Composition and form of release

• white tablet: estradiol - 1 mg;
• 1 gray tablet: estradiol - 1 mg; Didrogesterone - 10 mg;
• auxiliary substances: lactose monohydrate; hypimloose; corn starch; silicon colloidal dioxide; magnesium stearate; OPADRY OY-1-7000 White (white tablets only); OPADRY OY-8243 gray (only for gray tablets).

In the blister 28 pcs. (14 white and 14 gray); In a pack of cardboard 1, 3 or 10 blisters.

Shell-covered tablets - 1 set:

• 1 pink tablet: estradiol - 2 mg;
• 1 Tablet light yellow color: estradiol - 2 mg; Didrogesterone - 10 mg;
• auxiliary substances: lactose monohydrate; hypimloose; corn starch; silicon colloidal dioxide; magnesium stearate; OPADRY OY-6957 Pink (for pink tablets only), OY-02B22764 yellow (only for light yellow tablets).

In the blister 28 pcs. (14 pink and 14 light yellow); In a pack of cardboard 1, 3 or 10 blisters.

Description of the dosage form

Estradiol Tablets 1 mg: Round, double-screw, covered with a white shell, embossed "S" above the "6" icon on one side and embossed "379" - to another.

Tablets 1 mg of estradiol / 10 mg of Didrogesterone: round, double-screw, coated with gray shell, embossed "S" over the "6" icon on one side and embossed "379" to another.

White core tablet.

Estradiol tablets 2 mg: Round, double-screwed, covered with a pink shell, embossed "S" over the "6" icon on one side and embossed "379" - to another.

White core tablet.

Tablets 2 mg of estradiol / 10 mg of Didrogesterone: Round, double-screw, covered with a shell of light yellow color, embossed "S" over the "6" icon on one side and "379" - on the other side.

White core tablet.

Characteristic

The drug for hormonal replacement therapy with normal (2/10) and low-volume (1/10) content as an estrogen component - estradiol, as a gestagne component - Didrogesterone.

pharmachologic effect

Estrogen-Gestagenic.

Pharmacokinetics

After taking inside, the micronized estradiol is easily absorbed. Metabolized in the liver to estrer and estron sulfate, which is also exposed to liver biotransformation. The glucuronides of estrone and estradiol are predominantly with urine.

Didrogesterone after taking inside is quickly absorbed from the gastrointestinal tract. Metabolized completely. The main metabolite is a 20-dihydrotiderogesterone present in the urine mainly in the form of a glucuronic acid conjugate. The complete derivation of the Didrogesterone occurs after 72 hours.

Pharmacodynamics

Estradiol - estrogen, which is part of the preparation of Fermoston®, is identical to the endogenous estradio of the person. Estradiol replenishes the deficiency of estrogen in the female organism after the onset of menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms: "tides", increased sweating, sleep disorders, increased nervous excitability, dizziness, headache, the involution of the skin and mucous membranes, especially mucous meters of the genitourinary system (dry and irritation of the mucous membrane of the vagina, soreness during sexual interchange). Restaurant hormone therapy (HRT) drug Femoston® prevents the loss of bone mass in a postmenopausal period caused by estrogen deficiency. Reception of the drug Femoston® leads to a change in the lipid profile towards reducing the level of general cholesterol and LDL and increase HDL.

Didrogesterone is a progestogen, effective when taking inside, which fully ensures the offensive phase of secretion in endometrial, thereby reducing the risk of developing endometrial hyperplasia and / or carcinogenesis, rising against the background of estrogen. Didrogesterone does not have estrogen, androgenic, anabolic or glucocorticosteroidal activity.

The combination of 1 mg of estradiol with the Didrogesterone is a modern low-volume CGT mode.

Indications for use

• UGT with disorders due to natural or coming due to surgical intervention by menopausosis;
• prevention of postmenopausal osteoporosis.

Contraindications for use

• installed or alleged pregnancy;
• breastfeeding period;
• diagnosed or suspected breast cancer, breast cancer in history;
• diagnosed or suspected estrogen-dependent malignant neoplasms;
• vaginal bleeding of unclear etiology;
• preceding idiopathic or confirmed vein thromboembolism (deep veins thrombosis, pulmonary vessel thromboembolism);
• active or recently transferred arterial thromboembolism;
• acute diseases of the liver, as well as liver diseases in history (until the normalization of laboratory indicators of the liver function);
• uncured endometrial hyperplasia;
• increased sensitivity to any of the components of the drug;
• porphyry.

With care - patients receiving UGT and having the following states (currently or in the past), should be under the close observation of the doctor:

• leiomioma uterus, endometriosis;
• thrombosis or their risk factors in history;
• risk factors for estrogen-dependent tumors (for example, breast cancer in patient's mother);
• arterial hypertension;
• benign liver tumor;
• diabetes;
• holithiasis;
• epilepsy;
• migraine or intensive headache;
• endometrial hyperplasia in history;
• system red lupus;
• bronchial asthma;
• renal failure;
• otosclerosis.

After agreeing with the doctor, the drug should be discontinued in such cases as:

• the appearance of jaundice or deterioration of the liver function;
• strong rise of blood pressure;
• for the first time revealed by a migreen attack;
• pregnancy;
• manifestation of any contraindication.

Application during pregnancy and children

Contraindicated during pregnancy and in the period of breastfeeding.

Side effects

CO Pide Blood and Lymph System: Very rarely (

From the nervous system: headache, migraine (1-10%); Sometimes (0.1-1%) - dizziness, nervousness, depression, change of libido; Very rare - Khorora.

From the cardiovascular system: sometimes venous thromboembolism; Very rarely - myocardial infarction.

From the head of the gastrointestinal tract: nausea, abdominal pain, meteorism; Very rarely vomiting.

From the side of the liver and the biliary tract: sometimes cholecystitis; Rarely (in 0.01-0.1%) - a violation of the liver function, sometimes accompanied by asthenia, malaise, jaundice or abdominal pain.

From the side of the skin and subcutaneous fatty tissue: sometimes allergic reactions, rash, urticaria, itching, peripheral swelling; Very rarely - chlorism, melasm, polymorphic erythema, nodular erythema, hemorrhagic purpura, angioedema swelling.

From the reproductive system and the mammary glands: the painfulness of the mammary glands, breakthrough bleeding, pain in the pelvic area; Sometimes - changes in the erosion of the cervix, change in secretion, dysmenorrhea; Rarely - an increase in the mammary glands, premenstrual-like syndrome.

Others: Changes in body weight; Sometimes - vaginal candidiasis, breast carcinoma, increase in leomyoma in size; rarely - the intolerance to the contact lenses, an increase in the curvature of the cornea; Very rarely - exacerbation of Porphyria (

Medicinal interaction

LS, which are inductors of microsomal liver enzymes (barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine), can weaken the estrogen effect of Fermoston® drug. Ritonavir and Nelfinavir, although known as inhibitors of microsomal metabolism, can play the role of inductors while at the same time reception with steroid hormones. Herbs-based preparations containing St. John's wort can stimulate the exchange of estrogen and progestogennes.

Didrogesterone's interaction with other drugs are unknown.

The patient should inform a physician about drugs that it currently takes or accepted before appointing the drug Femoston®.

Dosage

Inside, preferably at the same time of the day, regardless of meals - 1 table. per day without a break. Fermoston® 1/10 is taken according to the following scheme: In the first 14 days of the 28-day cycle, they receive daily 1 white tablet (from half of the package with an arrow marked "1") containing 1 mg of estradiol, in the remaining 14 days - daily by 1 gray tablet (from half of the package with an arrow marked with a number "2") containing 1 mg of estradiol and 10 mg of Didrogesterone.

Fermoston® 2/10 is taken according to the following scheme: in the first 14 days of the 28-day cycle take daily 1 table. Pink colors (from half of the package with an arrow marked with a number "1") containing 2 mg of estradiol, and in the remaining 14 days - daily 1 light yellow tablet (from half of the package with an arrow labeled "2") containing 2 Mg estradiol and 10 mg of Didrogesterone.

Patients who did not stop menstruation, it is recommended to begin treatment on the first day of the menstrual cycle (the 1st day of the start of menstruation). Patients with irregular menstrual cycle It is advisable to begin treatment after 10-14 days of monotherapy with the help of a progestogen. Patients who have the last menstruation have been observed over 1 years ago, can begin treatment at any time.

Overdose

Symptoms: nausea, vomiting, drowsiness, dizziness.

Treatment: symptomatic.

Precautionary measures

Before appointment or renewal of the UGT, it is necessary to collect a complete medical and family history and carry out a general and gynecological examination in order to identify possible contraindications and states that require compliance with precautions. During treatment with the drug, it is recommended to periodically examine women (the frequency and nature of studies are determined individually). In addition, it is advisable to conduct a study of mammary glands and / or mammography in accordance with adopted norms, taking into account clinical indications. The use of estrogen can affect the results of the following laboratory tests: determination of glucose tolerance, study of the functions of the thyroid gland and the liver.

Recognized factors of the risk of thrombosis and thromboembolism against the background of the TROMBEMBOLOLIC complications in history, severe obesity forms (body mass index of more than 30 kg / m2) and systemic red lupus. Regarding the role of a varicose expansion of veins in the development of the thromboembolism there is no generally accepted opinion.

Risk of development of deep vein thrombosis lower extremities It may temporarily increase with long-term immobilization, extensive injuries or surgical interventions. In cases where long-term immobilization is necessary after surgical interventions, one should consider the possibility of temporary termination of the UGT for 4-6 weeks before the operation.

When solving the issue of GTR in patients with recurrent thrombosis of deep veins or thromboembolis that receive treatment with anticoagulants, it is necessary to carefully evaluate the benefit and risk of UGT.

If thrombosis is developing after the start of the UGT, the drug should be canceled. The patient should be informed about the need to appeal to the doctor in case of the appearance of the following symptoms: the painful swelling of the lower extremities, the sudden loss of consciousness, the disposage, violation of vision.

There are data that demonstrates a slight increase in the frequency of detection of breast cancer in women, for a long time (more than 10 years) obtained by the UGT. The probability of diagnosing breast cancer increases along with the length of treatment and returns to the norm 5 years after the cessation of the UGT.

Patients who received earlier HRT with the use of only estrogenic drugs should be particularly examined before the treatment of treatment in order to identify possible endometrial hyperstimulation. Breakthrough uterine bleeding And non-timbbled menstrual bleeding can be celebrated in the first months of treatment with the drug. If, despite the adjustment of the dose, such bleeding does not stop, the drug must be canceled until the cause of the bleeding is established. If the bleeding recurns after the amenorrhea period or continues after the cancellation of treatment, its etiology should be installed. This may require endometrial biopsy.

The drug Femoston® is not a contraceptive. Patients in the perimenopausus are recommended to use non-flame contraceptives.

The effect on the ability to control the car and other mechanisms does not.

Fermoston (Germany) is a calendar packaging with 28 tablets, of which 14 orange tablets contain 2 mg of estradiol, and 14 yellow tablets contain 2 mg of estradiol and 10 mg of dihydogestonon. The drug replenishes the lack of genital hormones in the body of a woman, stops mailing symptoms with natural menopause, after surgical removal of ovaries. Also, the drug is used to treat and prevent osteoporosis in postmenopausal.

The drug affects lipid metabolism to a much greater extent than other drugs for the UGT, normalizes lipid exchange, significantly reduces the risk of atherosclerosis and other diseases of the cardiovascular system. Fermoston does not affect carbohydrate exchange. Even with long therapy, the drug does not cause thrombosis or thromboembolic violations. Causes an adequate secretory phase of endometrial. Increases the quality of life of patients, reducing the number of complaints and objectively detected climacteric symptoms. Fermoston is a basic drug for the CGT in the presence of diseases of the cardiovascular system. What are the latest recommendations of the international society on menopause regarding hormone therapy?

The international society on Menopause (IMS) was the first organization, which in his statement about hormone therapy in February 2004 (the document was updated in February 2007) emphasized the value of the age in determining the risk profile of hormone therapy. In addition, IMS experts once again pointed to the positive effect of hormone therapy in the treatment of estrogender deficient states and the need for its appointment to all patients in need.

After discussing the results of WHI research (initiative in the name of women's health) and MWS (a million women's study), the Executive Committee of the International Society for Menopause, conclusions were made and the recommendations were given (first discussion - December 2003, revision - February, October 2004, February 2007):

1. Continue the previously adopted global practice of substitution hormone therapy.

2. The reduction in the duration of hormone therapy is not substantiated during its effectiveness.

3. Termination of replacement hormone therapy may contribute to the growth of the frequency of cardiovascular diseases.

4. The question of creating and / or termination of replacement hormone therapy is solved individually.

5. Replacement hormone therapy reduces the frequency of colorectal cancer and fractures, but is associated with a slight increase in risk of developing breast cancer, deep veins thrombosis and thromboembolism.

6. Violation of metabolism, tumors, cardiovascular diseases are characteristic of all women on the outcome of reproductive age, and not just for receiving replacement hormone therapy.

7. It is useful to combine replacement hormone therapy with other drugs (statins, anticoagulants, etc.).

8. When risk thrombosis, the parenteral administration path is preferable.

9. Unified approaches are impossible to assess the effectiveness of substitution hormone therapy: different compositions and regimes contribute to different tissue and metabolic effects.

10. The results of population studies are necessary for general manual. They should not be distributed on individual patients.
What are the recommendations of expert working Group International Menopausis Society concerning doses of estrogen in preparations for the GTR?

Recommendations of the Expert Working Group of the International Society for Menopause (February 16-17, 2004) concerning doses of estrogen: estrogen dose
Must be as low as possible and at the same time to stop menopause symptoms. Recommended starting doses are:

0.5-1 mg of 17 β-estradiol;

0.3-0.45 mg of conjugated equine-estrogen;

25-37.5 μg of transdermal estradiol (plaster);

0.5 μg of Estradiol gel.

After 8-12 weeks from the beginning of treatment, the symptoms should be estimated again and, if necessary, the dose may be revised. Approximately in 10% of cases, higher doses may be required. At the same time, from time to time, the dose should be revised and reduced where it is possible.
What components are used for combined substitution hormone therapy?

As estrogen components of the HGT are recommended for the use of "natural" estrogens. Natural estrogens are preparations that are identical to estradiole in the chemical structure, synthesized in the body of women. Currently, 17 β-estradiol and estradiol Valerat are used most often for oral forms in the clinical practice of European countries.

The Gestagon component of the UGT is prescribed to protect the endometrium and the prevention of the development of endometrial hyperplasia and endometrial cancer. With cyclic reception, the gestagens must be assigned at least 10-14 days every month. The main requirement to the gestagenic component is its metabolic neutrality, as it is necessary that it does not reduce the cardioprotective effect of estrogen (Didrogesterone).

For example, the Didrogesterone, which is part of the femooston, is deprived of androgenic effects and reliably protects the endometrium.

What are the contraindications for substitution hormone therapy?

AT lately The number of contraindications for the UGT decreased, and the contraindications that were previously considered absolute were relative. This is due to the fact that during a certain period of contraindications to the use of hormonal contraceptives were automatically transferred to the UGT. The main differences of these 2 groups of drugs consist in types of estrogen used, as well as in doses and types of progestogennes. For combined oral contraceptives, synthetic estrogen is used - ethinyl estradiol, which is not applied to the UGT. In the composition of the UGT, derivatives of progesterone are more often used, and in oral contraceptives - Northestosterone derivatives.

Absolute contraindications for the UGT are:

Bleeding from sexual paths of unclear gene;

Breast cancer and endometrial;

Acute hepatitis;

Acute thrombosis of deep veins;

Untreated tumors of genital organs and mammary glands;

Allergies to the ingredients of the UGT;

Skin porphyry.

Contraindications should be separately allocated to some sex hormones:

1) for estrogen:

ER + breast cancer (history);

Endometrial cancer (a history);

Severe liver dysfunction;

Porphyry;

2) for Gestagenov:

Meningioma.

Relative contraindications for the UGT:

Myoma uterus, endometriosis;

Migraine;

Venous thrombosis or embolism (a history);

Family hyperitriglyceridemia;

Cholelithiasis;

Epilepsy;

Ovarian cancer (a history).

Endometriosis: monotherapy with estrogen monotherapy, however, combined estrogen-gestagne therapy is possible using an adequate dose of active gestagen.

Mioma uterus: The combined therapy is shown in the morning of the uterus of small sizes and asymptomatic flow. Women should be under special observation; Ultrasound is recommended every 3 months. According to today, the reaction of Moma to the UGT, as well as on monotherapy by progestogencies, largely depends on the prevalence of A- or B-progesterone receptors in myomatous nodes. It has been established that, depending on this, growth, regression or neutral reaction of nodes may be marked. The clinical picture and the magnitude of the nodes on the ultrasound testifies to the reaction of myomatous nodes to the UGT of a particular patient.
What survey must be carried out before appointing the UGT?

Communicable before appointment of the UGT for each woman are:

Collecting anamnesis (clarification of the factors of heredity, the nature of the suffered somatic, oncological diseases, thromboembolism, liver diseases, vessels, reactions to combined oral contraceptives, etc.);

Gynecological study with oncocytology;

Ultrasound genital organs with a mandatory estimate of the thickness and structures of the endometrium;

Mammography or ultrasound of the mammary glands.

Estimation of data from endometrial thickness in postmenopausal:

Endometrial thickness up to 4 mm - the UGT is not contraindicated;

Endometrial thickness from 4 to 8 mm - biopsy of endometrial, as well as the appointment of gestagens within 12-14 days and re-ultrasound on the 5th day of the menstrual-like reaction;

Endometrial thickness more than 8 mm - is shown hysteroscopy or diagnostic embodiment of endometrial with histological examination of the material.

According to the testimony, additional surveys are carried out:

Biochemical blood test (lipid spectrum, glucose);

Coagulogram;

Somatic inspection, determination of basic hemodynamic parameters (blood pressure, pulse);

Hormonal examination: FSH, LH, estradiol, TG, T3, T4;

Consultation of specialists: neuropathologist, cardiologist, therapist, urologist, endocrinologist;

This article allows you to familiarize yourself with the instructions for the use of the drug. Femoston. Reviews of site visitors - consumers of this medicine, as well as the opinions of doctors of specialists in the use of femoston in their practice. A big request to more actively add your reviews about the preparation: helped or did not help the medicine to get rid of the disease, which complications were observed and side effects, possibly not stated by the manufacturer in annotations. Analogs of Fermoston in the presence of available structural analogues. Use for the treatment of climax and prevention of postmenopausal osteoporosis in women, including in pregnancy and breastfeeding. Side effects of drug intake (bleeding, selection).

Femoston - a combined two-phase preparation for hormonal replacement therapy, containing micronized 17 cycling-estradiol as an estrogenic component and as a gestage constituent of the Didrogesterone. Both components are analogues of female sex hormones (estradiol and progesterone).

Estradiol fills the deficiency of estrogen in the female organism after the occurrence of menopause and provides effective relief of psycho-emotional and vegetative climacteric symptoms, such as tides, increased sweating, sleep disorders, increased nervous excitability, dizziness, headache, the involution of the skin and mucous membranes, especially the genital system (dryness and irritation of the mucous membrane, pain in sexual intercourse).

The replacement hormone therapy (UGT) drug Femoston warns the loss of bone mass in the postmenopausal period caused by estrogen deficiency.

Reception of the drug Femoston leads to a change in the lipid profile towards reducing the level of total cholesterol and LDL and increase HDL.

Didrogesterone is a Gestagen effective when taking inside, which fully ensures the offensive phase of secretion in endometrial, thereby reducing the risk of developing endometrial hyperplasia and / or carcinogenesis (rising against the background of the use of estrogen). Didrogesterone does not have estrogen, androgenic, anabolic or glucocorticoid activity.

Structure

Estradiol + Didrogesterone + excipients.

Estradiol Gemihydrate + Didrogesterone + auxiliary substances (Fermoston Conti).

Pharmacokinetics

Estradiol

After taking the drug inside, the micronized estradiol is easily absorbed. Estradiol is metabolized in the liver with the formation of estron and estrone sulfate. Estron sulfate is subjected to intrahepatic metabolism. The glucuronides of estrone and estradiol are predominantly with urine.

Didrogesterone

In the human body, the Didrogesterone is quickly absorbed from the gastrointestinal tract. Metabolized completely. The main metabolite of the Didrogesterone is a 20-dihydrotiderogesterone present in the urine mainly in the form of a glucuronic acid conjugate. The complete derivation of the Didrogesterone occurs after 72 hours.

Indications

• replacement hormone therapy of disorders due to natural menopause, or menopauz, which has come as a result of surgical intervention;
• prevention of postmenopausal osteoporosis.

Forms of release

Tablets covered with shell 1/5 mg (Conti), 1/10 mg, 2/10 mg.

Instructions for use and reception scheme

Fermoston 1/5 Conti.

The drug is taken inward daily, in continuous mode of 1 tablet per day (preferably at the same time of the day), regardless of meals.

Patients who make a transition from another continuous sequential or cyclic drug intake mode must complete the current cycle, and then go to Fermoston Conti. Patients who make the transition from continuous combined therapy mode, can start receiving Fermoston Conti on any day.

If the patient missed the reception of the tablet, it must be taken within 12 hours after the usual reception time; Otherwise, the missed tablet should not be taken, and the next day it is necessary to take a tablet at normal time. The passage of reception of the drug may increase the likelihood of "breakthrough" uterine bleeding.

Fermoston 1/10.

In the first 14 days of the 28-day cycle, 1 tablets of white color (from half of the package with an arrow labeled "1") containing 1 mg of estradiol, and in the remaining 14 days - daily 1 gray tablets (from half of the package With an arrow marked with a digit "2") containing 1 mg of estradiol and 10 mg of Didrogesterone.

Fermoston 2/10.

Take 1 tablet per day (preferably at the same time day) without a break, regardless of meals.

In the first 14 days of the 28-day cycle, 1 tablets of pink colors are taken daily (from half of the packaging with an arrow labeled "1") containing 2 mg of estradiol, and in the remaining 14 days - daily 1 Tablets of light yellow color (from Half Packaging with an arrow marked with "2") containing 2 mg of estradiol and 10 mg of Didrogesterone.

Patients who did not stop menstruation, recommend starting treatment on the first day of the menstrual cycle. Patients with an irregular menstrual cycle It is advisable to begin treatment after 10-14 days of the monotherapy of progestogen ("Chemical Curetzh").

Patients who have the last menstruation have been observed over 1 years ago, can begin treatment at any time.

Side effect

• disease soreness;
• breakthrough bleeding;
• pain in the pelvis area;
• changes in erosion of the cervix;
• changing secretion;
• dysmenorrhea;
• increasing the mammary glands;
• premenstrual-like syndrome;
• change of libido;
• nausea, vomiting;
• flatulence;
• abdominal pain;
• back pain (lower back);
• headache;
• migraine;
• dizziness;
• nervousness;
• depression;
• chorea;
• venous thromboembolism;
• myocardial infarction;
• hemolytic anemia;
• rash;
• chloasm;
• melasm;
• multiform erythema;
• erythema noded;
• hemorrhagic purple;
• hives;
• angioedema edema;
• changing body weight;
• vaginal candidiasis;
• breast carcinoma;
• increase in the size of Leiomyoma;
• peripheral edema;
• intolerance to contact lenses;
• the aggravation of porphyry.

Contraindications

• installed or alleged pregnancy;
• lactation period (breastfeeding);
• diagnosed or suspected breast cancer, breast cancer in history;
• diagnosed or suspected estrogen-dependent malignant neoplasms;
• uncured endometrial hyperplasia;
• vaginal bleeding of unclear etiology;
• preceding idiopathic or confirmed vein thromboembolism (deep veins thrombosis, pulmonary vessel thromboembolism);
• active or recently transferred arterial thromboembolism;
• acute diseases of the liver, as well as liver diseases in history (until the normalization of laboratory indicators of the liver function);
• porphyria;
• increased sensitivity to the components of the drug.

Application in pregnancy and breastfeeding

Femoston is contraindicated to use during pregnancy and during lactation.

special instructions

Before appointment or resumption of substitution hormone therapy, it is necessary to collect a complete medical and family history, to carry out a general and gynecological examination in order to identify possible contraindications and states that require compliance with precautions. During treatment with the drug, Fermoston is recommended to periodically conduct a survey (the frequency and nature of studies is determined individually). In addition, it is advisable to conduct a study of the mammary glands (including mammography) in accordance with the clinical indications adopted by the norms.

Factors of risk thrombosis and thromboembolism Against the background of receiving the UGT are thromboembolic complications in history, severe forms of obesity (body weight index is more than 30 kg / m2) and systemic red lupus. Regarding the role of varicose veins in the development of the thromboembolism, there is no generally accepted opinion.

The risk of developing deep veins of the lower limbs can temporarily increase with long-term immobilization, extensive injuries or surgical interventions. In cases where long-term immobilization is necessary after surgery, one should consider the possibility of temporary termination of the UGT in 4-6 weeks before the operation.

When solving the issue of GTR in patients with recurrent thrombosis of deep veins or thromboembolis that receive treatment with anticoagulants, it is necessary to carefully evaluate the benefit and risk of UGT.

If thrombosis develops after the start of the UGT, the drug Fermoston should be canceled.

The patient should be informed about the need to consult a doctor in case of the appearance of the following symptoms: a painful swelling of the lower extremities, a sudden loss of consciousness, a disposage, violation of vision.

After coordination with the doctor, the patient should stop taking the drug in the appearance of a jaundice or worsening the liver function, a pronounced admission of blood pressure, first identified by a mignery-like attack, pregnancy, manifestation of any contraindication.

There are research data that demonstrate a minor increase in the frequency of breast cancer detection in women who received UGT for a long time (more than 10 years). The probability of diagnosing breast cancer increases along with the length of treatment and returns to the norm 5 years after the cessation of the UGT.

The patients who received previously VGT with the use of only estrogenic drugs should be particularly examined before the treatment of femoston preparation in order to identify possible endometrial hyperimulation.

Blooming uterine bleeding and non-timber expressed menstrual bleeding can be marked in the first months of treatment with the drug. If, despite the correction of the dose, such bleeding does not stop, the reception of the drug must be stopped before establishing the cause of bleeding. If the bleeding recurns after the amenorrhea period or continues after the cancellation of treatment, its etiology should be installed. This may require endometrial biopsy.

The drug femoston is not a contraceptive. Patients in the perimenopausus are recommended to use non-nonal contraceptives.

The patient must inform a physician of drugs that it currently takes or took to the appointment of the drug Fermoston.

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

Impact on the ability to driving vehicles and control mechanisms

Femoston does not affect the ability to drive vehicles and managing mechanisms.

Medicinal interaction

The simultaneous use of drugs that are inductors of microsomal liver enzymes (including barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine), can weaken the estrogen effect of the drug Femoston.

Ritonavir and Nelfinavir, although known as inhibitors of microsomal metabolism, can play the role of inductors while at the same time reception with steroid hormones.

Herbs-based preparations containing St. John's wort can stimulate the exchange of estrogen and progestogennes.

The interaction of the Didrogesterone, which is part of the drug Fermoston, with others drugs Not known.

Analogs of the drug Femoston

Structural analogs on the active substance medicine femoston has no.

Analogs on the treatment effect (menopause and menopause in women):

• Angelica;
• Artemis;
• Ginodian depot;
• Hormoplex;
• Dermisterl;
• Divitren;
• Duphaston;
• Women's start (Demeter);
• St. John's wort;
• Indiline;
• Inoklim;
• Climadinon;
• Climadine Uno;
• Klimaxan homeopathic;
• Climatic hohel;
• Climatoplan;
• Climate;
• Kliten;
• Climodiene;
• Closure;
• Microfollins;
• Ovariane;
• Ovrestin;
• Pauseogest;
• Premarin;
• Proginova;
• Rensus;
• Synestrol;
• Triaclim;
• TRISEKENS;
• Cycle Proginova;
• Estrumax;
• Estrovale;
• Estrole;
• Estropherage.

In the absence of analogues of drugs on the active substance, you can follow the links below on the disease, which helps the appropriate drug, and see the analogues on therapeutic effects.

• Instructions for use Fermoston ® 1/10
• The composition of the drug Femoston ® 1/10
• Indications of the drug Femoston ® 1/10
• Conditions for the storage of the drug Femoston ® 1/10
• The shelf life of the drug Femoston ® 1/10

ATX code: Greeting system and sex hormones (G)\u003e Sex hormones and sexual system modulators (G03)\u003e progestogens in combination with estrogens (G03F)\u003e Progestogens in combination with estrogens (combinations for sequential reception) (G03FB)\u003e Didrogesterone and estrogen (G03FB08)

Release form, composition and packaging

Tab., Pok. film shell, two types: 28 pcs. in the package, 1 pack in a pack, including :; Tab. White color 1 mg: 14 pcs. ,; Tab. Gray 1 mg + 10 mg: 14 pcs.
Reg. №: RK-LS-5-number 010043 dated 06/26/2012 - Existing

Tablets covered with film shell, Two types.

Tablets covered with film shell white

Excipients: Lactoses of monohydrate, hypimosellos, corn starch, silicon colloididoid dioxide, magnesium stearate.

The composition of the shell: OPADRY ® Y-1-7000-White (hypimloose, titanium dioxide (E171), macrogol 400).

Tablets covered with a gray gray shell, round, double-screw, with marking "379" on one side and diameter of 7 mm (14 pcs. Packaging).

Excipients: Lactoses of monohydrate, hypimosellose (HPMC 2910), corn starch, silicon colloididoid dioxide, magnesium stearate.

The composition of the shell: OPADRY ® II gray 85F27664 (polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron (III) oxide black (E172)).

28 pcs. - Packaging cell contour (1) - packs cardboard.

Description of the medicinal preparation Fermoston ® 1/10. Based on officially approved instructions for the use of the drug and made in 2013. Renewal date: 04/23/2013

pharmachologic effect

Combined hormonal preparation for consistent reception containing estrogen and progestogen.

Estradiol. The active substance is 17-β estradiol, chemically and biologically identical to the endogenous human estradio. It replaces the lost products of estrogen in women in menopause and facilitates symptoms of estrogen deficiency. Estrogens warn the loss of bone tissue due to menopause or ovariectomy.

Didrogesterone.The activity of the Didrogesterone when taking inside is comparable to the activity of parenterally administered progesterone. Because Estrogens contribute to the growth of endometrial, the reception of estrogen without adding progestogenins increases the risk of endometrial hyperplasia and cancer. Adding progestogenis significantly reduces the risk of estrogen-caused risk of endometrial hyperplasia in women with a unlucky uterus.

EFFICIENCY OF FERMOSTON 1/10 in the treatment of symptoms of estrogen deficiency and dysfunctional uterine bleeding (according to the results of clinical studies)

Regular bleeding cancellation on average for an average of 5 days was observed in 76% of women. Bleeding cancellations usually started on average on the 28th day of the cycle. Breakthrough bleeding and (or) separations were registered in 23% of women during the first 3 months of therapy and in 15% of women during 10-12 months of therapy. Throughout the first year, Amenorrhea's therapy (the absence of bleeding or gas selections) was observed in 21% of cycles. Reducing the severity of climacteric symptoms was achieved during the first weeks of treatment.

Prevention of osteoporosis

Estrogen deficiency in menopause is associated with accelerated bone remodeling and reduction of bone mass. The effect of estrogen on the mineral density of bone tissue depends on the dose. Protection is valid throughout the course of therapy. After the termination of the UGT, the volume of bone mass decreases at a rate of similar to the reduction rate of bone mass in women who do not pass treatment. The results of clinical studies suggest that the current use of the UGT (separately or in combination with a progestogen appointed mainly to healthy women) reduces the risk of thigh fractures, spine and other osteoporous fractures. The UGT may also prevent fractures in women with low bone density and / or installed osteoporosis, but the data is limited about it.

After receiving Fermostron 1/10 for 2 years, the mineral density of the bone tissue (MPT) of the lumbar spine increased by 5.8% ± 3.8% (the mean value of ± is standard deviation). During treatment, 93% of women who took Fermoston ® 1/10, the Lumbar Division was preserved at the same level or increased. Fermoston ® 1/10 also affects the High Bone MPKT. After receiving a femostron 1/10 for 2 years, the IPT increased by 2.7% ± 4.2% in the neck of the femoral bone, by 3.5% ± 5.0% in the area of \u200b\u200bthe scene of the femur and by 2.7% ± 6.7% in the Vard triangle. In 67-78% of women after therapy, 1/10 PTCs in the indicated 3 femoral departments remained unchanged or increased.

Pharmacokinetics

Estradiol

Absorption . The absorption of estradiol depends on the particle size: unlike the crystalline estradiol, which is poorly absorbed, the micronized estradiol is easily absorbed from the gastrointestinal tract. The following is a table with the average values \u200b\u200bof pharmacokinetic parameters of estradiol (E2), estron (E1) and estron sulfate (E1S) for dose of estradiol 1 mg after repeated reception:

Estradiol 1 mg

Distribution. Estrogen is poorly binding to albumin plasma by non-specific binding or specifically binds to a high degree of affinity with globulin binding sex hormones (GSPG). The percentage of binding to the GSPG varies from 9-37% in women in perimenopause to 23-53% in postmenopausal women receiving conjugated estrogens.

Metabolism. After taking the drug inside estradiol, it is quickly metabolized. The main non-conjugated and conjugated metabolites are estrone and estron sulfate. These metabolites can exhibit estrogenic activity both themselves and after transformation into estradiol. Estron sulfate is subjected to intrahepatic metabolism.

Elimination. Estron and estradiol are removed with urine, mainly in the form of glucuronides. The half-life is 10-16 hours. Estrogens stand out with nursing mothers milk.

Dosage and temporal dependencies. After each day, the daily reception of the pill tablets 1/10 inside, the stable concentration of estradiol is achieved after 5 days of reception, most often to 8-11 days.

Didrogesterone

Absorption. The reception is quickly absorbed from the gastrointestinal tract. The time to achieve maximum concentration (T MAX) from 0.5 to 2.5 hours. The absolute bioavailability of the Didrogesterone at a dose of 20 mg inside (when compared with 7.8 mg intravenously) is 28%

The table shows the average values \u200b\u200bof the pharmacokinetic parameters of the Didrogesterone (D) and Dihydrodrogesterone (DGD) after repeated reception of the DIDROGESTERON inside at a dose of 10 mg.

Didrogesterone 10 mg

Distribution. With a stable concentration of the Didrogesterone, with intravenous administration, the distribution volume is about 1400 liters. Didrogesterone and DGD are associated with blood plasma proteins by more than 90%.

Metabolism. After the intake, the Didrogesterone is rapidly metabolized in DGD. The concentration of the main metabolite of 20-α-dihydrodrogesterone (DGD) reaches a peak of about 1.5 hours after the dose is taking. The concentration of DGD in the blood plasma is significantly higher than the Didrogesterone. The AUC ratios (area under the curve) and C Max (maximum concentration) of DGD and DIDROGESTERON are approximately 40 and 25, respectively. The half-life of the Didrogesterone and DGD is an average of 5-7 hours and 14-17 hours, respectively. The total feature of all metabolites is that the configuration of the parent compound 4.6 diode 3-it remains unchanged and the absence of 17-alpha hydroxylation. This explains the lack of estrogen and androgenic effects of Didrogesterone.

Elimination. After receiving inside the labeled Dydrogesterone, a 63% dose is outrethned with urine. General clearance of plasma 6.4 l / min. The complete removal of the Didrogesterone occurs after 72 hours. DHD is excreted with urine mainly in the form of glucuronic acid conjugate.

Dose and temporary dependence. Pharmacokinetics are linear in both single and multiple dosage in the range of 2.5 to 10 mg. Comparison of the kinetics of single and multiple doses shows that pharmacokinetics D and DGD do not change as a result of a dose again. Stable concentration is achieved after 3 days of treatment

Indications for use

• the replacement hormone therapy of symptoms of estrogen deficit in women during menopause no earlier than 6 months after the last menstruation (symptoms of estrogen deficiency in women are individual and may include: heat feeding, raising night sweating, sleep disorders, vaginal dryness and urination disorders);
• warning of osteoporosis in women during postmenopause with high risk of fractures in intolerance or contraindications to drugs intended for the treatment of osteoporosis.

Dosing mode

Femoston ® 1/10 takes inside regardless of meals.

Estrogen in the composition of the drug Femoston ® 1/10 is designed for continuous reception. The progestogen is added over the last 14 days of each 28-day cycle for consistent application.

Treatment should be started with a reception of 1 white tablet daily during the first 14 days of the cycle, then the treatment continues, taking 1 gray tablet daily over the next 14 days, according to the instructions on the packaging designed to receive the drug within 28 calendar days. Fermoston ® 1/10 should be taken continuously without interruptions between packages.

As a rule, consistent combined HGT begin with the drug Fermoston ® 1/10. In the future, the dose of hormones can be corrected individually, in accordance with the clinical results of treatment.

To transition from another drug for continuous or cyclic therapy, you should complete a 28-day cycle and then switch to Fermoston ® 1/10.

When moving from the drug for continuous combination therapy, you should start receiving this drug on any day.

If a woman forgot to take a tablet on time, then it should be taken within 12 hours from the moment of proper reception. If more than 12 hours passed, then the "forgotten" tablet must be destroyed, and the next tablet is taken as usual. Do not take a dual dose to compensate for missed. Pass of reception of the tablet can increase the likelihood of bleeding breakthrough.

Treatment experience elderly women older than 65 years limited.

There is no indication for the use of 1/10 femoston Children and teenagers.

Side effects

Contraindications for use

• diagnosed or suspected breast cancer;
• diagnosed or suspected estrogen-dependent malignant tumors (for example, endometrial cancer or other);
• diagnosed or suspected progestogen-dependent neoplasms (including meningioma);
• bleeding from the genital paths of unclear etiology;
• non-heined endometrial hyperplasia;
• deep vessel thrombosis or thromboembolism of pulmonary vessels in history or at present;
• diagnosed thrombophylastic disorders (protein C deficiency, protein S or antithrombin);
• arterial thromboembolism or in the recent past (including IBS, myocardial infarction, ischemic stroke);
• liver diseases are active or in history, until the normalization of hepatic tests;
• porphyria;
• installed or alleged pregnancy;
• lactation period (breastfeeding);
• children's and teenage age up to 18 years;
• increased sensitivity to the components of the drug.

Application in pregnancy and breastfeeding

The use of the drug Fermoston ® 1/10 with an established or alleged pregnancy and during lactation (breastfeeding) is contraindicated.

Application with violations of the kidney function

Estrogens contribute to the fluid delay, so patients with renal failure need careful observation. Patients with renal failure in the terminal stage should be carefully observed, because The concentration of active ingredients of the drug Fermoston 1/10 will be increased.

special instructions

The UGT is prescribed in cases where the symptoms of menopause significantly affect the quality of life of a woman. In all cases, careful risk assessment and advantages are needed at least once a year. Reception of Fermoston 1/10 continues when the expected benefits significantly exceed possible risks.

Regarding the risks associated with the UGT in the treatment of premature menopause, these data is limited. However, due to the low absolute risk of young women, the ratio of advantages and risks may be more favorable than for older.

Medical examination and observation

Before starting or renewing the HRT, it is necessary to collect a complete medical and family history. Medical examination (including the examination of the mammary glands and the small pelvis organs) is carried out in order to identify possible contraindications and states that require compliance with precautions. During the treatment with the drug Fermoston ® 1/10, dynamic observation is recommended (the frequency and nature of studies is determined individually). Patients should be aware that they must immediately report their attending physician about all changes in the mammary glands. Special studies, including mammography, are carried out in accordance with the accepted screening standards, taking into account clinical indications.

Conditions requiring observation

During the treatment of 1/10 femoston, the patients must be under the careful observation of the doctor if they have or were in the past the following states:

• momat or endometriosis, thromboembolism or risk factors for its development;
• risk factors for estrogen-dependent tumors, for example, breast cancer in relatives of 1 degree;
• arterial hypertension;
• liver diseases (hepatocellular adenoma), diabetes diabetes with angiopathy or without it, bile disease, migraine or (heavy) headache, system red lupus, endometrial hyperplasia in history, epilepsy, bronchial asthma, otosclerosis.

This is also applicable to those patients who have intensified the severity of these states during pregnancy or preceding hormonal treatment. It is necessary to take into account that in the treatment of femooston 1/10, these states can be resumed or becoming more pronounced.

Causes of immediate termination of therapy

The reception of femoston 1/10 should be discontinued when identifying contraindications and in the following situations:

• jaundice or violation of the liver function;
• significant increase in blood pressure;
• the appearance of a migreen headache;
• pregnancy.

Hyperplasia and Endometrial Cancer

The risk of hyperplasia and endometrial cancer increases with long-term taking estrogen. In women who received UGT using only estrogenic drugs, an increase in the risk of endometrial cancer is observed from 2 to 12 times compared with patients who did not receive such therapy, depending on the duration of treatment and dose of estrogen. After stopping the taking estrogen, the risk remains elevated for 10 years. Adding progestogenes for at least 12 days of a 28-day cycle significantly reduces this risk in women with a unlucky uterus.

Bleeding breakthrough and cargo bleeding are sometimes observed in the first few months of treatment. When bleeding breakthrough or cargo bleeding during the reception of femostron 1/10 or after discontinuation of treatment, it is necessary to conduct a survey to identify the cause. It may include the endometrial biopsy to eliminate the malignant process.

Mammary cancer

According to current data on the results of clinical and epidemiological studies, in women hosting combined preparations for the UGT and, possibly monoestrogenic drugs, increased the risk of breast cancer, and this value depends on the duration of therapy.

A randomized placebo-controlled WHI study and pharmaco-epidemiological studies have shown an increase in the risk of breast cancer in women hosting combined drugs for the UGT, which manifests itself 3 years after the start of treatment.

Monotherapy with estrogen-containing drugs.The WHI study did not reveal the risk of breast cancer in women with a remote uterus used preparations with an estrogen content only. Observational studies report on a minor increase in the risk of breast cancer, which is much lower than women receiving combined drugs.

Excess risk of breast cancer is observed in the first few years of treatment , But returns to the initial level for several years after the cessation (maximum of 5 years) treatment. When receiving combined drugs for the UGT, the density of the mammographic image is increased, which may have negative influence on the radiological diagnosis of breast cancer.

Ovarian cancer

The incidence of ovarian cancer is much less common than breast cancer. Long-term use (minimum 5-10 years) monoestrogenic drug is associated with a slight increase in the risk of ovarian cancer. Some studies, including WHI, suggest that the long-term use of combined drugs for the UGT can be associated with the same, or somewhat less risk.

Venous thromboembolia

UGT, the relative risk of the development of venous thromboembolism (VTE) is increased - thrombosis of deep veins and pulmonary thromboembolism - 1.3-3 times. The probability of such a complication is higher in the first years of treatment than in the next.

Patients indicating a history of VTE or with diagnosed thrombophilic states have an increased risk of VTE, and the HRT can increase this risk. Therefore, the UGT is contraindicated in such cases.

The risk factors of the development of VTE include:

• taking estrogen, elderly age, extensive surgical surgery, long-term immobilization, severe obesity (BMI with more than 30 kg / m 2), pregnancy and postpartum period, systemic red lupus and cancer. Currently, there is no single opinion on the relationship of varicose veins to the risk factors of VTE.

It is necessary to take measures to prevent VTE in patients in the postoperative period. In cases where long-term immobilization is assumed after the operation, especially on the abdominal organs or orthopedic operations on the lower limbs, it is necessary to suspend the reception of femoston 1/10, if possible, for 4-6 weeks. Renewal treatment is possible only after the complete restoration of motor activity.

Women who do not have an anamnesis, but the relatives of the first degree of kinship have an ITE anamnesis in young age, should be examined for thrombophilia. In this case, it should be taken into account and warn the patient that not all types of blood coagulation pathology are revealed during screening. The UGT is contraindicated, if members of the family identified a thrombophilic defect (for example, a deficiency of antitrombin, protein S or protein C or a combination of defects). Patients of this risk group receiving anticoagulant therapy require a thorough assessment of the risk ratio and the advantages of the appointment of the UGT.

If VTE developed against the background of receiving a femoston 1/10, treatment should be suspended. If the first possible SME symptoms appear (painful swelling of the lower extremities, sudden chest pain, shortness of breath) The patient should immediately turn to the doctor.

In randomized clinical studies, evidence was not received in favor of the fact that the UGT (only estrogens or in combination with progestogen) protects against the development of myocardial infarction in women with IHS or without it.

Combined preparations containing estrogen + progestogen.The relative risk of CDS during the treatment period by combined drugs for the UGT is increasingly increasing. Because The absolute risk of developing the IBS largely depends on the age, the frequency of additional cases of the CHD in women receiving HGT by combined drugs is very low in the group healthy women At the age of close to the beginning of menopause, and rises with age.

Monotherapy with estrogen-containing drugs.According to randomized studies, the risk of CDS in women with a remote uterus receiving estrogens in monotherapy does not increase.

Ischemic stroke

The risk of ischemic stroke in healthy women with HGT combined drugs for the SGT increases by 1.5 times. Relative risk does not depend on age or length of menopause. However, it is known that the risk of ischemic stroke depends on the age, therefore the risk of stroke in women receiving the UGT is rising with age.

Other states

Estrogens contribute to the fluid delay, so careful medical observation is required to patients with heart or renal failure.

With hyperitriglyceridemia, careful observation is required during the UGT, because There are rare messages about a substantial increase in blood plasma triglycerides, which led to the development of pancreatitis in women with a similar state that took estrogens.

Estrogens increase the level of thyroid-binding globulin, which leads to an increase in the overall level of circulating thyroid hormone, which is measured by the level of associated with the protein iodine, T4 and T3. The levels of free T4 or T3 do not change.

It is possible to increase the levels of other binding proteins, for example, corticoid-binding globulin, globulin binding sex hormones, which leads to an increase in the level of circulating corticosteroid and sex hormones, respectively. The concentrations of free or biologically active hormones do not change. The levels of other plasma proteins (the substrate angiotensin / renin, α-1-antitripsein, ceruloplasmin) can also increase.

UGT does not improve cognitive function. There is a risk of possible dementia in women who started the UGT over the age of 65.

Patients with rare hereditary intolerance to galactose, LAPP lactase deficiency or glucose-galactose absorption violations should not be prescribed Fermoston ® 1/10.

Fermoston ® 1/10 is not a contraceptive agent.

Impact on the ability to driving vehicles and control mechanisms

During the application of the drug, the patient must be careful when managing motor transport and moving mechanisms.

Overdose

To date, no messages are registered symptoms Overdose of the drug Fermoston ® 1/10. Estradiol and Didrogesterone have a low degree of toxicity. It is possible to strengthen the side effects of the drug, such as nausea, vomiting, drowsiness and dizziness.

Treatment: Conducting symptomatic therapy. No specific antidote.

Medicinal interaction

The doctor should figure out what medicines the woman takes at present or took 1/10 to the appointment of Fermoston.

It is possible to reduce the effectiveness of estrogen and progestogen

Estrogen metabolism can increase with the simultaneous use of drugs induced by microsomal liver enzymes of the cytochrome P450 system, for example, CYP2B6, CYP3A4, CYP3A5, CYP3A7. These include anticonvulsant (phenobarbital, carbamazepine, phenytoin) and anti-infectious (rifampicin, ribavirin, nevirapin, efavirenesis) drugs.

Ritonavir and Nelfinavir, although known as powerful CYP3A4, CYP3A5, CYP3A7 inhibitors, by contrast, induce liver enzymes while simultaneously use with steroid hormones.

Medicinal preparations of vegetable origin containing the grass of the Hyperoboy (Hypericum Perforatum) increase the metabolism of estrogen by inhibiting CYP3A4.

Increasing the metabolism of estrogen and progestogencies to clinically can manifest itself with a decrease in the effectiveness and change in the nature of the menstrual-like reaction.

Effect of estrogen on the metabolism of other medicines

Estrogens are capable of inhibiting CYP450 isoenzymes involved in medicinal metabolism through a competitive mechanism. This is especially important if you need to simultaneously use drugs with a narrow therapeutic range, such as tacrolimus and cyclosporine A (CYP3A4, CYP3A3), fentanyl (CYP3A4), Theophylline (CYP1A2). This interaction clinically can manifest itself in an increase in the concentrations of these drugs in plasma to a toxic level. Therefore, it should be carefully observed for the state of patients receiving estrogen preparations, and, if necessary, decrease the dose of tacrolimus, fentanyl, theophylline and cyclosporine A.

Shell-covered tablets , two species.

Tablets covered with white shell, round, double-screw, embossed "s" above the "∇" icon on one side, "379" - on the other side (14 pcs. In blister).

Excipients:

The composition of the shell: OPADRY OY-1-7000 white.

Tablets covered with gray shell, round, double-screw, embossed "S" over the "∇" icon on one side, "379" - on the other side; The kernel of white tablets (14 pcs. in blister).

Excipients: Lactoses of monohydrate, hypimosellos, corn starch, silicon colloid dioxide, magnesium stearate.

The composition of the shell: OPADRY OY-8243 Gray.

Shell-covered tablets , two species.

Tablets covered with a shell of pink color, round, double-screw, embossed "s" over the "∇" icon on one side and "379" - on the other side; The kernel of white tablets (14 pcs. in blister).

Excipients: Lactoses of monohydrate, hypimosellos, corn starch, silicon colloid dioxide, magnesium stearate.

The composition of the shell: OPADRY OY-6957 Pink.

Tablets covered with a shell of light yellow color, round, double-screw, embossed "S" over the "∇" icon on one side and "379" - on the other side; The kernel of white tablets (14 pcs. in blister).

Excipients: Lactoses of monohydrate, hypimosellos, corn starch, silicon colloid dioxide, magnesium stearate.

The composition of the shell: OPADRY OY-02B22764 yellow.

28 pcs. - Blister (1) - packs cardboard.
28 pcs. - Blister (3) - Cardboard packs.
28 pcs. - Blister (10) - packs cardboard.

Clinical and Pharmacological Group

Anti-flame preparation

pharmachologic effect

Combined two-phase preparation for hormonal replacement therapy, containing micronized 17β-estradiol as an estrogen component and as a rattage component of the Didrogesterone. Both components are analogues of female sex hormones (estradiol and progesterone).

Estradiol fills the deficiency of estrogen in the female organism after the occurrence of menopause and provides effective relief of psycho-emotional and vegetative climacteric symptoms, such as tides, increased sweating, sleep disorders, increased nervous excitability, dizziness, headache, the involution of the skin and mucous membranes, especially the genital system (dryness and irritation of the mucous membrane, pain in sexual intercourse).

Restaurant hormone therapy (HRT) The drug Femoston ® prevents the loss of bone mass in a postmenopausal period caused by estrogen deficiency.

The reception of the drug Fermoston ® leads to a change in the lipid profile towards a decrease in the level of total cholesterol and LDL and increase HDL.

Didrogesterone is a Gestagen effective when taking inside, which fully ensures the offensive phase of secretion in endometrial, thereby reducing the risk of developing endometrial hyperplasia and / or carcinogenesis (rising against the background of the use of estrogen). Didrogesterone does not have estrogen, androgenic, anabolic or glucocorticoid activity.

Pharmacokinetics

Estradiol

Suction

After taking the drug inside, the micronized estradiol is easily absorbed.

Metabolism and elimination

Estradiol is metabolized in the liver with the formation of estron and estrone sulfate. Estron sulfate is subjected to intrahepatic metabolism.

The glucuronides of estrone and estradiol are predominantly with urine.

Didrogesterone

Suction

In the human body, the Didrogesterone is quickly absorbed from the gastrointestinal tract.

Metabolism

Metabolized completely. The main metabolite of the Didrogesterone is a 20-dihydrotiderogesterone present in the urine mainly in the form of a glucuronic acid conjugate.

Election

The complete derivation of the Didrogesterone occurs after 72 hours.

Indications for the use of the drug

- replacement hormone therapy of disorders caused by natural menopause, or menopauz, which has occurred as a result of surgical intervention;

- Prevention of postmenopausal osteoporosis.

Dosing mode

Fermoston ® 1/10 take 1 tab. / Day (preferably at the same time) without a break, regardless of meals.

In the first 14 days of the 28-day cycle, 1 tab is accepted daily. White color (from half of the package with an arrow marked with a number "1") containing 1 mg of estradiol, and in the remaining 14 days - daily 1 tab. Gray (from half of the package with an arrow marked with a number 2 ") containing 1 mg of estradiol and 10 mg of Didrogesterone.

Fermoston ® 2/10 take 1 tab. / Day (preferably at the same time) without interruption, regardless of meals.

In the first 14 days of the 28-day cycle, 1 tab is accepted daily. Pink colors (from half of the package with an arrow marked with a number 1 ") containing 2 mg of estradiol, and in the remaining 14 days - daily 1 tab. Light yellow colors (from half of the packaging with an arrow marked with a digit "2") containing 2 mg of estradiol and 10 mg of Didrogesterone.

Patients who did not stop menstruation, recommend starting treatment on the first day of the menstrual cycle. Patients with an irregular menstrual cycle It is advisable to begin treatment after 10-14 days of the monotherapy of progestogen ("Chemical Curetzh").

Patients who have the last menstruation have been observed over 1 years ago, can begin treatment at any time.

Side effect

From the side of the sexual system: Possible diseases of the mammary glands, breakthrough bleeding, pain in the pelvis area; Sometimes - changes in the erosion of the cervix, change in secretion, dysmenorrhea; rarely - an increase in the mammary glands, premenstrual-like syndrome; at some cases (0.1-1%) - Libido change.

From side digestive system: Possible nausea, flatulence, abdominal pain; sometimes - cholecystitis; rarely (0.01-0.1%) - violation of the liver function, in some cases accompanied by asthenia, malaise, jaundice or abdominal pain; Very rarely vomiting.

From the CNS: Headache, Migraine (1-10%); Sometimes (0.1-1%) - dizziness, nervousness, depression; Very rare - Khorora.

From the side of the cardiovascular system: Sometimes - venous thromboembolism; Very rarely - myocardial infarction.

From the hematopopitation system: very rarely (

Dermatological reactions: Sometimes - rash, itching; Very rarely - chlorism, melamism, multiform erythema, noded erythema, hemorrhagic purple.

Allergic reactions: Sometimes - urticaria; Very rare - angioedema swelling.

Others: changing body weight; sometimes - vaginal candidiasis, breast carcinoma, increase in the size of leomyoma; rarely - peripheral swelling, intolerance to the contact lenses, an increase in the curvature of the cornea; In some cases (

Contraindications for the use of the drug

- installed or alleged pregnancy;

- lactation period (breastfeeding);

- diagnosed or suspected breast cancer; breast cancer in history;

- diagnosed or suspected estrogen-dependent malignant neoplasms;

- vaginal bleeding unclear etiology;

- preceding idiopathic or confirmed vein thromboembolic (deep veins thrombosis, pulmonary vessel thromboembolism);

- active or recently transferred arterial thromboembolism;

- acute liver diseases, as well as diseases of the liver in history (until the laboratory indicators of the liver function);

- untreated endometrial hyperplasia;

- Porphyria;

- Increased sensitivity to the components of the drug.

WITH caution And under the control of the doctor, to apply in patients receiving the GHT and those of the listed states (currently or in history): Leiomioma of the uterus, endometriosis, thrombosis and the factors of their risk in history, while the risk factors of estrogen-dependent tumors (for example, breast cancer Mother patients), arterial hypertension, benign liver tumor, diabetes mellitus, cholertiasis, epilepsy, migraine or intensive headache, endometrial hyperplasia in history, systemic red lupus, bronchial asthma, renal failure, otosclerosis.

Application of the drug during breastfeeding and breastfeeding

Femoston ® is contraindicated to use during pregnancy and during lactation.

Application with violations of liver function

Contraindicated in acute liver diseases, as well as liver diseases in history (until the normalization of laboratory laboratory indicators of the liver function).

Application with violations of the kidney function

With caution, you should take the drug with renal failure.

special instructions

Before appointment or renewal of the UGT, it is necessary to collect a full medical and family history, to carry out a general and gynecological examination in order to identify possible contraindications and states that require compliance with precautions. During treatment with the drug, Fermoston ® is recommended to periodically conduct an examination (frequency and nature of studies are determined individually). In addition, it is advisable to conduct a study of the mammary glands (including mammography) in accordance with the clinical indications adopted by the norms.

After coordination with the doctor, the patient should stop taking the drug in the appearance of a jaundice or worsening the liver function, a pronounced admission of blood pressure, first identified by a mignery-like attack, pregnancy, manifestation of any contraindication.

Factors of risk of thrombosis and thromboembolism Against the background of receiving the UGT are thromboembolic complications in history, severe forms of obesity (body mass index is more than 30 kg / m 2) and systemic red lupus. Regarding the role of varicose veins in the development of the thromboembolism, there is no generally accepted opinion.

The risk of developing deep veins of the lower limbs can temporarily increase with long-term immobilization, extensive injuries or surgical interventions. In cases where long-term immobilization is necessary after surgery, one should consider the possibility of temporary termination of the UGT in 4-6 weeks before the operation.

When solving the issue of GTR in patients with recurrent thrombosis of deep veins or thromboembolis that receive treatment with anticoagulants, it is necessary to carefully evaluate the benefit and risk of UGT.

If thrombosis is developing after the start of the UGT, the drug Fermoston ® should be canceled.

The patient should be informed about the need to consult a doctor in case of the appearance of the following symptoms: a painful swelling of the lower extremities, a sudden loss of consciousness, a disposage, violation of vision.

There are research data that demonstrate a minor increase in the frequency of breast cancer detection in women who received UGT for a long time (more than 10 years). The probability of diagnosing breast cancer increases along with the length of treatment and returns to the norm 5 years after the cessation of the UGT.

The patients who received previously ygt with the use of only estrogenic drugs should be particularly examined before the treatment of femoston ® with the purpose of identifying possible endometrial hyperstimulation.

Blooming uterine bleeding and non-timber expressed menstrual bleeding can be marked in the first months of treatment with the drug. If, despite the correction of the dose, such bleeding does not stop, the reception of the drug must be stopped before establishing the cause of bleeding. If the bleeding recurns after the amenorrhea period or continues after the cancellation of treatment, its etiology should be installed. This may require endometrial biopsy.

Femoston ® drug is not a contraceptive. Patients in the perimenopausus are recommended to use non-nonal contraceptives.

The patient must inform the doctor about the drugs that it currently takes or took before the appointment of the drug Femoston ®.

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

Impact on the ability to driving vehicles and control mechanisms

Fermoston ® does not affect the ability to driving vehicles and managing mechanisms.

Overdose

Symptoms: Nausea, vomiting, drowsiness, dizziness.

Treatment: Symptomatic therapy.

Medicinal interaction

The simultaneous use of drugs that are inductors of microsomal liver enzymes (including barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine), can weaken the estrogen effect of the drug Femoston ®.

Ritonavir and Nelfinavir, although known as inhibitors of microsomal metabolism, can play the role of inductors while at the same time reception with steroid hormones.

Herbs-based preparations containing St. John's wort can stimulate the exchange of estrogen and progestogennes.

The interaction of the Didrogesterone, which is part of the preparation of Fermoston ®, is not known with other drugs.

Conditions of vacation from pharmacies

The drug is released by the prescription.

Terms and Storage Terms

List B. The drug should be stored in an inaccessible place for children, at a temperature not higher than 30 ° C. Shelf life - 3 years.