†РёСЏ ещС' РЅРµ закончРелась.

Рсть ли необходимость РІ контрацепции РІРѕ время 7-РґРЅРµ RІРЅРѕРіРѕ перерыва?

Противозачаточный эффект препарата распростр аняется Рё РЅР° 7-дневный перерыв, поэтому дополнительная RєРѕРЅС‚рацепция РІ SЌS‚РѕС‚ период РЅРµ нужна. RћРґРЅР°РєРѕ данное SѓS‚верждение SЃРїСЂР°РІРµРґР»РёРІРѕ S‚олько РІ тРѕРј случае, если предыдущая SѓРїР°РєРѕРІРєР° принималась без погрешностей. Рсли была пропущена 1 Рели более S‚аблеток, была рвота РёР »Рё диарея, то перерыв делать РЅРµ нужно, нужно просто R Sачать прием РЅРѕРІРѕР№ конвалюты .

Переход СЃ РґСЂСѓРіРіРє… РїСЂРѕС‚Ревозачаточных таблеток

РџСЂРё переходе СЃ РґСЂСѓРіРѕРіРѕ РІРІРґР° противозачаточных таб леток РЅР° РљРћРљ РЇСЂРеРЅР° необходмо придерживаться следующих правил:

• Рсли РІС‹ РїСЂРенимали противозачаточные S‚аблетки, РіРґРµ Р±С ‹Р»Рѕ 28 С ‚аблеток, то РІ этом SЃР»СѓС‡Р°Рµ РЇСЂРеРЅСѓ надо начинать РїСЂРёРЅР емать, РЅРµ делая перерыв, то есть сразу RїРѕСЃР»Рµ 28 таблетки.
• Рсли Сѓ предыдущего препарата была 21 таблетка РІ конваР"юте, С‚ Рѕ нужно начать прием РЇСЂРёРЅС‹ после 7-дневного РїРµСЂРµСЂС ‹РІР°.

Переход Рє РчСЂРеРЅР° после примененнвагонального РєРѕР»СЊС †Р° или пластыря

Начало РїСЂРеема РЇСЂРёРЅР° совпадает СЃ днем удаления кольца или снятия пластыря.

Переход к Ярина с ВМС

Первая таблетка РЇСЂРёРЅР° совпадает СЃ удалением Р’РњРЎ. РџСЂРё этом РІ первые 7 дней необходРеРјР° дополнительная Рє онтрацепция.

Прием Ярина после аборта

Начало приема РЇСЂРёРЅР° совпадает СЃ днем аборта. Р' случае, если СЃСЂРѕРє беременности был более 12 недель, тРѕ использование РїСЂРµРїР°СЂР°С ‚Р° можно начать S‡РµСЂРµР· 3-4 недели после аборта.

RџСЂРёРјРµРЅРµРЅРёРµ RЇСЂРёРЅС‹ RїРѕСЃР»Рµ SЂРѕРґРѕРІ

RџСЂРёРµРј RїСЂРµРїР°СЂР°С‚Р° RїРѕСЃР»Рµ SЂРѕРґРѕРІ RјРѕР¶РЅРѕ RЅР°С‡Р°С‚СЊ S‡РµСЂРµР· 21-28 R ґРЅРµР№, если РІС‹ РЅРµ кормите РіСЂСѓРґСЊСЋ. Рсли прием РЇСЂРеРЅС‹ начат позже 28 дней, то необходима РґРѕРїР ѕР»РЅРёС‚ельная барьерная РєРѕРЅС ‚рацепция РІ течение 1 недели. RќР°С‡РёРЅР°С‚СЊ RїСЂРеем RЇСЂРёРЅС‹ RјРѕР¶РЅРѕ S‚олько RІ S‚РѕРј SЃР»СѓС‡Р°Рµ, РєРѕР іРґР° женщина уверена РІ РЕтсутствии беременности. R”R”SЏ RєRѕSЂRјSЏS‰РёС… R¶РµРЅС‰РёРЅ RљРћРљ RSRµ RїРѕРґС…РѕРґСЏС‚ РІ RєР°С‡РµСЃС‚РІРµ RєРѕРЅ S‚рацепцРеРё, так RєР°Рє SЌSЃS‚рогены ... R”R”SЏ RєRѕSЂRјSЏS‰РёС… существуют S‡РёСЃС‚опрогестиновые RїS ЂРµРїР°СЂР°С‚С‹.

Что предпринять в случае пропуска Ярины?

КонтрацептРевный эффект препарата РЅРµ SЃРЅРёР¶Р°РµС‚СЃСЏ если произошла задержка РІ приеме препарата РЅРµ более 12 часов. Нужно выпить пропущенную S‚аблетку. RћS‡РµСЂРµРґРЅСѓСЋ S‚аблетку выпить RїРѕ RїР»Р°РЅСѓ. R' данном SЃР»СѓС‡Р°Рµ дополнолнительная RєРѕРЅС‚рацепция РЅРµ РЅСѓ жна. Рсли РїСЂРѕРїСѓСЃРє составил более 12 часов, то дальнейшая так S‚РёРєР° Р·Р°РІРІРёСЃРёС ‚ РѕС‚ того какая РѕјРµРЅРЅРѕ S‚аблетка РїРѕ счету была РїСЂРѕРїСѓ щена. Рсли это СЃ 1 РїРѕ 7 таблетки, то нужно выпить S‚аблетку, РєР° Rє S ‚олько вспомнили Рѕ РїСЂРѕРїСѓСЃРєРµ Рё далее RїРѕ RѕР±С‹С‡РЅРѕР№ схемРµ. R' SЌS‚РѕРј SЃР»СѓС‡Р°Рµ необходима дополнительная контрацепция 7 дней. Рсли это СЃ 8 РїРѕ 14 таблетки, схема действий как РІ предыдуS ‰РµРј случае, РЅРѕ РІ дополнительной контрацепцРеРё нет необходимос S‚Рё, если РґРѕ этого РЅРµ было RїСЂРѕРїСѓСЃРєРѕРІ РІ приеме. R' RїSЂRѕS‚РёРІРЅРѕРј SЃР»СѓС‡Р°Рµ нужна дополнительная RєРѕРЅС‚раце пция 7 дней. Рсли это СЃ 15 РїРѕ 21 таблетки, то нужно выпить РїСЂРѕїСѓС‰РµРЅР ЅСѓСЋ таблетку, РєР °Рє только вспомнило РїСЂРѕРїСѓСЃРєРµ, далее RїРѕ обычной схеРјРµ, РїРѕ окончании конвалюты нужно РЅР° S‡Р°С‚СЊ РЅРѕРІСѓСЋ без 7-дневного перерыва. R SЃР»Рё РґРѕ этого РїСЂРѕРїСѓСЃРєР° РІ S‚ечение 7 дней погрешности R I S…одимости РІ дополнительной контрацепцРеРё, РІ протиРІРЅРѕРј случае – 7 дней пспользовать през ерватив.

R SЃР»Рё пропущено несколько S‚аблеток

R SЃР»Рё пропущено 2 таблетки RїРѕРґСЂСЏРґ, S‚Рѕ нужно RїРѕСЃС‚СѓРїРёS ‚СЊ следующим образом: Рсли СЌС ‚Рѕ СЃ 1 РїРѕ 14 РґРЅРё, то нужно принять 2 таблетки Рё ещС' 2 С‚Р°Р±Р»РµС ‚РєРё РЅР° СЃР» едующий день. ДаДее РїРѕ обычной схеме. РџСЂРё этом нужно Пспользовать 7 дней барьерную контрацепцию. Рсли РїСЂРѕРїСѓСЃРє выпал РЅР° 15-21 РґРЅРё, то есть 2 варРеанта: 1) РґРѕРїРёС ‚СЊ РЇСЂРёРЅСѓ РґРѕ конца РїРѕ 1 таблетке 1 раз РІ день Рё, РЅРµ делая 7-дневный перерыв‡, РЅР°С‡Р°С ‚СЊ РЅРѕРІСѓСЋ упаковку, испольР·СѓСЏ дополнительную контрацепцию 7 дней; 2). обычРСРѕР№ СЃС… еме, предохраняясь дополнительно. R SЃР»Рё пропущено 3 таблетки, начните RЅРѕРІСѓСЋ SѓRїR°РєРѕРІРєСѓ RїР * обычной схеме, используя 7 дней барьерную RєРѕРЅС‚рацепцию. После РїСЂРѕРїСѓСЃРєР° таблеток через 1-2 РґРЅСЏ РјРѕРіСѓС‚ РїРѕСЏРІРёС‚С ЊСЃСЏ мажущие выделения. RS‚Рѕ нормально Рё РЅРµ опасно.

Что может снизить эффективность Ярины?

• R'ольшРеРµ РґРѕР·С‹ алкоголя
• Диарея
• Рвота
• Прием некоторых лекарственных препаратов

RљР°Рє отсрочить RјРµРЅСЃС‚руацию СЃ RїRѕRјРѕС‰СЊСЋ РљРјРёРЅС‹?

Начните РїСЂРеем очередного блистера без 7-дневного ерерыва. Отсрочить менструацию СЃ RїРѕРјРѕС‰СЊСЋ приема РґР°РхРЅРѕРѕРѕ R їСЂРµРїР°СЂР°С‚Р° можно S‚олько І случае, есл Рё РІС‹ принимали РЇСЂРёРЅСѓ РІ предыдущем S†РёРєР»Рµ.

R'еременность на фоне Ярины

РЇСЂРёРЅР° – это препарат СЃ высокой эффективностью, РѕРґР ЅР°РєРѕ беременность РІСЃРµ же RјРѕР¶РµС‚ наступить РїСЂРё погрешностях РІ прмменении. R SЃР»Рё беременность наступила, следует RїСЂРµРєСЂР°С‚ить RїS ЂРёРµРј таблеток. R”оказаРСРѕ, что препарат РЅРµ RѕРєР°Р·С‹РІР°РµС‚ негативного РІР” РЅСЏРЅРёРµ РЅР° плод Рё S‚еч ение беременности, RїРѕСЌС‚РѕРјСѓ RїСЂРё R¶РµР»Р°РЅРёРё RјРѕР¶РЅРѕ сохранять беременность.

R SЃР»Рё предстоит RїR»Р°РЅРѕРІРѕРµ RѕРїРµСЂР°С‚РёРІРЅРѕРµ R»РµС‡РµРЅРёРµ

R SЃР»Рё предстоит RїR»Р°РЅРѕРІРѕРµ RѕРїРµСЂР°С‚РёРІРЅРѕРµ R»РµС‡РµРЅРёРµ, СЃР»РµРґС ѓРµС‚ прекратить прием РЇСЂРёРЅС‹ Р·Р° 4 недели РґРѕ РѕРїРµСЂР°С †RyoRyo. RS‚Рѕ нужно для снижения СЂРёСЃРєР° осложнений РІ РІРІрґРµ тромбРѕР·Р° СЃРѕСЃСѓРґРѕРІ. R' SЃР»СѓС‡Р°Рµ SЃСЂРѕС‡РЅРѕР№ операцРеРё необС...РѕРґРјРјРѕ RїСЂРµРґСѓРїСЂРµРґРёС‚С Њ S…РёСЂСѓСЂРіР° Рѕ приеме RљРћРљ.

Частота посещения гнеколога при приеме Ярины

Посещать гонеколога необходммо 1 раз РІ РіРѕРґ, даже если Р Sет РЅРекаких жалоб.

www.ginekologspb.ru

Yarina: instructions for use

Each Yarina tablet contains: □ Active substances Ethinyl estradiol 0.03 mg Drospirenone 3 mg □ Excipients Lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25, magnesium stearate, hypromellose (hydroxypropyl methylcellulose), macrogol 6000, talc (magnesium hydrosilicate), titanium dioxide (E 171), iron (II) oxide (E 172).

The tablets are film-coated, round, biconvex, light yellow in color, with a hexagon engraved on one side with the letters “DO” inside.

pharmachologic effect

Yarina is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

Yarina's contraceptive effect is carried out through complementary mechanisms, the most important of which include suppression of ovulation and changes in the properties of cervical secretion, as a result of which it becomes impenetrable to sperm.

When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

In women taking combined oral contraceptives, the cycle becomes more regular, painful menstrual-like bleeding is less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduced risk of endometrial and ovarian cancer.

Drospirenone contained in Yarin has an antimineralocorticoid effect and is able to prevent weight gain and the appearance of other symptoms (for example, edema) associated with estrogen-dependent fluid retention.

Drospirenone also has antiandrogenic activity and helps reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to the effect of natural progesterone produced by the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea.

Indications for use

Contraception (prevention of unwanted pregnancy).

Contraindications

Yarina should not be used if you have any of the conditions/diseases listed below.

Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.

Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.

Hereditary or acquired predispositions to venous or arterial thrombosis, such as APC resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Migraine with focal neurological symptoms, current or history

Diabetes mellitus with vascular complications.

Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.

Pancreatitis with severe hypertriglyceridemia, currently or in history.

Liver failure and severe liver disease (until liver tests normalize)

Liver tumors (benign or malignant) currently or in history.

Severe and/or acute renal failure.

Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.

Bleeding from the vagina of unknown origin.

Pregnancy or suspicion of it.

Breastfeeding period.

Hypersensitivity to any of the components of the drug Yarina

If any of these conditions appear for the first time while taking Yarina, stop taking this drug immediately and consult your doctor. In the meantime, use non-hormonal birth control. See also “Special Instructions”.

Pregnancy and lactation

Yarina should not be used during pregnancy and breastfeeding. If pregnancy is detected while taking Yarina, the drug should be discontinued immediately and consult a doctor. However, extensive epidemiological studies have not found an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or when taking sex hormones inadvertently in early pregnancy.

Taking combined oral contraceptives may reduce the amount of breast milk and change its composition, so their use is not recommended until you stop breastfeeding.

Directions for use and doses

The calendar pack contains 21 tablets. In the package, each tablet is marked with the day of the week on which it should be taken. Take the tablets orally at the same time every day with a small amount of water. Follow the direction of the arrow until all 21 tablets have been taken. You do not take the drug for the next 7 days. Menstruation (withdrawal bleeding) should begin within these 7 days. It usually starts 2-3 days after taking the last pill.

Yarina. After a 7-day break, start taking the next tablets from the pack, even if the bleeding has not stopped yet. This means that you will always start a new pack of pills on the same day of the week, and that your withdrawal bleed will occur on approximately the same day of the week each month.

Taking pills from Yarina’s first package

When no hormonal contraceptive was used in the previous month

Start taking Yarina on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the pill that is marked with the appropriate day of the week. Then take the pills in order. You can also start taking it on days 2-5 of the menstrual cycle, but in this case you must use an additional barrier method of contraception (condom) during the first 7 days of taking the pills from the first package.

When switching from other combined oral contraceptives, vaginal ring or contraceptive patch

You can start taking Yarina the day after you take the last tablet of the current package of combined oral contraceptives (i.e., without interruption). If the current package contains 28 tablets, you can start taking Yarina the next day after taking the last active tablet. If you are not sure which pill it is, ask your doctor. You can also start taking it later, but in no case later than the next day after the usual break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package).

Taking Yarina should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.

When switching from oral contraceptives containing only gestagen (mini-pills)

You can stop taking the mini-pill on any day and start taking Yarina the next day at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.

When switching from an injectable contraceptive, an implant, or from a progestogen-releasing intrauterine contraceptive (Mirena)

Start taking Yarina on the day your next injection is due or on the day your implant or intrauterine device is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.

After childbirth

If you have just given birth, your doctor may recommend that you wait until the end of your first normal menstrual cycle before starting to take Yarina. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.

After spontaneous or medical abortion in the first trimester

pregnancy

Taking missed pills

If the delay in taking the next pill is less than 12 hours,

Yarina's contraceptive effect remains. Take the tablet as soon as

remember this. Take the next tablet at your usual time.

If the delay in taking the pills is more than 12 hours, contraceptive protection may be reduced. The more pills in a row are missed, and the closer this missed dose is to the start or end of the dose, the higher the risk of pregnancy.

In this case, you can be guided by the following rules:

More than one tablet is forgotten from the pack. Consult your doctor.

One tablet missed in the first week of taking the drug

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). Take the next tablet at your usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before missing the pill, the possibility of pregnancy must be taken into account. Consult your doctor immediately.

One tablet was missed in the second week of taking the drug

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). Take the next tablet at your usual time. If you took the pills correctly during the 7 days preceding the first missed pill, the contraceptive effect of Yarina remains, and you do not need to use additional contraceptive measures. “Otherwise, as well as if you miss two or more pills, you must additionally use barrier methods of contraception for 7 days.

One tablet was missed in the third week of taking the drug

If all tablets have been taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods. You can follow either of the following two options without the need for additional contraceptive measures.

1. Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take the next tablet at your usual time. Start taking the tablets from the next pack immediately after you finish taking the tablets from the current pack, so there is no break between packs. Withdrawal bleeding is unlikely until the second pack of tablets is gone, but spotting or breakthrough bleeding may occur on the days you take the drug.

2. Stop taking the pills from the current pack, take a break of 7 days or less (including the day you missed the pills), and then start taking the pills from the new pack.

Using this regimen, you can always start taking the next pack of tablets on the day of the week that you usually do.

If you do not get your expected period after taking the pills, you may be pregnant. Consult your doctor before starting a new pack.

If you have had vomiting or diarrhea (stomach upset) within 4 hours of taking Yarina tablets, the active ingredients may not have been completely absorbed. This situation is similar to skipping a drug dose. Therefore, follow the instructions for missed pills.

Delaying the onset of menstruation

You can delay the onset of menstruation if you start taking the tablets from the next package of Yarina immediately after finishing the current package. You can continue taking the tablets in this pack for as long as you wish, or until the tablets in this pack run out. If you want your period to start, stop taking the pills. While taking Yarina from the second package, spotting or bleeding may occur on the days of taking the pills. Start taking the tablets from the next package after the usual 7-day break.

Changing the day your period starts

If you take the pills as recommended, you will have your period on about the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the period of time you are free from taking pills. For example, if your menstrual cycle usually starts on Friday, but in the future you want it to start on Tuesday (3 days earlier), you should start taking the pills in the next pack 3 days earlier than usual. If your pill-free break is very short (for example, 3 days or less), menstruation may not occur during the break. In this case, bleeding or spotting may occur while taking the tablets from the next package. Additional information for special populations Children and adolescents

The drug Yarina is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.

Elderly patients

Not applicable. Yarina is not indicated after menopause.

Patients with liver disorders

Yarina is contraindicated in women with severe liver disease until liver function tests return to normal. See also section "Contraindications".

Patients with kidney problems

Yarina is contraindicated in women with severe renal failure or acute renal failure. See also section "Contraindications".

Side effect

When taking Yarina, like any other medicine, adverse reactions may occur, although their occurrence is not necessary in all patients. If any adverse reaction becomes serious or you notice an adverse reaction not listed in this leaflet, please tell your doctor or pharmacist.

Serious unwanted effects:

In case of undesirable effects, including serious reactions associated with the use of the drug, see the sections “Precautions”, “Special Instructions” and “Contraindications”. Please read these sections carefully and consult your doctor if necessary. The following adverse reactions have been reported in women using Yarina:

Common undesirable effects (more than 1/100 and less than 1/10):

□ mood swings, depression/low mood

□ decrease or loss of libido (decreased or loss of sexual desire)

□ migraine

□ nausea

□ pain in the mammary glands, irregular uterine bleeding (“breakthrough” bleeding), bleeding from the genital tract (bleeding from the vagina) of unspecified origin

Rare undesirable effects (more than 1/10000 and less than 1/1000):

□ venous or arterial thromboembolism*

□ *Approximate frequency based on the results of epidemiological studies covering the group of combined oral contraceptives. The frequency bordered on very rare.

□ “Venous or arterial thromboembolism” includes the following nosological units: occlusion of peripheral deep veins, thrombosis and

embolism/pulmonary vascular occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not defined as hemorrhagic.

Side effects that have been reported during use of Yarina, but the incidence of which could not be assessed: erythrema multiforme (a skin condition characterized by itchy red rashes or local swelling of the skin).

Additional Information:

Listed below are adverse reactions with a very rare incidence or with delayed symptoms, which are believed to be associated with taking drugs from the group of oral combined contraceptives (see also “Contraindications” and “Special instructions”).

□ The incidence of breast cancer diagnosis in women taking combined oral contraceptives is slightly increased. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in women taking combined oral contraceptives is small relative to the overall risk of breast cancer.

Other states

□ Erythema nodosum.

□ Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives).

□ Increased blood pressure.

□ Conditions that develop or worsen while taking combined oral contraceptives, but their relationship has not been proven: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis.

□ In women with hereditary angioedema, estrogen may cause or worsen symptoms.

□ Liver dysfunction.

□ Impaired glucose tolerance or effects on insulin resistance.

□ Crohn's disease, ulcerative colitis.

□ Chloasma.

□ Hypersensitivity (including symptoms such as rash, urticaria). Interaction

Interaction of oral contraceptives with other drugs

agents (inducers of microsomal liver enzymes, some antibiotics)

can lead to

breakthrough bleeding and/or decreased contraceptive effectiveness (see “Interaction with other drugs”).

Overdose

No serious adverse events have been reported following overdose. Based on cumulative experience with combined oral contraceptives, symptoms that may occur with an overdose of active tablets: nausea, vomiting, spotting or metrorrhagia.

In case of overdose, consult a doctor.

Interaction with other drugs

Some medications may reduce the effectiveness of Yarina. These include drugs used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin), and HIV infection (eg, ritonavir, nevirapine); antibiotics to treat certain other infectious diseases (eg penicillin, tetracyclines, griseofulvin); and St. John's wort medicines (used mainly to treat low mood). Oral combination contraceptives may affect the metabolism of other drugs (eg, cyclosporine and lamotrigine).

There is a theoretical possibility of increased serum potassium levels in women receiving Yarina concomitantly with other drugs that may increase serum potassium levels. These drugs include angiotensin II receptor antagonists, some anti-inflammatory drugs (eg, indomethacin), potassium-sparing diuretics, and aldosterone antagonists. However, in a study evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium concentrations compared with placebo.

Always tell the doctor prescribing Yarina what medications you are already taking. Also tell any doctor or dentist who prescribes other drugs, or the pharmacist who sells drugs to you at the pharmacy, that you are taking Yarina.

Features of application

The following warnings regarding the use of other combined oral contraceptives should also be taken into account when using Yarina.

□ Thrombosis

Thrombosis is the formation of a blood clot (thrombus) that can block a blood vessel. When a blood clot breaks off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), vessels of the heart (myocardial infarction), brain (stroke), and very rarely in the vessels of other organs.

The results of epidemiological studies indicate a relationship between the use of combined oral

contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. An increased risk is present after initial use of combined oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large study suggest that the increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (

In very rare cases, venous or arterial thromboembolism can cause serious functional impairment, be life-threatening, or be fatal.

VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any combined oral contraceptives.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:

□ with age;

□ in smokers (with increasing number of cigarettes or increasing age, the risk increases, especially in women over 35 years old);

in the presence of:

□ family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug;

□ obesity (body mass index more than 30 kg/m2);

□ dislipoproteinemia;

□ arterial hypertension;

□ migraine;

□ heart valve diseases;

□ atrial fibrillation;

□ prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using the drug Yarina (in the case of a planned operation, at least four weeks before it) and not to resume taking it for a period of time.

two weeks after the end of immobilization.

□ Tumors

The connection between taking combined oral contraceptives and breast cancer has not been proven, although it is detected slightly more often in women taking combined oral contraceptives than in women of the same age who are not using them. This difference may be due to the fact that women are screened more often when taking the drug and therefore breast cancer is detected at an early stage.

In rare cases, during the use of sex steroids, the development of benign, and in extremely rare cases, malignant liver tumors, which can lead to life-threatening intra-abdominal bleeding, has been observed. The connection with the use of drugs has not been proven. If you suddenly experience severe abdominal pain, consult your doctor immediately.

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. Cervical cancer was detected slightly more often in women using combined oral contraceptives for a long period of time. The connection with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations to detect cervical diseases or to characteristics of sexual behavior (less frequent use of barrier methods of contraception).

The above mentioned tumors can be life threatening or fatal.

□ Reduced efficiency

The effectiveness of Yarina may be reduced in the following cases: if you miss pills, with vomiting and diarrhea, or as a result of drug interactions.

□ Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking the drug.

□ In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema

□ During the use of combined oral contraceptives, cases of Crohn's disease and ulcerative colitis, as well as worsening of endogenous depression and epilepsy, have been described.

Insufficient control of the menstrual cycle

As with other combined oral contraceptives, when taking Yarina, irregular vaginal bleeding (spotting or breakthrough bleeding) may be observed during the first few months. Use hygiene products and continue taking your tablets as usual. Irregular menstrual-like bleeding usually stops as your body adapts to Yarina (usually after 3 cycles of taking the pills). If they continue, become severe, or return after stopping, consult your doctor. No regular menstrual bleeding If you took all the pills correctly and did not have vomiting or diarrhea

while taking pills or not taking other medications at the same time, then the likelihood of pregnancy is low. Continue taking Yarina as usual.

If there are no two menstrual bleeding in a row, consult a doctor immediately. Do not start taking the next pack until your doctor has ruled out pregnancy.

Impact on the ability to drive a car and operate machinery

Not found.

When to Consult a Doctor Regular Checkups

If you are taking Yarina, your doctor will tell you about the need for regular check-ups, at least once every 6 months.

Consult your doctor as soon as possible:

□ if you have any health changes, especially any of the conditions listed in this leaflet (see also “Contraindications” and “Use with caution”);

□ with local compaction in the mammary gland;

□ if you are going to use other medications (see also “Interactions with other medications”);

□ if prolonged immobility is expected (for example, a leg is in a cast), hospitalization or surgery is planned (consult your doctor at least 4 - 6 weeks in advance);

□ if unusual heavy vaginal bleeding occurs;

□ if you forgot to take a pill in the first week of taking the pack and had sexual intercourse seven days or less before;

□ you have not had your regular menstruation twice in a row or you suspect that

that you are pregnant (do not start taking the next pack until you have consulted your doctor).

Stop taking the tablets and consult your doctor immediately if you notice possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath; unusual, severe or prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe leg pain or sudden swelling of either leg.

Yarina does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Precautionary measures

If you are using combined oral contraceptives if you have any of the diseases/conditions listed below, you may need to be closely monitored as your doctor explains why. Before you start taking Yarina, tell your doctor if you have any of the following conditions and diseases.

Risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family; obesity; dyslipoproteinemia (for example, high blood cholesterol); arterial hypertension; migraine; heart valve defects; prolonged immobilization, major surgery, major trauma

Other diseases in which peripheral circulatory disorders may occur (diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia), phlebitis of the superficial veins

Hereditary angioedema

Hypertriglyceride emia

Liver diseases

Diseases that first appeared or worsened during pregnancy or during previous use of sex hormones (for example, jaundice and/or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes of pregnancy, Sydenham's chorea)

Postpartum period

Release form

Film-coated tablets. 21 tablets are placed in a blister made of aluminum foil and polyvinyl chloride film. 1 or 3 blisters, along with a pocket for carrying the blister and instructions for use, are placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date!

Conditions for dispensing from pharmacies

On prescription.

Yarina analogues, synonyms and group drugs

• Midiana
• Dimia
• Janine
• Novinet
• Rigevidon 21 + 7
• Lindinet 20
• Lindinet 30

Self-medication may be harmful to your health. You should consult your doctor and also read the instructions before use.

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Yarina

Composition and release form Yarina is available in the form of film-coated tablets. The active substances included in the drug are ethinyl estradiol in a dosage of 30 mg. and Drospirenone at a dosage of 3 mg. One package of the drug contains 21 tablets. How does Yarina work? Yarina's contraceptive is a combined drug, as it contains two sex hormones - estrogen and gestagen. In addition, the product is low-dose (low doses of hormones) and monophasic (all tablets contain the same amount of hormones). Yarina’s ability to protect against pregnancy is based on two mechanisms - suppression of ovulation (ovum maturation) and a change in the properties of the secretion (mucus) located in the cervix. Thick cervical mucus becomes an obstacle to sperm penetration. In addition, taking Yarina helps to regulate the menstrual cycle (if it is irregular). Pain during menstruation decreases, bleeding becomes less intense (this fact reduces the risk of developing iron deficiency anemia). Other beneficial effects of Yarina are antimineralocorticoid and antiandrogenic effects. The hormone Drospirenone has this effect - it reduces fluid retention in the body, reduces swelling, so that body weight does not increase. The antiandrogenic effect is the ability of the drug to reduce the symptoms of acne (acne) and regulate the production of sebum in the skin and hair (reduces seborrhea). Indications for use

The main indication for the use of tablets is to prevent unwanted pregnancy.

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