Femoden - instructions for use and reviews. Medicinal reference book geotar Instructions for use and regimen
Against the background of the use of the drug, the menstrual cycle becomes more regular, painful menstruation is less common, the intensity of menstrual flow decreases, resulting in a reduced risk of iron deficiency anemia.
Indications
- contraception.Dosing regimen
The drug is taken 1 tablet / day for 21 days at the same time, preferably in the evening.In the absence of taking any hormonal contraceptives in the previous month, taking Femodena begins on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding). It is allowed to start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.
When switching from combined oral contraceptives, it is preferable to start taking Femodena 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 admission (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets) packaged).
When switching from contraceptives containing only gestagens, a woman can start taking Femoden on any day (without a break) when switching from a "mini-pill", from an implant - on the day it is removed, from an injection form - from the day when it should have been the next injection. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy, a woman can start taking it immediately, without the need for additional contraceptive measures.
After childbirth or abortion in the second trimester of pregnancy, a woman should be advised to start taking the drug on days 21-28. 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 lived sexually, before taking Femodena pregnancy must be excluded or the first menstruation must be waited.
A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that the intake of dragees should never be interrupted for more than 7 days, and that 7 days of continuous intake of dragees are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.
If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. In addition, a barrier method of contraception must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. The more pills missed, and the closer this pass is to the 7-day break in taking pills, the higher the risk of pregnancy.
If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. Additionally, an additional barrier method of contraception must be used for the next 7 days. In addition, if you miss a dragee during the third week of taking the drug, taking the dragee from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.
If a woman misses a pill and then does not have withdrawal bleeding in the first normal drug-free interval, pregnancy should be ruled out.
If a woman vomits within 3 to 4 hours after taking dragee Femodena absorption of active substances may not be complete. It is necessary to follow the recommendations when skipping dragees. If a woman does not want to change the normal regimen of taking the drug, she should take, if necessary, an additional tablet (or several tablets) from another package.
In order to delay the onset of menstruation, a woman should continue taking pills from a new package. Femodena immediately after taking all the pills from the previous one, without interruption in taking. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume appointment Femodena from a new package follows after the usual 7-day break.
In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by 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 and breakthrough bleeding during the second pack (as well as in the case when she would like to delay the onset of menstruation).
Side effect
From the digestive system: sometimes - nausea, vomiting.From the reproductive system: sometimes - intermenstrual spotting, changes in vaginal secretion.
From the endocrine system: sometimes - engorgement, soreness and secretion from the mammary glands, changes in body weight, changes in libido.
From the side of the central nervous system: decreased mood, headaches, migraines.
Other: chloasma (especially in women with a history of pregnancy chloasma), poor tolerance to contact lenses, fluid retention in the body, allergic reactions.
The relationship of undesirable effects with taking the drug has not been confirmed or refuted.
Contraindications
- pregnancy;- severe liver dysfunction (including porphyria);
- idiopathic jaundice or itching of the skin during a previous pregnancy;
- Dubin-Johnson or Rotor syndrome;
- liver tumors (including history);
- thromboembolic processes (including history);
- predisposition to thrombosis and embolism (disorders of the blood coagulation system with a tendency to thrombosis, some heart diseases);
- sickle cell anemia;
- cancer of the mammary glands and genital organs (including in history);
- severe diabetes mellitus with angiopathy;
- disorders of lipid metabolism;
- herpes of pregnant women (in history);
- progressive otosclerosis during a previous pregnancy;
- uterine bleeding of unknown etiology;
- Hypersensitivity to the components of the drug.
Pregnancy and lactation
The drug is contraindicated for use during pregnancy.If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.
The active substances that make up the drug are excreted in small amounts with breast milk.
special instructions
Before use Femodena a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of cervical mucus), to exclude pregnancy and disorders of the blood coagulation system. Control examinations must be carried out at least once a year.The woman should be warned Femodene does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
With caution, the drug is prescribed to patients with diabetes mellitus, arterial hypertension, varicose veins, impaired renal function, uterine myoma, otosclerosis, migraine, multiple sclerosis, epilepsy, porphyria, systemic lupus erythematosus, overweight, fibrocystic mastopathy, severe depression in history; with a family history of thromboembolism, chronic heart failure, stroke, breast cancer.
The relative risk of developing arterial thrombosis increases when combined hormonal contraceptive use is combined with risk factors such as age over 35 and smoking. In this regard, smoking women over 35 years of age are advised to quit smoking if they intend to take Femodene for the purpose of contraception.
The risk of thrombosis is also increased in the presence of a burdened family history, obesity, dyslipoproteinemia, arterial hypertension, heart valve disease, atrial fibrillation.
The drug is stopped 6 weeks before the planned surgical intervention, as well as if long-term immobilization is necessary, and resumed 2 weeks after the end of immobilization due to an increased risk of thrombosis.
If pain occurs in the lower extremities along the veins, swelling of the extremities, acute pain or a feeling of pressure or heaviness in the chest, sudden shortness of breath, the drug should be discontinued and examinations should be carried out to detect possible thrombosis or thromboembolism.
When using Femodena, it should be borne in mind that while taking hormonal contraceptives, the normal course of the menstrual cycle, rectal temperature and the properties of cervical mucus may change.
If you experience persistent skin itching, severe pain in the lower abdomen, severe headaches and migraines, severe depression, a significant increase in blood pressure, increased seizures, with sudden changes in vision, hearing or speech, you should stop the drug and conduct an additional examination.
Intermenstrual bleeding may occur during the first few months of admission and stop after the body has adapted to Femodene. If such secretions recur or increase in intensity, an additional examination of the patient should be carried out.
If during the 7-day break in taking the dragee there is no menstrual-like bleeding, it is necessary to examine the patient without resuming the drug.
With vomiting, diarrhea within 3-4 hours from the moment of taking the drug, its contraceptive effect may decrease. In this case, you should continue taking Femodena and at the same time use additional non-hormonal methods of contraception.
In the case of the combined use of Femodena and rifampicin, the contraceptive effect decreases. Femodena effect therefore, additional methods of contraception should be used within 4 weeks after the end of the antibiotic.
Women receiving a short course of drugs that affect the effectiveness of Femoden should temporarily use a barrier method of contraception while taking the corresponding drugs and within 7 days after their withdrawal.
Patients who develop chloasma should avoid sun exposure during the period of drug use.
Overdose
Symptoms: nausea, vomiting, in young patients - uterine bleeding. No serious toxic effects were noted.Treatment: carry out symptomatic therapy. There is no specific antidote.
drug interaction
With the simultaneous use of Femodena with hydantoins, barbiturates, primidone, carbamazepine and rifampicin, and possibly oxcarbazepine, topiramate, felbamate and griseofulvin, the clearance of sex hormones increases, which can lead to breakthrough uterine bleeding or reduce the reliability of contraception. The mechanism of this interaction is based on the induction of liver enzymes by these drugs.With the simultaneous use of Femodena with ampicillins and tetracyclines, the reliability of contraception decreases.
Main settings
Name: | FEMODEN |
ATX code: | G03AA10 - |
The modern market for contraceptives is diverse. Contraceptive medicines include a large group of drugs. One of them is Femoden, which belongs to monophasic contraceptives. It has a low dosage of hormones, which allows you to minimize the risk of side effects. The package contains one blister containing 21 tablets and instructions.
General information
Femodene tablets contain two substances: ethinylestradiol (30 mcg) and gestodene (75 mcg). For better digestibility, a number of excipients were added to the drug. It is used to prevent unwanted pregnancy.
The main action of the tablets is aimed at suppressing ovulation and increasing the viscosity of cervical mucus. Along with the contraceptive effect, the drug helps:
- set up a cycle
- reduce menstrual pain;
- reduce discharge;
- reduce the risk of anemia.
Femodena has no complete analogues. You can try replacing it with Artisia or Logest. When choosing a replacement, it is better to give preference to well-known manufacturers. You should not use Femulen, since this medicine contains only gestodene.
Femodene and alcohol are compatible, alcohol does not reduce the effectiveness of the drug. However, this combination increases the risk of complications.
Instructions for use
Each pack of medication contains detailed instructions for Femoden. To increase the effectiveness of the drug you need to follow some rules:
- dragees drink every day;
- it is desirable to do this at the same time;
- You can drink the tablet only with clean water.
They drink the drug for three weeks, after which they take a break for one week. If a woman has not previously used such hormonal drugs, then she begins to drink Femoden on the first day of the menstrual cycle.
You can do this in the period from the second to the fifth day, but then it is better to use additional methods of protection.
When using hormonal drugs, the scheme is different. Femodene begin to use immediately after taking the last tablet of another medication.
After childbirth, the drug can be used in a month. Given that a small amount of active ingredients passes into breast milk, it is better not to use it during the feeding period. Before drinking the drug, it is better to make sure that there is no pregnancy and take tests.
Side effects
Femoden tablets do not have many side effects. Often there is an increase in body weight, less often its decrease. On the part of the psyche, mood swings, a decrease in libido are observed. Swelling may occur due to fluid retention in the body. While taking the drug, the mammary glands coarsen and become hypersensitive.
Before using the tablets, it is better to study the instructions for the use of Femodena. It is also better to read the price and reviews. This medicine has contraindications. These include any kind of thrombosis, conditions preceding their appearance (angina pectoris), diabetes mellitus with complications.
Any medication puts a strain on the liver. Therefore, the presence of jaundice is a contraindication to the use of oral contraceptives.
Since scientists have proven the relationship between hormones and tumor growth, it is not recommended to use pills when any neoplasms are detected.
Any vaginal bleeding is a reason to immediately stop taking the drug. The same should be done if pregnancy is suspected, as a miscarriage may occur due to an unstable hormonal background.
The consequences of an overdose of Femodena were not found. Vomiting, nausea, and slight vaginal bleeding may occur. There is no specific treatment.
- Instructions for use FEMODEN
- Ingredients of FEMODEN
- Indications for FEMODEN
- Storage conditions of the drug FEMODEN
- Shelf life of the drug FEMODEN
Release form, composition and packaging
dragee 30 mcg + 75 mcg: 21 pcs.Reg. No: RK-LS-5-No. 005350 dated 10/19/2001 - Canceled
Dragee round, white.
Excipients: lactose, corn starch, polyvidone 25,000, sodium calcium edetate, magnesium stearate, polyvidone 700,000, polyethylene glycol 6000, calcium carbonate, talc, montan glycol wax.
21 pcs. - blisters with a calendar scale (1) - packs of cardboard.
Description of the medicinal product FEMODEN based on officially approved instructions for use of the drug and made in 2006. Date of update: 04/18/2006
Monophasic low-dose combined progestogen-estrogen contraceptive. The contraceptive effect of Femodena is based on the interaction of various factors, the most important of which are the inhibition of ovulation and the increase in the viscosity of cervical mucus.
Against the background of the use of the drug, the menstrual cycle becomes more regular, painful menstruation is less common, the intensity of menstrual flow decreases, resulting in a reduced risk of developing iron deficiency anemia, as well as endometrial cancer and ovarian cancer.
Gestodene
Suction
After oral administration, gestodene is rapidly and completely absorbed from the gastrointestinal tract. C max is 4 ng / ml and is achieved 1.0 hours after ingestion. Bioavailability - about 99%.
Distribution
Gestodene binds to serum albumin and sex steroid-binding globulin (SHBG). The free fraction is only about 1-2% of the total amount of gestodene in serum, approximately 50-70% is specifically associated with SHPS. The relative distribution of fractions (free gestodene bound to albumin, bound to SHBG) depends on the concentration of SHBG in serum. Following the induction of the binding protein, the SHBG-bound fraction increases while the free and albumin-bound fraction decreases.
The pharmacokinetics of gestodene is affected by the serum level of SHBG, which increases approximately 3-fold under the influence of ethinyl estradiol. With daily administration of the drug, an increase in the concentration of gestodene in the blood serum is observed. The average serum concentration is approximately four times higher at steady state (usually reached during the second half of the cycle).
Metabolism
The subsequent biotransformation is similar to the known metabolism of steroids. V d is 0/7 l/kg and metabolic clearance from serum is about 0.8 ml/min/kg.
breeding
There is a biphasic decrease in serum gestodene levels. T 1/2 in the distribution phase is about 12-15 hours. Gestodene is excreted only in the form of metabolites (T 1/2 about 24 hours). Gestodene metabolites are excreted in the urine and bile in a ratio of about 6:
- 4. Pharmacologically active metabolites of gestodene are not known.
There were no drug interactions with concomitantly taken ethinyl estradiol.
Ethinylestradiol
Suction
After oral administration, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. Cmax of ethinylestradiol in plasma is about 80 pg / ml and is reached after 1-2 hours. During absorption and as a result of the "first pass" effect through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability of approximately 45% with individual variability 20-65%.
Distribution
About 98% of the serum level of ethinyl estradiol non-specifically binds to serum albumin. Ethinylestradiol increases the hepatic synthesis of SHBG (globulin that binds sex steroids). V d - approximately 2.8-8.6 l / kg. C ss in serum is reached after about one week of taking the drug.
During lactation, about 0.02% of the daily dose of ethinyl estradiol is excreted in breast milk and may enter the child's body.
Metabolism
Ethinylestradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The rate of clearance from blood plasma is 2.3-7 ml/kg.
breeding
There is a two-phase decrease in the level of ethinylestradiol in plasma, in the first phase T 1/2 about 1 hour, in the second phase - 10-20 hours. Excreted only as metabolites in the urine and bile in a ratio of 4:
The drug is taken 1 tablet / day for 21 days at the same time, preferably in the evening.
In the absence of taking any hormonal contraceptives in the previous month Femodena intake begins 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 the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the 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 admission (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 dragees per package).
When switching from contraceptives containing only gestagens, a woman can start taking Femoden on any day (without a break) when switching from a "mini-pill", from an implant - on the day it is removed, from an injection form - from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy a woman can start taking it immediately, without the need for additional contraceptive measures.
After childbirth or abortion in the second trimester of pregnancy the woman should be advised to start taking the drug on days 21-28. 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 sexual life, pregnancy should be ruled out before Femodena is started, or it is necessary to wait for the first menstruation.
Missed dragee the woman should take it as soon as possible, the next pill is taken at the usual time. If the delay is less than 12 hours, the reliability of contraception does not decrease. If the delay in taking the pills was more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that the intake of dragees should never be interrupted for more than 7 days, and that 7 days of continuous intake of dragees are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.
If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second weeks of taking the drug, then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. In addition, a barrier method of contraception must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. The more pills missed, and the closer this pass is to the 7-day break in taking pills, the higher the risk of pregnancy.
If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), then the woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. In addition, a barrier method of contraception must be used for the next 7 days. In addition, if you miss a dragee during the third week of taking the drug, taking the dragee from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.
If a woman misses a pill and then does not have withdrawal bleeding in the first normal drug-free interval, pregnancy should be ruled out.
If a woman had vomit within 3 to 4 hours after taking Femodena dragees, the absorption of active substances may not be complete. It is necessary to follow the recommendations when skipping dragees. If a woman does not want to change the normal regimen of taking the drug, she should take, if necessary, an additional tablet (or several tablets) from another package.
In order to delay the onset of menstruation, the woman should continue taking the pills from the new package of Femodena immediately after all the pills from the previous one have been taken, without interruption in the reception. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Femodena should be resumed from a new package after the usual 7-day break.
In order to move your period 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 and breakthrough bleeding during the second pack (as well as in the case when she would like to delay the onset of menstruation).
From the digestive system: sometimes - nausea, vomiting.
From the reproductive system: sometimes - intermenstrual spotting, changes in vaginal secretion.
From the endocrine system: sometimes - engorgement, soreness and secretion from the mammary glands, changes in body weight, changes in libido.
From the side of the central nervous system: decreased mood, headaches, migraines.
Others: chloasma (especially in women with a history of pregnancy chloasma), poor tolerance to contact lenses, fluid retention in the body, allergic reactions.
The relationship of undesirable effects with taking the drug has not been confirmed or refuted.
- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
- migraine with a history of focal neurological symptoms;
- diabetes mellitus with vascular complications;
- multiple or pronounced risk factors for venous or arterial thrombosis (including lesions of the valvular apparatus of the heart, arrhythmias, diseases of the cerebral vessels or coronary arteries of the heart);
- uncontrolled arterial hypertension;
- pancreatitis with severe hypertriglyceridemia (currently or in history);
- liver failure and severe liver disease (until normalization of laboratory parameters);
- liver tumors (benign or malignant) at present or in history;
- identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them;
- vaginal bleeding of unknown origin;
- pregnancy (including suspected);
- hypersensitivity to the components of the drug.
If any of these conditions occur for the first time while taking Femoden, it should be immediately canceled.
Use during pregnancy and lactation
Femodene is contraindicated in pregnancy.
If pregnancy is detected while taking Femoden, the drug should be discontinued immediately. However, extensive epidemiological studies have not found any increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormone preparations are inadvertently taken in early pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use during lactation is not recommended. A small amount of sex steroids and / or their metabolites can be excreted in breast milk, but their negative impact on the health of the newborn has not been confirmed.
Treatment: carry out symptomatic therapy. There is no specific antidote.
Interactions between oral contraceptives and other medicinal products may result in breakthrough bleeding and/or reduced contraceptive efficacy.
Possible interaction of the drug Femoden with drugs that induce liver enzymes, resulting in increased clearance of sex hormones (for example, phenytoin, barbiturates, primidone, carbamazepine and rifampicin; there are also suggestions regarding oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and drugs containing St. John's wort).
When used together, some antibiotics (for example, ampicillins and tetracyclines) can reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol. Women taking these drugs should temporarily use an additional barrier method of contraception or choose another method of contraception.
With the simultaneous use of drugs that induce microsomal enzymes, the barrier method should be used during the entire time of their administration, as well as within 28 days after its completion. While taking antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception.
If the period of using the barrier method of protection ends later than the pills in the package, you need to move on to the next package of the combined oral contraceptive without the usual break in taking the pills.
Oral combined contraceptives can affect the metabolism of other drugs (including cyclosporine), which leads to a change in their concentration in plasma and tissues.
Last update of the description by the manufacturer 25.09.2014
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pharmachologic effect
pharmachologic effect- estrogen-gestagenic, contraceptive.Dosage and administration
inside, in the order indicated on the package, every day at about the same time, with a small amount of water, 1 tablet per day continuously for 21 days. The next pack is started after a 7-day tablet break, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last pill and may not end before starting a new pack.
How to start taking Femodena ®
In the absence of taking any hormonal contraceptives in the previous month
Reception Femodena ® begins on the first day of the menstrual cycle (ie the first day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
When switching from other combined oral contraceptives, vaginal ring or contraceptive patch
It is preferable to start taking Femodena ® 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 containing 28 dragees per package). Femoden ® should be started on the day the vaginal ring or contraceptive patch is removed, but no later than the day when a new ring is to be inserted or a new patch is pasted.
When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena ®)
A woman can switch from a mini-pill to Femoden ® any day (without a break), from an implant or intrauterine contraceptive with a progestogen - 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 the tablets.
After an abortion in the first trimester of pregnancy
A woman can start taking the drug immediately. If this condition is met, the 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 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 tablets. However, if a woman has already been sexually active, pregnancy must be ruled out before Femodena ® is started, or the first menstruation must be waited for.
Taking missed pills
If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next one is taken at the usual time.
If the delay in taking the pill was 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 tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.
Accordingly, the following advice can be given if the delay in taking the tablets was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours):
First week of taking the drug
The woman should take the last missed tablet as soon as she remembers (even if that means taking 2 tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before the pill was missed, the possibility of pregnancy should be taken into account. The more tablets missed, and the closer they are to the break in taking the active substances, the greater the likelihood of pregnancy.
Second week of taking the drug
The woman should take the last missed tablet as soon as she remembers (even if that means taking 2 tablets at the same time). The next dragee is taken at the usual time.
Provided that the woman has taken her pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping 2 (or more) Table. you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
Third week of taking the drug
The risk of reduced reliability is inevitable due to the upcoming break in taking pills.
A woman must strictly adhere to one of the two following options. In this case, if in the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods.
1. The woman should take the last missed tablet as soon as she remembers (even if it means taking 2 tablets at the same time). The next tablet is taken at the usual time until the pills from the current package run out. The next pack should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.
2. The woman may also stop taking the pills from the current package. Then she should take a break for 7 days, including the day she missed the pill, and then start taking a new pack.
If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.
If a woman has had vomiting or diarrhea 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 the pill.
Changing the start date of the menstrual cycle
In order to delay the onset of menstruation, a woman should continue taking the pills from the new Femodena ® pack immediately after taking all the pills from the previous one, without interrupting the intake. The tablets in this new pack can be taken for as long as the woman wishes (until the pack runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Femodena ® should be resumed from a new pack after the usual 7-day break.
In order to move the day of the start of menstruation to another day of the week, a woman should be advised to shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and subsequently spotting and breakthrough bleeding during the second pack (as well as in the case when she would like to delay the onset of menstrual bleeding).
In this article, you can read the instructions for using a contraceptive drug Femodene. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Femodena in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Femodena analogs in the presence of existing structural analogs. Use for contraception in women, including during pregnancy and lactation. The composition of the drug.
Femodene- low-dose monophasic oral contraceptive.
The contraceptive effect of Femodena is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus. In addition to the contraceptive effect, combined oral contraceptives have a positive effect, which should be considered when choosing a method of birth control. The cycle becomes more regular, painful menstruation is less common. the intensity of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases.
Compound
Ethinylestradiol + Gestodene + excipients.
Pharmacokinetics
Gestodene
Orally administered gestodene is rapidly and completely absorbed. The absolute bioavailability of gestodene is about 99% of the administered dose. Gestodene binds to serum albumin and sex steroid-binding globulin (SHBG). Only about 1-2% of the total serum level of gestodene is in free form, approximately 50-70% is specifically associated with SHBG. The relative distribution of fractions (free gestodene bound to albumin, bound to SHBG) depends on the concentration of SHBG in serum. Following the induction of the binding protein, the SHBG-bound fraction increases while the free and albumin-bound fraction decreases. There was no interaction with the simultaneous administration of ethinyl estradiol.
There is a biphasic decrease in serum gestodene levels. The terminal phase of distribution is characterized by a half-life of about 12-15 hours. Gestodene is not excreted in unchanged form, only in the form of metabolites, which are eliminated with a half-life of about 1 day. Gestodene metabolites are excreted in the urine and bile in a ratio of about 6:4. Pharmacologically active metabolites of gestodene are not known.
The pharmacokinetics of gestodene is affected by the serum level of SHBG, which increases approximately 3-fold under the influence of ethinyl estradiol. With daily administration of the drug, an increase in the concentration of gestodene in the blood serum is observed. Average serum levels are approximately 4 times higher when reaching the equilibrium concentration (usually reached during the second half of the cycle).
Ethinylestradiol
After oral administration, ethinylestradiol is rapidly and completely absorbed. During absorption and the first passage through the liver, a significant part of ethinylestradiol is metabolized. Absolute bioavailability is about 60%.
About 98.5% of the serum level of ethinyl estradiol is nonspecifically bound to serum albumin. Ethinylestradiol increases the hepatic synthesis of SHBG (globulin that binds sex steroids).
During absorption and the first passage through the liver, a significant part of ethinylestradiol is metabolized (mainly by hydroxylation). Metabolites are found 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 a T1 / 2 of the final phase of about 24 hours. It is not excreted unchanged from the body. Metabolites of ethinylestradiol are excreted in the urine and bile. The equilibrium concentration achieved after 3-4 days of administration was 40-60% higher than the concentration of ethinylestradiol after a single dose.
In nursing mothers, about 0.02% of the daily dose of ethinyl estradiol can enter the child's body with breast milk.
Indications
- contraception.
Release forms
Coated tablets 30 mcg + 75 mcg.
Instructions for use and regimen
Before starting the use of Femoden, a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of cervical mucus), to exclude pregnancy. In addition, violations 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 preparations such as Femodena do not protect against HIV infection (AIDS) and other sexually transmitted diseases!
The pills should be taken in the order indicated on the package, every day at about the same time with a little water. Take one tablet per day continuously for 21 days. Reception of each next pack begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually starts 2-3 days after taking the last pill and may not end before the start of a new package.
In the absence of taking any hormonal contraceptives in the previous month, Femodena is started 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 the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the 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 pill 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 pills) or after taking the last inactive dragee (for preparations containing 28 tablets per package).
When switching from contraceptives containing only gestagens (mini-pill, injectable forms, implant), a woman can switch from mini-pill to Femoden on any day (without a break), from an implant - on the day it is removed, from an injection form - from the day. when the next injection should be given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy, a woman can start taking it 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 advised 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 dragee. However, if a woman has already had a sexual life, pregnancy should be ruled out before Femodena is started, or it is necessary to wait for the first menstruation.
Taking missed pills
If the delay in taking the dragee was less than 12 hours, contraceptive protection is not reduced. A woman should take the pill as soon as possible, the next pill is taken at the usual time.
If the delay in taking the pill was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:
- reception of the dragee should never be interrupted for more than 7 days;
- 7 days of continuous pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.
Accordingly, the following advice can be given if the delay in taking the pill was more than 12 hours (the interval from the moment the last pill was taken was more than 36 hours):
First and second week of taking the drug
The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. The more pills missed, and the closer this pass is to the 7-day break in taking pills, the higher the risk of pregnancy.
Third week of taking the drug
The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee 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, taking pills from a new package should be started as soon as the current package is over, i.e. nonstop. It is most likely that the woman will not have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.
If a woman misses a pill and then does not have withdrawal bleeding in the first normal drug-free interval, pregnancy should be ruled out.
If a woman vomits within 3 to 4 hours after taking Femodena tablets, absorption may not be complete. In this case, it is necessary to focus on the advice regarding skipping dragees. If a woman does not want to change the normal regimen of taking the drug, she should take, if necessary, an additional tablet (or several tablets) from another package.
In order to delay the onset of menstruation, a woman should continue taking the pills from the new package of Femodena immediately after taking all the pills from the previous one, without interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Femodena should be resumed from a new package after the usual 7-day break.
In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the greater the risk that she will not have withdrawal bleeding and, in the future, will have spotting and breakthrough bleeding during the second pack (as well as if she would like to delay the onset of menstruation).
Side effect
- engorgement, soreness of the mammary glands, secretion from them;
- headache;
- migraine;
- change in libido;
- decreased mood;
- poor tolerance to 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 pregnancy chloasma.
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 while taking the drug, the drug should be immediately canceled:
- the presence of thrombosis (venous and arterial) at present or in history (for example, deep vein thrombosis, pulmonary thromboembolism, myocardial infarction, cerebrovascular disorders);
- the presence or 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;
- current or history of jaundice or severe liver disease (until liver tests return to normal);
- the presence or history of liver tumors (benign or malignant);
- identified hormone-dependent malignant diseases of the genital organs 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 Femodena.
Use during pregnancy and lactation
Femodene is contraindicated in pregnancy or suspicion of it, during lactation.
Use in children
Contraindicated in children and adolescents before menarche.
special instructions
Irregular bleeding (spotting or breakthrough bleeding) may occur while taking a combination of estrogen/gestagens, especially during the first months of use. Therefore, assessment of any irregular bleeding should only be made 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, it is unlikely that the woman is pregnant. However, if the pills were previously taken irregularly or if there are no consecutive menstrual bleeding, pregnancy should be excluded before continuing to take the drug.
If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of Femodena should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, worsen, or first appear, the woman should consult her physician, 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 oral contraceptives.
Venous thromboembolism (VTE), in the form of deep vein thrombosis and / or pulmonary thromboembolism, can develop during the use of all combined oral contraceptives. The approximate incidence of VTE in women taking memoral contraceptives with a low dose of estrogen (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year compared with 0.5-3 per 10,000 women per year in women not using OCs. However, the frequency of VTE developing while taking combined oral contraceptives is less than the frequency 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, have been described; 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 Femodene and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include: unilateral leg pain and / or swelling; sudden severe chest pain, with or without radiating to the left arm; sudden shortness of breath; sudden onset of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraine; 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 appeared on one side or in one part of the body; movement disorders; "sharp" abdomen.
The risk of 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 further increases, especially in women over 35 years old);
in the presence of:
- family history (i.e. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age);
- obesity (body mass index over 30 kg/m2);
- dyslipoproteinemia;
- arterial hypertension;
- heart valve disease;
- atrial fibrillation;
- prolonged immobilization, major surgery, any operation on the legs, or major trauma. In these situations, it is advisable to discontinue the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume use within 2 weeks after the end of immobilization.
An increased risk of thromboembolism in the postpartum period should be taken into account.
Circulatory disorders can also be observed 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 risk of thrombosis associated with them.
Biochemical parameters that may indicate a predisposition to thrombosis include activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin 3 deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, 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 developing cervical cancer with long-term use of combined oral contraceptives has been reported in some epidemiological studies. Its relationship with the use of combined oral contraceptives has not been proven. Controversy remains 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 demonstrated that there is a slightly increased relative risk (RR = 1.24) of developing breast cancer diagnosed in women who were using combined oral contraceptives at the time of the study. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to 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, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. The relationship between taking combined oral contraceptives and arterial hypertension has not been established. However, if persistent arterial hypertension develops during their administration, it is advisable to cancel combined oral contraceptives and treat arterial hypertension. Reception can be continued if normal blood pressure values are 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 itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea minor (Sydenham's disease); herpes of pregnant women; 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 that 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 antidiabetic drugs in diabetic patients taking these drugs. However, these women should be under close medical supervision.
In women with hypertriglyceridemia, or a family history of it, an increased risk of pancreatitis cannot be excluded while taking combined oral contraceptives.
Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
If women suffering from hirsutism, symptoms have developed recently or have significantly increased, other causes, such as an androgen-producing tumor, congenital dysfunction of the adrenal cortex, should be considered when making a differential diagnosis.
Laboratory tests
Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.
Influence on the ability to drive vehicles and control mechanisms
No effects were observed.
drug interaction
Drug interactions resulting in increased clearance of sex hormones may lead to breakthrough uterine bleeding or decreased contraceptive reliability. This has been established for hydantoins. barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, and griseofulvin are also suspected. The mechanism of this interaction is based on the induction of liver enzymes by these drugs.
Contraceptive reliability is reduced when taking antibiotics such as ampicillins and tetracyclines. The mechanism of this action has not been elucidated.
Women receiving any of the above classes of drugs in a short course, in addition to Femodene, should temporarily use a barrier method of contraception during concomitant use of drugs and within 7 days after their withdrawal. While taking rifampicin and within 28 days after its withdrawal, in addition to Femodene, a barrier method of contraception (for example, a condom) should be used. If the use of the listed drugs is started at the end of the Femodena package, the next package should be started without the usual interruption in the intake.
Women on long-term use of these drugs should be advised to use other (non-hormonal) methods of contraception (such as a condom).
Analogues of the drug Femoden
Structural analogues for the active substance:
- Artisia;
- Lindinet 20;
- Lindinet 30;
- Logest;
- Mirelle.
Analogues for the pharmacological group (contraceptives):
- Belara;
- Belluna 35;
- Benatex;
- Ginepriston;
- Diana 35;
- Dimia;
- Jeanine;
- Genetten;
- Zoely;
- Implanon NKST;
- Lactinet;
- Lindinet 20;
- Lindinet 30;
- Midian;
- Mirelle;
- Mirena;
- NuvaRing;
- Novinet;
- Oralcon;
- Postinor;
- Regulon;
- Rigevidon 21+7;
- Silhouette;
- Three regols 21+7;
- Trigestrel;
- Pharmatex;
- Escapelle;
- Eskinor F.
In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.