Certificate of conformity (COC) Femoden, pills, 21pcs

Femoden, pills, 21pcs

$74.0

Active ingredient:	Ethinylestradiol, Gestodene
Dosage form:	Drage
Indications for use:	Contraception

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Categories: Contraceptive, Medication, Obstetrics, gynecology

Description
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Composition

Active ingredient:

0.075 mg of gestodene and 0.03 mg of ethinyl estradiol.

Auxiliary substances:

lactose monohydrate,

corn starch,

povidone 25000,

sodium calcium edetate,

magnesium stearate,

sucrose,

povidone 700000,

polyethylene glycol (macrogol) 6000,

calcium carbonate,

talc,

montano-glycol wax.

Pharmacological action

Femoden is a low-dose monophasic oral contraceptive.

The contraceptive effect of Femoden is based on the interaction of various factors, the most important of which are inhibition of ovulation and changes in the secretion of cervical mucus.

In addition to the contraceptive effect, combined oral contraceptives have a positive effect, which should be taken into account when choosing a method of birth control. The cycle becomes more regular, less painful menstruation is observed. the intensity of bleeding decreases, which reduces the risk of iron deficiency anemia.

Pharmacokinetics

of Gestoden

Taken orally, gestoden is rapidly and completely absorbed. Cmax of gestodene in serum, equal to 4 ng / ml, is reached in 1.0 hours after oral use. The absolute bioavailability of gestodene is about 99% of the dose taken.

Gestodene binds to serum albumin and sex steroid binding globulin (SHBG). Only about 1-2% of total serum gestodene levels are in free form, and approximately 50-70% are specifically associated with SHBPS. The relative distribution of fractions (free gestodene, bound to albumin, bound to SHBPS) depends on the concentration of SHBPS in serum. Following the induction of binding protein, the SHBS-bound fraction increases, while the free and albumin-bound fractions decrease.

The subsequent biotransformation is similar to the known steroid metabolism. For gestoden, the apparent volume of distribution is 0.7 l / kg and the rate of serum metabolic clearance is about 0.8 ml / min / kg. There was no interaction with simultaneous use of ethinyl estradiol.

There is a two-phase decrease in the level of gestodene in serum. The terminal phase of distribution is characterized by a half-life of about 12-15 hours. Gestoden 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: 4Pharmacologically active gestodene metabolites are not known.

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

Ethinyl Estradiol

After oral use, ethinyl estradiol is rapidly and completely absorbed. Cmax of ethinyl estradiol in plasma, which is about 80 pg / ml, is reached in 1-2 hours. During absorption and the first passage through the liver, a significant part of ethinyl estradiol is metabolized. Absolute bioavailability is about 60%.

About 98.5% of the serum ethinyl estradiol level is non-specifically bound to serum albumins. Ethinyl Estradiol increases hepatic synthesis of SHBPS (sex steroid binding globulin). For ethinyl estradiol, the apparent volume of distribution is approximately 5 l / kg.

During absorption and the first passage through the liver, a significant part of ethinyl estradiol 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 biphasic decrease in the level of ethinyl estradiol in plasma, with T1/2 of the final phase of about 24 hours. It is not excreted unchanged from the body. Metabolites of ethinyl estradiol are excreted in the urine and bile in a ratio of 4: 6 with T1 / 2 for about 1 day. The equilibrium concentration reached after 3-4 days of use was 40-60% higher than the concentration of ethinyl estradiol after a single dose.

In nursing mothers, about 0.02% of the daily dose of ethinyl estradiol can enter the baby’s body with breast milk.

Indications

Pregnancy prevention.

Contraindications

tumors of the mammary glands and genitals
spotting from the genital tract of unknown origin
thrombophlebitis
impaired kidney and liver function
severe diabetes mellitus
atherosclerosis
migraine.

Side effects

The following adverse effects have been described in women taking Femoden, and their relationship with the drug was neither confirmed nor denied: engorgement, soreness of the mammary glands, secretions from them; headache; migraine; changes in libido; decreased mood; poor tolerance to contact lenses; nausea; vomiting; changes in vaginal secretion; various skin reactions; fluid retention; changes in body weight; hypersensitivity reactions.

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

Interaction

Interaction of oral contraceptives with other medications can lead to breakthrough bleeding and / or reduced contraceptive reliability. The following types of interaction have been reported in the literature.

Effects on hepatic metabolism: the use of drugs that induce microsomal liver enzymes may lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and preparations containing St. John’s wort.

Effects on hepatic circulation: Some antibiotics (such as penicillins and tetracycline) have been shown to reduce the hepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

When taking medications that affect microsomal enzymes, and for 28 days after their withdrawal, you should additionally use a barrier method of contraception.

When taking antibiotics (such as ampicillins and tetracyclines) and for 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 Femoden without the usual break in taking pills. Oral combined contraceptives can affect the metabolism of other drugs (including cyclosporine), which leads to changes in their concentration in plasma and tissues.

How to take, course of use and dosage

Pills should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Take one tablet a day continuously for 21 days. Taking the next package begins after a 7-day break in taking pills, during which withdrawal bleeding usually occurs. Bleeding usually begins 2-3 days after taking the last tablet and may not end until the start of taking a new package.

How to start taking Femoden

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

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

When switching from other combined oral contraceptives.

It is preferable to start taking Femoden the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package).

When switching from progestogen-only contraceptives (mini-pills, injectable forms, implants), or from a progestogen-releasing intrauterine contraceptive (Mirena).

A woman can switch from a mini-pill to Femoden on any day (without a break), from an implant or intrauterine contraceptive with a progestogen-on the day of its removal, from an injectable form-from the day when the next injection should be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills.

After an abortion in the first trimester of pregnancy.

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

After giving birth or having an abortion in the second trimester of pregnancy.

It is recommended to start taking the drug on 21-28 days after delivery 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 pills. However, if a woman has already had sexual activity, pregnancy should be excluded before taking Femoden or it is necessary to wait for the first menstruation. If the delay in taking the drug is less than 12 hours, the contraceptive protection is not reduced. A woman should take a tablet as soon as possible, the next one is taken at the usual time.If the delay in taking pills is more than 12 hours, the contraceptive protection may be reduced. In this case, you can follow the following two basic rules::

The drug should never be interrupted for more than 7 days.
7 days of continuous intake of pills are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

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

First week of taking the drug

A woman should take the last missed tablet as soon as she remembers (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) should be used for the next 7 days. If sexual intercourse took place during the week before skipping pills, it is necessary to take into account the probability of pregnancy. The more pills missed, and the closer they are to a break in taking active substances, the more likely pregnancy is.

The second week of taking the drug

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

Provided that the woman took the pills correctly during 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 pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of reducing the reliability of contraception is inevitable due to the upcoming break in taking pills.

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

1. A woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). The next tablet is taken at the usual time, until the pills from the current package run out. The next package should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but there may be spotting and breakthrough bleeding while taking pills.

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

If a woman has missed taking pills, and then during a break in taking pills, she does not have withdrawal bleeding, it is necessary to exclude pregnancy.

Recommendations for vomiting and diarrhea

If a woman has had vomiting or diarrhea for 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 follow the recommendations when skipping pills.

Changing the day when your menstrual cycle starts

In order to delay the onset of menstruation, a woman should continue taking pills from the new package of Femoden immediately after taking all the pills from the previous one, without a break in reception. Pills from this new package can be taken as long as the woman wants (until the package is finished). Against the background of taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Femoden from a new pack after the usual 7-day break.

In order to move the day of the beginning of menstruation to another day of the week, a woman should be advised to speed up the next break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future, there will be spotting and breakthrough bleeding while taking the second package (as well as in the case when she would like to delay the onset of menstruation).

Overdose

No serious overdose violations were reported. Symptoms that may occur with an overdose: nausea, vomiting, spotting or metrorrhagia.

There is no specific antidote, and symptomatic treatment should be performed.

Special instructions

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed on a case-by-case basis and discussed with the woman before she decides to start taking the drug.

If any of these conditions or risk factors become more severe, worsen, or first appear, a woman should consult with her doctor, who may decide whether to discontinue the medication.

Diseases of the cardiovascular system

There is evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) when taking combined oral contraceptives. The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these medications. The approximate incidence of VTE among women taking low-dose oral contraceptives (

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 increases further, especially in women over 35 years of age);in the presence of: – family history (i. e. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); in the case of hereditary predisposition, the woman should be examined by an appropriate specialist to decide whether to take combined oral contraceptives;-obesity (body mass index more than 30 kg/m2); – dyslipoproteinemia; – arterial hypertension; – migraines; – heart valve diseases; – atrial fibrillation; – long – term immobilization, major surgery, any leg surgery, or extensive trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least four weeks before it) and not resume taking them for two weeks after the end of immobilization.

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. The increased risk of developing thromboembolism in the postpartum period should be taken into account. Peripheral circulatory disorders can also occur with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) and sickle cell anemia. An increase in the frequency and severity of migraines during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be a reason for immediate discontinuation of these drugs.

Tumors

The most significant risk factor for developing cervical cancer is persistent papilloma, a viral infection. There are reports of a slight increase in the risk of cervical cancer with prolonged use of combined oral contraceptives. The association with the use of combined oral contraceptives has not been proven. There are still contradictions about the extent to which these findings are related to screening for cervical pathology or sexual behavior (more rarely, the use of barrier methods of contraception).

It also found that there was a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these medications. Its association with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of earlier breast cancer diagnosis in women using combined oral contraceptives. Women who have ever used combined oral contraceptives are more likely to develop early-stage breast cancer than women who have never used them. In rare cases, the use of combined oral contraceptives resulted in the development of liver tumors, which in some cases led to life-threatening intra-abdominal bleeding. If there is severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Other states

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking combined oral contraceptives.

Although a small increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically significant increases have rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these medications should be discontinued and treatment for hypertension should be initiated.The use of combined oral contraceptives can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and with combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes of pregnancy; hearing loss associated with otosclerosis. There are also cases of Crohn’s disease and ulcerative colitis associated with the use of combined oral contraceptives.

Acute or chronic liver function disorders may require discontinuation of combined oral contraceptives until liver function indicators return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives. Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives ( Sometimes chloasma may develop, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking combined oral contraceptives.

Laboratory tests

The use of combined oral contraceptives may affect the results of certain laboratory tests, including liver, kidney, thyroid, and adrenal function, plasma transport protein levels, carbohydrate metabolism, and coagulation and fibrinolysis parameters. Changes usually do not exceed the limits of normal values.

Effects on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should only be evaluated after an adjustment period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignancies or pregnancy.

Some women may not develop withdrawal bleeding during a break from taking pills. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken on an irregular basis or if there are no consecutive withdrawal bleeds, pregnancy should be excluded before continuing the drug.

Medical examinations

Before starting or resuming the use of Femoden, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical (including blood pressure measurement, heart rate, body mass index determination) and gynecological examination (including breast examination and cytological examination of cervical mucus), and exclude pregnancy. The scope of additional examinations and the frequency of follow-up examinations are determined individually. Usually, control examinations should be carried out at least once a year.

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

Influence on the ability to drive a car and machinery. Not detected.