Femoden - instructions for use and reviews. What you need to know about the contraceptive Femoden? Terms and conditions of storage
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Femodene is a monophasic oral contraceptive.
Release form and composition
Dosage form of Femodena release - coated tablets (pellets): white, round (in blisters of 21 pcs., 1 or 3 blisters are placed in a cardboard bundle).
Active substances 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 a history of indications);
- arterial / venous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, cerebrovascular disorders, myocardial infarction (current or history of indications);
- multiple/severe risk factors for arterial/venous thrombosis;
- diabetes mellitus, accompanied by vascular complications;
- benign / malignant tumors of the liver (currently or a history of indications);
- jaundice or severe liver disease (current or history of indications; Femodene should not be administered before liver tests normalize);
- vaginal bleeding of unknown etiology;
- hormone-dependent malignant diseases of the genital organs or mammary glands (diagnosed or suspected);
- 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 while taking Femodena, the drug should be discontinued.
Method of application and dosage
Prior to the use of Femodena, 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 a cytological examination of cervical mucus.
Control examinations should be carried out at least once a year.
It must 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 use for 21 days. During the period of therapy, the order of taking the pills indicated on the package should be observed. After the end of taking the dragee from the package, a break of 7 days should be taken. During this period, withdrawal bleeding (menstrual-like bleeding) usually occurs. As a rule, it starts 2-3 days after taking the last pill from the package. By the time you start taking the drug from a new package, it may not end.
Features of the beginning of Femodena reception:
- switching from taking combined oral contraceptives: therapy is started the next day after taking the last active pill from the previous package, if necessary, later, but the break should not be more than 7 days (for preparations containing 21 pills - 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 injectable form: it is recommended to start therapy from the day of the next injection (for 7 days you need to use an additional barrier method of contraception);
- not 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 an abortion in the second trimester of pregnancy or childbirth: it is recommended to start therapy on the 21-28th day; if Femodena was started later and the woman did not have a sexual life during this period, an additional barrier method of contraception should be used for 7 days (otherwise, pregnancy must first be excluded).
Contraceptive protection is not reduced in cases where the delay in taking the pill was less than 12 hours, so if you accidentally miss a single dose, it is recommended to take it as soon as possible. Changing the usual scheme of application of Femodena in the future is not required.
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 is 7 days.
If a woman missed taking Femodena within 1-14 days from the moment she started taking the drug from a new package, then it is recommended to take the pill as soon as possible, even if this means taking two single doses at the same time. The timing of the next single dose should not be changed. Additionally, barrier methods of contraception should be used for the next 7 days. If sexual intercourse has taken place within a week before skipping the dragee, the risk of pregnancy should be taken into account. It must be taken into account 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 for more 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 should be guided by the above principles. At the same time, you can start taking the dragee from the next package without interruption. As a rule, in this case, withdrawal bleeding does not occur until the end of the second package, but therapy may be accompanied by spotting spotting or breakthrough uterine bleeding.
If a woman misses a dose, after which there is no withdrawal bleeding on the first normal drug-free break, the possibility of pregnancy should be considered.
In cases where vomiting occurs within 3-4 hours after taking Femodena, a violation of the absorption of active substances is possible (it is recommended to focus on the rules that apply 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, Femodene should be taken without interruption.
Side effects
Possible adverse reactions: hypersensitivity reactions, soreness / engorgement of the mammary glands, secretion from them, migraine, headache, decreased mood, change in libido, vomiting, poor tolerance to contact lenses, nausea, various skin reactions, changes in vaginal secretion, change in body weight , fluid retention. The connection between taking Femodena and their development has not been proven / refuted.
In some cases, chloasma may be observed / appear, especially with a burdened history of chloasma in pregnant women.
special instructions
Any irregular bleeding should only be assessed after an adjustment period of approximately 3 menstrual cycles.
In cases where irregular bleeding recurs or occurs after previous regular cycles, the physician should consider non-hormonal causes and prescribe adequate diagnostic measures (possibly with diagnostic curettage) to rule out pregnancy or malignancy.
Sometimes during a break in taking pills, withdrawal bleeding does not develop. In cases where Femoden is taken without violations, pregnancy is unlikely. In the absence of two menstrual-like bleeding in a row, pregnancy must be excluded.
In cases of the presence of the conditions / risk factors listed below, a careful assessment of the ratio of the expected benefit with the possible risk is required before starting Femodena. With the strengthening of existing symptoms or their appearance for the first time, it is necessary to assess the feasibility of further use of the drug.
The appearance of symptoms of arterial / venous thrombosis is among the reasons that can lead to the abolition of Femodena. These symptoms 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, 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 a 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.
It is also necessary to take into account the presence of factors that increase the likelihood of developing thromboembolism and thrombosis (venous and / or arterial): smoking, age, major surgical interventions, dyslipoproteinemia, arterial hypertension, atrial fibrillation, heart valve disease, prolonged immobilization, aggravated family history of thromboembolism at a relatively young age, obesity (with a body mass index> 30 kg / m 2), extensive injuries, any surgery on the legs. In addition, it must 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 of these diseases can reduce the risk of thrombosis associated with them.
Also, the following biochemical parameters can indicate a predisposition to thrombosis: resistance to activated protein C (APC), hyperhomocysteinemia, deficiency of antithrombin III, protein C and S, antiphospholipid antibodies.
There is some evidence that long-term use of Femodene is associated with an increased risk of cervical cancer. However, these data have not received 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, if there is severe pain in the abdomen, an enlarged liver, or signs of intra-abdominal bleeding during the differential diagnosis, Femodena 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 the use of Femodena after the normalization of the indicators.
During the period of therapy, the following conditions may develop / worsen (a causal relationship with Femodena has not been proven): jaundice and / or itching, which is associated with cholestasis, porphyria, hemolytic uremic syndrome, the formation of gallstones, systemic lupus erythematosus, chorea (Sydenham's disease), hearing loss, herpes in pregnancy.
Hepatic dysfunction in acute / chronic course may cause discontinuation of the drug. The resumption of therapy is possible after the restoration of indicators. Recurrent cholestatic jaundice, which first occurred during pregnancy or previous use of sex steroids, requires discontinuation of Femodena.
Women with diabetes during the period of therapy should be under the close supervision of a specialist.
In hypertriglyceridemia, including the presence of indications of a burdened family history, one should take into account the increased likelihood of pancreatitis.
In cases of a tendency to develop chloasma, prolonged exposure to the sun and exposure to ultraviolet radiation should be avoided.
If symptoms have recently appeared in women suffering from hirsutism, or if there is a significant increase in them, other causes should be taken into account in the differential diagnosis, including congenital adrenal dysfunction, androgen-producing tumors.
Reception Femodena may affect the results of some laboratory tests. This applies to indicators of kidney, adrenal, liver, thyroid function, plasma level of transport proteins, carbohydrate metabolism, fibrinolysis and coagulation. Usually such violations do not go beyond the boundaries of normal values.
drug interaction
Simultaneous use with certain substances / drugs, which may increase the clearance of the active substances of Femodena, may cause breakthrough uterine bleeding or reduce 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 has not been elucidated).
If a woman takes any of the above medicines in a short course, during the period of combination therapy and for another 7 days (for rifampicin this period should be extended to 28 days) after its completion, 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 Femodena package, it is recommended to take it without a seven-day break.
Content
Pregnancy planning has long been part of the lifestyle of millions of women. It is important to use products that combine efficiency and maximum safety for health. Femoden is a proven drug that is recommended by experienced gynecologists.
The composition of Femodena
Dragee Femoden (Femoden) have a combined composition, are produced in 21 pcs. in a blister. Features of their components:
How the drug works
The drug has estrogen-gestagen and contraceptive effects, refers to drugs with a low dosage of hormones. Femoden affects the ovary-hypothalamus-pituitary system, suppresses the hormonal production of substances that stimulate the maturation of follicles. It leads to the suppression of ovulation, the activation of changes in the secretion of cervical mucus. The drug does not have an androgenic effect, it reduces the susceptibility of the endometrium to fixation of the blastocyst.
Both active ingredients are rapidly absorbed. Gestodene primarily passes through the liver, but is not cleaved, unlike ethinylestradiol, which is largely metabolized. Most of estradiol binds to plasma proteins and passes into breast milk. The drug has 99% bioavailability. Gestodene combines with globulin and albumin that bind sex steroids. Both components are excreted as metabolites in the urine and bile.
Indications for use
The drug is used as an oral contraceptive. The tool serves to prevent unwanted pregnancy, it can be prescribed to normalize the menstrual cycle in cases where bleeding is too painful, heavy or irregular. You need to take the drug as directed by your doctor. You should not decide to drink it on your own - it is dangerous, even if you carefully read the instructions. Before starting the course, it is worth taking a blood test for female hormones.
Method of application and dosage
Contraceptives Femoden are taken orally. Dragees are consumed at the same time of day every day, washed down with a small amount of water. Dragee is taken 1 piece for three weeks, after a seven-day break is made, a new pack begins. On the 2-3rd day of the break, bleeding begins. In the instructions for use there are rules for taking contraceptives:
- If a woman has not taken hormonal pills before, she should start packing on days 1-5 of her menstrual cycle. In the first week, additional protection is required.
- If the patient was taking combined oral contraceptives, then Femodena should be started the next day after the previous medication has ended. If there was a break for menstruation, then you need to take the dragee no later than the next day.
- When switching from progestogen-containing tablets (mini-pills) or from progestogen-releasing intrauterine devices or drugs, Femodena can be started on any day. If an implant was used - on the day of removal. During the first week, additional methods of protection (condoms) are used.
- After an abortion in the first trimester of pregnancy, the drug is taken immediately, additional protection is not required. During an abortion in the second trimester or after childbirth, dragees are used after 3-4 weeks. If you take the pills later, you first need to make sure that you are not pregnant.
- If the pill is missed less than 12 hours ago, the contraceptive is effective. The missed dose is taken as soon as possible, the next - at the scheduled time. With a delay in taking more than 12 hours, the dosage is taken as early as possible, then the pills are used at the usual time, but during the week you need to additionally protect yourself and exclude the possibility of pregnancy.
- When Femodena is missed for 12 hours or more in the third week of the dragee cycle, it is taken as early as possible, the next dose is standard, but a week-long break at the end of the package is not made. Immediately begin to take the second. Until it ends, the risk of bleeding is minimal, but spotting from the vagina may appear.
- If there was no bleeding during the seven-day break, the risk of pregnancy should be excluded.
- If within four hours after taking the medicine there was vomiting or diarrhea, it is necessary to additionally protect yourself.
- If it is necessary to delay menstruation, the drug is continued to be taken without a seven-day break until the second package is over. During the reception, there may be spotting or minor bleeding.
drug interaction
According to the instructions for use, the simultaneous use of Femodena is unacceptable with other gestagen- or ethinylestradiol-containing drugs. Antibiotics reduce the level of active substances in the blood plasma, reduce the effectiveness of protection. Rifampicin, Hydantoin, Phenylbutazone have a similar effect. Such combinations should be avoided.
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Side effects of Femodena
While taking the contraceptive dragee Femoden, side effects may occur. They are mentioned in the instructions:
- the appearance of chloasma (hyperpigmentation of the skin);
- nausea, weight change, fluid retention in the body (edema), vomiting;
- urticaria on the skin, rash;
- breast engorgement, nipple discharge, chest pain;
- headache, migraine;
- change in the abundance and indicators of vaginal secretions, decreased libido;
- angioedema, anaphylaxis;
- tachycardia;
- frequent mood swings;
- intolerance to contact lenses due to dryness of the cornea.
Overdose
If you take an increased dose of Femodena at one time, an overdose may develop. Its symptoms are vaginal bleeding, nausea, spotting vaginal discharge, tachycardia, and vomiting. There is no specific treatment for drug overdose. The decision on therapy is made by the gynecologist. He can prescribe gastric lavage, symptomatic therapy.
Contraindications
Instructions for use Femodena reveals contraindications for which the drug should not be used. These include:
- negative reaction of the body to the components of the composition;
- liver tumors, including their manifestation in history;
- severe diabetes mellitus with complications in the vascular system;
- hypertriglyceridemia;
- migraine with focal neurological pathologies;
- unknown cause of uterine bleeding;
- liver dysfunction;
- thromboembolism;
- pancreatitis;
- pregnancy.
Terms of sale and storage
Femodene is a prescription drug that must be stored at temperatures up to 25 degrees for five years.
Femodena's analogs
You can replace the drug if it is not available in pharmacies with similar oral contraceptives. These include:
- Lindinet - tablets based on ethinyl estradiol and gestodene;
- Midiana - tablets containing drospirenone, ethinyl estradiol;
- Jess - tablets based on ethinyl estradiol, drospirenone;
- Regulon - tablets containing desogestrel, ethinyl estradiol;
- Yarina - tablets based on drospirenone, ethinyl estradiol;
- Jeanine - dragees containing dienogest, ethinyl estradiol;
- Qlaira - tablets based on estradiol valerate, dienogest.
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Femodena price
Femoden tablets can be bought through pharmacies or Internet sites at prices that depend on the price policy of sellers. The approximate cost in Moscow will be.
Registration number P N011455/01-130314
Tradename
Femoden®
International non-proprietary name or grouping name
Gestodene + Ethinylestradiol
Dosage form
Coated tablets
Compound
Each tablet contains
Core:
Active substances: 0.075 mg gestodene and 0.030 mg ethinyl estradiol.
Excipients: lactose monohydrate 37.430 mg, corn starch 15.500 mg, povidone 25 thousand 1.700 mg, sodium calcium edetate 0.065 mg, mania stearate 0.200 mg.
Shell: sucrose 19.660 mg, povidone 700 thousand 0.171 mg, macrogol-6000 2.180 mg, calcium carbonate 8.697 mg, talc 4.242 mg, mountain glycol wax 0.050 mg.
Description
White film-coated tablets, round shape
Pharmacotherapeutic group
Combined contraceptive (estrogen + gestagen)
ATX Code G03AA10
Pharmacological properties
Femoden® is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.
The contraceptive effect of the drug Femoden® is carried out through complementary mechanisms, the most important of which include the suppression of ovulation and the change in the state of the secret of the cervix (increased viscosity), as a result of which it becomes impermeable to spermatozoa.
When used correctly, the number of pregnancies per 100 women per year is less than 1. If the pills are used incorrectly, including missing pills, the Pearl index may increase.
In women taking combined oral contraceptives, the cycle becomes more regular, soreness and intensity of menstrual-like bleeding decrease, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence that the risk of endometrial cancer and ovarian cancer is reduced.
Indications
Oral contraception (prevention of unwanted pregnancy).
Contraindications
Femoden® is contraindicated in the presence of any of the conditions/diseases listed below.
Thrombosis (venous and arterial) and thromboembolism at present or in the past (including deep vein thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction), cerebrovascular disorders (eg, stroke).
Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in the past.
Identified predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant).
Uncontrolled hypertension.
The presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, subacute bacterial endocarditis, extended surgery with prolonged immobilization, extensive trauma, atrial fibrillation).
Migraine with focal neurological symptoms, present or in the past.
Diabetes mellitus with vascular complications.
Pancreatitis with severe hypertriglyceridemia, present or in the past.
Liver failure and severe liver disease (until liver tests return to normal), including jaundice, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes).
Liver tumors (benign or malignant), present or in the past.
Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
Bleeding from the vagina of unknown origin.
Pregnancy or suspicion of it.
Breast-feeding.
Hypersensitivity to any of the components of the drug Femoden®.
Lactase deficiency, glucose-galactose malabsorption, sucrase-isomaltase deficiency, fructose intolerance, lactose intolerance.
If any of these conditions appear for the first time while taking Femoden®, stop taking this drug immediately and consult your doctor. In the meantime, use non-hormonal birth control. See also "Special Instructions".
Use with caution
If combined oral contraceptives are used in the presence of any of the conditions listed below, you may need to be carefully observed, why - the doctor will explain. Tell your doctor before you start taking Femoden®
if you have any of the conditions and diseases listed below.
Risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis or predisposition to thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the immediate family; obesity; dyslipoproteinemia (for example, high blood cholesterol levels); arterial hypertension; migraine without focal neurological symptoms; uncomplicated valvular disease.
Other diseases in which peripheral circulatory disorders may occur (diabetes mellitus without vascular complications; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia), as well as phlebitis of superficial veins.
Hypertriglyceridemia.
Liver disease with normal liver function tests.
Diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing loss, porphyria, herpes pregnant, Sydenham's chorea).
The onset of severe depression.
Varicose veins of the lower extremities, uterine fibroids.
Therapy with anticoagulants.
In women with hereditary angioedema, exogenous estrogens may cause or exacerbate the symptoms of angioedema.
Pregnancy and lactation
The drug Femoden® is contraindicated during pregnancy and during breastfeeding.
If pregnancy is detected while taking Femoden®, the drug should be immediately discontinued and consult a doctor. 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 who inadvertently took sex hormones in early pregnancy.
Children and teenagers
The drug Femoden® is indicated only after the onset of menarche.
Dosage and administration
When and how to take pills
The calendar package contains 21 tablets. In the package, each tablet is marked with the day of the week on which it should be taken. Take the tablets at the same time each day with a small amount of water. Follow the direction of the arrow until all 21 tablets have been taken. You do not take the drug for the next 7 days. Menstrual-like bleeding ("withdrawal" bleeding) must begin within these 7 days. It usually starts 2-3 days after taking the last tablet of Femoden®. After a 7-day break, start taking the tablets from the next pack, even if the bleeding has not yet stopped. This means that you will always start a new pack on the same day of the week, and that withdrawal bleeding will occur on approximately the same day of the week each month.
Taking pills from the first package of Femoden®
If no hormonal contraceptive has been used in the previous month
Start taking Femoden® on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the pill labeled with the corresponding day of the week. Then take the tablets in order. You can also start taking on days 2-5 of the menstrual cycle, but in this case, you must use an additional barrier method of contraception (condom) 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
You can start taking Femoden® the next day after you take the last pill from the current pack of combined oral contraceptives (i.e. without a break in taking). If the current package contains 28 tablets, you can start taking Femoden® the next day after taking the last one. hormone-containing pill. If you are not sure which tablet it is, ask your doctor. You can also start taking later, but in no case later than the next day after the usual break in taking (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack).
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 oral contraceptives containing only progestogen ("mini-pill")
You can stop taking the mini-pill any day and start taking Femoden® the next day, at the same time. During the first 7 days of taking the tablets, you must also use an additional barrier method of contraception.
When switching from an injectable contraceptive, an implant, or a progestogen-releasing intrauterine contraceptive (Miren®)
Start taking Femoden® on the day your next injection is due or on the day your implant or intrauterine contraceptive is removed. During the first 7 days of taking the tablets, you must also use an additional barrier method of contraception.
After childbirth
If you have just had a baby, your doctor may recommend that you wait until the end of your first normal menstrual cycle before you start taking Femoden®. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.
After a spontaneous miscarriage or abortion in the first trimester of pregnancy
Check with your doctor. It is usually recommended to start taking immediately.
Taking missed pills
If you are late in taking the next pill less than 12 hours, the contraceptive effect of Femoden® is preserved. Take the pill as soon as you remember. Take the next tablet at the usual time.
If the delay in taking the tablets was more than 12 hours, contraceptive protection may be reduced. The more pills missed in a row, and the closer this gap is to the start of the intake or to the end of the intake, the higher the risk of pregnancy.
In this case, you can follow the following rules:
Forgotten more than one tablet from the package
Consult your doctor.
One tablet missed in the first week of taking the drug
Take the missed pill as soon as you remember (even if it means taking two pills at the same time). Take the next tablet at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place during the week before the pill was missed, the possibility of pregnancy should be considered. Consult your physician immediately.
One tablet missed in the second week of taking the drug
Take the missed pill as soon as you remember (even if it means taking two pills at the same time). Take the next tablet at the usual time. The contraceptive effect of Femoden® is preserved, and you do not need to use additional contraceptive measures.
One tablet missed in the third week of taking the drug
You can stick to either of the following two options without the need for additional contraceptive precautions.
1. Take the missed pill as soon as you remember (even if it means taking two pills at the same time). Take the next tablet at the usual time. Start the next pack as soon as you finish taking the tablets in the current pack, so there is no gap between doses. "Withdrawal" bleeding is unlikely until the pills in the second pack run out, but there may be "spotting" spotting or "breakthrough" bleeding from the vagina on the days of taking the drug.
2. Stop taking the pills from the current package, take a break for 7 days (including skip day) and then start taking the pills from the new package.
Using this schedule, you can always start taking the next pack of pills on the day of the week you normally do.
If there is no expected menstrual bleeding after a break in taking the pills, you may be pregnant. Talk to your doctor before starting a new pack of tablets.
Recommendations and case of vomiting and diarrhea
If you have had vomiting or diarrhea (indigestion) within 4 hours of taking Femodene® tablets, the active substances may not have been completely absorbed. This situation is similar to skipping a drug. Therefore, follow the instructions in the previous subsection of the instructions.
Delaying the onset of menstrual bleeding
You can delay the onset of menstrual bleeding if you start taking the tablets from the next package of Femoden® immediately after the end of the current package. You can continue taking the tablets in this package for as long as you wish or until the package runs out. If you want menstrual-like bleeding to start, stop taking the pills. While taking the drug Femoden® from the second package, "spotting" spotting or bleeding may occur on the days of taking the tablets. Start taking the tablets from the next pack after the usual 7-day break.
Changing the day of onset of menstrual bleeding
If you take the pills as recommended, you will have menstrual-like bleeding on about the same day every 4 weeks. If you want to change it, shorten (but don't lengthen) the amount of time you don't take pills. For example, if your menstrual cycle usually starts on Friday and in the future you want it to start on Tuesday (3 days earlier), you should start taking the pills from the next pack 3 days earlier than usual. If the pill-free break is very short (eg, 3 days or less), "withdrawal" bleeding during the break may not occur. In this case, there may be bleeding or "spotting" spotting while taking the tablets from the next package.
Additional information for individual groups of patients
Elderly patients
Not applicable. The drug Femoden® is not indicated after the onset of menopause.
Patients with kidney disorders
Femoden has not been specifically studied in patients with renal impairment. Available data do not suggest adjustment of the dosing regimen in these patients.
Side effect
The table below lists adverse events that have been reported during the use of combined oral contraceptives, the relationship of which with the use of drugs has not been confirmed, but not refuted.
Organ system Often (≥1 / 100) Infrequently (≥1 / 1000 and Organ of vision intolerance to contact lenses (unpleasant sensations when wearing them), blurred vision
Gastrointestinal tract nausea, abdominal pain, vomiting, diarrhea
Immune system hypersensitivity
General symptoms weight gain weight loss
Metabolism fluid retention
Nervous system headache migraine
Mental disorders decreased mood, mood swings decreased libido increased libido
Reproductive system and breast breast tenderness/pain, breast engorgement breast hypertrophy vaginal discharge, breast discharge
Skin and subcutaneous tissue rash, urticaria, erythema nodosum, erythema multiforme
The following serious adverse events have been reported in women using combined oral contraceptives. Additional information about possible side effects of oral combined contraceptives, including Femoden®, is presented in the "Special Instructions" section.
Venous thromboembolic disorders.
Arterial thromboembolic disorders.
Cerebrovascular disorders.
Increase in blood pressure.
Hypertriglyceridemia
Impaired glucose tolerance or effects on peripheral insulin resistance.
Tumors of the liver (benign and malignant).
Violation of the functional parameters of the liver.
Chloasma.
The onset or worsening of conditions for which the relationship with the use of combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of gallbladder stones; porphyrin disease; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis, Crohn's disease; ulcerative colitis; cervical cancer.
The frequency of diagnosing breast cancer in women using oral contraceptives is increased very slightly. Breast cancer is rarely observed in women under 40 years of age, the excess frequency is insignificant in relation to the overall risk of breast cancer. A causal relationship between the occurrence of breast cancer and the use of combined oral contraceptives has not been established. For more information, see the section "Contraindications" and "Special Instructions".
Exogenous estrogens may cause or exacerbate the symptoms of angioedema in women with hereditary angioedema.
Overdose
Serious violations in case of overdose have not been reported.
Symptoms that may occur in overdose: nausea, vomiting, "spotting" spotting or bleeding from the vagina.
In case of overdose, you should consult a doctor.
Interaction with other drugs
Some medicines may reduce the effectiveness of Femoden®. These include drugs used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin), and HIV infection (eg, ritonavir, nevirapine); antibiotics to treat certain other infectious diseases (eg, penicillin, tetracyclines, griseofulvin); and drugs based on St. John's wort (used mainly in the treatment of depressed mood).
Oral combined contraceptives may interfere with the metabolism of other drugs (eg, cyclosporine and lamotrigine).
Always tell the doctor who prescribes Femoden® for you what medicines you are already taking. Also tell any doctor or dentist who prescribes other drugs, or any pharmacist who sells you drugs at a pharmacy, that you are taking Femoden®.
In some cases, your doctor may recommend that you additionally use a barrier method of contraception (condom).
special instructions
The following warnings related to the use of other combined oral contraceptives should also be taken into account when using Femoden®.
Thrombosis
Thrombosis is the formation of a blood clot (thrombus) that can block a blood vessel. When a thrombus breaks off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), the vessels of the heart (myocardial infarction), the brain (stroke), and extremely rarely in the vessels of other organs.
The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of combined oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show that this increased risk is present predominantly during the first 3 months.
The overall risk of VTE in patients taking low-dose combined oral contraceptives (< 50 мкг этинилэстрадиола) в два-три раза выше, чем у небеременных пациенток, которые не принимают комбинированные пероральные контрацептивы, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах.
In very rare cases, venous or arterial thromboembolism can lead to serious functional impairment or death.
VTE manifesting as deep vein thrombosis or pulmonary embolism can occur with any combined oral contraceptive.
Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina.
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
in the presence of:
- family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
- obesity (body mass index more than 30 kg/m2);
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- diseases of the heart valves;
- atrial fibrillation;
- prolonged immobilization, major surgery, any operation on the legs or major trauma. In these situations, it is advisable to stop the use of combined oral contraceptives (and in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization.
Tumors
The relationship between taking combined oral contraceptives and breast cancer has not been proven, although in women taking combined oral contraceptives, it is slightly more common than in women of the same age who do not use them. Perhaps this difference is due to the fact that when taking the drug, women are examined more often and therefore breast cancer is detected at an early stage.
In rare cases, against the background of the use of sex hormones, the development of benign, and in extremely rare cases, malignant liver tumors, which can lead to life-threatening intra-abdominal bleeding, was observed. The relationship with the use of drugs has not been proven. If you suddenly develop severe abdominal pain, consult your doctor immediately.
The most significant risk factor for developing cervical cancer is persistent papillomavirus infection, cervical cancer was detected somewhat more often in women using combined oral contraceptives for a long period of time. The relationship with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations for cervical disease or to sexual behavior (more rare use of barrier methods of contraception).
Reduced efficiency
The effectiveness of combined oral contraceptives may be reduced in the following cases: when you skip pills, with vomiting and diarrhea, or as a result of drug interactions.
Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Frequency and severity of menstrual bleeding
As with other combined oral contraceptives, irregular bleeding from the vagina ("spotting" spotting or "breakthrough" bleeding) in the intermenstrual period may occur during the first few months when taking Femoden®. Use hygiene products and continue taking the tablets as usual. Irregular bleeding usually stops as your body adapts to Femoden® (usually after 3 pill cycles). If they (irregular bleeding) continue, become heavy, or recur after stopping, see your doctor.
Absence of regular menstrual bleeding
If you have taken all the pills correctly and you have not vomited while taking the pills or taking other medicines at the same time, then the chance of pregnancy is low. Continue taking Femoden® as usual.
If there are no two menstrual-like bleeding in a row, consult a doctor immediately. Do not start taking the next pack of tablets until your doctor has ruled out pregnancy.
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 mechanisms
Not found.
When to consult a doctor
Regular checkups
If you are taking Femoden®, your doctor will inform you about regular check-ups, which a woman should usually have at least once every 6 months.
Consult your doctor as soon as possible:
for any health condition, especially any of the conditions listed in this package insert (see also "Contraindications" and "Use with caution");
in the presence of seals in the mammary gland;
if you are going to use other drugs (see also "Interaction with other drugs");
if prolonged immobility is expected (for example, a cast is applied to the leg), hospitalization or surgery is planned (consult your doctor at least 4-6 weeks before);
if you experience unusual heavy vaginal bleeding;
if you forgot to take a tablet in the first week of taking the tablets from the package and had sexual intercourse seven days or less before;
you have not had your next period twice in a row or you suspect you are pregnant (do not start taking the pills from the next pack until you have consulted with your doctor).
Stop taking the tablets and tell your doctor immediately if you notice possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath; unusual, severe or prolonged headache or migraine attack; partial or complete loss of vision or double vision; inarticulate speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe pain in the abdomen; severe pain in the leg or sudden swelling of any of the legs.
Femoden® does not protect against contracting HIV infection (AIDS) or any other sexually transmitted disease.
The drug Femoden® is recommended by your doctor personally to you, do not pass the drug to others!
Compound
Each tablet contains:
Active substances: gestodene 0.075 mg and ethinyl estradiol 0.03 mg.
Excipients: lactose monohydrate, corn starch, povidone 25000, sodium calcium edetate, magnesium stearate, sucrose, povidone 700000, polyethylene glycol (macrogol) 6000, calcium carbonate, talc, montan glycol wax.
Description
Tablets of white color of a round form.
pharmachologic effect
Femodene is a low-dose monophasic oral combined estrogen-progestin contraceptive drug.
The contraceptive effect of Femodena is carried out through complementary mechanisms, the most important of which include the suppression of ovulation and changes in the properties of the cervical secret.
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 periods are less often observed, the intensity of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer. High-dose oral contraceptives (0.05 mg ethinyl estradiol) reduce the incidence of ovarian cysts, pelvic inflammatory disease, benign breast disease, and ectopic pregnancy. The extent to which these data relate to low-dose contraceptives requires further study.
Pharmacokinetics
Gestodene
Absorption. Orally administered gestodene is rapidly and completely absorbed. After taking one tablet of Femodene, the maximum serum concentration of gestodene, equal to 4 ng / ml, is reached after 1 hour. The bioavailability of gestodene is about 99% of the administered dose.
Distribution 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. As a result of the induction of binding protein synthesis by ethinylestradiol, the fraction associated with SHBG increases, while the fraction associated with albumin decreases. The apparent volume of distribution of gestodene is 0.7 l/kg.
Metabolism. Gestodene is completely metabolized, passing through the metabolic pathways characteristic of steroids. The serum clearance rate is 0.8 ml/min/kg. Withdrawal. The content of gestodene in the blood serum undergoes a two-phase decrease. The half-life in the terminal phase is about 12-15 hours. Gestodene in unchanged form is not excreted, but only in the form of metabolites, which are excreted with a half-life of about 24 hours with urine and bile in a ratio of approximately 6:4.
Equilibrium concentration The pharmacokinetics of gestodene is affected by the level of SHBG in the blood serum, which increases approximately two-fold while taking ethinyl estradiol. As a result of daily administration of the drug, the level of substances in the serum increases by about four times, and the equilibrium concentration is reached in the second half of the course.
Ethinylestradiol
Absorption. After oral administration, ethinylestradiol is absorbed rapidly and completely. The maximum concentration in blood serum, equal to approximately 80 pg / ml, is reached in 1-2 hours. During absorption and the first passage through the liver, ethinylestradiol is extensively metabolized, resulting in its oral bioavailability averaging about 45%, with significant individual differences ranging from 20-65%.
Distribution. Ethinylestradiol is almost completely (98%), although non-specific, bound by albumin. Ethinylestradiol induces the synthesis of SHPS. The apparent volume of distribution of ethinylestradiol is 2.8 - 8.6 l / kg
Metabolism. Ethinylestradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, with the formation of a variety of hydroxylated and methylated metabolites, presented both in the form of free metabolites and in the form of conjugates with glucuronic and sulfuric acids. The rate of metabolic clearance of ethinyl estradiol varies from 2.3 to 7.0 ml / min / kg.
Withdrawal. The content of ethinylestradiol in the blood serum undergoes a two-phase decrease; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and liver in a ratio of 4:6 with a half-life of about 24 hours. Steady-state concentration Steady-state concentration is reached after about one week, taking into account the half-life of the final phase and the daily dose.
Indications for use
oral contraception
Contraindications
Femodene should not be used in the presence of any of the conditions listed below.
Thrombosis (venous and arterial) and thromboembolism in the present or in the past (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders such as stroke Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) in present or in the past.
Multiple or prominent risk factors for venous or arterial thrombosis.
Pancreatitis with severe hypertriglyceridemia, present or in the past.
Migraine with focal neurological symptoms, present or in the past.
Diabetes mellitus with vascular complications.
Liver failure and severe liver disease (until liver tests return to normal).
Liver tumors (benign or malignant), present or in the past.
Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
Vaginal bleeding of unknown origin. "
Pregnancy or suspicion of it.
Hypersensitivity to any of the components of the drug Femoden.
If any of these conditions appear for the first time while taking Femodene, stop taking this drug immediately and consult your doctor. In the meantime, use non-hormonal birth control. See also Precautions.
Pregnancy and lactation
Femodene should not be used during pregnancy and during breastfeeding. If pregnancy is detected while taking the drug Femoden, the drug should be immediately discontinued and consult a doctor. 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 who inadvertently took sex hormones in early pregnancy.
Reception Femodena can reduce the amount of breast milk and change its composition, so its use is not recommended during lactation. Small amounts of sex steroids and/or their metabolites may be excreted in milk.
Dosage and administration
Combined oral contraceptives, including Femoden, have a high contraceptive reliability. The "method failure" rate is no more than 1% per year. Contraceptive reliability may be reduced if a pill is missed or taken incorrectly.
The tablets should be taken orally 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 package begins after a 7-day break, during which menstrual-like bleeding is observed. It usually starts 2-3 days after taking the last pill and may not end before starting a new pack.
.Reception of the first package of Femodena
When no hormonal birth control is used this month
Start Femodena on the first day of your cycle, that is, on the first day of your menstrual bleeding. Take the pill labeled with the corresponding day of the week. Then take the tablets in order. You can also start taking on days 2-5 of the menstrual cycle, but in this case, you must use an additional barrier method of contraception during the first 7 days of taking the tablets from the first package.
When switching from combined hormonal contraceptives (combined oral contraceptive, vaginal ring, transdermal patch)
It is preferable to start taking Femoden the day after taking the last hormone-containing tablet from the previous package, but in no case later than the next day after the usual 7-day break in reception (for preparations containing 21 tablets) or after taking the last hormone-free tablet (for preparations containing 28 tablets per package). When switching from a vaginal ring or transdermal patch, it is preferable to start Femodena on the day the ring or patch is removed, but in no case later than the day when the next ring or patch should have been applied.
When switching from contraceptives containing only gestagens ("mini-pill", 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 an intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day the next injection was 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. 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 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 next pill is less than 12 hours, the contraceptive effect of Femodena is preserved. Take the pill as soon as you remember. Take the next tablet 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:
First week of taking the drug
The woman should immediately take the last missed pill (even if it means taking two pills 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 tablet was missed, the reliability of the drug is reduced, so the possibility of pregnancy must be taken into account.
As the number of missed pills increases and the regular break period approaches, the chance of pregnancy increases.
Second week of taking the drug The woman should immediately take the last missed pill (even if it means taking two pills at the same time). The next tablet is taken at the usual time.
If the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, 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 the pills. A woman must strictly adhere to one of the two following options. At the same time, there is no need to use additional contraceptive measures if the drug was taken correctly in the previous 7 days before missing the pills.
1. The woman should immediately take the last missed pill (even if it means taking two pills at the same time). The next tablet is taken at the usual time until the tablets 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.
Recommendations in case of vomiting and diarrhea
In severe gastrointestinal disorders, the absorption of the drug may be incomplete. In this case, additional contraceptive measures should be taken.
If a woman vomits within 3-4 hours after taking the tablets, it is necessary to focus on the advice regarding skipping the tablets. If a woman does not want to change the normal regimen of taking the drug, she should take an additional tablet if necessary (or 2 tablets from another package).
Delaying the onset of menstruation
In order to delay the onset of menstruation, a 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 interrupting the intake. Tablets from a new package can be taken for as long as the woman wishes (until the package runs out). Against the background of taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resuming Femodena from a new pack should be 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 (same as if she would like to delay the onset of her period).
Side effect
Undesirable effects have been described in women taking Femodene, and their relationship with the drug has not been confirmed or refuted:
IOrgan system |
Often (=1/100) |
Uncommon (=1/1000 and< 1 / 100 ) |
Rarely (<1/1000) |
Organ of vision |
intolerance to contact lenses (discomfort when wearing them) |
||
Gastrointestinal |
nausea, abdominal pain |
vomiting, diarrhea | |
The immune system |
allergic reactions |
||
General symptoms |
weight gain |
weight loss |
|
Metabolism |
fluid retention | ||
Nervous system |
headache |
migraine | |
Psychiatric disorders |
decreased mood, mood swings |
decreased libido |
increased libido |
Reproductive system and mammary glands |
breast pain, breast engorgement |
mammary hypertrophy |
vaginal discharge, breast discharge |
Skin and subcutaneous tissue |
rash, hives |
erythema nodosum, erythema multiforme |
Overdose
No serious side effects have been reported with overdose.
Symptoms . nausea, vomiting and, in young girls, minor vaginal bleeding.
Treatment there is no specific antidote; symptomatic treatment should be carried out.
Interaction with other drugs
Interaction with certain drugs (drugs that induce liver enzymes, some antibiotics) may lead to breakthrough bleeding and / or reduce the contraceptive effectiveness of Femoden. While taking these drugs, a woman should additionally use a barrier method of contraception or choose another method of contraception. While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception. 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 contraception from unwanted pregnancy ends later than the tablets in the package, you need to move on to the next package of Femodena without the usual break in taking the tablets.
Drugs that reduce contraceptive effectiveness include drugs that induce liver enzymes (increase hepatic metabolism): phenytoin, barbiturates, primidone. carbamazepine and rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and products containing St. John's wort.
In addition, HIV proteases (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (such as nevirapine), and combinations thereof, have the potential to interfere with hepatic metabolism.
Contraceptive protection is reduced when taking antibiotics (such as penicillins and tetracyclines), since, according to some reports, they can reduce the intrahepatic circulation of estrogens, thereby lowering the concentration of ethinylestradiol.
Femodene may interfere with the metabolism of other drugs, resulting in an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
Precautionary measures
If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of Femodena treatment should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. In the event of an increase or first manifestation of any of these conditions or risk factors, a decision should be made to discontinue the drug.
Diseases of the cardiovascular system
When taking combined oral contraceptives, there is a slight increase in the incidence of venous and arterial thrombosis and thromboembolic processes, such as myocardial infarction, deep vein thrombosis, pulmonary embolism and cerebrovascular disorders. These processes occur in rare cases.
The risk of developing venous thromboembolism is slightly higher in the first year of taking oral contraceptives. An increased risk is noted at the beginning of treatment or when treatment is resumed after a break of 4 weeks or more in treatment with this or another combined oral contraceptive. The data suggest that the risk is increased mainly in the first 3 months after the start of the drug. The approximate incidence of venous thromboembolism (deep vein thrombosis or pulmonary embolism) in women taking oral contraceptives with a low dose of estrogens (less than 50 micrograms of ethinyl estradiol) is 2-3 times higher than in women who do not use them in the absence of pregnancy. However, the frequency of venous thromboembolism (VTE) developing while taking combined oral contraceptives is less than the frequency associated with pregnancy and childbirth.
Venous thromboembolism can be fatal in 1-2% of cases.
Venous thromboembolism, manifesting as deep vein thrombosis and / or pulmonary embolism, may occur against the background of the use of all combined oral contraceptives.
In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as liver,
mesenteric, renal, cerebral arteries and veins, as well as the retina. Communication with
taking combined oral contraceptives has not been proven.
Symptoms of deep vein thrombosis may include: unilateral swelling in the leg or along the vein; pain or tenderness in the leg that may only be felt when standing or walking, a feeling of warmth in said limb, redness or discoloration in the limb.
Symptoms of a pulmonary embolism may include: the sudden onset of unexplained shortness of breath or rapid breathing, a sudden onset of coughing that may be accompanied by hemoptysis, sudden severe chest pain that may worsen with deep breathing, feeling restless, severe dizziness, rapid or abnormal heartbeat. Some of these symptoms, such as shortness of breath and cough, are non-specific and may therefore be misinterpreted as more frequent and less severe disorders, such as manifestations of respiratory system infections. Arterial thromboembolic disorders include cerebrovascular disorders, vascular occlusion, or myocardial infarction. Symptoms of cerebrovascular disorders may include weakness or numbness of the face, upper and lower extremities, especially on one side of the body, sudden confusion, impaired speech, or difficulty with perception; sudden loss of vision in one or both eyes, sudden deterioration in gait, dizziness, loss of balance or coordination, sudden severe or prolonged headache of unknown cause, loss of consciousness or fainting with or without seizures. Other signs of vascular occlusion can also be sudden pain, swelling or cyanosis of the extremities, symptoms of an "acute abdomen".
Symptoms of a myocardial infarction may include pain, discomfort, a feeling of pressure, fullness, heaviness or fullness in the chest, arm or lower sternum, a feeling of discomfort radiating to the back, jaw, throat, arm, abdomen, a feeling of fullness or fullness in the stomach, a feeling of suffocation, fever, nausea, vomiting or dizziness, weakness in the lower extremities, anxiety, shortness of breath, rapid or abnormal heartbeat. Arterial thromboembolic processes can be fatal.
The risk of thrombosis (venous and / or arterial), thromboembolism and cerebrovascular disorders 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);
if there is a family history (i.e. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); If a hereditary predisposition is known or suspected, a woman should consult her doctor before deciding to use combined oral contraceptives.
obesity (body mass index over 30 kg/m2);
dyslipoproteinemia;
arterial hypertension;
migraine;
heart valve disease;
atrial fibrillation;
prolonged immobilization, major surgery, any operation on
legs or major injury. In these situations, it is advisable to stop using
Femodena (in the case of a planned operation, at least four weeks before it) and not
resume reception within two weeks after the end of immobilization.
As for the role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism, there is no generally accepted opinion on this issue.
An increased risk of thromboembolism in the postpartum period should be taken into account. Circulatory disturbances can also be seen in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of Femodena (which may precede cerebrovascular disorders) may be grounds for its immediate termination.
Biochemical parameters that may be indicative of a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).
When evaluating the risk/benefit ratio, the physician should take into account that adequate treatment may reduce the associated risk of thrombosis and that the risk associated with pregnancy is higher than the risk associated with low-dose combined oral contraceptives (less than 0.05 mg ethinyl estradiol).
Tumors
The most important risk factor for developing cervical cancer is the persistence of the human papillomavirus (HPV). With long-term use of combined oral contraceptives, the risk may increase, but data remain conflicting about the extent to which this may be due to other factors, including cervical screening and sexual behavior, including the use of barrier methods of contraception.
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. The risk gradually decreases over 10 years after stopping oral contraceptives. 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. Breast cancers in women who have ever used combined oral contraceptives were clinically less pronounced than in women who have never used them.
In rare cases, against the background of the use of combined oral contraceptives, the development of benign liver tumors and, in even more rare cases, the development of malignant liver tumors was observed. In some cases, liver tumors can lead to life-threatening intra-abdominal bleeding. In the event of severe pain in the abdomen, liver enlargement or signs of intra-abdominal bleeding, the possibility of liver tumors in women taking should be considered. Women with hypertriglyceridemia (or the presence of this condition in a family history) may increase the risk of developing pancreatitis while taking Femodena.
Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking Femodena, this drug should be discontinued and treatment of arterial hypertension should be started. Reception of Femodena can be continued if normal values of arterial pressure are achieved with the help of antihypertensive therapy.
The following conditions observed during pregnancy may also appear or worsen when taking combined oral contraceptives: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. However, the relationship between the development of these conditions and the use of combined oral contraceptives has not been proven. In women with hereditary angioedema, exogenous estrogens contained in the drug may provoke or exacerbate the symptoms of this disease.
In the presence of acute or chronic liver dysfunction, it is necessary to resolve the issue of discontinuing the use of Femoden until liver function indicators return to normal. With the development of recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, Femodena should be discontinued.
Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема Фемодена.
Against the background of the use of combined oral contraceptives, manifestations of Crohn's disease and ulcerative colitis were observed.
In some cases, chloasma may occur, especially in women with a history of chloasma of pregnancy.
Women with a tendency to develop chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking Femodena.
A woman should be warned that Femoden does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Laboratory tests
Femodena intake may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.
Effect on the menstrual cycle
While taking Femodena, irregular bleeding (spotting) may occur.
spotting or breakthrough bleeding), during the first months
applications.
Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.
Some women may not develop withdrawal bleeding during their pill break. If Femodene was taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take the drug.
Medical examinations
Before starting the use of the drug 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.
In the case of long-term use of the drug, it is necessary to conduct control examinations every 6 months.
Use in children and adolescents
Femodene should be used only after the onset of menstruation.
Use in the elderly
Not applicable. Femodene is not indicated for women after menopause.
Influence on the ability to drive a car and mechanisms
The use of the drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.
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 considered. 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).