Femoden, 75 mcg+30 mcg 21 pcs

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 alteration of cervical mucus secretion.

In addition to their contraceptive effect, combined oral contraceptives have positive effects that should be considered when choosing a method of birth control. The cycle becomes more regular, painful menstrual periods are less frequent. the intensity of bleeding decreases, and as a result the risk of iron deficiency anemia decreases.

Pharmacokinetics

Gestoden

Gestoden taken orally is quickly and completely absorbed. The Cmax of gestoden in serum, equal to 4 ng/ml, is reached 1.0 h after oral administration. Absolute bioavailability of gestoden is about 99% of the dose taken.

Gestoden binds to serum albumin and sex steroid-binding globulin (SBSG). Only about 1-2% of total serum gestoden levels are in the free form; approximately 50-70% are specifically bound to hSPCs. The relative distribution of the fractions (free gestoden, albumin-bound, HSPC-bound) depends on the concentration of HSPC in the serum. Following induction of binding protein, the HSPC-bound fraction increases, whereas the free and albumin-bound fractions decrease.

The subsequent biotransformation is similar to the known metabolism of steroids. For gestoden, the apparent volume of distribution is 0.7 L/kg and the metabolic clearance rate from serum is approximately 0.8 ml/min/kg. No interaction has been observed with concomitant administration of ethinylestradiol.

There is a biphasic decrease in serum levels of gestodenone. The terminal phase of distribution is characterized by a half-life of about 12-15 h. Gestoden is not excreted unchanged, only as metabolites which are eliminated with half-life of about 1 day. Gestoden metabolites are excreted with urine and bile in the ratio of about 6:4. Pharmacologically active metabolites of gestoden are not known.

The pharmacokinetics of gestodenes is influenced by the serum level of HSPC, which increases approximately 3-fold under the influence of ethinylestradiol. Increased serum gestoden concentrations are observed with daily administration of the drug. Mean serum levels are approximately 4 times higher when equilibrium concentrations are reached (usually reached during the second half of the cycle).

Ethinylestradiol

Ethinylestradiol is quickly and completely absorbed after oral administration. The Cmax of ethinylestradiol in plasma is about 80 pg/ml and is reached after 1-2 hours. During absorption and the first passage through the liver, a significant portion of ethinylestradiol is metabolized. Absolute bioavailability is about 60%.

About 98.5% of the serum level of ethinylestradiol binds nonspecifically to serum albumin. Ethinylestradiol increases hepatic synthesis of HSPC (sex steroid binding globulin). For ethinylestradiol, the apparent volume of distribution is approximately 5 L/kg.

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

There is a biphasic decrease in plasma levels of ethinylestradiol, with a T1/2 end phase of about 24 hours. It is not excreted in unchanged form. Metabolites of ethinylestradiol are excreted in the urine and bile at a ratio of 4:6 with a T1/2 of about 1 day. The equilibrium concentration reached after 3-4 days of administration was 40-60% higher than the concentration of ethinylestradiol after a single dose.

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

Indications

Preventing pregnancy.

Active ingredient

Composition

Active ingredient:

0.075 mg of gestoden and 0.03 mg of ethinylestradiol.

Associates:

Lactose monohydrate,

corn starch,

p> povidone 25000,

sodium calcium edetate,

magnesium stearate,

sucrose,

povidone 700000,

polyethylene glycol (macrogol) 6000,

calcium carbonate,

talc,

montane glycol wax.

How to take, the dosage

The tablets should be taken orally in the order given on the package, at approximately the same time each day, with a little water. One tablet per day is taken continuously for 21 days. The next package is taken after a 7-day break in the intake of the pills, during which you usually have a bleeding withdrawal. Bleeding usually begins 2 to 3 days after taking the last dose and may not end until a new dose is taken.

How to start taking Femoden

Pemoden starts on the first day of your menstrual cycle (i.e. the first day of menstrual bleeding). It is allowed to start taking Femoden on days 2-5 of the menstrual cycle, but in this case it is recommended to use an additional barrier method of contraception during the first 7 days of taking pills from the first package.

Preferably, Femoden should be started the day after taking the last active tablet from the previous package, but never later than the day after the usual 7-day break (for products containing 21 pills) or after taking the last inactive tablet (for products containing 28 pills per package).

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

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

It is recommended that the drug be started 21-28 days after delivery or second trimester abortion. If intake is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee. However if a woman is already sexually active you should exclude pregnancy or wait for your first menstrual period before taking Femoden.
Taking overdue pills
If the delay in taking the pills is less than 12 hours the contraceptive protection is not reduced. The woman should take the pill as soon as possible and take the next one at the usual time.
If the delay in taking the pill is more than 12 hours, contraceptive protection may be reduced. The following two basic rules may guide you in doing so:

The following advice may be given accordingly if the delay in taking the dragee is more than 12 hours (the interval since the last dragee was taken is more than 36 hours):

The woman should take the last missed dragee as soon as she remembers (even if this means taking two dragees at once). The next pill 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 the pills, it is necessary to consider the possibility of pregnancy. The more the pills are skipped, and the closer they are to a break in the active ingredient, the more likely pregnancy is.

The woman should take the last missed dragee as soon as she remembers (even if that means taking two dragees at once). The next one is taken at the usual time.

As long as the woman has taken the dragee correctly in the 7 days preceding the first missed dragee, no additional contraceptive measures are necessary. Otherwise, and if two or more pills are missed, additional barrier methods of contraception (e.g., a condom) should be used for 7 days.

The risk of decreased contraceptive reliability is inevitable because of the impending interruption of the pills.

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

1. The woman should take the last missed pills as soon as she remembers (even if that means taking two pills at the same time). Take the next pill at the usual time until the pills from the current package are finished. The next pack should be started immediately. Bleeding cancellation is unlikely until the second pack is finished, but there may be oozing and breakthrough bleeding while taking the pills.

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

If a woman misses a dose and then has no bleeding cancellation during a break in the dragee, pregnancy must be ruled out.

Recommendations for vomiting and diarrhea

If a woman has had vomiting or diarrhea within 4 hours of taking active pills, absorption may not be complete and additional contraceptive measures must be taken. In these cases, the recommendations for skipping the dragee should be followed.

Changing the start day of the menstrual cycle

In order to delay the start of menstruation, women should continue the pills in the new Femoden pack immediately after taking all the pills in the previous pack without interruption. This new pack can be taken as long as the woman wishes (until the pack runs out). While taking the drug from the second pack, a woman may experience mucous discharge or breakthrough uterine bleeding. You should resume Femoden from the new pack after the usual 7-day break.

In order to postpone the day her period starts to another day of the week, a woman should be advised to accelerate the nearest break from taking the pills for as many days as she wants. The shorter the interval, the higher the risk that she won’t have a bleeding withdrawal, and subsequently, there will be oozing and breakthrough bleeding while taking the second pack (just like when she would like to delay the start of her period).

Interaction

Interactions between oral contraceptives and other medications may result in breakthrough bleeding and/or decreased contraceptive reliability. The following types of interactions have been reported in the literature.

Influence on hepatic metabolism: the use of drugs that induce hepatic microsomal enzymes may lead to increased clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there is also speculation about oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and drugs containing St John’s wort.

Influence on intrahepatic circulation: Some antibiotics (e.g., penicillins and tetracyclines) may decrease intrahepatic circulation of estrogen, thereby lowering the concentration of ethinylestradiol, according to individual studies.

When taking drugs that affect microsomal enzymes, and for 28 days after their withdrawal, an additional barrier method of contraception should be used.

When taking antibiotics (such as ampicillins and tetracyclines) and for 7 days after their withdrawal, an additional barrier method of contraception should be used. If the period of use of a barrier method of contraception ends later than the pills in the package, you should proceed to the next package of Femoden without the usual break in the intake of pills. Oral combination contraceptives may affect the metabolism of other drugs (including cyclosporine), resulting in changes in their plasma and tissue concentrations.

Special Instructions

If any of the conditions/risk factors listed below are currently present, the potential risks and expected benefits of 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 medication.

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

. 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 venous thromboembolism (VTE) is highest in the first year of taking these drugs. 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 more cigarettes or increased age, the risk further increases, especially in women over 35);
if there is:
– a family history (i.e.е. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); in case of hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
– obesity (body mass index over 30 kg/m2);
– dyslipoproteinemia;
– arterial hypertension;
– migraine;
– heart valve diseases;
– atrial fibrillation;
– prolonged immobilization, serious 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 to resume taking them for two weeks after the end of immobilization.

The possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism remains controversial. The increased risk of thromboembolism in the postpartum period should be considered.
Peripheral circulatory disorders may also be noted in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn’s disease or nonspecific 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 grounds for immediate discontinuation of these drugs.

The most significant risk factor for cervical cancer, is persistent papillomavirus infection. There have been reports of some increased risk of cervical cancer with long-term use of combined oral contraceptives. The association with taking combined oral contraceptives has not been proven. There remains controversy about the extent to which these findings are related to screening for cervical abnormalities or to patterns of sexual behavior (less frequent use of barrier methods of contraception).

It was also found that there was a slightly increased relative risk of breast cancer diagnosed in women who used combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Its association with the use of combined oral contraceptives has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives. Women who have ever used combined oral contraceptives are detected earlier stages of breast cancer than women who have never used them.
In rare cases, against the background of combined oral contraceptives development of liver tumors, which in some cases led to life-threatening intra-abdominal bleeding was observed. If severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding occur, this should be considered in the differential diagnosis.

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

While small increases in blood pressure have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, the medications should be stopped and treatment for arterial hypertension should be initiated. The combined oral contraceptives may be continued if normal blood pressure values are achieved with hypotensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and while taking combined oral contraceptives, but their association with taking 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. Cases of Crohn’s disease and nonspecific ulcerative colitis have also been described with combined oral contraceptives.

Acute or chronic liver dysfunction may require withdrawal of the combined oral contraceptives until liver function returns 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 affect insulin resistance and glucose tolerance, there is no need to change therapeutic regimens in diabetic patients using low-dose combined oral contraceptives ( Sometimes chloasma may develop, especially in women with nal Women who are prone to chloasma should avoid prolonged sun exposure and exposure to ultraviolet radiation while taking combined oral contraceptives.

Laboratory tests

The use of combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid and adrenal function, plasma levels of transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. The changes usually do not go beyond normal values.

The effect on the menstrual cycle

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

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

Some women may not develop withdrawal bleeding during a break in the drags. If the combined oral contraceptives have been taken as directed, it is unlikely that the woman is pregnant. However, if the combined oral contraceptives have been taken irregularly before, or if there are not two consecutive bleeding withdrawals, pregnancy must be ruled out before continuing the drug.

Medical examinations

Before starting or resuming Femoden, a woman’s medical history, family history, a thorough general medical examination (including measurement of BP, heart rate, body mass index) and gynecological examination (including breast examination and cervical mucus cytology) should be performed, and pregnancy should be excluded. The volume of additional examinations and the frequency of follow-up examinations are determined individually.
Normally, follow-up examinations should be performed at least once a year.

Warn women that Femoden does not protect against HIV infection (AIDS) or other sexually transmitted diseases!

The effect on the ability to drive and operate machinery. Not detected.

Contraindications

Side effects

The following adverse effects have been described in women taking Femoden and their relationship to the drug has neither been confirmed nor disproven: breast engorgement, breast tenderness, secretions; headache; migraine; changes in libido; decreased mood; poor contact lens tolerance; nausea; vomiting; changes in vaginal secretion; various skin reactions; fluid retention; body weight changes; hypersensitivity reactions.

Chloasma may sometimes develop, especially in women with a history of pregnancy chloasma.

Overdose

Serious disorders in overdose have not been reported. Symptoms that may occur in case of overdose: nausea, vomiting, mucous bloody discharge or metrorrhagia.

There is no specific antidote, symptomatic treatment should be carried out.

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