Composition
1 tablet contains:
active ingredients:
drospirenone 3 mg,
ethinyl estradiol 0.03 mg;
excipients:
lactose monohydrate — 48.17 mg;
corn starch-14.4 mg;
pregelatinized corn starch-9.6 mg;
povidone K 25-4 mg;
magnesium stearate-800 mcg;
hypromellose (hydroxypropylmethylcellulose) – 1.0112 mg;
macrogol 6000-202.4 mcg;
talc (magnesium hydrosilicate) – 202.4 mcg;
titanium dioxide (E 171) – 556.5 mcg;
iron (II) oxide (E 172) — 27.5 mcg
Pharmacological action
Yarina is a low-dose monophasic combined contraceptive with antimineralocorticoid and antiandrogenic properties. It inhibits the secretion of pituitary gonadotropins, inhibits the maturation of follicles and interferes with the ovulation process. Increases the viscosity of cervical mucus, which makes it difficult for sperm to enter the uterus.
Drospirenone has an antimineralocorticoid effect and is able to prevent weight gain and other symptoms associated with fluid retention in the body.
Prevents sodium retention caused by estrogens, provides very good tolerance and has a positive effect on premenstrual syndrome. In combination with ethinyl estradiol, drospirenone improves the lipid profile and increases HDL levels.
Drospirenone has antiadrogenic activity and helps to reduce the appearance of acne and reduce the production of sebaceous glands. It does not counteract the ethinylestradiol-induced increase in sex hormone binding globulin (SHBG), which promotes the binding and inactivation of endogenous androgens.
Drospirenone does not have any androgenic, estrogenic, glucocorticoid or anti-glucocorticoid activity, which in combination with antimineralocorticoid and antiandrogenic action provides drospirenone with a biochemical and pharmacological profile very close to natural progesterone. There is evidence of a reduced risk of endometrial and ovarian cancer.
Against the background of the use of the drug Yarina, the menstrual cycle becomes more regular, painful menstruation is less frequent, the intensity of menstrual discharge decreases, as a result of which the risk of developing iron deficiency anemia decreases.
Indications
Hormonal contraception.
The drug is recommended for acne and seborrhea, as well as for hormone-dependent fluid retention in the body.
Use during pregnancy and lactation
The drug is not prescribed during pregnancy and lactation. 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 careless use of sex hormones in early pregnancy.
At the same time, data on the results of taking 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 fetus. Currently, no significant epidemiological data are available.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is not recommended before stopping breastfeeding. Small amounts of sex steroids and / or their metabolites can be excreted in milk.
Contraindications
– the presence of thrombosis (venous and arterial) in the present or in history (e. g., deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);– the presence in the present or in the anamnesis States prior thrombosis (e. g., transient disorders of cerebral circulation, angina);– diabetes mellitus with vascular complications;– the presence of a severe or multiple risk factors for venous or arterial thrombosis;– the presence or history of severe forms of liver diseases (as long as the indicators of liver samples normalized);– the presence in the present or in history of benign or malignant tumors of the liver;– identification of hormone-dependent cancers of the genitals or mammary glands or suspected them;– severe or acute renal failure; vaginal bleeding of unknown origin;– pregnancy or suspicion of it;– lactation (breastfeeding);– hypersensitivity to the components of the drug.
Side effects
The most frequently 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 in clinical trials of Yarina®(N=4897). Within each group, selected according to 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
Table 1
System-organ classes (MedDRA version)Partial pastoralfrequency unknown Psychiatric disorders Mood swings, depression, depressed mood, decreased or lost libido Nervous System Migraine Vascular disorders Venous or arterial thromboembolism * Gastrointestinal nausea Skin and subcutaneous tissues Erythematoproductive system multiforme and mammary glandsbothole in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified originagypertrophy of the mammary glandsexclusions from the vagina, discharge from the mammary glands
Adverse events in clinical trials were codified using the MedDRA Dictionary (Medical Dictionary of Regulatory Activities, version 12.1). Different MedDRA terms reflecting the same symptom were grouped together and presented as a single adverse reaction, in order to avoid weakening or blurring 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 nosological units: 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, migraines, see also “Contraindications” and “Special instructions”.
Additional information
Listed below are adverse reactions with very rare frequency or delayed symptoms that are believed to be associated with the use of drugs from the group of combined oral contraceptives (see also “Contraindications” and “Special Instructions”).
Tumors:
– the frequency of breast cancer diagnosis in women taking combined oral contraceptives is slightly increased. Because breast cancer is rare in women under the age of 40, the increase in breast cancer diagnoses among women taking combined oral contraceptives is insignificant relative to the overall risk of this disease.
– liver tumors (benign and malignant).
Other states:
– erythema nodosum;
– women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);
– increase in blood pressure;
– state, developing or deteriorating while taking combined oral contraceptives, but their relationship with the drug has not been proven (jaundice and/or pruritus associated with cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes pregnant; hearing loss associated with otosclerosis);
– in women with hereditary angioedema estrogen can cause or aggravate the symptoms;
– disorders of the liver;
– violation of glucose tolerance or effect on insulin resistance;
– Crohn’s disease, ulcerative colitis;
– chloasma;
– hypersensitivity (including symptoms such as rash, hives).
Interaction
Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and / or reduced contraceptive reliability. Women taking these medications should temporarily use barrier methods of contraception in addition to Yarina®, or choose a different method of contraception.
The following types of interaction have been reported in the literature.
Effect on hepatic metabolism. The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or a decrease in the reliability of contraception. 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 (e. g. ritonavir) and non-nucleoside reverse transcriptase inhibitors (e. g. nevirapine) and their combinations may also potentially affect hepatic metabolism.
Effect on intestinal-hepatic circulation.According to some studies, some antibiotics (such as penicillins and tetracycline) can reduce the intestinal-hepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.
When taking medications that affect microsomal enzymes, and for 28 days after their withdrawal, you should additionally use a barrier method of contraception.
When taking antibiotics (such as penicillins and tetracyclines) and for 7 days after their withdrawal, you should additionally use a barrier method of contraception. If you run out of pills in the current package during these 7 days of the barrier method of contraception, then you should start taking pills from the next package of Yarina® without the usual break in taking pills.
The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of cytochrome P450 inhibitors on drospirenone metabolism is unlikely.
Oral combination contraceptives may interfere with the metabolism of other drugs, leading to an increase (for example, cyclosporine). or a decrease (for example, lamotrigine) in their concentration in plasma and tissues.
Based on in vitro interaction studies, as well as an in vivo study on female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other medicinal substances is unlikely.
There is a theoretical possibility of increasing serum potassium levels in women receiving Yarina® concomitantly with other medications that may increase serum potassium levels. These drugs include angiotensin II receptor antagonists, certain anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or Indometacin, there was no significant difference between serum potassium concentrations compared to placebo.
How to take, course of use and dosage
Inside, in the order indicated on the package, every day at about the same time, with a small amount of water.
Take one tablet a day continuously for 21 days. Taking tablets from the following package begins after a 7-day break, during which menstrual-like bleeding (withdrawal bleeding) usually develops. As a rule, it begins on the 2nd-3rd day after taking the last tablet and may not end before taking tablets from a new package.
How to start taking Yarina®
In the absence of taking any hormonal contraceptives in the previous month
Yarina® begins on the first day of the menstrual cycle (i. e., on the first day of menstrual bleeding). It is allowed to start taking on the 2nd-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 tablets from the first package.
When switching from other combined oral contraceptives, a vaginal ring, or a contraceptive patch
It is preferable to start taking Yarina® the 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 28 tablets in a package).
Yarina® should be started on the day of removal of the vaginal ring or patch, but not later than the day when a new ring is to be inserted or a new patch is to be applied.
When switching from progestogen-only contraceptives (mini-pills, injectable forms, implants), or from a progestogen-releasing intrauterine contraceptive (Mirena)
You can switch from mini-pili to Yarina® on any day (without a break), from the implant or intrauterine contraceptive with progestogen – on the day of its removal, from the injectable form-from the day when the next injection should be made. 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
Start taking the drug no earlier than 21-28 days after delivery (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if the woman has already had sexual activity, pregnancy should be excluded before taking Yarina® or it is necessary to wait for the first menstruation.
Taking missed pills
If the delay in taking the drug is less than 12 hours, the contraceptive protection is not reduced. The woman should take the pill as soon as possible, and the next one is taken at the usual time.
If the delay in taking pills is more than 12 hours, the contraceptive protection is reduced. The more pills you skip and the closer the skip is to the 7-day pill break, the more likely you are to get pregnant.
In this case, you can follow 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 tips can be given if the delay in taking pills exceeds 12 hours (the interval from the last pill is more than 36 hours).
The first week of taking the drug
It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers about it (even if you need to take 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 during the week before skipping the pill, the likelihood of pregnancy should be taken into account.
Second week of taking the drug
It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers about it (even if you need to take two pills at the same time). The next tablet is taken at the usual time. Provided that the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no 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 example, a condom) for 7 days.
The third week of taking the drug
increases the risk of pregnancy due to the upcoming break in taking pills. A woman should strictly adhere to one of the two options listed below. However, if all pills were taken correctly during the 7 days preceding the first missed pill, 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 about it (even if you need to take two pills at the same time). The next tablets are taken at the usual time, until the tablets from the current package run out. Tablets from the next package should be taken immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but there may be spotting and breakthrough bleeding while taking the pills.
2. You can stop taking pills from the current package, thus starting a 7-day break (including the day of skipping pills), and then start taking pills from the new package.
If a woman has missed taking pills and then has no withdrawal bleeding during the break, pregnancy should be ruled out.
Recommendations for vomiting and diarrhea
In case of vomiting or diarrhea within 4 hours after taking the tablets, absorption may be incomplete, and additional measures should be taken to prevent unwanted pregnancy. In such cases, you should follow the above recommendations when skipping pills.
Changing the day of onset of menstrual-like bleeding
In order to delay the onset of menstrual-like bleeding, it is necessary to continue taking tablets from the new Jarina ® package without a 7-day break. Tablets from a new package can be taken for as long as necessary, including until the tablets from the package run out. Against the background of taking the drug from the second package, spotting spotting from the vagina or breakthrough uterine bleeding is possible. 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 reduce the next break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and will continue to experience spotting and breakthrough bleeding while taking the second package (as well as in the case when she would like to delay the onset of menstrual-like bleeding).
Overdose
Symptoms (identified based on total experience with oral contraceptives): nausea, vomiting, spotting or metrorrhagia.
Treatment: symptomatic. There is no specific antidote.
No serious overdose violations were reported.
Special instructions
If any of the conditions, diseases, and risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed on a case-by-case basis and discussed with the woman before she decides to start taking the drug.
If any of these conditions, diseases, or risk factors increase in severity, severity, or first appearance, a woman should consult with her doctor, who may decide whether to discontinue the drug.
CVD diseases
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, and cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.
The risk of developing VTE is highest in the first year of taking these medications. An increased risk is present after the initial use of combined oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of the drug for 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that this increased risk is present mainly 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 the risk of VTE during pregnancy and childbirth. VTE can be life-threatening or fatal (in 1-2% of cases).
VTE, which manifests as deep vein thrombosis, or pulmonary embolism, can occur with any combination of 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 on the association between the occurrence of these events and the use of combined oral contraceptives.
Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower limb or along a vein in the leg, pain or discomfort in the leg only when standing upright or walking, local fever in the affected leg, redness or discoloration of the skin on the leg.
Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden coughing, including with hemoptysis; acute chest pain, which can increase with deep breathing; anxiety; severe dizziness; rapid or irregular heartbeat.
Some of these symptoms (for example, shortness of breath, cough) are non-specific, and can be misinterpreted as signs of other more or less severe events (for example, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of sensation in the face, arm, or leg, especially on one side of the body; sudden confusion, problems with speech and understanding; sudden one – or two-way loss of vision; sudden gait disturbance, 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 include sudden pain, swelling and slight blueness of the extremities, and a sharp stomach.
Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or behind the sternum; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting, or dizziness; severe weakness, anxiety, or shortness of breath; rapid or irregular heartbeat. Arterial thromboembolism can be fatal. The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:
– with age;
– in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years of age).
If available:
– obesity (body mass index greater 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 whether to take combined oral contraceptives;
– prolonged immobilization, serious surgery, any foot surgery or extensive 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 taking them for 2 weeks after the end of immobilization;
– dyslipoproteinemia;
– arterial hypertension;
– migraines;
– 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 developing thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders can also occur in patients with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis), and sickle cell anemia. An increase in the frequency and severity of migraines during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be a reason for immediate discontinuation of these drugs.
Biochemical parameters that indicate 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 (anti-cardiolipin antibodies, lupus anticoagulant). When assessing the risk-benefit ratio, consider that adequate treatment of the 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 papillomavirus infection. There are reports of a slight increase in the risk of cervical cancer with prolonged use of combined oral contraceptives. However, the association with the use of combined oral contraceptives has not been proven. The possibility of correlation of these data with disease screening is discussed. There are still contradictions about the extent to which these data are related to screening for cervical pathology or sexual behavior (more rarely, the use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk — 1.24).
The increased risk gradually disappears within 10 years after discontinuation of these medications. Because breast cancer is rare in women under the age of 40, the increase in breast cancer diagnoses among women who are currently or have recently taken combined oral contraceptives is insignificant relative to the overall risk of this disease.
Its association with the use of combined oral contraceptives has not been proven. The observed increased risk may also be due to careful monitoring and earlier diagnosis of breast cancer in women using combined oral contraceptives. Women who have ever used combined oral contraceptives are more likely to develop early-stage breast cancer than women who have never used them.
In rare cases, the use of combined oral contraceptives resulted in the development of benign, and in extremely rare cases — malignant liver tumors, which sometimes led to life-threatening intra-abdominal bleeding. If severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding occur, 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 insufficiency. However, in patients with impaired renal function and an initial concentration of potassium at the ULN level, the risk of hyperkalemia cannot be excluded against the background of taking drugs 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 combined oral contraceptives.
Although a small increase in blood pressure has been reported 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 for 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 with combined oral contraceptives (but their association with combined oral contraceptives has not been proven): jaundice and / or pruritus associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes of pregnancy; hearing loss associated with otosclerosis.
There are also cases of Crohn’s disease and ulcerative colitis associated with the use of combined oral contraceptives. In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Acute or chronic liver function disorders may require discontinuation of the drug until liver function indicators 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 carefully monitored while taking this medication.
Sometimes chloasma can develop, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should avoid prolonged exposure to the sun and UV radiation while taking Yarina®.
Preclinical safety data sheet
Preclinical data obtained during standard studies for the detection of toxicity with multiple doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of 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
The use of combined oral contraceptives may affect the results of certain laboratory tests, including liver, kidney, thyroid, and adrenal function, plasma transport protein levels, carbohydrate metabolism, blood clotting, and fibrinolysis. Changes usually do not exceed the limits of normal values. Drospirenone increases the activity of plasma renin and the level of aldosterone in plasma, which is associated with its antimineralocorticoid effect.
Reduced efficiency
The effectiveness of Yarina® may be reduced in the following cases:: if you miss taking pills, if you have vomiting and diarrhea (see “Taking missed pills”), or as a result of a drug interaction.
Insufficient control of the menstrual cycle
While taking Yarina®, irregular (acyclic) spotting/bleeding from the vagina (spotting spotting or breakthrough bleeding) may occur, especially during the first months of use.
Therefore, any irregular menstrual-like bleeding should be evaluated after an adjustment 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 malignancies or pregnancy.
Some women may not develop withdrawal bleeding during the pill break. If Yarina® has been taken as recommended, it is unlikely that the woman is pregnant. However, with irregular use of the drug and the absence of two consecutive menstrual-like bleeding, the drug can not be continued until pregnancy is excluded.
Medical examinations
Before starting or resuming the use of Yarina®, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical and gynecological examination, and exclude pregnancy. The scope of studies and frequency of follow-up examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each patient. As a rule, blood pressure and heart rate are measured, body mass index is determined, and the condition of the mammary glands, abdominal cavity, and pelvic organs is checked, including cytological examination of the cervical epithelium (Pap test). Usually, follow-up examinations should be performed at least once every 6 months.
A woman should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Influence on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. Not detected.
Form of production
Coated tablets.
Storage conditions
At room temperature no higher than 25 °C
Shelf life
3 years
Active ingredient
Drospirenone, Ethinyl Estradiol
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
For adults as prescribed by a doctor, For women of childbearing age
Indications
Contraception
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