Femoden, film-coated tablets, 21 pcs.

Pharmacodynamics and pharmacokinetics

This medicine belongs to the drugs with a low dosage of hormones. It affects the hypothalamus-pituitary-ovarian system. Femoden suppresses the synthesis of hormones that stimulate follicle . It provokes inhibition of ovulation , and also activates changes in the secretion of cervical mucus.

The drug has no androgenic activity. It also reduces the susceptibility of the endometrium to blastocyst .

After oral administration , gestodene and ethinyl estradiol rapidly and completely absorbed . During the initial passage through the liver, gestodene is not broken down, but ethinyl estradiol , on the contrary, is largely metabolized . In this case, most of the latter binds to plasma proteins. It also passes into breast milk.

The bioavailability of the drug is 99%. Gestodene binds to globulin and albumin , which bind sex steroids . Like ethinyl estradiol , it is excreted from the body in the form of metabolites in urine and bile.

Contraindications

Femoden should not be used in case of negative reactions of the body to its components, tumors (including a history ), severe diabetes mellitus with complications of the vascular system with severe hypertriglyceridemia , migraine a history of focal neurological manifestations ), uterine bleeding of unknown origin, severe liver dysfunction, thromboembolism (including a history , as well as an increased risk of its development), pancreatitis with severe hypertriglyceridemia (including a history ), pregnancy .

Interactions of the drug Femoden

Interactions between oral contraceptives and other drugs may result in breakthrough bleeding and/or decreased contraceptive effectiveness. Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, which may cause increased clearance of sex hormones (e.g. phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs that contain Hypericum perforatum L. Interaction with the enterohepatic circulation: Some clinical studies suggest that the enterohepatic circulation of estrogens may be decreased when taking certain antibiotics that reduce ethinyl estradiol concentrations (for example, penicillin and tetracycline antibiotics).When using any of the above drugs, a woman should temporarily use the barrier method in addition to taking COCs or choose another method of contraception.When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When taking antibiotics (with the exception of rifampicin and griseofulvin), the barrier method must be used for another 7 days after their discontinuation. If the barrier method is still being used, and the tablets in the PDA package have already run out, taking the tablets from the next package should be started without the usual break. Oral contraceptives may affect the metabolism of other drugs. Taking this into account, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change. Note : To determine the potential for interaction with drugs that are prescribed concomitantly with COCs, it is necessary to read the instructions for the medical use of these drugs. Effect on laboratory results . Taking contraceptives may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, parameters contained in blood plasma proteins (carriers), such as SHBG and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, as well as coagulation and fibrinolysis parameters.

Side effects

Taking the medicine may cause:

• the appearance of chloasma ;
• nausea;
• weight change;
• hives;
• fluid retention;
• engorgement of the mammary glands;
• rash;
• nipple discharge;
• headache;
• change in vaginal secretion;
• change in libido;
• Quincke's edema;
• tachycardia;
• mood changes;
• painful sensations in the chest;
• vomiting;
• intolerance to contact lenses;
• anaphylaxis;
• migraine pain.

Side effects of the drug Femoden

The most serious side effects associated with the use of COCs are described in the USES section. Other undesirable effects have been reported with the use of COCs, but their connection with the use of COCs has been neither confirmed nor refuted:

Instructions for use of Femoden (Method and dosage)

The instructions for Femoden indicate that the pills should be taken orally . This needs to be done daily, at approximately the same time. The dragees are washed down with some water. Take one piece for three weeks. After this, a seven-day break is taken and the pills are taken again. Bleeding usually begins 2 or 3 days after the break and may end before you need to switch to a new pack.

The instructions for use of Femoden indicate that if a woman has not previously taken any hormonal contraceptives, the medicine should be taken from the first day of the menstrual cycle or on days 2-5. In this case, it is advisable to additionally protect against pregnancy during the first week.

If you have previously taken other combined oral medications , it is recommended to take Femoden the day after taking the last medication, and in no case later than the next day after the usual one-week menstrual break .

The transition from drugs that contain only gestagens , or from gestagen-releasing intrauterine drugs can be done any day. In the case of an implant or intrauterine device - on the day of removal; when using a solution for internal administration - from the next day. In this case, it is necessary to additionally use barrier methods of protection during the first week.

If a woman had an abortion in the first trimester of pregnancy, she should take the drug immediately. No need for additional protection. If the abortion was done in the second trimester , as well as after childbirth, it is advisable to start taking Femoden after 3 or 4 weeks. If you start taking it later, other methods of protection are additionally needed, in addition, you should make sure that there is no pregnancy.

If Femoden is missed for less than 12 hours, the contraceptive is still effective. The medicine must be taken as quickly as possible. The next dosage is taken at the same time. And if the dose is overdue by more than 12 hours (but not longer than 7 days), the required dosage must be taken as soon as possible. Then the pills are taken at the usual time. Throughout the week, an additional method of protection against unwanted conception is used. It is also necessary to exclude the possibility of pregnancy.

If the drug is missed for more than 12 hours in the 3rd week of the course, the tablets should be taken as soon as possible. Then the reception continues at the usual time, and then the next package begins. Until it ends, withdrawal bleeding is unlikely. At the same time, spotting and some bleeding may occur while taking the medicine. In addition, you can take the required seven-day break when the first pack runs out. Only after that move on to the next one.

When you missed taking the drug, and then there was no bleeding during the usual seven-day period, you must definitely rule out an unwanted pregnancy.

If a woman has had cases of vomiting or diarrhea 4 hours or less after taking the medicine, additional barrier methods of protection are needed. In this case, it is also necessary to follow the recommendations of the instructions when skipping pills.

There are times when the menstrual cycle needs to be delayed. Then the drug is continued to be taken, without taking a seven-day break, for as long as needed until the second package runs out. There may be spotting or some minor bleeding. Upon completion of the second pack, a seven-day break must be taken.

Femoden®

If any of the conditions/diseases/risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including Femoden®, should be carefully weighed in each individual case and discussed with the woman before how she decides to start taking the drug. If any of these conditions or risk factors worsen, intensify, or appear for the first time, 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 COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as DVT, TED, myocardial infarction, cerebrovascular disorders). These diseases are rare.

The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. An increased risk exists during the first 3 months of taking COCs or resuming use after a break 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 COCs (<50 mcg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, although this risk remains lower than the risk of VTE during pregnancy and childbirth .

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

VTE, manifested as DVT, or PE, can occur with the use of any COC. It is extremely rare when using COCs that 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 COCs.

Symptoms of DVT: unilateral swelling of the lower extremity or along the vein, pain or discomfort only in an upright position or when walking, local fever, redness or discoloration of the skin on the lower extremity.

Symptoms of 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 common and less severe conditions (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 convulsions. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the limbs, “acute” abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or behind the breastbone; 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;

- in smokers (with an increase in the number of cigarettes or an increase in 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 under the age of 50 years). 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 COCs;

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

- dislipoproteinemia;

- arterial hypertension;

- migraine;

— diseases of the heart valves;

- atrial fibrillation;

- prolonged immobilization, major surgery, any operation on the lower extremities or major trauma. In these cases, you should stop taking the drug (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. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors. The possible role of varicose veins and superficial thrombophlebitis in the development of VTE 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 migraine during COC use (which may precede cerebrovascular events) is grounds for immediate discontinuation of COC use.

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, antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can 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 (<0.05 mg ethinyl estradiol).

— Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. A slight increase in the risk of cervical cancer has been reported with long-term use of COCs. 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. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who are currently or recently taking COCs is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in the risk of developing breast cancer may be due to the biological effects of COCs, earlier diagnosis of breast cancer, or a combination of these two factors. In women who have ever used COCs, earlier stages of breast cancer are detected than in 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 has been observed, which in some cases led to life-threatening intra-abdominal bleeding. 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.

— Other states

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 been reported rarely. However, if a persistent clinically significant increase in blood pressure develops while taking COCs, these drugs should be discontinued and treatment of arterial hypertension should be initiated. COCs can be continued if normal blood pressure levels are achieved with 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 worsening the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis during the use of COCs have also been described.

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

Acute or chronic liver disease may require discontinuation of COCs 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 COC use.

Although COCs may have an effect on insulin resistance and glucose tolerance, adjustment of the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus taking low-dose COCs is usually not required. However, women with diabetes mellitus should be carefully monitored while taking COCs.

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

Laboratory tests

Taking COCs may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein concentrations, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values.

Reduced efficiency

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

Insufficient control of the menstrual cycle

While taking COCs, irregular bleeding may occur (“spotting” or “breakthrough” bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles. If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.

Some women may not develop withdrawal bleeding while off the pill. If COCs are taken as directed and there is no diarrhea or vomiting while taking the pills, pregnancy is unlikely.

However, if COCs have not been taken regularly before, or if there are no two withdrawal bleedings in a row, pregnancy should be ruled out before continuing to take the drug.

Medical examinations

Before starting or resuming taking Femoden®, you should familiarize yourself in detail with the woman’s medical history, including family history, 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 the woman (but at least once every 6 months) and should include measurement of blood pressure, assessment of the condition of the mammary glands, abdominal and pelvic organs, including cytological examination of the cervical epithelium.

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

You should consult your doctor as soon as possible:

- in case of any health changes, especially any of the conditions listed in the sections “Contraindications” and “Use with caution”;

- if there are lumps in the mammary gland;

- when planning to take other medications (see also “Interaction with other medications”);

- if long-term immobilization is expected (for example, a plaster cast is applied to the leg), hospitalization or surgery is planned (you should consult your doctor at least 4-6 weeks before);

- if unusual heavy bleeding from the vagina occurs;

- if you miss a pill in the first week of taking the drug and have sexual intercourse seven days or less before;

- if there are no two menstrual-like bleeding in a row or there is a suspicion of pregnancy (you should consult your doctor before starting to take tablets from the next package).

You should stop taking the tablets and consult your doctor immediately if possible signs of thrombosis, myocardial infarction or stroke are detected: 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.

Femoden reviews

Reviews about Femoden on forums are very different. There are definitely no negative opinions. However, many women complain of side effects. Typically, weight gain, nausea, vomiting, and mood changes are reported. However, those who have found the drug suitable are satisfied.

Reviews from doctors about Femoden indicate that the drug can indeed have side effects. For some it just doesn't suit. However, it is often recommended for more than just pregnancy protection. So, it can be prescribed for inflammation of the endometrium against the background of anti-inflammatory therapy. In addition, in some cases, Femoden is taken before IVF IVF protocol before .

Femoden price, where to buy

The price of Femoden in pharmacies is usually about 580 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• Femoden tablets p.p.o.
  75mcg+30mcg 21 pcs. Bayer Weimar GmbH/ Jenapharm GmbH RUB 822 order

Pharmacy Dialogue

• Femoden (table no. 21)Bayer

  RUB 803 order

• Femoden (tablet. No. 21)Jenapharm

  RUB 859 order

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Pharmacy24

• Femoden No. 21 tablets Bayer Pharma AG, Nimecchina/Bayer Weimar GmbH i Co.
  KG, Nimechchyna 163 UAH. order