Femoden is a monophasic oral contraceptive.

Release form and composition

The dosage form of Femoden is coated tablets (dragees): white, round (in blisters of 21 pcs., 1 or 3 blisters are placed in a cardboard box).

Active ingredients in 1 tablet:

• ethinylestradiol - 0.03 mg;
• gestodene - 0.075 mg.

Auxiliary components:

• core: lactose monohydrate - 37.43 mg; corn starch - 15.5 mg; magnesium stearate - 0.2 mg; sodium calcium edetate - 0.065 mg; povidone 25,000 - 1.7 mg;
• shell: calcium carbonate - 8.697 mg; sucrose - 19.66 mg; macrogol 6000 - 2.18 mg; glycolic mountain wax - 0.05 mg; talc - 4.242 mg; povidone 700,000 - 0.171 mg.

Indications for use

Femoden is prescribed for the purpose of contraception.

Contraindications

• conditions preceding thrombosis, including angina pectoris, transient ischemic attacks (currently or with a history of indications);
• arterial / venous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, cerebrovascular disorders, myocardial infarction (currently or with a history of indications);
• multiple / severe risk factors for arterial / venous thrombosis;
• diabetes mellitus, accompanied by vascular complications;
• benign / malignant liver tumors (currently or with a history of indications);
• jaundice or liver disease, proceeding in severe forms (currently or with indications in the anamnesis; Femoden should not be prescribed earlier than liver tests are normalized);
• vaginal bleeding of unknown etiology;
• hormone-dependent malignant diseases of the genital organs or mammary glands (diagnosed or in the presence of suspicion);
• pregnancy (confirmed or suspected) and the period of breastfeeding;
• individual intolerance to the components of the drug.

If any of the listed diseases / conditions develop during the reception of Femoden, the drug must be canceled.

Method of administration and dosage

Before using Femoden, it is necessary to exclude pregnancy, as well as the presence of disorders of the blood coagulation system. A woman should undergo a thorough general medical and gynecological examination, which should include an examination of the mammary glands and cytological examination of cervical mucus.

Control examinations should be carried out at least once a year.

It should be taken into account that Femoden does not protect against HIV infection and other sexually transmitted diseases.

The drug is taken orally with a small amount of water, preferably at about the same time. Femoden is intended for daily intake for 21 days. During the period of therapy, the procedure for taking pills indicated on the package should be observed. After the end of taking pills from the package, a break of 7 days should be taken. Withdrawal bleeding (menstrual bleeding) usually occurs during this period. As a rule, it starts 2-3 days after taking the last tablet from the package. By the time you start taking the drug from a new package, it may not end.

Features of starting Femoden's reception:

• transition from taking combined oral contraceptives: therapy begins the next day after taking the last active tablet from the previous package, if necessary, it can be later, however, the break should not be more than 7 days (for drugs containing 21 tablets - the next day after the usual seven-day break; containing 28 pills per package - after taking the last inactive pill);
• transition from an implant: it is recommended to start therapy on the day of its removal (an additional barrier method of contraception must be used for 7 days);
• transition from the injection form: it is recommended to start therapy on the day of the next injection prescribed (for 7 days, an additional barrier method of contraception must be used);
• lack of taking any hormonal contraceptives: therapy can be started on the first day of the menstrual cycle, which is considered the first day of menstrual bleeding. It is also permissible to start therapy on days 2–5 of the menstrual cycle, however, in such cases, a woman should use additional barrier methods of contraception during the first 7 days of taking the drug from the first package;
• conditions after an abortion in the first trimester of pregnancy: therapy can be started immediately (the use of additional contraceptive methods is not required);
• conditions after abortion in the second trimester of pregnancy or childbirth: therapy is recommended to start on days 21–28; if Femoden is started later and the woman during this period was not sexually active, an additional barrier method of contraception must be used for 7 days (otherwise, pregnancy must first be excluded).

Contraceptive protection does not decrease in cases where the delay in taking the pills was less than 12 hours, therefore, if you accidentally skip taking a single dose, it is recommended to take it as soon as possible. Changing the usual scheme of using Femoden is not required in the future.

If the break exceeds the specified time interval, the following rules should be followed:

• the maximum allowable break in taking the drug is 7 days;
• the time to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis - 7 days.

If a woman missed taking Femoden within 1-14 days from the start of taking the drug from a new package, then it is recommended to take the pill as soon as possible, even if it means taking two single doses at the same time. The time of taking the next single dose should not be changed. Additionally, over the next 7 days, you need to use barrier methods of contraception. If sexual intercourse has taken place within a week before skipping the pills, the risk of pregnancy should be taken into account. It should be borne in mind that the more pills are missed, and the closer the pass is to the seven-day break in taking pills, the higher the likelihood of pregnancy.

If a break in taking the drug lasting longer than 12 hours was in the period from the 14th to the 21st day from the moment you started taking the drug from a new package, you need to be guided by the above principles. At the same time, you can start taking pills from the next package without interruption. As a rule, in this case, withdrawal bleeding does not occur until the end of the second pack, but therapy may be accompanied by spotting bleeding or breakthrough uterine bleeding.

If a woman missed a dose, after which there is no withdrawal bleeding in the first normal drug-free break, the likelihood of pregnancy must be taken into account.

In cases where vomiting occurs within 3-4 hours after taking Femoden, a violation of the absorption of active substances is possible (it is recommended to be guided by the rules that relate to skipping pills). If a woman does not want to change the normal regimen of taking the drug, she should take an additional tablet / tablets from another package.

To delay the onset of menstruation, Femoden should be taken without interruption.

Side effects

Possible side reactions: hypersensitivity reactions, tenderness / engorgement of the mammary glands, secretion from them, migraine, headache, decreased mood, changes in libido, vomiting, poor tolerance of contact lenses, nausea, various skin reactions, changes in vaginal secretion, changes in body weight , fluid retention. The connection between Femoden's reception and their development has not been proven / refuted.

In some cases, chloasma may occur / appear, especially with a burdened history of chloasma in pregnant women.

special instructions

Any irregular bleeding should only be assessed after an adaptation period of approximately 3 menstrual cycles.

In cases where irregular bleeding recurs or occurs after previous regular cycles, the doctor should consider non-hormonal causes and prescribe adequate diagnostic measures (possibly with diagnostic curettage) in order to exclude pregnancy or malignant neoplasms.

Sometimes during a break in taking pills, withdrawal bleeding does not develop. In cases where Femoden is taken without disturbances, pregnancy is unlikely. In the absence of two menstrual bleeding in a row, pregnancy must be excluded.

In cases where the conditions / risk factors listed below are present, a careful assessment of the ratio of the expected benefit with the possible risk is required before starting Femoden. When the existing symptoms increase or they appear for the first time, it is necessary to assess the feasibility of further use of the drug.

The onset of symptoms of arterial / venous thrombosis is one of the reasons that can lead to the cancellation of Femoden. These symptoms include: unilateral leg pain and / or swelling, sudden severe chest pain with / without irradiation to the left arm, sudden shortness of breath, sudden coughing fit, increased severity and frequency of migraine, any unusual, severe, prolonged headache, sudden partial / complete loss of vision, slurred speech or aphasia, diplopia, dizziness, collapse with / without partial seizure, acute abdomen, movement disorders, weakness, or significant loss of sensation that appears suddenly on one side or in one part of the body.

You also need to take into account the presence of factors that increase the likelihood of thromboembolism and thrombosis (venous and / or arterial): smoking, age, major surgical interventions, dyslipoproteinemia, arterial hypertension, atrial fibrillation, heart valve disease, prolonged immobilization, a burdened family history of thromboembolism at a relatively young age, obesity (with a body mass index\u003e 30 kg / m 2), extensive trauma, any leg surgery. In addition, it should be borne in mind that in the postpartum period, the likelihood of thromboembolism increases.

Diseases / conditions that may increase the risk of developing these circulatory disorders: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia. Adequate therapy for these diseases can reduce the associated risk of thrombosis.

Also, the following biochemical parameters can indicate the presence of a predisposition to thrombosis: resistance to activated protein C (APC), hyperhomocysteinemia, deficiency of antithrombin III, protein C and S, antiphospholipid antibodies.

There is some information indicating the relationship of long-term use of Femoden with an increased risk of cervical cancer. However, these data did not receive reliable confirmation, since it is difficult to take into account other factors influencing the development of the disease, in frequency, sexual behavior.

In rare cases, with the use of sex steroids, the development of liver tumors was noted, and therefore, in the event of severe pain in the abdomen, an enlarged liver, or signs of intra-abdominal bleeding during the differential diagnosis, Femoden's intake should be taken into account.

If persistent arterial hypertension develops during therapy, treatment of arterial hypertension and refusal to take the drug is recommended. You can continue using Femoden after the normalization of the indicators.

During the period of therapy, the following conditions may develop / worsen (a causal relationship with Femoden's intake has not been proven): jaundice and / or itching, which is associated with cholestasis, porphyria, hemolytic uremic syndrome, formation of stones in the gallbladder, systemic lupus erythematosus, chorea (Sydenham's disease), hearing loss, herpes during pregnancy.

Hepatic dysfunction in acute / chronic course may lead to drug withdrawal. Resumption of therapy is possible after restoration of indicators. Recurrent cholestatic jaundice, which first occurred during pregnancy or previous use of sex steroids, requires discontinuation of Femoden.

Women with diabetes mellitus during the period of therapy should be under the close supervision of a specialist.

With hypertriglyceridemia, including the presence of indications of a burdened family history, an increased likelihood of pancreatitis should be taken into account.

In cases where there is a tendency to develop chloasma, prolonged exposure to the sun and exposure to ultraviolet radiation should be avoided.

If the symptoms of women suffering from hirsutism have appeared recently, or there is a significant increase in them, other reasons should be taken into account in the differential diagnosis, including congenital dysfunction of the adrenal cortex, androgen-producing tumors.

Taking Femoden may interfere with the results of some laboratory tests. This applies to indicators of renal, adrenal, liver, thyroid function, plasma levels of transport proteins, carbohydrate metabolism, fibrinolysis and coagulation. Usually, such violations do not go beyond the normal range.

Drug interactions

Simultaneous use with certain substances / drugs, as a result of which the clearance of the active substances of Femoden may increase, can cause breakthrough uterine bleeding or a decrease in contraceptive reliability. These drugs include:

• hydantoins, rifampicin, barbiturates, primidone, carbamazepine; probably - oxcarbazepine, topiramate, griseofulvin, felbamate (the mechanism is based on the induction of liver enzymes by these drugs);
• drugs with antibacterial action, including tetracyclines, ampicillins (the mechanism is not clear).

If a woman takes any of the above drugs for a short course, during the period of combination therapy and for another 7 days (for rifampicin, this period should be increased to 28 days) after its termination, the patient should temporarily use a barrier method of contraception. In cases where the use in combination with the listed drugs was started at the end of the Femoden package, it is recommended to take it without a seven-day break.

Calendar package (for 1 cycle) of 21 pills. Active ingredient: 1 tablet contains ethinylestradiol 30 mcg, gestodene 75 mcg. Excipients: lactose monohydrate, corn starch, povidone, sodium calcium edetate, magnesium stearate.

pharmachologic effect

Low-dose, monophasic oral contraceptive. The contraceptive effect of Femoden is based on the interaction of various factors, the most important of which are inhibition of ovulation and changes in the secretion of cervical mucus. In addition to the contraceptive effect, combined oral contraceptives have a positive effect that should be considered when choosing a method of birth control. The cycle becomes more regular, painful periods are less common. the intensity of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases.

Indications for use

- oral contraception.

Method of administration and dosage

Before using Femoden, a woman is advised to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and cytological examination of cervical mucus), to exclude pregnancy. In addition, disorders of the blood coagulation system should be excluded. Control examinations must be carried out at least once a year.

A woman should be warned that Femoden-type drugs do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Start of reception

Dragee should be taken in the order indicated on the package, every day at about the same time with a little water. Take one tablet a day continuously for 21 days. Reception of each subsequent pack begins after a 7-day break, during which there is withdrawal bleeding (menstrual bleeding). It usually starts 2-3 days after taking the last tablet and may not end before taking a new package.

• In the absence of taking any hormonal contraceptives in the previous month
  Femoden's reception 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 pills from the first package.
• When switching from combined oral contraceptives
  It is preferable to start taking Femoden 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 in taking (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 pills per pack).
• When switching from contraceptives containing only gestagens (mini-pills, injection forms, implant)
  A woman can switch from a mini-drink to Femoden any day (without a break), from an implant - on the day of its removal, from an injection form - from the day. when the next injection should have been given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills.
• After an abortion in the first trimester of pregnancy
  The woman can start taking it immediately. If this condition is met, a woman does not need additional contraceptive protection.
• After childbirth or abortion in the second trimester of pregnancy
  A woman should be advised to start taking the drug on days 21-28 after childbirth or abortion in the second trimester of pregnancy. If the appointment is started later. it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. However, if a woman has already had sexual intercourse, pregnancy should be excluded or it is necessary to wait for the first menstruation before taking Femoden.

Reception of missed pills

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

If the delay in taking the pills is more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

• taking pills should never be interrupted for more than 7 days;
• 7 days of continuous dragee intake are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, the following tips can be given if the delay in taking the pills was more than 12 hours (the interval from the moment of taking the last pills is more than 36 hours):

The first and second week of taking the drug
A woman should take the last missed pills as soon as possible, as soon as she 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 (for example, a condom) must be used for the next 7 days. If intercourse took place within a week before skipping the pills, the likelihood of pregnancy must be taken into account. The more pills are missed, and the closer this pass is to the 7-day break in taking pills, the higher the risk of pregnancy.

The third week of taking the drug
A woman should take the last missed pills as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Additionally, you should use a barrier method of contraception (for example, a condom) for the next 7 days. In addition, the reception of pills from a new package should be started as soon as the current package ends, i.e. nonstop. Most likely, the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting bleeding or breakthrough uterine bleeding on the days of taking the pills.

If a woman missed taking pills, and then in the first normal drug-free interval, she does not have withdrawal bleeding, pregnancy must be excluded.

If a woman has vomited within 3 to 4 hours after taking Femoden pills, absorption may be incomplete. In this case, you need to be guided by the advice on skipping pills. If a woman does not want to change the normal regimen of taking the drug, she should, if necessary, take additional pills (or several pills) from another package.

How to delay or delay the onset of menstrual bleeding

In order to delay the onset of menstruation, a woman should continue taking pills from a new Femoden package immediately after all pills from the previous one have been taken, without interruption. Dragee from this new package can be taken as long as the woman wishes (until the package is finished). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Femoden from a new package after the usual 7-day break.

In order to postpone the day of the onset of menstruation 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, will have spotting spotting and breakthrough bleeding while taking the second pack (as well as in the case when she would like to delay the onset of menstruation).

Side effect

The following undesirable effects have been described in women taking Femoden, and their relationship with the drug has not been confirmed or refuted:

• engorgement, soreness of the mammary glands, secretion from them;
• headache;
• migraine;
• change in libido;
• decreased mood;
• poor tolerance of contact lenses;
• nausea;
• vomiting;
• changes in vaginal secretion;
• various skin reactions;
• fluid retention;
• change in body weight;
• hypersensitivity reactions.

Chloasma can sometimes develop, especially in women with a history of pregnant chloasma.

Contraindications for use

Combined oral contraceptives should not be used if you have any of the conditions listed below. If any of these conditions develop for the first time while taking, the drug should be discontinued immediately.

• the presence of thrombosis (venous and arterial) currently or in history (for example, deep vein thrombosis, pulmonary thromboembolism, myocardial infarction, cerebrovascular disorders);
• presence at present or in history of conditions preceding thrombosis (for example, transient ischemic attacks, angina pectoris);
• diabetes mellitus with vascular complications;
• the presence of severe or multiple risk factors for venous or arterial thrombosis may also be considered a contraindication;
• present or a history of jaundice or severe liver disease (until liver tests return to normal);
• the presence of a current or history of liver tumors (benign or malignant);
• identified hormone-dependent malignant diseases of the genitals or mammary glands or suspicion of them;
• vaginal bleeding of unknown origin;
• pregnancy or suspicion of it;
• lactation;
• hypersensitivity to any of the components of Femoden.

Application for violations of liver function

Contraindication: Severe liver disease (until liver tests return to normal).

special instructions

While taking a combination of estrogen / gestagens, irregular bleeding (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, then non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. These may include diagnostic curettage.

In some women, withdrawal bleeding may not develop during a break in taking pills. If the drug was taken as directed, the woman is unlikely to be pregnant. Nevertheless, if before this pills were taken irregularly or if there are no two menstrual bleeding in a row, pregnancy should be excluded before continuing to take the drug.

If any of the conditions / risk factors listed below are currently available, then the potential risk and expected benefits of using Femoden in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the drug. In the event of an aggravation, intensification, or the first manifestation of any of the abated conditions or risk factors, a woman should consult with her doctor, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system

A number of epidemiological studies have revealed a slight increase in the incidence of venous and arterial thrombosis and thromboembolism when taking combined psroral contraceptives.

Venous thromboembolism (VTE), in the form of deep vein thrombosis and / or pulmonary thromboembolism, can develop with all combined psroral contraceptives. The approximate incidence of VTE in women taking oral contraceptives with a low dose of estrogen (less than 50 mcg ethinylestradiol) is up to 4 per 10,000 women per year compared to 0.5-3 per 10,000 women per year in women who do not use OC. However, the incidence of VTE developing with combined oral contraceptives is less than the incidence associated with pregnancy (6 per 10,000 pregnant women per year).

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, for example, renal, hepatic, mesenteric, are described; retinal veins and arteries. The relationship of these cases with taking combined oral contraceptives has not been proven.

A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include: one-sided leg pain and / or edema; sudden severe chest pain, with or without radiation to the left arm; sudden shortness of breath; sudden attack of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraines; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with / or without partial seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; "sharp" stomach.

The risk of thrombosis (venous and / or arterial) and thromboembolism is increased:

• with age;
• in smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years old);
• in the presence of a family history (i.e. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age);
• in the presence of obesity (body mass index more than 30 kg / m 2);
• in the presence of dyslipoproteinemia;
• in the presence of arterial hypertension;
• in the presence of heart valve disease:
• in the presence of atrial fibrillation;
• if necessary, 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 a planned operation, at least four weeks before it) and not resume taking within 2 weeks after the end of immobilization.

Consideration should be given to the increased risk of thromboembolism in the postpartum period.

Circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, nspecific ulcerative colitis, sickle cell anemia. Adequate treatment of these conditions can reduce the associated risk of thrombosis.

Biochemical parameters that may indicate a predisposition to thrombosis include resistance to activated protein C (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).

It should be borne in mind that the risk of thrombosis during pregnancy is higher than when taking combined oral contraceptives.

Tumors

An increased risk of cervical cancer with long-term use of combined oral contraceptives has been reported in some epidemiological studies. Its connection with the use of combined oral contraceptives has not been proven. Controversy persists as to the extent to which these cases are associated with sexual behavior and other factors such as human papillomavirus (HPV).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk (RR \u003d 1.24) of developing breast cancer diagnosed in women who were using combined oral contraceptives at the time of the study. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to an earlier diagnosis of breast cancer in women using combined oral contraceptives.

In rare cases, against the background of the use of sex steroids, the development of liver tumors was observed. In the event of severe pain in the abdomen, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Other conditions

Although mild increases in blood pressure have been reported in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. The relationship between the use of combined oral contraceptives and arterial hypertension has not been established. However, if persistent arterial hypertension develops during their administration, it is advisable to discontinue combined oral contraceptives and treat arterial hypertension. Reception can be continued if normal blood pressure values \u200b\u200bare achieved with the help of antihypertensive therapy.

The following conditions break down or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or pruritus associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea minor (Sydenham's disease); herpes during pregnancy; hearing loss associated with otosclerosis.

Acute or chronic liver dysfunction 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 steroids, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives have an effect on tissue insulin resistance and glucose tolerance, there is usually no need to adjust the dose of anti-hypoglycemic drugs in diabetic patients taking these drugs. However, these women must be under close medical supervision.

In women with hypertriglyceridemia, or a family history of it, an increased risk of developing pancreatitis while taking combined oral contraceptives cannot be ruled out.

Women with a tendency to chloasms while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Singing in women suffering from hirsutism, the symptoms have developed recently or have increased significantly, other reasons should be taken into account when making a differential diagnosis, such as a gene producing tumor, congenital adrenal cortex dysfunction.

Laboratory tests

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

Influence on the ability to drive vehicles and use mechanisms

No effects were observed.

Overdose

No serious side effects have been reported in overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, minor vaginal bleeding. There is no specific antidote; symptomatic treatment should be carried out.

Drug interactions

Drug interactions that increase the clearance of sex hormones can lead to breakthrough uterine bleeding or a decrease in contraceptive reliability. This has been found for hydantoins. barbiturates, primidone, carbamazepine and rifampicin; there is also suspicion of oxcarbazepine, topiramate, felbamate and griseofulvin. The mechanism of this interaction is based on the induction of liver enzymes by these drugs.

Contraceptive reliability is reduced with antibiotics such as ampicillins and tetracyclines. The mechanism of this action is not clear.

Women receiving any of the above classes of drugs in a short course, in addition to Femoden, should temporarily use a barrier method of contraception during concomitant use of drugs and for 7 days after their cancellation. While taking rifampicin and within 28 days after its cancellation, a barrier method of contraception (for example, a condom) should be used in addition to Femoden. If the use of the listed drugs is started at the end of the Femoden package, the next package should be started without the usual interruption in taking.

Women who receive these drugs for a long time should be advised to use other (non-hormonal) methods of contraception (for example, a condom).

G.03.A.A.10 Gestodene and ethinyl estradiol

"Femoden" is a combined oral contraceptive intended for systemic use. Active and excipients are the components that make up the Femoden product. Instructions, reviews report that the necessary effect of the drug is achieved due to the action of gestodene and ethinyl estradiol.

pharmachologic effect

"Femoden" refers to drugs with a low dosage of hormones. It inhibits the synthesis of estrogens, the presence of which is required for the maturation of follicles. The contraceptive effect of the drug is based on a combination of several factors interacting with each other, the most important of which are inhibition of ovulation, changes in the secretion of cervical mucus. The drug acts on the endometrium, making it less susceptible to blastocyst anchorage. There is no androgenic activity.

Contraceptives "Femoden" make the cycle regular, and menstruation less painful. The drug helps to reduce the intensity of bleeding, which reduces the risk of anemia due to iron deficiency.

Pharmacokinetics

The active ingredients of "Femodena" (gestodene and ethinyl estradiol) are absorbed completely and quickly enough when administered orally. The primary passage of gestodene through the liver is not accompanied by its cleavage, while most of the ethinyl estradiol is metabolized and binds to plasma proteins. The bioavailability of the active substance is approximately 99% of the taken dose of the drug "Femoden". The doctors' comments indicate that ethinyl estradiol passes into breast milk, therefore, its penetration into the body should be excluded during lactation. Gestodene binds to plasma albumin, which are involved in the binding of sex steroids, and to globulin. Active components are excreted from the body in the form of metabolites through the liver and kidneys.

Indications

Women over 40 are prescribed drugs that contain small doses of estrogen. These drugs include "Femoden". Reviews of women after 40 years of age display information about the frequent prescription of this drug in the initial stages of menopause for the implementation of hormone therapy.

The tablets are used as a systemic means of preventing pregnancy. The drug is effective for menstrual irregularities and heavy bleeding.

In some cases, "Femoden" is used before IVF. Reviews show that it is prescribed to those women for whom the previous IVF protocol was unsuccessful. Acceptance of funds is carried out taking into account individual characteristics.

Contraindications

Consider the contraindications for taking Femoden. The doctors' reviews contain some information about the use of this medication. If conditions in which it is forbidden to take Femoden tablets develop during the period of treatment with this drug, it should be immediately canceled. Doctors do not prescribe "Femoden" during pregnancy and if it is suspected, lactation, menopause of the hyperfollicular stage, and when the patient has such disorders:

• jaundice, severe illness, liver tumors;
• diabetes mellitus, accompanied by vascular complications with severe hypertriglyceridemia;
• impaired renal function;
• disorders of cerebral circulation;
• migraines, in which focal neurological manifestations are noted;
• negative reaction of the body to the components of the drug;
• porphyria;
• epilepsy;
• congenital hyperbilirubinemia;
• vaginal bleeding, the causes of which could not be established;
• pancreatitis, in which there is severe hypertriglyceridemia;
• arterial and venous thrombosis, the development of conditions that can lead to their appearance;
• inflammation of the female genital organs;
• malignant diseases of the genitals and breasts, which require regular intake of hormones, or suspicion of their presence.

Pregnancy is possible after a certain period of time after the end of taking Femoden. Reviews of women whose pregnancy planning was carried out after using this contraceptive shows that you can think about having a baby three months after the drug is discontinued, when the functions of the ovaries and hormonal levels are restored.

Drug use

Before using the drug, women undergo a general medical examination and a full examination by a gynecologist. In the course of the research, pregnancy, blood clotting disorders and predisposition to them are excluded. Once a year (at least), women need to undergo a follow-up examination.

As for taking Femoden, instructions for use, doctors' reviews recommend starting the use of tablets on the first day of the cycle, but they are allowed to be taken on the 2-5th day. In this case, a barrier-type contraceptive should be used for seven days. In cases where the medication was taken more than 12 hours apart, additional contraception is also needed.

If a woman previously took combined oral contraceptives, "Femoden" begins to drink the next day. If it is necessary to switch from a preparation based on gestagens (mini-pills), it can be replaced with Femoden any day (without interruption). Reviews show that after removal of the implant, you can start taking the contraceptive immediately. After the abolition of drugs with injectable progestogens, you can switch to Femoden on the day when the next injection was to be performed. In all cases, the first 7 days for contraception, additional barrier methods should be used.

Dragees are intended for daily use for 21 days. It is desirable that they always be received at the same time. A new package begins after 7 days, during which menstrual bleeding is noted.

After an abortion, the drug is used immediately on the first day, and after childbirth - on the 21-28th day.

Irregular bleeding is possible when using Femoden. Reviews of women, however, show that in most cases they are present only at the initial stage - for several months. If they do not disappear after three cycles, a diagnosis is required to exclude the presence of malignant tumors and pregnancy.

Taking missed pills

If the drug was taken with a delay, which was no more than 12 hours, the protective effect deteriorates. The tablet should be taken as soon as possible, while the following should be consumed at the usual time.

With a longer delay (more than 12 hours), the protective effect decreases more. You should never interrupt the use of the drug for more than one week. For those who took Femoden contraceptives more than 36 hours ago, the reviews contain some tips:

• 1 and 2 weeks of taking the drug - you need to take the missed pill faster, even if you have to use two pills at the same time. The following pills should be drunk at the usual time. Be sure to provide additional protection (barrier method) for 7 days. With intercourse within 7 days before skipping the pill, there is a chance of pregnancy. The longer the drug has not been used and the closer the pass to a break of 1 week, the higher the likelihood of pregnancy.
• 3rd week of taking the funds - in addition to the actions specified in the first paragraph, it should be borne in mind that the next package must be started without interruption, immediately after using the previous pack of Femoden. Instructions for use, reviews indicate that, most likely, withdrawal bleeding in this case will not occur until the second pack of tablets ends. But there may be spotting bleeding or breakthrough uterine bleeding during the period of use of the drug. If there was a pass and there is no withdrawal bleeding on the first day after the end of the drug intake, the woman needs to be checked for pregnancy.

If vomiting occurs 3 hours after using the product, the absorption of the components may be incomplete. What should be done if there is such a result after taking Femoden? Reviews of women contain tips that indicate that if you do not want to break the usual regimen of taking pills, then if necessary, you need to drink one or more additional pills. In such a situation, you can use the same recommendations as when skipping a pill.

Side effects

Consider the side effects that Femoden birth control pills can have. Reviews indicate that this remedy can lead to the development of such side effects:

• change in body weight;
• headache;
• nausea, vomiting;
• migraine pain;
• fluid retention;
• urticaria, rash, Quincke's edema;
• anaphylaxis;
• tachycardia;
• chest pain;
• engorgement of the breast;
• discharge from the nipples, change in vaginal discharge;
• the formation of chloasma;
• changes in mood and libido;
• intolerance to lenses for vision correction.

special instructions

There are special instructions that must be taken into account when using the Femoden tool. Reviews report that the effect of the drug is fully manifested after 2 weeks of its use. In this regard, during this period, it is recommended to use also contraceptives that do not contain hormones.

If menstrual bleeding is heavy, you should consult with your gynecologist. If the reaction to the drug after 21 days of its use does not appear within 7 days, you cannot continue to use it yourself. We need a doctor's consultation on the advisability of further taking Femoden tablets. Reviews show that women who smoke are much more likely to develop vascular diseases with serious consequences, such as stroke, myocardial infarction, than those patients who do not smoke. In addition, this risk increases with age, as with smoking large quantities of cigarettes. With high blood pressure, there is a possibility of thrombosis.

Taking the drug is stopped not only when side effects appear, but also with prolonged bed rest, as well as in cases when an operation is planned (6 months before it).

Drug interaction "Femodena"

What drugs, when taken simultaneously, can reduce the contraceptive effect of Femoden? Reviews indicate that these drugs include:

• "Griseofulvin";
• "Topiramate";
• Felbamat;
• Rifampicin;
• Oxcarbazepine;
• "Primidon";
• "Carbamazepine";
• hydantoins;
• barbiturates;
• antibiotics.

dragee; blister 21, pack of cardboard 1;

Composition
Dragee 1 dragee
gestodene 0.075 mg
ethinyl estradiol 0.03 mg
excipients: lactose monohydrate; corn starch; polyvidone 25000; sodium calcium edetate; magnesium stearate; sucrose; polyvidone 70,000; polyethylene glycol (macrogol) 6000; calcium carbonate; talc; Montan glycol wax
in a blister with a calendar scale 21 pcs .; in the box 1 blister.

Pharmacodynamics of the drug Femoden

Inhibits the secretion of FSH and LH by the pituitary gland. Suppresses follicle maturation and ovulation. Reduces the susceptibility of the endometrium to the blastocyte, increases the viscosity of cervical mucus. Hinders the penetration of sperm into the uterine cavity. There were no fetal malformations, impaired fertility, lactation and reproductive function of the offspring of animals that had previously taken the drug. The study of ethinyl estradiol and gestodene in vitro and in vivo did not reveal mutagenic properties.

Pharmacokinetics of the drug Femoden

After oral administration, gestodene is rapidly and completely absorbed. It is not metabolized during the primary passage through the liver. Bioavailability - 99%. It binds to plasma albumin and sex steroid binding globulin. It is excreted in the form of metabolites in urine and bile in a ratio of 6: 4.

Ethinylestradiol is rapidly and completely absorbed after oral administration. To a large extent metabolized during absorption and first pass through the liver. Most of it binds to plasma proteins (free fraction - 2%). Excreted in urine and bile in a ratio of 4: 6. Penetrates into breast milk (about 0.02% of the daily dose enters the child's body during breastfeeding).

Use of the drug Femoden during pregnancy

Contraindicated in pregnancy.

Contraindications to the use of Femoden

Hypersensitivity, severe liver dysfunction, liver tumors (including a history); thromboembolism (including a history and an increased risk of its development, for example, disorders of the blood coagulation system with a tendency to thrombosis, some heart diseases); severe diabetes mellitus with vascular complications, pancreatitis or a history of pancreatitis, accompanied by severe hypertriglyceridemia; migraine with a history of focal neurological symptoms, breast and endometrial cancer (including a history); uterine bleeding of unknown origin, pregnancy.

Side effects of the drug Femoden

In rare cases - headache, depression, nausea, abnormal stomach function, tenderness and engorgement of the mammary glands, changes in body weight and libido, chloasma, deterioration in the tolerance of contact lenses.

Method of application and dose of the drug Femoden

Inside, in the order indicated on the package, every day at about the same time, with a small amount of water, 1 tablet a day continuously for 21 days. Reception of the next package begins after a 7-day break in taking pills, during which withdrawal bleeding usually occurs. Bleeding, as a rule, begins 2-3 days after taking the last tablet and may not end until you start taking a new package.

How to start taking Femoden®

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

Femoden® is taken on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking it 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 pills from the first package.

When switching from other combined oral contraceptives

It is preferable to start taking Femoden® 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 preparations containing 21 tablets) or after taking the last inactive tablet (for preparations, containing 28 pills per pack).

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

A woman can switch from a mini-drink 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 use an additional barrier method of contraception during the first 7 days of taking 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 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 pills. However, if a woman has already had a sex life, pregnancy should be excluded or it is necessary to wait for the first menstruation before taking Femoden®.

Reception of missed pills

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

If the delay in taking pills is more than 12 hours, contraceptive protection may be reduced. 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 dragee intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following tips can be given if the delay in taking the pills is more than 12 hours (the interval since taking the last pills is more than 36 hours):

The first week of taking the drug

A woman should take the last missed pills as soon as possible, as soon as she remembers (even if this means taking 2 pills at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (eg a condom) must be used for the next 7 days. If intercourse took place within a week before skipping the pills, the likelihood of pregnancy must be taken into account. The more pills are missed, and the closer they are to a break in taking active substances, the more likely pregnancy is.

Second week of taking the drug

A woman should take the last missed pills as soon as possible, as soon as she remembers (even if this means taking 2 pills at the same time). The next dragee is taken at the usual time.

Provided that the woman took the pills correctly within 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping 2 (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 a decrease in reliability is inevitable due to the upcoming break in taking pills.

A woman must strictly adhere to one of the following two options. Moreover, if in the 7 days preceding the first missed pills, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. A woman should take the last missed pills as soon as possible, as soon as she remembers (even if this means taking 2 pills at the same time). The next pills are taken at the usual time, until the pills from the current package run out. The next packaging should be started immediately. Withdrawal bleeding is unlikely until the second pack ends, but spotting and breakthrough bleeding may occur while taking pills.

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

If a woman missed taking pills, and then during a break in taking pills, she does not have withdrawal bleeding, pregnancy must be excluded.

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

Changing the day the menstrual cycle starts

In order to delay the onset of menstruation, a woman should continue taking pills from a new Femoden® package immediately after all pills from the previous one have been taken, without interruption. Dragee from this new package can be taken as long as the woman wishes (until the package is finished). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Femoden® from a new pack after the usual 7-day break.

In order to postpone the day of the onset of menstruation to another day of the week, a woman should be advised to 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 and breakthrough bleeding while taking the second pack (as well as in the case when she would like to delay the onset of menstruation).

Interaction of the drug Femoden with other drugs

Some antibiotics, incl. ampicillin reduces the content of active components in plasma. Hydantoin, rifampicin, phenylbutazone may weaken the effect.

Precautions when taking Femoden

Against the background of the first cycles, in rare cases, "smearing" intermenstrual bleeding is possible, which stops when the drug is continued. With constant or repeated intermenstrual bleeding, with intermenstrual bleeding that first appeared after prolonged use of the drug, a thorough examination, including diagnostic curettage, is necessary to exclude organic changes.

In case of short-term vomiting and diarrhea, it is recommended to additionally use non-hormonal methods of contraception until the end of the corresponding cycle of taking the drug, and continue taking Femoden from the package to avoid the development of premature withdrawal bleeding.

The drug should be discontinued 6 weeks before planned surgery, if prolonged bed rest is prescribed. In cases of migraine-like or frequent headaches, sudden visual disturbances, the first signs of thrombosis (pain and swelling of the lower extremities, stabbing pain when breathing or coughing for no apparent reason, chest pain and feeling short of breath), with the appearance of jaundice, cholestasis, hepatitis, the onset of pregnancy, a significant increase in blood pressure, an increase and increase in the frequency of epileptic seizures, you must immediately stop taking the drug and consult a doctor. The relative risk of developing arterial thrombosis increases over the age of 35 and with smoking.

Special instructions when taking Femoden

Despite the fact that steroid hormones can affect glucose tolerance, changes in the patient's need for insulin or oral antidiabetic drugs when taking low-dose contraceptives (ethinyl estradiol content< 0,05 мг) не происходит. Однако при наличии сахарного диабета необходимо тщательное наблюдение за женщинами, которые принимают гормональные контрацептивы.

Storage conditions of the drug Femoden

List B.: At a temperature not exceeding 25 ° C.

Shelf life of the drug Femoden

Femoden belongs to the ATX classification:

G Genitourinary system and sex hormones

G03 Sex hormones and modulators of the reproductive system

G03A Hormonal contraceptives of systemic action

G03AA Progestogens and estrogens (fixed combinations)