Femoston 1 5 what does conti mean. Internet Ambulance Medical portal. Interaction with other medicinal products

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Femoston is a drug for hormone replacement therapy, which is used to treat various natural changes in a woman's body, caused by the onset of menopause or removal of the ovaries (surgical castration). Femoston provides a woman's body with sex hormones, which, as a result of menopause or surgical castration, are produced by the ovaries and adipose tissue in insufficient quantities and, thereby, maintains the normal state and functioning of various organs and systems. Femoston eliminates various disorders caused by a deficiency of sex hormones, such as autonomic, psychoemotional and sexual disorders, and also prevents coronary artery disease and osteoporosis.

Types, names, release forms and composition of Femoston

Currently, three varieties of Femoston are produced - Femoston 1/10, Femoston 2/10 and Femoston 1/5 (Conti). All three varieties are available in a single dosage form - pills for oral administration, and differ from each other only in the dosage of the active ingredients. Femoston 1/5 tablets are correctly called "Femoston Conti 1/5", but in everyday speech they are often referred to as "Femoston 1 5" or "Femoston Conti". Femoston 1/10 and Femoston 2/10 tablets are often written and called "Femoston 1 10" and "Femoston 2 10". Femoston 1, Femoston 2 and Femoston 5 tablets do not exist. The varieties of Femoston tablets differ from each other only in the dosages of the active substance in the tablets.

All varieties of Femoston include estradiol (estrogen hormone) and dydrogesterone (progesterone hormone) in various dosages.

Femoston 1/5 is available in packs of 28 tablets, each containing 1 mg of estradiol and 5 mg of dydrogesterone. The tablets are orange-pink in color, have a round biconvex shape and are engraved with "379" on one side and "S" on the other.

Femoston 1/10 Available in packs of 28 tablets. Each package contains 14 tablets of two types - white and gray. White tablets contain 1 mg of estradiol, and gray ones - 1 mg of estradiol + 10 mg of dydrogesterone. Both the white and gray tablets are round, biconvex and engraved with "379" on one side.

Femoston 2/10 is available in packs of 28 tablets, among which there are two varieties - pink and light yellow. Both types of tablets are the same number, that is, there are 14 pieces of both pink and light yellow in one pack. Each pink tablet contains 2 mg of estradiol, and the light yellow tablets contain 2 mg of estradiol + 10 mg of dydrogesterone. Both types of tablets have the same size, rounded biconvex shape and engraving "379" on one side.

As auxiliary components, all types of tablets of the three varieties of Femoston (pink-orange, white, gray, pink, light yellow) contain the same substances, such as:

• Hypromellose;
• Magnesium stearate;
• Colloidal silicon dioxide;
• Lactose monohydrate;
• Talc;
• Titanium dioxide;
• Polyethylene glycol 400;
• Iron oxides black, red and yellow (to give the tablets color).

Therapeutic action

All varieties of Femoston have the same therapeutic effect, and different dosages of active hormones allow you to choose the optimal drug for each woman that best suits her.

Femoston is a combined, modern, low-dose hormonal drug, the therapeutic effects of which are due to the constituent estradiol and dydrogesterone.

Estradiol, which is part of Femoston, is identical to the natural one, normally produced by a woman's ovaries. That is why it compensates for the deficiency of estrogens in the body with their insufficient production in menopause or almost complete absence in case of castration syndrome. Estrogens in women in menopause or after removal of the ovaries provide smoothness, elasticity and slow aging of the skin, slow down hair loss, induce the production of vaginal lubrication, preventing dryness and discomfort during intercourse, and also prevent atherosclerosis and osteoporosis. In addition, estradiol eliminates specific manifestations of menopause or castration syndrome, such as hot flashes, sweating, sleep disturbances, irritability, dizziness, headaches, atrophy of the skin and mucous membranes, etc.

Dydrogesterone is a progesterone hormone that promotes endometrial growth in the second half of the menstrual cycle in women. When taken in the composition of Femoston, dydrogesterone reduces the risk of developing hyperplasia or endometrial cancer, which increases with the use of estrogens. This progesterone hormone does not have any other effects, and was introduced into Femoston specifically to level the risk of endometrial hyperplasia and cancer, which increases due to estradiol intake.

Femoston - indications for use

The indications for use for all three varieties of Femoston (1/10, 2/10 and 1/5) are the same:
1. Hormone replacement therapy for a specific climacteric or castration syndrome in women, manifested by hot flashes, sweating, palpitations, sleep disturbances, irritability, nervousness, vaginal dryness and other symptoms of estrogen deficiency. Femoston 1/10 and 2/10 can be used six months after the last menstruation, and Femoston 1/5 - only after a year;
2. Prevention of osteoporosis and increased fragility of bones in women during menopause with intolerance to other drugs intended to maintain normal bone mineralization, prevention of calcium deficiency and treatment of this pathology.

Instructions for use

Femoston 1/5 - instructions (how to take)

Femoston 1/5 must be taken one tablet every day, preferably at the same time, regardless of the meal. After the end of the tablets from one pack, they immediately start the next one, without taking any breaks.

If on some day a woman forgot to take another Femoston 1/5 pill, but less than 12 hours have passed from the checkout time, then you should drink it as soon as possible. If more than 12 hours have passed since the moment when the pill was supposed to be taken, then it is necessary to skip it, and from the next day take the pills as usual until the end of the pack. Do not take two tablets at once to compensate for the gap. If a woman has forgotten to take a pill, then while taking the current pack she has an increased risk of bleeding and smearing discharge from the genital tract.

The duration of the drug is determined individually, based on the rate of normalization of the condition and the disappearance of menopausal symptoms. Usually the drug is taken for at least 3 to 6 months without interruption. In principle, Femoston 1/5 is suitable for long-term continuous use, that is, the tablets can be drunk for several years in a row without taking any breaks.

If Femoston 1/5 is ineffective for stopping the manifestations of menopause, then you can switch to taking Femoston 1/10 or Femoston 2/10, which contain a large dosage of hormones. Depending on the state of health and the effectiveness of treatment in the future, the dosage of Femoston can be changed again.

If a woman is already taking any estrogen-progestogenic drug (for example, Femoston 1/10, Femoston 2/10, Angelik, Kliogest, Climodien, Indivina, etc.) and wants to replace it with Femoston 1/5, then you should first drink until the end of the started packaging of the medicine. Then, without taking any break, the day after taking the last pill from the pack of the estrogen-progestogen drug, you should start taking Femoston 1/5 tablets.

If a woman takes an estrogen-progestogenic drug (for example, Trissequencing, Divisek, etc.) and wants to switch to Femoston 1/5, then this can be done any day. That is, it is not necessary to finish the started pack of estrogen-progestin drug pills, it is enough just to start taking Femoston 1/5 the next day.

Femoston 1/10 and Femoston 2/10 - instructions (how to take)

A pack of Femoston 1/10 contains 14 white and 14 gray tablets, and Femoston 2/10 contains 14 pink and 14 light yellow tablets, which are taken regardless of food. In each new pack of Femoston 1/10, all white tablets are first taken, one piece a day, preferably at the same time. Then they take all the gray pills, 1 piece per day, also preferably at the same time. They do the same with Femoston 2/10, first taking all the pink pills one piece a day, and then the light yellow ones, also one a day.

After the end of one pack of Femoston 1/10 or Femoston 2/10, and opening a new one, again first take all white from 1/10 or pink from 2/10, and then gray from 1/10 or light yellow tablets from 2 / 10 one piece a day. There are no breaks between the packs, that is, after the end of one, the next day, start taking pills from a new one.

Women who have not stopped menstruating should start taking Femoston 1/10 or Femoston 2/10 on the first day of menstruation. If the menstrual cycle is irregular, then before starting Femoston 1/10 or 2/10, progestogen preparations (for example, Veraplex, Gestanin, Gormofort, Dufaston, Levonova, etc.) should be taken for two weeks, which will ensure withdrawal bleeding in order to remove it from the uterine cavity of all the remnants of the endometrium. If a woman's menstruation stopped more than six months ago, then you can start taking Femoston 1/10 and 2/10 on any day.

If a woman has forgotten to take a pill and less than 12 hours have passed from the time of her usual intake, then the missed pill should be taken. If more than 12 hours have passed from the time of the usual intake, then the missed pill is taken out of the pack and discarded, and the next day the next pill is taken according to the schedule. Do not take two tablets at the same time in order to eliminate the gap. During the intake of the pack with the missed pill, the woman has an increased risk of bleeding from the genital tract.

The duration of the use of Femoston 1/10 and Femoston 2/10 is determined individually, depending on the rate of normalization of the condition and the relief of climacteric syndrome. The preparations are suitable for long-term use and can be used for several years without interruption. If the treatment is not effective enough, then you can replace the drug with another or choose Femoston with a lower or higher dosage of hormones. Usually, hormone replacement therapy begins with Femoston 1/10, and then, depending on the reaction of the woman's body, leave it on this type of drug or transfer to Femoston 1/5 or Femoston 2/10.

If a woman wants to switch to taking another drug with 2 or 3 types of tablets, then you should first finish the started pack of Femoston 1/10 Femoston 2/10 to the end. Then, without any interruption, the next day after taking the last tablet from a pack of Femoston 1/10 or Femoston 2/10, you need to start taking another drug.

If a woman wants to switch to Femoston 1/10 or Femoston 2/10 from any other drug containing only one type of pill, then this can be done at any time. That is, you do not need to finish drinking a pack of another drug to the end, it is enough just to drink the first of a pack of Femoston 1/10 or Femoston 2/10 instead of the old pill any day.

special instructions

All three varieties of Femoston are contraindicated for use during pregnancy and lactation. If, while taking Femoston, a pregnancy accidentally occurs, then you should immediately stop taking the drug. The question of continuing pregnancy should be decided individually with a gynecologist.

Since estrogens contribute to fluid retention in the body and the formation of edema, all three types of Femoston should be used with caution in women suffering from kidney disease, renal or heart failure. During the entire period of use of any type of Femoston, the function of the kidneys and heart should be monitored, and the woman's condition should be monitored.

Femoston 2/10 should not be used by women suffering from acute or chronic liver diseases at any stage. And Femoston 1/10 and Femoston 1/5 can be used for liver diseases, but only after the liver function tests (the activity of AsAT, ALAT and alkaline phosphatase) are normalized.

Against the background of the use of Femoston, at least once a year, the risks and benefits should be assessed, as well as correlated with each other, and on the basis of this, a decision should be made to continue or stop hormone replacement therapy. Any kind of Femoston is continued as long as the benefits outweigh the risks.

Before starting to use any kind of Femoston, it is necessary to carefully find out all the existing and transferred diseases, as well as to examine the condition of the genitals and mammary glands. If there are any benign neoplasms in the uterus, ovaries or mammary glands, then Femoston cannot be taken. If any lumps or lumps form in the breast during the course of taking the drugs, you should immediately consult a doctor.

During the entire period of taking Femoston, women who are suffering in the present or have had the following diseases in the past should visit a doctor at least once every three months:

• Endometriosis;
• High risk of thrombosis or thromboembolism;
• The presence of breast cancer in blood relatives (mother, sister, grandmother, etc.);
• Hypertonic disease;
• Hepatocellular adenoma;
• Cholelithiasis;
• Severe obesity (BMI over 30);
• Migraine;
• Severe headache;
• Systemic lupus erythematosus;
• Bronchial asthma;
• Porphyria;
• Epilepsy;

In women, in the past or present, suffering from the listed diseases, while taking Femoston, their symptoms may worsen. In the presence of these diseases, a woman significantly increases the risks of developing complications of hormone replacement therapy, such as, for example, breast cancer, thromboembolism, coronary heart disease, heart attack, stroke, etc., and that is why this category of women needs to constantly monitor their condition by visiting doctor at least once a quarter.

You should know that taking Femoston or any hormone replacement therapy drug containing estrogens slightly increases the risk of developing endometrial and breast cancer. Therefore, women who have not removed the uterus and mammary glands should be attentive and alert about possible endometrial cancer during the entire period of taking Femoston. The risk of developing cancer is higher the longer Femoston is taken. In addition, while taking Femoston in women, the risk of coronary heart disease and stroke increases. However, the risk of developing stroke and ischemic heart disease is more influenced by the woman's age and her existing chronic diseases, but it does not depend at all on the duration of Femoston's use.

Most strongly against the background of therapy with any type of Femoston in women, the risk of venous thromboembolism increases. Moreover, the risk of thromboembolism is highest during the first year of treatment, and in subsequent years it, on the contrary, decreases. Therefore, women who have an increased risk of venous thromboembolism can take Femoston only under medical supervision and under close supervision. If any of the blood relatives has a thrombolytic defect (for example, a deficiency of antithrombin, protein C, protein S, etc.), then the woman should not take Femoston.

Since any major surgical operation is accompanied by the risk of thromboembolism, it is necessary to stop taking Femoston 4-6 weeks before it is performed. It will be possible to resume taking Femoston again only after motor activity is fully restored after the operation.

During the entire period of Femoston therapy, the concentration of triglycerides, thyroid-binding globulin, corticoid-binding globulin and sex hormone-binding globulin, as well as alpha-1-antitrypsin and ceruloplasmin, may increase in the blood. However, this does not lead to an increase in the concentration of circulating active hormones.

Femoston does not improve mental performance and is not a contraceptive drug.

At the beginning of treatment with any type of Femoston, a woman may develop breakthrough bleeding or spotting. If bleeding or bleeding occurs, Femoston should be discontinued, consult a doctor and be examined for tumors or endometrial hyperplasia.

With the development of jaundice, migraine-like headaches, liver dysfunction, a strong increase in blood pressure, pregnancy, or the appearance of symptoms of thromboembolism (painful swelling of the legs, sharp chest pain, shortness of breath, visual impairment), you should immediately stop taking the drug and consult a doctor.

Overdose

Overdose cases with Femoston 1/5 have not been reported, however, theoretically, if this happens, then side effects may increase.

An overdose of Femoston 1/10 and Femoston 2/10 is possible, and it is manifested by the development of nausea, vomiting, drowsiness and dizziness. There is no specific antidote, therefore, in case of an overdose with Femoston, it is necessary to wash the stomach, give the woman a sorbent (for example, activated carbon, Polyphepan, Polysorb, etc.) and then, if necessary, eliminate various symptoms, maintaining the normal functioning of vital organs.

Influence on the ability to control mechanisms

Any type of Femoston does not affect the ability to control mechanisms, however, women who take hormone replacement therapy should be careful when driving a car or working with equipment and machines.

Interaction with other drugs

Drugs that increase the activity (inducers) of microsomal liver enzymes (for example, barbiturates, Phenytoin, Rifampicin, Carbamazepine, Rifabutin, Oxcarbazepine, Topiramate, Felbamat, Nevirapine, Efavirenez, etc.), reduce the severity of Femoston's effects. The drugs Ritonavir and Nelfinavir, despite the fact that they are inducers of microsomal oxidation, do not reduce the effects of Femoston.

Any phytopreparations containing St. John's wort or its parts accelerate the excretion of Femoston components, and thereby weaken its therapeutic effect.

Femoston slows down the excretion of Tacrolimus, Fentanyl, Theophylline and Cyclosporin A from the body, therefore, the dosage of these drugs should be reduced in order to prevent overdose and poisoning.

Femoston when planning pregnancy

In recent years, practicing gynecologists have often prescribed a combination of Femoston + Dufaston to women who have problems with conception. Femoston is not indicated for use for the treatment of infertility, but in practice it is prescribed to women to normalize hormonal levels and increase the thickness of the endometrium, which significantly increases the likelihood of pregnancy. In such situations, doctors use the pharmacological properties of the drug to achieve a certain effect in conditions that are not an indication for use. This off-label practice is known throughout the world and is called off-label prescriptions. Consider why Femoston contributes to the onset of pregnancy and in what cases its use is justified in case of difficulties with conception.

Since Femoston contains natural estrogens and progesterone hormone, it has the ability to replenish estrogen deficiency and enhance the growth of the endometrium, making it thicker, denser and more blood-filled. Replenishing the estrogen deficiency helps restore ovulation, and an additional dosage of progesterone improves the growth of the endometrium, making it thick enough for the ovum to attach. This means that Femoston can help women get pregnant who do not conceive due to a too thin endometrium or existing estrogen deficiency.

However, Femoston therapy is not very effective, since pregnancy occurs only in half of the woman after discontinuation of the drug, since there is no ovulation during the course of treatment. In addition, Femoston causes numerous side effects in women, which are poorly and difficult to tolerate. Therefore, many gynecologists consider the use of Femoston unjustified for the treatment of infertility. This category of doctors believes that in such situations, women in the first half of the cycle should take a special drug containing estrogens, and in the second half - Duphaston.

When planning pregnancy, Femoston is usually prescribed in a dosage of 2/10, and it is recommended to take it according to the instructions, that is, one tablet per day, regardless of food intake, preferably at the same time. Women need to drink all of the pills in the pack. And first all 14 pink tablets are taken, then 14 light yellow tablets. After the end of taking pills from one pack without any interruption, the next one begins, and so on until the end of the course of therapy. Quite often, in addition to Femoston, doctors prescribe Duphaston, which must be taken only in combination with light yellow tablets from each pack, that is, in the second half of the menstrual cycle. This means that at first, from each pack, a woman takes only pink pills, and then the light yellow Femoston + Duphaston pills.

Femoston should be taken on the first day of the next menstrual cycle. If menstruation is irregular, then it is recommended to start taking the pink Femoston tablets on the day of the expected start of menstruation.

Femoston side effects

Different types of Femoston can provoke the same side effects with different frequencies. In addition, some side effects are inherent only in one form or another of Femoston. Therefore, we give the side effects of each type of Femoston, indicating the frequency of their occurrence in the table.

Frequency of side effects	Femoston side effects 1/5	Femoston side effects 1/10	Femoston side effects 2/10
Often (more than one woman in a hundred, but less than one in ten)	Migraine; Headache; Asthenia; Nausea; Stomach ache ; Bloating; Spasms in the calf muscles; Tension and soreness of the mammary glands; Uterine bleeding ; Pain in the small pelvis; Change in body weight (decrease or increase).
	Spotting discharge		Spotting discharge
Uncommon (more than one woman in a thousand, but less than one in a hundred)	; Intolerance to contact lenses; Liver dysfunction, manifested by jaundice, asthenia and pain in the upper abdomen; Increase in breast size.
	Premenstrual syndrome	Strained chest syndrome before menstruation
	Very rare (occurs in fewer than one woman in 10,000)	Hemolytic anemia; Allergic reactions; Chorea; Myocardial infarction; Stroke; Vomiting; Quincke's edema; Erythema nodosum multiforme; Vascular purpura; Chloasma or melasma; Deterioration of the course of porphyria.

Contraindications to the use of Femoston

All Femoston preparations (1/5, 1/10 and 2/10) have absolute and relative contraindications for use. Absolute contraindications include conditions in which drugs cannot be used under any circumstances. Relative contraindications include conditions in which the use of Femoston is undesirable, but it is possible under close medical supervision and with caution.

Absolute contraindications to the use of all three varieties of Femoston are shown in the table.

Absolute contraindications to the use of Femoston 1/5	Absolute contraindications to the use of Femoston 1/10 and Femoston 2/10
Cerebral circulation disorders	Pre-existing or recent arterial thromboembolism (eg, heart attack, stroke, coronary artery disease, etc.)
	Untreated endometrial hyperplasia
	Porphyria
	Identified or suspected progestogen-dependent tumors, such as meningioma
Pregnancy or suspected pregnancy
Breast-feeding
Identified breast cancer
Suspected breast cancer
Past breast cancer
Endometrial cancer, identified or suspected
Bleeding from the genital tract of an unknown cause
Acute deep vein thrombosis or past pulmonary embolism
Hypersensitivity to drug components
Acute or chronic liver disease in the present or in the past (the drug can be used after normalization of laboratory parameters of liver function)
Identified thrombophilic disorders (protein C or S or antithrombin deficiency)
Age under 18

Relative contraindications are the same for all three forms of Femoston, and they include the following diseases or conditions that a woman has at present or suffered in the past:

Pregnancy;

The appearance of any side effect.

Femoston - analogues

Femoston does not have synonymous preparations that would contain the same active substances in identical dosages. However, on the domestic pharmaceutical market there is a fairly wide range of different Femoston analog preparations, which have a similar therapeutic effect, but contain other active substances. Below is a list of Femoston analogues that have the same anti-climacteric effect and contain a combination of estrogen and progesterone hormones as active components:
1. Activel tablets;
2. Angelique tablets;
3. Gynodian Depot solution for injection;
4. Divitren tablets;
5. Individual tablets;
6. Klymen tablets;
7. Climodien tablets;
8. Kliogest tablets;
9. Pauzogest tablets;
10. Triaclim tablets;
11. Trisequencing tablets;
12. Eviana pills;
13. Revmelid tablets;
14. Cyclo-Proginova dragee.

To eliminate the symptoms of menopause, you can use not only hormonal agents, but also various phytopreparations and biologically active food additives, which include only natural plant and animal components. Such non-hormonal analogues of Femoston in terms of anti-climacteric effect include the following drugs:

• Inoklim;
• Klimadinon UNO;
• Klimalanin;
• Livial;
• Femiwell;
• Feminal;
• Estrovel, etc.

Structure

Active ingredients: 17-β-estradiol 1 mg (as hemihydrate), dydrogesterone 5 mg.

Excipients: lactose monohydrate 114.7 mg, hypromellose 2.8 mg, corn starch 14.4 mg, colloidal anhydrous silicon dioxide 1.4 mg, magnesium stearate 0.7 mg.

Film sheath: mixed film coating Orange I 4.0 mg (hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)).

Description

Round, biconvex, orange-pink film-coated tablets with “379” engraving on one side of the tablet.

Pharmacotherapeutic group

Progestogens and estrogens, fixed combinations. ATX:G03FA14.

Pharmacological properties

Pharmacodynamics

Estradiol

The active ingredient, synthetic 17-β-estradiol, is chemically and biologically identical to endogenous human estradiol. It compensates for the decreased estrogen levels in women during menopause, thus alleviating the symptoms of menopause.

Estrogens prevent bone loss that occurs during menopause or after ovariectomy.

Dydrogesterone

The activity of oral dydrogesterone is comparable to that of parenterally administered progesterone.

Since estrogens promote endometrial growth, taking estrogens alone increases the risk of endometrial hyperplasia and cancer. The addition of progestogens significantly reduces the estrogen-induced risk of endometrial hyperplasia in women who have not undergone hysterectomy.

Clinical trial data

Reducing the severity of estrogen deficiency symptoms and improving the menstrual profilestrual-like bleeding.

Relief of climacteric symptoms occurs in the first weeks of treatment.

Amenorrhea (absence of menstruation or spotting bloody discharge) was observed in 88% of women within 10-12 months of treatment. Irregular bleeding and / or spotting spotting was observed in 15% of women in the first 3 months of treatment and in 12% during 10-12 months of treatment.

Relief of climacteric symptoms occurs in the first weeks of treatment.

Prevention of osteoporosis.

Estrogen deficiency during menopause contributes to bone loss and a decrease in bone mass in a woman's body. The effect of estrogens on bone mass is dose-dependent.

The protective effect lasts as long as the treatment lasts. After discontinuation of hormone replacement therapy (HRT), bone loss occurs at the same rate as in women who have not taken estrogen. The WHI (Women Health’s Initiative) study and meta-analyzes of studies show that current use of HRT alone or in combination with a progestogen, given to predominantly healthy women, reduces the risk of hip, spine, and other fractures associated with osteoporosis. HRT may also prevent fractures in women with low bone mineral density and / or established osteoporosis, but there is limited evidence to support this assumption.

After 1 year of treatment with the drug Femoston® 1/5 conti, the bone mineral density (BMD) in the lumbar spine increased by 4 ± 3.4% (mean ± standard deviation). During treatment, BMD in the lumbar spine increased or remained unchanged in 90% of women. Femoston® 1/5 conti affects the BMD of the femur. After 1 year of treatment, BMD of the femoral neck increased by 1.5 ± 4.5%, by 3.7 ± 6.0% in the trochanter region, and by 2.1 ± 7.2% in the Ward's triangle region. BMD in three zones of the femur increased or remained unchanged after therapy with Femoston® 1/5 conti and amounted to 71%, 66% and 81%, respectively.

Pharmacokinetics

Estradiol

Suction

The absorption of estradiol depends on the particle size: micronized estradiol is readily absorbed from the gastrointestinal tract.

Below is a table showing the mean steady state pharmacokinetic parameters for estradiol (E2), estrone (E1) and estrone sulfate (E1S) for each dose of micronized estradiol. Data are presented as mean (SD). estradiol 1 mg:

Distribution

Estrogens can be found in both bound and unbound states. About 98-99% of the dose of estradiol binds to plasma proteins, of which about 30-52% with albumin and about 46-69% with sex hormone binding globulin (SHBG).

Metabolism

After taking the drug inside, estradiol is rapidly metabolized. The main unconjugated and conjugated metabolites are estrone and estrone sulfate. These metabolites can exhibit estrogenic activity both on their own and after conversion to estradiol. Estrone sulfate undergoes intrahepatic metabolism.

Withdrawal

Estrone and estradiol are excreted in the urine, mainly in the form of glucuronides. T1 / 2 is 10-16 hours. Estrogens are excreted in the milk of nursing mothers. With the daily intake of Femoston, the equilibrium concentration of estradiol is achieved after 5 days of administration, most often by 8-11 days.

Dydrogesterone

Suction

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The time to reach Tmax is from 0.5 to 2.5 hours. The absolute bioavailability of dydrogesterone at a dose of 20 mg orally (when compared with 7.8 mg i / v) is 28%.

The table shows the average values \u200b\u200bof the pharmacokinetic parameters of dydrogesterone (D) and dihydrodidrogesterone (DHD). Data are presented as mean (SD). dydrogesterone 5 mg:

Distribution

With the on / in the introduction, the volume of distribution at equilibrium is about 1400 liters.

Dydrogesterone and DHD bind to blood plasma proteins by more than 90%.

Metabolism

After oral administration, dydrogesterone is rapidly metabolized to DHD. The concentration of the main metabolite, 20-a-dihydro-dihydrogesterone, reaches a peak approximately 1.5 hours after the dose. The plasma concentration of DHD is significantly higher than that of dydrogesterone. The AUC and Cmax ratios of DHD and dydrogesterone are approximately 40 and 25, respectively. T1 / 2 of dydrogesterone and DHD averages 5-7 hours and 14-17 hours, respectively. A common characteristic feature of all metabolites of dydrogesterone is the preservation of the 4,6-dien-3-one configuration of the parent substance and the absence of 17α-hydroxylation, which leads to the absence of estrogenic and androgenic activity.

Withdrawal

After oral administration of labeled dydrogesterone, an average of 63% of the dose is excreted in the urine.

The total plasma clearance is 6.4 l / min. Complete excretion of dydrogesterone occurs after 72 hours. DHD is excreted in the urine mainly in the form of glucuronic acid conjugate.

Pharmacokinetics is linear with both single and repeated administration from 2.5 to 10 mg. Comparison of the kinetics of single and multiple doses shows that the pharmacokinetics of dydrogesterone and DHD are not altered by repeated dosing. A stable concentration is achieved after 3 days of treatment.

Indications for medical use

Hormone replacement therapy (HRT) for disorders caused by estrogen deficiency in postmenopausal women who have stopped menstruating at least 12 months ago. Prevention of postmenopausal osteoporosis in women at high risk of fractures with intolerance or contraindications to the use of other drugs for the prevention of osteoporosis (see section "Precautions for medical use").

Experience in treating women over 65 is limited.

Method of administration and dosage

Femoston® 1/5 conti is a drug for continuous combined hormone replacement therapy for oral administration.

Estrogen and progestogen are given daily on a continuous basis.

Take 1 tablet daily for 28 days of the cycle.

Femoston® 1/5 conti should be taken consistently and without interruption between packages. At the beginning or during the continuation of treatment of menopausal symptoms, the lowest effective dose should be used for the shortest period.

The continuous combined treatment regimen is started with Femoston 1/5 conti, depending on the time of menopause and the severity of symptoms. For women with natural menopause, treatment with Femoston® 1/5 conti should be prescribed no earlier than 12 months after natural menstruation. In the case of surgically induced menopause, treatment can begin immediately.

Depending on the effectiveness of treatment in the future, the dose may be changed.

When switching from another estrogen-progestogen drug for a continuous sequential or cyclic regimen, patients should stop taking the current 28-day cycle and then start taking Femoston 1/5 contin without taking a break between cycles.

When switching from a combined estrogen-progestin drug for a continuous regimen, patients can start taking Femoston 1/5 conti on any day.

If you miss the next dose of the pill, take the missed dose as soon as possible. If the time to skip the next pill has exceeded 12 hours, treatment should be continued with the next pill, without taking the missed pill. Skipping the medication may increase the likelihood of breakthrough bleeding and spotting spotting.

Femoston® 1/5 conti can be taken with or without food.

Pediatric population

There are no valid indications for the use of Femoston® 1/5 conti in children and adolescents.

Side effect

The most common adverse reactions in patients treated with estradiol / dydrogesterone in clinical trials are headache, abdominal pain, breast pain / breast tenderness, and back pain.

* For more information, see below.

* Adverse reactions from spontaneous messages that were not observed in clinical trials were added to the frequency of "Rare (≥1 / 10,000, but

Mammary cancer

Women who received combination therapy with estrogen and progestogen for 5 years or more had a twofold increase in the risk of developing breast cancer. Any increase in risk in women who received estrogen-only HRT was smaller compared to women who received combined estrogen-progestogen HRT. The level of risk depends on the duration of therapy (see section "Precautions for medical use").

The results of the largest randomized placebo-controlled clinical trial (WHI) and the largest epidemiological study (MWS) are presented:

StudyMWS- Estimated additional risk of breast cancer after five years of therapy:

Age, years	Additional cases per 1000 women who have never received HRT for more than 5 years	Risk ratio	Additional cases per 1000 women who received HRT for more than 5 years (95% CI)
HRT with estrogen only
50-65	9-12	1.2	1-2 (0-3)
HRT with a combination of estrogens and progestogens
50-65	9-12	1.7	6 (5-7)
# Overall risk ratio. The hazard ratio is not constant and increases with the duration of HRT. Note: Since the baseline incidence of breast cancer is different in different EU countries, the number of additional cases of breast cancer will also differ proportionally.

a Based on baseline frequency in developed countries

StudyWHI, USA - Additional risk of breast cancer after 5 years of therapy:

b A W-HI study in women without a uterus, which did not show an increased risk of breast cancer.

# When the analysis included only women who did not receive HRT before the start of the study, during the first 5 years there was no increased risk: after 5 years the risk was higher than in women who did not receive HRT.

Endometrial cancer risk

Postmenopausal women with uterus.

The risk of developing endometrial cancer is approximately 5 cases per 1000 women with a uterus not receiving HRT.

Depending on the duration of estrogen monotherapy and estrogen dose, the increase in risk in epidemiological studies ranged from 5 to 55 additional cases per 1000 women aged 50 to 65 years.

Prescribing additional progestogen for at least 12 days during the cycle can prevent this risk from increasing.

In the MWS study, the use of combined (continuous or cyclic) HRT for 5 years did not lead to an increased risk of endometrial cancer (hazard ratio 1.0 (0.8-1.2)).

Ovarian cancer

The use of estrogen-only HRT or combined estrogen-progestogen HRT was accompanied by a slight increase in the risk of diagnosed ovarian cancer. Data from a meta-analysis of 52 epidemiological studies indicate an increased risk of ovarian cancer in women currently using HRT compared with women who have never used HRT (hazard ratio 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 who had been taking HRT for 5 years, this resulted in approximately one additional case in 2000 patients. In women between the ages of 50 and 54 who have not used HRT, approximately two out of 2000 women are diagnosed with ovarian cancer within 5 years.

Risk of venous thromboembolism

HRT is associated with a 1.3-3-fold increase in the relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis of the lower extremity or thromboembolism of the pulmonary artery. The development of such a phenomenon is more likely during the first year of receiving HRT (see section "Precautions for medical use").

The results of the WHI studies are presented:

ResearchWHI- Additional risk of VTE after 5 years of therapy;

c Study in women with a history of hysterectomy.

Risk of coronary heart disease

The risk of coronary heart disease is slightly higher in women receiving combined estrogen and progestogen HRT at the age of 60 (see section "Precautions for medical use").

Risk of ischemic stroke

Or, estrogen-only therapy is associated with a 1.5-fold increase in the relative risk of ischemic stroke. The risk of hemorrhagic stroke does not increase with HRT

The relative risk is independent of age or timing of menopause. However, due to the fact that the initial risk of stroke is highly dependent on age, the overall risk of stroke in women receiving HRT will increase with age (see section "Precautions for medical use").

Cumulative research dataWHI- Additional risk of ischemic stroked over 5 years of hormone replacement therapy;

d There was no difference between ischemic and hemorrhagic stroke.

Other Adverse Reactions Associated with Estrogen Treatment /progestogens (includingestradiol / dydrogesterone):

Benign, malignant and unspecified neoplasms: estrogen-dependent tumors, both benign and malignant, e.g. endometrial cancer, ovarian cancer. An increase in the size of the meningioma.

Disorders of the blood and lymphatic system: hemolytic anemia.

Immune system disorders: systemic erythematous lupus.

Nervous system disorders: possible dementia, chorea, relapse of epilepsy.

Metabolic and nutritional disorders: hypertriglyceridemia.

Violations of the organ of vision: steepening of the curvature of the cornea, intolerance to contact lenses.

Vascular disorders: arterial thromboembolism.

Disorders from the gastrointestinal tract: pancreatitis (in women with prior hypertriglyceridemia).

Skin and subcutaneous tissue disorders: erythema multiforme, erythema nodosum, chloasma or melasma, which may persist after discontinuation of the drug.

Musculoskeletal and connective tissue disorders: cramps in the calf muscles.

Renal and urinary tract disorders: urinary incontinence.

Violations of the genital organs and mammary gland: cystic fibrous mastopathy, erosion of the cervix.

Congenital, familial and genetic disorders: worsening with porphyria.

Influences on the results of laboratory and instrumental studies: an increase in the total level of thyroid hormones.

Contraindications

Diagnosed or suspected breast cancer, history of breast cancer. Diagnosed or suspected estrogen-dependent malignancies (eg, endometrial cancer). Diagnosed or suspected progestogen-dependent malignant neoplasms (eg, meningioma). Vaginal bleeding of unknown etiology. Untreated endometrial hyperplasia. Current or history of thromboembolic disease (eg, deep vein thrombosis, pulmonary embolism). Diagnosed thrombophilic disorders (for example, lack of protein C, protein S or antithrombin). Current or history of arterial thromboembolism (eg, angina pectoris or myocardial infarction). A history of acute liver disease or liver disease in which liver function tests have not returned to normal. Porphyria. Known hypersensitivity to active ingredients or other components of the drug.

Precautions for medical use

Hormone replacement therapy (HRT) is prescribed when symptoms associated with postmenopause negatively affect a woman's quality of life. It is necessary to conduct a thorough assessment of the risks and benefits, at least annually, HRT is continued until the expected benefits significantly outweigh the possible risks. The available information on the risks associated with HRT in the treatment of premature menopause is limited. At the same time, due to the low level of absolute risk in younger women, the benefit / risk ratio in these women may be in favor of HRT, compared with older women.

Medical examination / observation

Before starting or resuming HRT, the patient's medical history and family history should be reviewed. In this case, a physical examination (including the pelvic organs and mammary glands) should be performed and contraindications and special precautions for medical use should be taken into account. In the course of treatment, it is recommended to conduct periodic examinations of the patient, the frequency and volume of which must be selected individually for each patient. Women should be encouraged to report their observed changes in the mammary glands to their doctor or nurse (see section on Breast Cancer). In accordance with current screening practice, examinations, including mammography, should be adjusted according to individual clinical indications.

Conditions requiring medical supervision

In the presence of any of the following diseases at the moment, in the past and / or their deterioration during pregnancy or previous hormone therapy, patients should be under close medical supervision.

It must be borne in mind that these diseases may recur or their course may worsen during treatment with Femoston® 1/5 conti, in particular:

Uterine leiomyoma (uterine fibroadenoma) or endometriosis; risk factors for the development of thromboembolism (see section "Venous thromboembolism") -, the presence of risk factors for the occurrence of estrogen-dependent tumors (for example, the presence of 1st-degree relatives with breast cancer); arterial hypertension; liver disease (eg, liver adenoma); diabetes mellitus with or without vascular lesions; cholelithiasis; migraine or severe headaches; systemic lupus erythematosus; history of endometrial hyperplasia (see section "Endometrial hyperplasia") -, epilepsy; bronchial asthma; otosclerosis; meningioma.

Reasons for immediate discontinuation of therapy

Therapy should be discontinued if contraindications are identified, as well as in the following situations:

Jaundice or liver dysfunction; significant increase in blood pressure; a new attack of a migraine-like headache; pregnancy.

Endometrial hyperplasia and cancer

In women with an intact uterus, the risk of developing endometrial hyperplasia and cancer increases with the use of estrogens alone for a long time. The risk of developing endometrial cancer with estrogen monotherapy is 2 to 12 times higher than in women who do not receive hormonal treatment. The increased risk depends on the duration of treatment and the dose of estrogen (see section "Side Effects"). After discontinuation of estrogen monotherapy for HRT, the risk may remain elevated for at least 10 years. The addition of progestogen in cycles of at least 12 days for a 28-day cycle, or continuous estrogen therapy in combination with a progestogen in women who have not undergone hysterectomy, may prevent the additional risk associated with estrogen monotherapy for HRT. In the first months of drug treatment, breakthrough bleeding and / or spotting bleeding from the vagina may occur. If breakthrough bleeding and / or spotting bleeding from the vagina appears some time after the start of therapy with Femoston® 1/5 conti or continues after stopping treatment, their cause should be clarified, for which it may be necessary to conduct an endometrial biopsy to exclude malignant neoplasm of the endometrium ...

Mammary cancer

Overall, the data indicate an increased risk of breast cancer in women taking combined estrogen and progestagen replacement therapy, and possibly estrogens alone. The risk depends on the duration of HRT use.

Combination therapy with estrogen and progestogen

The results of the WHI randomized placebo-controlled trial and epidemiological studies have shown an increased risk of breast cancer in women taking combined estrogen and progestogen HRT, which becomes evident approximately 3 years after starting treatment (see the Side Effects section).

Monotherapy with estrogen

In the WHI study, there was no increased risk of breast cancer in women with prior hysterectomy who received estrogen-only HRT. Most observational studies have shown a slight increase in the risk of breast cancer, which is much lower than in women taking combination therapy with estrogen and progestogen (see section "Side effects").

An increase in risk becomes evident within several years of HRT, but after discontinuation of therapy, it returns to the initial level within several (maximum five) years.

With HRT, especially with combined treatment with estrogen-progestogen, the density of the mammographic image increases, which can have a negative effect on the radiological diagnosis of breast cancer.

Ovarian cancer

Ovarian cancer is much less common than breast cancer.

Epidemiological data obtained from an extensive meta-analysis showed a slightly increased risk in women using estrogen or estrogen monotherapy in combination with a progestogen as HRT, which manifests itself within 5 years of use and decreases with time after discontinuation of use. Several other studies, including the WHI, suggest that the use of combination HRT medications may be associated with the same or slightly lower risk (see the Side Effects section).

Venous thromboembolism

HRT is associated with a 1.3-3-fold increase in the risk of developing venous thromboembolism (VTE), that is, deep vein thrombosis and pulmonary embolism. The likelihood of such a complication is higher in the first year of treatment than in subsequent years (see the "Side Effects" section). Patients with known thrombophilic conditions have an increased risk of VTE, and HRT may increase this risk. Therefore, HRT is contraindicated in this group of patients (see section "Contraindications"). The generally recognized risk factors for the development of VTE are: the use of estrogens, old age, extensive surgery, prolonged immobilization, severe obesity (BMI more than 30 kg / m2), pregnancy and the postpartum period, systemic lupus erythematosus, cancer. Currently, there is no consensus on the role of varicose veins in the development of VTE.

As with all patients in the postoperative period, special attention should be paid to the implementation of measures for the prevention of VTE after surgery. If after a planned operation a long period of immobilization is expected, it is recommended to cancel HRT 4-6 weeks before the operation. As with all patients in the postoperative period, special attention should be paid to the implementation of measures for the prevention of VTE after surgery. Resumption of treatment is possible only after complete restoration of physical activity.

Women who do not have a history of VTE, but who have venous thromboembolism in their next of kin at a young age, may be offered a screening examination (screening examination reveals not all disorders of the blood coagulation system). If a thrombosis disorder is identified, which explains cases of thrombosis in family members or in the case of a "severe" disorder (for example, lack of antithrombin, protein S, protein C, or a combined defect) HRT is contraindicated. Before prescribing HRT, women who are already receiving anticoagulant treatment should comprehensively assess the possible risks of hormone therapy. If VTE develops after starting therapy, the drug should be canceled. The patient should know that when the first possible symptoms of VTE appear (painful swelling of the lower extremities, sudden chest pain, shortness of breath), she should immediately consult a doctor.

Coronary artery disease (CHD)

In randomized clinical trials, there is no evidence that HRT (estrogen alone or in combination with progestogens) protects against the development of myocardial infarction in women with or without coronary artery disease.

Combination therapy with estrogen and progestogen

The relative risk of ischemic heart disease during the period of treatment with combined drugs for HRT slightly increases. Since the initial absolute risk of developing coronary artery disease significantly depends on age, the number of additional cases of coronary artery disease in women receiving combined HRT is very low in the group of healthy women at an age close to the onset of menopause, and increases with age.

Monotherapy with estrogen

Based on data from randomized controlled trials, there was no increase in the risk of coronary heart disease in women with previous hysterectomy who received estrogen-only replacement therapy.

Ischemic stroke

The risk of ischemic stroke in combination therapy with estrogen and progestogen or estrogen monotherapy increases by 1.5 times. The relative risk does not change with age or the time of menopause. However, due to the fact that the initial risk of stroke is highly dependent on age, the overall risk of stroke in women receiving HRT will increase with age (see the section "Side effects").

Other conditions

Estrogens can cause fluid retention and therefore patients with impaired cardiac and renal function should be closely monitored. Women with a history of hypertriglyceridemia should be further closely monitored while undergoing HRT (estrogens or estrogen-progestogens), since in very rare cases a significant increase in plasma triglyceride concentration has been reported in such women, which led to the development of pancreatitis. Estrogens increase the concentration of thyroxine-binding globulin, which leads to an increase in the total concentration of circulating thyroid hormones, determined by the content of protein-bound iodine, the concentration of thyroxine (T4) (determined by column chromatography or radioimmunoassay) or triiodothyronine (determined by radioimmunoassay) ... The level of absorption of triiodothyronine (T3) decreases, which indicates an increase in the concentration of thyroxine-binding globulin (TSH). The concentrations of free thyroxine (T4) and triiodothyronine (T3) remain unchanged. The concentration of other binding proteins in blood serum may increase, incl. corticoid-binding globulin (CBG), sex hormone binding globulins (SHBG), which leads to an increase in the concentration of circulating corticosteroids and sex hormones, respectively. The concentration of free or biologically active hormones does not change. The concentration of other plasma proteins (angiotensinogen / renin substrate, alpha 1-antitrypsin, ceruloplasmin) may also increase. HRT does not improve cognitive function. There are limited data on a possible increased risk of dementia in women who started taking continuous combined HRT or estrogen monotherapy over the age of 65 years. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Femoston® 1/5 conti. Femoston® 1/5 conti does not have a contraceptive effect.

Overdose

Estradiol and dydrogesterone are substances with low toxicity. In case of overdose, symptoms such as nausea, vomiting, tenderness of the mammary glands, drowsiness, dizziness, abdominal pain, lethargy / fatigue, withdrawal bleeding may occur. Overdose is unlikely to require any specific symptomatic treatment.

The above information also applies in case of overdose in children.

Interaction with other medicinal products

No drug interaction studies have been conducted.

The effectiveness of estrogen andprogestogens can be violated

The metabolism of estrogens and progestogens can increase with the concomitant use of substances known as inducers of isoenzymes of drug metabolism, in particular cytochrome P450 isoenzymes, such as antiepileptic drugs (for example, phenobarbital, phenytoin, carbamazepine) and anti-infectious agents (for example, rifabupin, efavirenz). Although ritonavir and nelfinavir are known to be potent inhibitors, when used concomitantly with steroid hormones, they exhibit stimulating properties on estrogen and progestogen metabolism. Herbal preparations containing St. John's wort (Hypericum perforatum) can also stimulate the metabolism of estrogens and progestogens. Clinically, increased metabolism of estrogens and progestogens can lead to a decrease in the effectiveness of action and changes in the nature of uterine bleeding.

Application during pregnancy and during breastfeeding

Taking Femoston® 1/5 conti is not indicated during pregnancy.

If pregnancy occurs during treatment with Femoston® 1/5 conti, therapy should be discontinued immediately.

The results of the majority of epidemiological studies carried out to date relating to the accidental exposure of the fetus to combined compositions of estrogens and progestogens indicate the absence of teratogenic and fetotoxic effects. The available data on the use of estradiol / dydrogesterone in pregnant women is limited.

Taking Femoston® 1/5 conti is not indicated during breastfeeding.

Influence on the ability to drive vehicles and mechanisms

Femoston® 1/5 conti does not have or has an insignificant effect on the ability to drive vehicles and mechanisms.

Marketing Authorization Holder

Abbott Healthcare Product B.V.

S. D. van Houtenlaan 36,

NL -1381 JV Weesp, the Netherlands.

Manufacturer

Abbott Biologicals B.V.

Veerweg 12,

8121 AA Olst, Netherlands

Complaints about the quality of the medicinal product should be sent to:

Representative office of JSC "Abbott Laboratories S.A." (Swiss Confederation), Republic of Belarus, 220073 Minsk, 1st Zagorodny per., 20, office 1503, tel./fax: +375 17 256 7920, e-mail:.

You can also inform Abbott about an adverse event when using the drug or a complaint about quality by calling +380 44 498 6080 (around the clock).

pharmachologic effect

Femoston
Femoston 1/5 (Femoston 1/5)

Composition and form of release
FEMOSTON 1/10 film-coated tablets

Two types.
Tablets are white, round, biconvex, with "S" embossed over the "dlt" icon on one side, "379" - on the other side (14 pcs. In a blister).
1 tablet contains estradiol 1 mg;
other ingredients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate
Sheath composition: Opadry OY-1-7000 white.

The tablets are gray, round, biconvex, with an "S" embossed over the "dlt" icon on one side, "379" on the other side; the core of a white tablet (14 pcs. in a blister).
1 tablet contains estradiol 1 mg, dydrogesterone 10 mg;

Shell composition: Opadry OY-8243 gray.

FEMOSTON 2/10 film-coated tablets

Two types.
The tablets are pink, round, biconvex, with an "S" embossed over the "dlt" icon on one side and "379" on the other side; the core of a white tablet (14 pcs. in a blister).
1 tablet contains estradiol 2 mg;
other ingredients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Shell composition: Opadry OY-6957 pink.

The tablets are light yellow, round, biconvex, with an "S" embossed over the "dlt" mark on one side and "379" on the other side; the core of a white tablet (14 pcs. in a blister).
1 tablet contains estradiol 2 mg, dydrogesterone 10 mg;
Other ingredients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Shell composition: Opadry OY-02В22764 yellow.
28 pcs. in a calendar package, 1, 3 or 10 blisters in a cardboard box.

FEMOSTON 1/5

film-coated tablets

1 tablet contains estradiol 1 mg, dydrogesterone 5 mg;
other ingredients: lactose monohydrate, methyl hydroxypropyl cellulose, corn starch, colloidal anhydrous silicon dioxide, magnesium stearate, macrogol 400, titanium dioxide (E171), iron oxide yellow and red (E172), Opadry orange (Y-8734).
28 pcs. in a blister, 1 blister in a cardboard box.

Registration numbers

FEMOSTON 1/10, FEMOSTON 2/10 - P No. 011361/01, 28.12.04
FEMOSTON 1/5 - P No. 014320 / 01-2002, 26.08.02

pharmachologic effect

FEMOSTON 1/10, FEMOSTON 2/10 are combined biphasic drugs for hormone replacement therapy, containing micronized 17-b-estradiol as an estrogen component and dydrogesterone as a gestagen component. Both components are chemically and biologically identical to a woman's endogenous sex hormones produced in the ovaries (estradiol and progesterone).
Estradiol replenishes the estrogen deficiency in the female body after menopause and provides effective relief of psychoemotional and vegetative climacteric symptoms such as hot flashes, increased sweating, sleep disturbances, increased nervous excitability, dizziness, headache, involution of the skin and mucous membranes (especially the urinary and irritation of the vaginal mucosa, soreness during intercourse).
Hormone replacement therapy (HRT) with Femoston prevents bone loss in the postmenopausal period caused by estrogen deficiency.
Taking Femoston leads to a change in the lipid profile towards a decrease in total cholesterol and LDL cholesterol levels and an increase in HDL cholesterol.
Dydrogesterone is an effective progestogen when taken orally, which completely ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of endometrial hyperplasia and / or carcinogenesis (increased with the use of estrogens). Dydrogesterone has no estrogenic, androgenic, anabolic, or glucocorticoid activity.

FEMOSTON 1/5 is a monophasic drug for hormone replacement therapy with a low-dose content as an estrogenic component - estradiol, as a gestagenic component - dydrogesterone.

Indications

Hormone replacement therapy for disorders caused by natural menopause or menopause resulting from surgery;
- prevention of osteoporosis in postmenopausal women.

Contraindications

Established or suspected pregnancy;
- lactation period (breastfeeding);
- diagnosed or suspected breast cancer; a history of breast cancer;
- diagnosed or suspected estrogen-dependent malignant neoplasms;
- vaginal bleeding of unknown etiology;
- Previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism);
- active or recent arterial thromboembolism;
- Acute liver disease, as well as a history of liver disease (before the normalization of laboratory parameters of liver function);
- untreated endometrial hyperplasia;
- porphyria;
- hypersensitivity to drug components.
Use with caution and under the supervision of a physician in patients receiving HRT and having the following conditions (currently or in history): uterine leiomyoma, endometriosis, thrombosis and their risk factors in history, in the presence of risk factors for estrogen-dependent tumors (for example, breast cancer glands in the patient's mother), arterial hypertension, benign liver tumor, diabetes mellitus, cholelithiasis, epilepsy, migraine or intense headache, a history of endometrial hyperplasia, systemic lupus erythematosus, bronchial asthma, renal failure, otosclerosis.

Method of administration and dosage
FEMOSTON 1/10

In the first 14 days of a 28-day cycle, take 1 tablet daily. white (from half of the package with an arrow marked with the number "1") containing 1 mg of estradiol, and in the remaining 14 days - 1 tab daily. gray (from half of the pack with an arrow marked "2") containing 1 mg estradiol and 10 mg dydrogesterone.

FEMOSTON 2/10

Take 1 tablet / day (preferably at the same time of day) without interruption.
In the first 14 days of a 28-day cycle, take 1 tablet daily. pink (from half of the package with an arrow marked with the number "1") containing 2 mg of estradiol, and in the remaining 14 days - 1 tab daily. light yellow (from half of the package with an arrow marked with the number "2") containing 2 mg of estradiol and 10 mg of dydrogesterone.
Patients who have not stopped menstruating are advised to start treatment on the first day of their menstrual cycle. It is advisable for patients with irregular menstrual cycles to begin treatment after 10-14 days of gestagen monotherapy ("chemical curettage").
Patients whose last period was more than 1 year ago can start treatment at any time.
When taking the drug, a regular menstrual reaction is observed monthly.

FEMOSTON 1/5

Assign orally 1 tab. / Day (preferably at the same time of day), without interruption.

Side effect

From the reproductive system: soreness of the mammary glands, breakthrough bleeding, pain in the pelvic region are possible; sometimes - changes in cervical erosion, changes in secretion, dysmenorrhea; rarely - an increase in the mammary glands, premenstrual-like syndrome; in some cases - a change in libido.
From the digestive system: possible nausea, flatulence, abdominal pain; sometimes - cholecystitis; rarely (0.01-0.1%) - impaired liver function, in some cases accompanied by asthenia, malaise, jaundice or abdominal pain; very rarely - vomiting.
From the side of the central nervous system: headache, migraine (1-10%); sometimes (0.1-1%) - dizziness, nervousness, depression; very rarely - chorea.
From the side of the cardiovascular system: sometimes - venous thromboembolism; very rarely - myocardial infarction.
From the hematopoietic system: very rarely (less than 0.01%) - hemolytic anemia.
Dermatological reactions: sometimes - rash, itching; very rarely - chloasma, melasma, erythema polymorphism, erythema nodosum, hemorrhagic purpura.
Allergic reactions: sometimes - urticaria; in some cases - angioedema.
Others: change in body weight; sometimes - vaginal candidiasis, breast carcinoma, an increase in the size of the leiomyoma; rarely - peripheral edema, intolerance to contact lenses, an increase in the curvature of the cornea; in some cases (less than 0.01%) - exacerbation of porphyria.

Pregnancy and lactation

Femoston is contraindicated for use during pregnancy and lactation.

special instructions

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history, conduct a general and gynecological examination in order to identify possible contraindications and conditions requiring precautionary measures. During treatment with Femoston, it is recommended to periodically conduct an examination (the frequency and nature of the studies are determined individually). In addition, it is advisable to conduct a study of the mammary glands (including mammography) in accordance with accepted standards, taking into account clinical indications.
Femoston 1/5 is prescribed for women who are postmenopausal for at least 1 year.
When switching from another estrogen-progestogen drug for HRT, Femoston 1/5 should be taken at the end of the estrogen-progestogen phase without interruption in taking the tablets.
After consultation with the doctor, the patient should stop taking the drug if jaundice or liver function deterioration, a pronounced rise in blood pressure, a newly diagnosed migraine-like attack, pregnancy, manifestation of any contraindication.
Risk factors for thrombosis and thromboembolism while taking HRT are history of thromboembolic complications, severe obesity (body mass index over 30 kg / m2) and systemic lupus erythematosus. There is no generally accepted opinion about the role of varicose veins in the development of thromboembolism.
The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, major trauma, or surgery. In cases where prolonged immobilization is necessary after surgery, consideration should be given to temporarily discontinuing HRT 4-6 weeks before surgery.
When deciding on HRT in patients with recurrent deep vein thrombosis or thromboembolism receiving anticoagulant treatment, it is necessary to carefully assess the benefits and risks of HRT.
If thrombosis develops after starting HRT, Femoston should be canceled.
The patient should be informed about the need to consult a doctor in case of the following symptoms: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, visual impairment.
There is research data showing a slight increase in the likelihood of developing breast cancer in women who received HRT for a long time (more than 10 years). The likelihood of being diagnosed with breast cancer increases with the duration of treatment and returns to normal 5 years after discontinuation of HRT.
Patients who previously received HRT using only estrogenic drugs should be especially carefully examined before starting treatment with Femoston in order to identify possible endometrial hyperstimulation.
Breakthrough uterine bleeding and mild menstrual bleeding may occur in the first months of drug treatment. If, despite dose adjustment, such bleeding does not stop, the drug should be discontinued until the cause of the bleeding is established. If bleeding recurs after a period of amenorrhea or continues after discontinuation of treatment, its etiology should be established. This may require an endometrial biopsy.
Femoston is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives.
The patient should inform the doctor about the medications that she is currently taking or took before prescribing Femoston.
The use of estrogens can affect the results of the following laboratory tests: determination of glucose tolerance, examination of the functions of the thyroid gland and liver.
Influence on the ability to drive vehicles and use mechanisms
Femoston does not affect the ability to drive vehicles and use mechanisms.

- helps to remain feminine even after the cessation of menstruation

Advantages: eliminates the signs of aging, poor health,

Disadvantages: no

Femoston 1/5 conti - helps to remain feminine even after the cessation of menstruation. No matter how old a woman is, she always wants to look great. Various tricks, masks, peels, injections are used.

However, when a certain age is reached, the changes begin at the hormonal level. Conventional cosmetic procedures are no longer effective. A period comes when a woman turns into a grandmother. And then the question arises, is it worth taking hormonal drugs to prolong youth, what will it give and what will be the result?

The negative sides of menopause

Preparation for menopause was difficult for me and, in my opinion, too early - at 48 years old. There were hot flashes, sweat threw, the pressure jumped. Menses went on and off for several months. Such manifestations interfered with work. Took Remens, all sorts of herbs, supporting. And by about fifty years of age, menstruation stopped altogether. It was then that the question arose whether to accept one's old age or still try to prolong youth.

Menopause, as you know, is the complete cessation of the production of sex hormones by the female ovaries. This leads to many external and internal changes.

Internal changes

The absorption of some trace elements, such as phosphorus and calcium, changes, which leads to fragility of bones - osteoporosis.

Vitamin D is poorly metabolized, so the body becomes more prone to colds, teeth begin to deteriorate, bones soften.

The functioning of other endocrine glands is disrupted: pituitary gland, hypothalamus, thyroid gland. This leads to disturbances in the work of the heart, a tendency to pressure, anxiety, and nervousness.

The uterus atrophies, its endothelium becomes thinner.

The release of lubricant stops, it can pursue a feeling of dryness, burning, discomfort.

The amount of fatty layer between organs increases, which increases the rate of development of atherosclerosis.

Insomnia develops.

The strength of the sphincters of the bladder decreases. They are not fully closed and urine is constantly leaking.

The processes of regeneration of the connective tissue slow down, which affects the joints.

The level of cholesterol in the blood rises.

Decreased memory, thought processes.

Hearing and vision are impaired.

The changes are most pronounced in the first years after postmenopause. The disappearance of the main female hormone estrogen is very bad for the appearance.

Visible changes

The skin on the face becomes thinner, covered with wrinkles, turgor goes away.

Hair falls out actively.

The mammary glands "deflate" and sag.

The butt becomes flat.

Positive points

It seems that there are no good sides, but still there are things that can please.

Menstruation disappears, there is no more pain, no need to fiddle with pads, exercise yourself in activity, bathing.

Fibroids, mastopathy, endometriosis decrease and disappear.

However, these advantages, of course, do not outweigh all the troubles, especially since the risk of developing tumors increases. Therefore, I fully supported the idea of \u200b\u200btaking hormonal drugs to increase the level of estrogen in the blood. Reception is not herbs, since with the complete disappearance of the production of endocrine substances, the changes that herbal preparations give are clearly not enough. It is hormones. Together with the doctor, we opted for Femoston Conti.

Femoston 1/5 Conti: what is it

Femoston is a popular drug that includes the main female hormones:

Estradiol (5).

Dydrogesterone (1).

It is prescribed for women with severe menopause, when hot flashes, pressure, insomnia and emotionality are concerned. It is also suitable for natural postmenopause and after surgery.

The tablets are round, pink-orange. Each package contains 28 pieces.

The drug is produced in the Netherlands.

Composition and properties of components

The amount of active ingredients in the pills is small. It is enough to maintain health, but there is no complete replacement of all previously produced hormones.

Estradiol is completely female. It helps to eliminate all emotional changes, ailments associated with disruption of the autonomic system and other glands.

Tearfulness, irritability, irritability pass.

Sweating disappears.

Redness of the skin fades.

Normalizes sleep.

Headache, dizziness go away.

The aging process of the skin and mucous membranes is stopped.

It also protects against bone loss and lowers cholesterol.

Dydrogesterone is a progestogenic compound. We are better known for such a "colleague" as progesterone. Usually, their number increases during the period of egg maturation and at the time of pregnancy. Progestogens prepare the body for conception. But even if pregnancy does not occur, they perform many functions:

They improve metabolic processes.

Maintain the condition and appearance of the mammary glands.

Increase thermoregulation.

Reduces the number of inflammatory processes.

Protects the endometrium from hyperplasia - an overgrowth of benign tumors.

It is the latter function that is important in hormone replacement therapy.

Femoston 1 mg and 5 mg Conti reviews

Taking hormones stabilized my condition. I feel at the same level as when I was 40. No deterioration in health, weakness, headaches. Since the start of treatment, there has been no cystitis. I calmly live a sex life, I do not feel any discomfort.

The condition of the skin is especially pleasing. It seems that even the wrinkles have decreased. Indeed, I look good among my peers. Even youthful. The appearance of the hair has improved. They have ceased to be so thin, they hardly fall out.

There has also been an increase in facial hair recently. I had to use preparations to remove excess vegetation. This is usually due to the fact that female hormones are reduced, while male hormones remain at the same level, and sometimes even higher. And with the onset of HRT, everything returned to normal.

Many women benefit

"I am 54 years old. Of the constantly present problems was uterine fibroids. And over time, fatigue, strong, pain in the lower back and crunch in the joints were added. Periods went irregularly, but if they start, then as out of a bucket. Sleep disturbances, some kind of despondency, depression also manifested themselves. The doctor referred me to an endocrinologist and a gynecologist. The latter was prescribed by Femoston Conti. I've been drinking for three months already. Joints do not bother at all. The condition of the skin is better, the weight has stopped gaining. There are, of course, age-related changes, but not so strong. I am very happy ”, - Alla, 57 years old.

“At the age of 44, my uterus with appendages was removed. I was very depressed. It seemed that I was not a woman anymore. I felt that life was over. The gynecologist prescribed Femoston for me immediately after discharge. I didn't even expect the effect to be good. I feel the same as always. I live a normal life. Four years have passed, and I’m not complaining about anything at all, ”- Lyudmila, 48 years old.

“I started taking Femoston as prescribed by a doctor, because premenopause was difficult. The pressure rose strongly, I hardly slept at night. And after the start of the reception, everything returned to normal. True, I gained a couple of kilograms, but in general there are no side effects, ”- Olga, 51 years old.

If you have a tendency to blood clots, such as varicose veins with deep vein thrombosis, then this treatment should be abandoned, as hormones increase the risk of thromboembolism and the risk of stroke. The likelihood is insignificant, but still. In my opinion, this is the most serious warning regarding therapy.

Cancers of the genitals and mammary glands are most often hormone-dependent. Therefore, by returning estrogen, progesterone to her life, a woman gets a small risk of these cancers. But since it is high even with a decrease in endocrine functions, I did not take these data into account.

The unpleasant symptoms accompanying treatment are associated with an incorrectly selected dose of the drug. Among them:

Puffiness.

Too high cholesterol.

Allergic rash.

If the course is accompanied by a severe headache, a sharp increase in pressure, then the treatment is stopped. Such sensations bypassed me. You can only check the reaction in practice.

You can not use pills during pregnancy, reproductive age. For various health disorders, such as lupus, diabetes mellitus, liver diseases, it is necessary to conduct a course under the supervision of a doctor, not to start taking pills on your own.

It is best to start therapy no later than 12 months after the last period. It is at the beginning that changes in the body begin to gain unprecedented momentum. Take a tablet a day. Start with the lowest dosage. No breaks are made between courses. Ended 28 days and immediately the next pack.

Structure

Tablets, film-coated 1 tab.
estradiol 1 mg
dydrogesterone 5 mg
excipients: lactose monohydrate; methyl hydroxypropyl cellulose; corn starch; colloidal anhydrous silica; magnesium stearate; Opadry Y 8734 orange (macrogol 400; titanium dioxide (E171); yellow and red iron oxide (E172);

Characteristic

A drug for hormone replacement therapy with a low-dose content as an estrogenic component - estradiol, as a gestagenic component - dydrogesterone.

pharmachologic effect

Estrogen is gestagenic.

Estradiol, which is part of the drug and is identical to endogenous estradiol, compensates for the estrogen deficiency in the female body after menopause.

Estradiol provides effective treatment of psychoemotional and vegetative climacteric symptoms: hot flashes, increased sweating, sleep disturbances, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes, especially the genitourinary system (dryness and irritation of the vaginal mucosa, pain during intercourse) ... Hormone replacement therapy (HRT) with Femoston 1/5 prevents bone loss in the postmenopausal period. Risk factors for osteoporosis in postmenopausal women are early onset of menopause, long-term use of corticosteroids in the recent past, smoking.

Taking Femoston® 1/5 changes the lipid profile: it lowers the level of total cholesterol, LDL and increases the level of HDL.

Dydrogesterone is an effective oral progestogen that promotes the onset of a secretion phase in the endometrium. Dydrogesterone reduces the risk of endometrial hyperplasia and / or carcinogenesis, increased by estrogen. Dydrogesterone has no estrogenic, androgenic, anabolic, or glucocorticoid activity.

To achieve the maximum preventive effect of HRT, it should be started immediately after menopause. The effect is manifested during the entire period of treatment (information on the use of estrogens for more than 10 years is limited).

Indications

• hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women;
• prevention of postmenopausal osteoporosis.

Contraindications

• established or suspected pregnancy;
• period of breastfeeding;
• diagnosed or suspected breast cancer, history of breast cancer;
• endometrial cancer or other hormone-dependent neoplasms;
• vaginal bleeding of unknown etiology;
• a history of confirmed acute deep vein thrombosis or pulmonary embolism;
• disorders of cerebral circulation;
• acute or chronic liver diseases, incl. history (before normalization of laboratory parameters of liver function);
• hypersensitivity to the components of the drug.

Side effects

Acyclic menstrual bleeding in the first months of treatment, spotting bleeding from the vagina, vaginal candidiasis, painful sensations and engorgement in the mammary glands.

Possible - nausea, vomiting, flatulence, abdominal pain, cholestatic jaundice, chloasma or melasma (may persist after drug withdrawal), erythema nodosum, rash, itching, contact lens intolerance.

Rarely - headache, migraine, dizziness, depressive conditions, chorea, arterial hypertension, thrombosis, peripheral edema, changes in body weight, changes in libido, muscle cramps of the lower extremities.

Interaction

Drugs that are inducers of microsomal liver enzymes (barbiturates, phenytoin, rifampicin, carbamazepine, oxcarbazepine, topiramate, felbamate), weaken the estrogenic effect. The interactions of dydrogesterone with other drugs are unknown.

The patient should inform the doctor about the medications that she is currently taking or took before prescribing Femoston® 1/5.

Method of administration and dosage

Inside (preferably at the same time of day), 1 table. per day without interruption.

Overdose

So far, there have been no reports of overdose symptoms.

Symptoms: Possible increased side effects of the drug.

Treatment: symptomatic, no specific antidote.

special instructions

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history, as well as conduct a general and gynecological examination in order to identify possible contraindications and conditions that require the necessary precautions to be taken. During treatment with Femoston®, 1/5 of women are recommended to be periodically examined (the frequency and nature of the studies are determined individually).

Examination of the mammary glands and / or mammography is carried out in accordance with accepted standards, taking into account clinical indications.

Femoston® 1/5 is prescribed for women who are postmenopausal for at least 1 year.

When switching from another estrogen-progestogen drug for HRT, Femoston 1/5 should be taken at the end of the estrogen-progestogen phase without interruption in taking the tablets.

The use of estrogens can affect the results of the following laboratory tests: determination of glucose tolerance, examination of the functions of the thyroid gland and liver.

Patients receiving HRT and having the following conditions (current or past) should be closely monitored by a doctor: uterine leiomyoma, endometriosis, thrombosis or their history of risk factors, arterial hypertension, renal dysfunction, diabetes mellitus with vascular complications , bronchial asthma, porphyria, hemoglobinopathy, cholelithiasis, epilepsy, otosclerosis, multiple sclerosis, migraine or intense headache.

The generally recognized risk factors for thrombosis and thromboembolism while taking HRT are a history of thromboembolic complications, severe obesity (body mass index over 30 kg / m 2) and systemic lupus erythematosus. There is no generally accepted opinion about the role of varicose veins in the development of thromboembolism.

The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, extensive trauma, or surgery. In cases where prolonged immobilization is necessary after surgery, consideration should be given to temporarily discontinuing HRT 4-6 weeks before surgery.

When deciding on HRT in patients with recurrent deep vein thrombosis or thromboembolism, receiving anticoagulant treatment, it is necessary to carefully assess its benefits and risks.

If thrombosis develops after starting HRT, Femoston 1/5 should be canceled. The patient should be informed about the need to see a doctor if the following symptoms appear: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, visual impairment.

There are data showing a slight increase in the frequency of detecting the development of breast cancer in women who received hormone replacement therapy for a long time (more than 10 years). Detection of breast cancer may be related to early diagnosis, biological effects of HRT, or a combination of both. The likelihood of being diagnosed with breast cancer increases with the duration of treatment and returns to normal 5 years after discontinuation of HRT.

Patients who previously received HRT using only estrogenic drugs should be especially carefully examined before starting treatment with Femoston 1/5 in order to identify possible endometrial hyperstimulation.

Breakthrough uterine bleeding and not pronounced menstrual bleeding may occur in the first months of drug treatment. If, despite the dose adjustment, such bleeding does not stop, the drug should be discontinued until the cause of the bleeding is established. If bleeding recurs after a period of amenorrhea or continues after discontinuation of treatment, its etiology should be established. This may require an endometrial biopsy.

Femoston® 1/5 is not a contraceptive. For perimenopausal patients, it is recommended to use non-hormonal contraceptives.

The effect on the ability to drive a car and other mechanisms is unknown.

Storage conditions

At a temperature not exceeding 30 ° C (do not freeze). In original packaging.

Keep out of the reach of children.

Shelf life

Do not use after the expiration date printed on the package.