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Femoden - instructions for use, analogs, reviews and release forms (birth control pills) of a drug for contraception in women, including during pregnancy and lactation. Composition and Contraindications

Femoden - instructions for use, analogs, reviews and release forms (birth control pills) of a drug for contraception in women, including during pregnancy and lactation. Composition and Contraindications

In this article, you can read the instructions for using the contraceptive drug Femoden. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of specialists on the use of Femodena in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Femodena in the presence of existing structural analogues.Use for contraception in women, including during pregnancy and lactation. Composition of the preparation.

 

Femoden - low-dose monophasic oral contraceptive.

 

The contraceptive effect of Femodena is based on the interaction of various factors, the most important of which are inhibition of ovulation and a change in the secretion of cervical mucus. In addition to contraceptive action, combined oral contraceptives have a positive effect, which should be considered when choosing a method of birth control. The cycle becomes more regular, less painful menstruation is observed less often. the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia.

 

Composition

 

Ethinyl estradiol + Gestodene + auxiliary substances.

 

Pharmacokinetics

 

Gestoden

 

Accepted orally gestoden quickly and completely absorbed. Absolute bioavailability of Gestodene is about 99% of the dose. Gestodene binds to serum albumin and globulin, which binds to sex steroids (GSPC). Only about 1-2% of the total serum level of Gestodene is in free form, approximately 50-70% are specifically associated with the GSP.The relative distribution of fractions (free Gestodene, bound with albumin, associated with the GSPC) depends on the concentration of the GHS in the serum. Following the induction of the binding protein, the fraction associated with the GHS is increased, while the free and albumin bound fraction is reduced. There was no interaction with simultaneous administration of ethinylestradiol.

 

There is a two-phase decrease in the serum Gestodene level. The terminal phase of the distribution is characterized by a half-life of about 12-15 hours. Gestodene is not excreted unchanged, only in the form of metabolites, which are eliminated with a half-life of about 1 day. Metabolites Gestodene excreted in urine and bile in a ratio of about 6: 4. Pharmacologically active metabolites of Gestodene are not known.

 

The pharmacokinetics of Gestodene is influenced by the serum level of GSH, which increases approximately 3-fold under the action of ethinyl estradiol. With daily intake of the drug, an increase in the concentration of Gestodene in the blood serum is observed. Mean serum levels are approximately 4 times higher when equilibrium concentration is reached (usually achieved during the second half of the cycle).

 

Ethinylestradiol

 

After ingestion, ethinylestradiol is rapidly and completely absorbed.During absorption and the first passage through the liver, a significant portion of ethinyl estradiol is metabolized. Absolute bioavailability is about 60%.

 

About 98.5% of the serum level of ethinyl estradiol binds non-specifically to serum albumins. Ethinyl estradiol increases the hepatic synthesis of GSPC (globulin, binding sex steroids).

 

During absorption and the first passage through the liver, a significant portion of ethinyl estradiol is metabolized (mainly by hydroxylation). Metabolites are both in free form, and in the form of glucuronides and sulfates. The rate of metabolic clearance from plasma is about 5 ml / min / kg.

 

There is a two-phase decrease in the level of ethinylestradiol in plasma, with T1 / 2 of the final phase of about 24 hours. Unchanged is not excreted from the body. Metabolites of ethinyl estradiol are excreted in urine and bile. The equilibrium concentration reached after 3-4 days of admission was 40-60% higher than the concentration of ethinyl estradiol after a single dose.

 

In nursing mothers, about 0.02% of the daily dose of ethinylestradiol can enter the body of a child with breast milk.

 

Indications

  • contraception.

 

Forms of release

 

Tablets coated with a coating of 30 μg + 75 μg.

 

Instructions for use and reception scheme

 

Before applying Femodena, a woman should undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), and exclude pregnancy. In addition, violations of the blood coagulation system should be avoided.

 

Control examinations should be conducted at least once a year.

 

A woman should be warned that preparations of the type of Femodena do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

 

Dragee should be taken in the order indicated on the package, every day at about the same time with a small amount of water. Take one pills a day continuously for 21 days. The admission of each next package begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually begins on day 2-3 from the reception of the last dragee and may not end before the start of taking a new package.

 

In the absence of taking any hormonal contraceptives in the previous monthThe use of Femodena begins on the first day of the menstrual cycle (ie on the first day of menstrual bleeding). It is acceptable to start taking the menstrual cycle on the 2nd-5th day, but in this case it is recommended to use the barrier method of contraception during the first 7 days of taking the pills from the first package.

 

When switching from combined oral contraceptives, it is preferable to start taking Femodena the day after receiving the last active pills from the previous package, but in no case later than the day after the usual 7-day suspension (for preparations containing 21 tablets) or after taking the last inactive dragee (for preparations containing 28 dragees in a package).

 

When switching from contraceptives containing only gestagens (minipillins, injection molds, implants), a woman can switch from a mini-drink to Femoden on any day (without interruption), from an implant - on the day of removal, from the injection form - from the day. when the next injection would be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

 

After an abortion in the first trimester of pregnancy, a woman can start taking the medicine immediately. If this condition is met, the woman does not need additional contraceptive protection.

 

After childbirth or abortion in the second trimester of pregnancy, a woman should be recommended to start taking the medication on the 21-28th day 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 already had sex, prior to the start of taking Femodena, pregnancy should be excluded or it is necessary to wait for the first menstruation.

 

Acceptance of missed pills

 

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

 

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

  • the taking of the dragee should never be interrupted, more than 7 days;
  • 7 days of continuous intake of pills 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 dragees was more than 12 hours (the interval from the last dragee was more than 36 hours):

 

The first and second week of taking the drug

 

The woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two pills simultaneously). The next dragee is taken at the usual time. In addition, a barrier method of contraception (for example, a condom) should be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragees, the probability of pregnancy should be taken into account. The more pills are missed, and the closer this pass to the 7-day break in taking the pills, the higher the risk of pregnancy.

 

The third week of taking the drug

 

The woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two pills simultaneously). The next dragee is taken at the usual time. In addition, a barrier method of contraception (for example, a condom) should be used for the next 7 days.In addition, the reception of a dragee from a new package should be started as soon as the current packaging is finished, i. E. nonstop. Most likely, the woman will not have withdrawal bleeding until the end of the second package, but she may have spotting spotting or breakthrough uterine bleeding on the days of taking the pills.

 

If the woman missed taking the pills, and then at the first normal interval from taking the drug, she does not have a withdrawal bleeding, it is necessary to exclude pregnancy.

 

If a woman had vomiting within 3 to 4 hours after taking the Femodena pellet, the absorption may be incomplete. In this case, it is necessary to be guided by the advice on skipping the dragees. If a woman does not want to change the normal mode of taking the drug, she should take, if necessary, an additional pellet (or several pills) from another package.

 

In order to delay the onset of menstruation, a woman should continue taking the dragee from a new package of Femodena immediately after taking all the pills from the previous one, without interruption in admission. Dragee from this new package can be taken for as long as the woman wishes (until the packaging is finished).Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking Femodena from the new package follows the usual 7-day break.

 

In order to transfer the day of the onset of menstruation on the next day of the week, the woman should shorten the nearest break in taking the dragees for as many days as she wants. The shorter the interval, the higher the risk that it will not have withdrawal bleeding and, in the future, there will be macular bleeding and breakthrough bleeding during the second package (as well as in case she would like to delay the onset of menstruation).

 

Side effect

  • soreness, tenderness of the mammary glands, secretion of secretions;
  • 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, especially in women with a history of chloasma pregnant women.

 

Contraindications

 

Combined oral contraceptives should not be used in the presence of any of the conditions listed below.If any of these conditions develop for the first time against the background of the drug, the drug should be immediately withdrawn:

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

 

Application in pregnancy and lactation

 

Femoden is contraindicated in pregnancy or suspected of it, during lactation.

 

Use in children

 

Contraindicated in children and adolescents before menarche.

 

special instructions

 

When taking an estrogen / progestogen combination, irregular bleeding (spotting or breakthrough bleeding) can occur, 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 occurs or repeats after previous regular cycles, then nonhormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. These can include diagnostic scraping.

 

In some women, bleeding cancellations may not develop during a break in taking a dragee. If the drug was taken as directed, it is unlikely that a woman is pregnant. Nevertheless, if before this, the pills were taken irregularly or, if there are no consecutive menstrual bleeding, the pregnancy should be excluded before the drug is continued.

 

If any of the conditions / risk factors outlined below are present, carefully weigh the potential risk and expected benefits of using Femodena in each individual case and discuss it with the woman before she decides to start taking the drug. In case of weighting, strengthening, or the first manifestation of any of these conditions or risk factors, a woman should consult with her doctor who can decide whether to cancel 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 oral contraceptives.

 

Venous thromboembolism (VTE), in the form of deep vein thrombosis and / or pulmonary thromboembolism, can develop during use of all combined contralceptive pals. The estimated incidence of VTE in women taking oral contraceptives with a low estrogen dose (less than 50 μg 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 frequency of VTE developing with combined oral contraceptives is less than the frequency associated with pregnancy (6 per 10 000 pregnant women per year).

 

Women receiving combined oral contraceptives describe extremely rare cases of thrombosis of other blood vessels, for example, renal, hepatic, mesenteric; veins and arteries of the retina. The relationship of these cases with the use of combined oral contraceptives has not been proven.

 

A woman should stop taking Femodena and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include: unilateral leg pain and / or swelling; sudden severe pain in the chest, with irradiation in the left arm or without irradiation; sudden shortness of breath; a sudden attack of coughing; any unusual, strong, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; Diplomacy; slurred speech or aphasia; dizziness; collapse with or without partial seizure; weakness or very significant loss of sensitivity, suddenly appeared on one side or in one part of the body; motor disorders; "acute"stomach.

 

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

  • with age;
  • smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years of age);

in the presence of:

  • family history (ie venous or arterial thromboembolism ever in close relatives or parents at a relatively young age);
  • Obesity (body mass index more than 30 kg / m2);
  • dyslipoproteinemia;
  • arterial hypertension;
  • heart valve diseases;
  • atrial fibrillation;
  • prolonged immobilization, serious surgical intervention, any foot surgery or extensive 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) and not resume reception for 2 weeks after the end of immobilization.

 

An increased risk of thromboembolism in the postpartum period should be considered.

 

Circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis,sickle-cell anemia. Adequate treatment of these diseases 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 deficiency 3, 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

 

The increased risk of developing cervical cancer with prolonged use of combined oral contraceptives has been reported in some epidemiological studies. His association with the use of combined oral contraceptives has not been proven. There are contradictions as to the extent to which these cases are associated with the characteristics of sexual behavior and other factors such as human papillomavirus (HPV).

 

A meta-analysis of 54 epidemiological studies has demonstrated that there is a slightly increased relative risk (RR = 1.24) in the development of breast cancer diagnosed in women,which at the time of the study used combined oral contraceptives. His association with the use of combined oral contraceptives has not been proven. The observed increase in risk may be the result of an earlier diagnosis of breast cancer in women using combined oral contraceptives.

 

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

 

Other states

 

Although a small increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically relevant increases have been rare. The relationship between the administration of combined oral contraceptives and hypertension has not been established. Nevertheless, if persistent arterial hypertension develops during their administration, the elimination of combined oral contraceptives and the treatment of arterial hypertension are advisable.Admission can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

 

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

 

Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until the liver function returns 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 insulin resistance and glucose tolerance, there is usually no need to correct the dose of hypoglycemic drugs in diabetic patients taking these drugs.However, these women should be carefully monitored by a physician.

 

In women with hypertriglyceridemia, or a family history of it, the risk of developing pancreatitis during oral combined oral contraceptives can not be ruled out.

 

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

 

They sang in women suffering from hirsutism, the symptoms developed recently or significantly increased, while conducting a differential diagnosis should take into account other causes, such as androgen-producing tumor, congenital adrenal cortex dysfunction.

 

Laboratory Tests

 

Admission of combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal, transport protein levels in the plasma, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the limits of normal values.

 

Impact on the ability to drive vehicles and manage mechanisms

 

No effects were observed.

 

Drug Interactions

 

Drug interactions, which increase the clearance of sex hormones, can lead to breakthrough uterine bleeding or a decrease in contraceptive reliability. This was established with respect to the hydantoins. barbiturates, primidon, Carbamazepine and rifampicin; there is also suspicion of oxcarbazepine, topiramate, felbamate and griseofulvin. The mechanism of this interaction is based on the induction of these drugs by liver enzymes.

 

Contraceptive reliability decreases with the administration of antibiotics, such as ampicillins and tetracyclines. The mechanism of this action is not clear.

 

Women receiving any of the aforementioned classes of medicines in a short course, in addition to Temodo, should temporarily use the barrier method of contraception during concomitant use of the drugs and within 7 days after their withdrawal. During the reception of rifampicin and within 28 days after it is withdrawn, a barrier method of contraception (for example, a condom) should be used in addition to Femoden. If the use of these drugs is started at the end of the reception of the Femodena package, the next package should be started without an ordinary break in admission.

 

Women who receive these drugs on a long-term course should be recommended other (non-hormonal) methods of contraception (for example, a condom).

 

Analogues of the drug Femoden

 

Structural analogs for the active substance:

  • Artisia;
  • Lindineth 20;
  • Lyndyneth 30;
  • Logest;
  • Mirell.

 

Analogues for the pharmacological group (means for contraception):

  • Belara;
  • Bellune 35;
  • Benatex;
  • Ginepristone;
  • Diane 35;
  • Dimia;
  • Janine;
  • Genetten;
  • Zoeli;
  • Implanon of the NKTS;
  • Lactineth;
  • Lindineth 20;
  • Lyndyneth 30;
  • Midian;
  • Mirell;
  • Mirena;
  • NovaRing;
  • Novinet;
  • Oralcon;
  • Postinor;
  • Regulon;
  • Rhevidone 21 + 7;
  • Silhouettes;
  • Three regol 21 + 7;
  • Trigestrel;
  • Pharmatex;
  • Escapel;
  • Eskinor F.

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