Active substances: 0.075 mg of gestodene and 0.030 mg of ethinylestradiol.

Excipients: lactose monohydrate 37.430 mg, corn starch 15.500 mg, povidone 25 thousand 1.700 mg, sodium calcium edetate 0.065 mg, magnesium stearate 0.200 mg.

Sheath:sucrose 19.660 mg, povidone 700 thousand 0.171 mg, macrogol-6000 2.180 mg, calcium carbonate 8.697 mg, talc 4.242 mg, mountain wax glycol 0.050 mg.

The contraceptive effect of Femoden® is carried out through complementary mechanisms, the most important of which are suppression of ovulation and a change in the state of cervical secretion (increased viscosity), as a result of which it becomes impermeable to sperm.

In women taking combined oral contraceptives, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, as a result of which one of the risk factors for iron deficiency anemia decreases. In addition, there is evidence that the risk of developing endometrial and ovarian cancer is reduced.

If used correctly, the Pearl index (an indicator reflecting the frequency of pregnancy in 100 women during the year of using the contraceptive) is less than 1. If the tablets are used incorrectly, including when the tablets are skipped, the Pearl index may increase.

Absorption. After oral administration, gestodene is rapidly and completely absorbed, its maximum plasma concentration of 4 ng / ml is reached after about 1 hour. Bioavailability is approximately 99%.

Distribution. Gestodene binds to blood plasma albumin and sex hormone binding globulin (SHBG). Only about 1-2% of the total concentration in blood plasma is in free form; about 50-70% are specifically associated with SHBG. The induction of SHBG synthesis by ethinylestradiol affects the binding of gestodene to plasma proteins.

Metabolism. Gestodene is almost completely metabolized. Plasma clearance is approximately 0.8 ml / min / kg.

Excretion. The concentration of gestodene in plasma undergoes a two-phase decrease. The half-life in the terminal phase is about 12-15 hours. Gestodene is not excreted unchanged, but only in the form of metabolites, which are excreted by the kidneys and through the intestines in a ratio of about 6: 4 with a half-life of about 24 hours.

Equilibrium concentration. The pharmacokinetics of gestodene is affected by the concentration of SHBG in the blood plasma. As a result of daily intake of the drug, the concentration of the substance in the plasma increases by about 4 times during the second half of the contraceptive cycle.

- Ethinylestradiol

Absorption.After oral administration, it is rapidly and completely absorbed. The maximum concentration in blood plasma, equal to about 80 pg / ml, is reached in 1-2 hours. During absorption and "primary passage" through the liver, it is metabolized, as a result of which its oral bioavailability averages about 45%.

Distribution... almost completely (approximately 98%), although nonspecifically, binds to albumin. induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8 - 8.6 l / kg.

Metabolism.Ethinyl estradiol undergoes presystemic conjugation, both in the mucous membrane of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation. The clearance rate from blood plasma is 2.3 - 7 ml / min / kg.

Excretion.The decrease in the concentration of ethinyl estradiol in the blood plasma is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted unchanged from the body. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestines in a ratio of 4: 6 with a half-life of about 24 hours.

Equilibrium concentration.Equilibrium concentration is reached after approximately one week.

Thrombosis (venous and arterial) and thromboembolism at the present time or in history (including deep vein thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction), cerebrovascular disorders (hemorrhagic or ischemic).

Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at the present time or in history.

Revealed predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyerhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant).

Uncontrolled hypertension.

The presence of pronounced or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, subacute bacterial endocarditis, extended surgery with prolonged immobilization, extensive trauma, atrial fibrillation).

Migraine with focal neurological symptoms at present or in history.

Diabetes mellitus with diabetic angiopathy.

Pancreatitis with severe hypertriglyceridemia at present or in history.

Liver failure and severe liver disease (before normalization of liver function tests), including jaundice, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes).

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

Identified hormone-dependent malignant neoplasms (including the genitals or mammary glands) or suspicion of them.

Vaginal bleeding of unknown origin.

Pregnancy or suspicion of it.

Lactation period.

Hypersensitivity to Fsmoden® or to any of the components of the drug.

Lactase deficiency, glucose-galactose malabsorption, sucrase / isomaltase deficiency, fructose intolerance, lactose intolerance.

Risk factors for thrombosis and thromboembolism: smoking; thrombosis or a predisposition to thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the next of kin; obesity; dyslipoproteinemia, arterial hypertension; migraine without focal neurological symptoms; uncomplicated heart valve disease.

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; as well as phlebitis of superficial veins.

Hypertriglyceridemia.

Liver disease with normal liver function tests.

Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with impaired hearing, porphyria, herpes during pregnancy, Sydenham's chorea).

The onset of severe depression.

Varicose veins of the lower extremities, uterine myoma.

Anticoagulant therapy.

In women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema.

Taking Femoden®, like other combined oral contraceptives, can reduce the amount of breast milk and change its composition, therefore, as a rule, their use is not recommended during lactation. Small amounts of sex hormones and / or their metabolites can be excreted in breast milk.

Femoden® is indicated only after the onset of menarche.

How to start taking Femoden®

- In the absence of taking any hormonal contraceptives in the previous month.

Taking Femoden® 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 days 2-5 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 pills from the first package.

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

It is preferable to start taking Femoden® the next day after taking the last hormone-containing pill 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 per pack). Femoden® should be taken on the day the vaginal ring or contraceptive 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 progestogen-releasing intrauterine contraceptive (Mirenac).

A woman can switch from "mini-pills" to Femoden® any day (without interruption), from an implant or intrauterine contraceptive with gestagen - on the day of its removal, from an injection form - from the day when the next injection is to be made. In all cases, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the pills.

- After an abortion in the first trimester of pregnancy.

The woman can start taking the drug immediately. If this condition is met, a woman does not need additional contraceptive protection.

- After childbirth or abortion in the second trimester of pregnancy.

It is recommended to start taking the drug on days 21-28 after childbirth if the woman is not breastfeeding, or after an 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 pills. However, if a woman has already had sexual intercourse, pregnancy should be excluded or the first menstrual period should be waited before taking Femoden®.

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, the next one is taken at the usual time.

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

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

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

7 days of continuous pill intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given:

The first week of taking the drug

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

Second week of taking the drug

The woman should take the last missed pill as soon as possible, as soon as she remembers (even if that means taking two pills at the same time). The next pill is taken at the usual time.

Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use

additional contraceptive measures. Otherwise, as well as when skipping 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

The risk of reduced reliability is inevitable due to the upcoming pill interruption. A woman must strictly adhere to one of the following two options. Moreover, if in 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. A woman should take the last missed pill as soon as possible, as soon as she remembers (even if that means taking two pills at the same time). The next pills are taken at the usual time until the pills from the current pack run out. You should start taking the tablets from the next pack immediately. Withdrawal bleeding is unlikely until the second pack runs out, but spotting bleeding and breakthrough vaginal bleeding may occur while taking the pills.

2. The woman can also stop taking the pills from the current package. Then she should take a break for 7 days, including the day of missing pills, and then start taking pills from a new package.

If a woman misses a pill and then does not have withdrawal bleeding during a break, pregnancy should be ruled out.

If a woman has vomiting or diarrhea within 4 hours after taking the pills, absorption may not be complete and additional contraceptive measures must be taken. In these cases, you should focus on the recommendations when skipping pills.

Change in day of onset of menstrual bleeding

In order to delay the onset of menstrual bleeding, a woman should continue taking pills from a new package of FSmoden® immediately after all pills from the previous one have been taken, without interruption. The pills from this new package can be taken as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience "smearing" spotting or "breakthrough" uterine bleeding. Resume taking the drug Fsmoden® from a new package after the usual 7-day break.

In order to postpone the day of the onset of menstrual bleeding to another day of the week, a woman should shorten 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 in the future there will be “spotting” spotting and “breakthrough” bleeding from the vagina while taking the pills from the second pack (as well as in the case when she would like to delay the onset of menstrual bleeding).

Additional information for specific patient groups

Elderly patients

Not applicable. FSmoden® is not indicated after menopause.

Patients with renal impairment

Femoden® has not been specifically studied in patients with renal impairment. The available data does not suggest a dosage adjustment in these patients.

The table below shows undesirable effects that were reported while taking combined oral contraceptives, the relationship of which with the intake of drugs has not been confirmed, but also not refuted.

The following serious adverse events have been reported in women using combined oral contraceptives. For additional information on the possible side effects of oral combined contraceptives, including Femoden®, see the "Special instructions" section:

Venous thromboembolic disorders.

Arterial thromboembolic disorders.

Cerebrovascular disorders.

Increased blood pressure.

Hypertriglyceride.

Impaired glucose tolerance or effects on peripheral insulin resistance.

Liver tumors (benign and malignant).

Violation of the functional parameters of the liver.

Chloasma.

The onset or worsening of conditions for which the connection with the use of combined oral contraceptives has not been proven: jaundice and / or itching. associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis; Crohn's disease; ulcerative colitis; cervical cancer. The intake of exogenous estrogens can cause or exacerbate symptoms of angioedema in women with angioedema.

The incidence of breast cancer diagnostics in women using oral contraceptives has been increased very slightly. Breast cancer is rarely observed in women under 40 years of age, the excess frequency is negligible in relation to the overall risk of breast cancer. The causal relationship of the occurrence of breast cancer with the use of combined oral contraceptives has not been established. For more information, see the section "Contraindications" and "Special instructions".

There is no specific antidote, symptomatic treatment should be carried out.

Effect on hepatic metabolism: the use of drugs-inducers of liver microsomal enzymes can lead to an increase in the clearance of sex hormones. Such drugs include:, barbiturates,. ,; there are also suggestions regarding oxcarbazspin, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

Inhibitors of HIV protease (for example) and non-nucleoside inhibitors of reverse transcriptase (for example) and their combinations can also potentially increase hepatic metabolism.

Impact on intestinal-hepatic recirculation, according to separate studies, some antibiotics (for example, penicillins and tetracyclines) can reduce intestinal-hepatic recirculation of estrogens, heme, thereby reducing the concentration of ethinyl estradiol.

While taking drugs that affect liver microsomal enzymes, and within 28 days after their cancellation, you should additionally use a barrier method of contraception.

While taking antibiotics (such as penicillins and tetracyclines) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If the period of using the barrier method of contraception ends later than the tablets in the package, you need to move on to the next package of Femoden® without the usual interruption in taking the tablets.

Combined oral contraceptives can interfere with the metabolism of other drugs, resulting in an increase (for example) or a decrease (for example) in plasma and tissue concentrations.

-Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) while taking combined oral contraceptives. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. Increased risk present after initial use

combined oral contraceptives or resuming the 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 predominantly during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (< 50 мкг этинилэстрадиола) в два-три раза выше, чем у небеременных пациенток, которые не принимают комбинированные пероральные контрацептивы, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах.

VTE can be fatal (in 1-2% of cases).

VTE, manifested as deep vein thrombosis, or pulmonary embolism, can occur with any combination oral contraceptive pill.

Thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina, occurs extremely rarely when using combined oral contraceptives. There is no consensus on 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 lower extremity, pain or discomfort in the lower extremity only in an upright position or when walking, a local increase in temperature in the affected lower extremity, redness or discoloration of the skin on lower limb.

The symptoms of pulmonary embolism (PE) are as follows: difficulty breathing or rapid breathing; sudden cough, including hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; a 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 complications (eg, respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. The symptoms of a stroke are: 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 unilateral or bilateral loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination of movements; 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, “sharp” abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, feeling of tightness or fullness in the chest, arm, or behind the breastbone; discomfort with radiation to the back, cheekbone, larynx, arm, stomach; cold sweats, nausea, vomiting, or dizziness, extreme weakness, anxiety, or shortness of breath; a fast 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);

in the presence of:

A 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, a woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;

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

Dyslipoprotsinemia;

Arterial hypertension;

Migraine;

Heart valve disease;

Atrial fibrillation;

Prolonged immobilization, major surgery, any lower limb surgery or major trauma. In these situations, it is advisable to discontinue the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking them within two weeks after the end of immobilization.

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

Consideration should be given to the increased risk of thromboembolism in the postpartum period. Peripheral circulatory disorders can 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 the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be the reason 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, lack of antithrombin III, lack of protein C, lack of protein S, antiphospholipid antibodies (angicardiolipin antibodies, anticoagulant lupus).

In assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the condition may reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (< 0,05 мг этинилэстрадиола).

- Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. A slight increase in the risk of developing cervical cancer has been reported with long-term use of combined oral contraceptives. The connection with the use of combined oral contraceptives has not been proven. Controversy persists as to the extent to which these findings are associated with screening for cervical pathology or with features of sexual behavior (more rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies has shown 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. Due to heme, breast cancer is rare in women under 40. the increase in the number of diagnoses of breast cancer in women who are currently taking combined oral contraceptives or have recently taken is insignificant in relation to the overall risk of this disease. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may also be due to the earlier diagnosis of breast cancer in women using combined oral contraceptives. Women who have ever used combined oral contraceptives have earlier stages of breast cancer than women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors was observed, which in some cases led to life-threatening intra-abdominal bleeding. In the event of severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

- Other conditions

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

Although mild increases in blood pressure have been reported in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of hypertension should be started. The reception of combined oral contraceptives can be continued if normal blood pressure values \u200b\u200bare 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 have not been proven to be associated with COCs: jaundice and / or pruritus associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis are also described with the use of combined oral contraceptives.

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

Acute or chronic liver disease may require discontinuation of combined oral contraceptives 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 combined oral contraceptives.

Although combined oral contraceptives can 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 (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема комбинированных пероральных контрацептивов.

Chloasma can sometimes develop, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Laboratory tests

Taking combined oral contraceptives can affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal gland function, the concentration of transport proteins in plasma, carbohydrate metabolism, clotting and fibrinolysis parameters. Changes usually do not go beyond the normal range.

Decreased efficiency

The effectiveness of combined oral contraceptive drugs can be reduced in the following cases: when you skip taking pills, with vomiting and diarrhea, or as a result of drug interactions.

Influence on the nature of bleeding

While taking combined oral contraceptives, irregular bleeding (“spotting” spotting or “breakthrough” bleeding) may occur, especially during the first months of use. Therefore, assessment of any irregular bleeding should only be done after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to rule out malignant neoplasms or pregnancy.

Some women may not develop “withdrawal” bleeding during a pill break. If combined oral contraceptives are taken as directed, the woman is unlikely to be pregnant. Hem, nevertheless, if before this combined oral contraceptives were taken irregularly or if there are no two consecutive “withdrawal” bleeding, pregnancy should be excluded before continuing to take the drug.

Medical examinations

Before starting or resuming taking Femoden®, you should familiarize yourself with the patient's medical history in detail and conduct a physical and gynecological examination. The frequency and nature of such examinations should be based on existing standards of medical practice with the necessary consideration of the individual characteristics of each patient (but at least once every 6 months) and should include blood pressure measurement, assessment of the state of the mammary glands, abdominal organs and small pelvis, including cytological examination of the epithelium of the cervix.

A woman should be warned that Femoden® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Keep out of the reach of children.