Femoston 1/5 Conti film-coated tablets 28 pcs. in Moscow

Femoston 1/5 Conti film-coated tablets 28 pcs. in Moscow

Round, biconvex, film-coated tablets, orange-pink in color, engraved with “379” on one side of the tablet and engraved with the letter “S” above the “7” icon on the other side of the tablet.

After oral administration, micronized estradiol is easily absorbed. Metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Glucuronides of estrone and estradiol are excreted primarily in the urine.

Dydrogesterone after oral administration is quickly absorbed from the gastrointestinal tract. Metabolized completely, the main metabolite is 20-dihydrodidrogesterone (DHD), present in the urine, mainly in the form of a glucuronic acid conjugate. T1/2 - 5-7 hours, DGD - 14-17 hours. Complete elimination occurs after 72 hours.

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

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

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

Dydrogesterone is a progestogen, effective when taken orally, which ensures the onset of the secretion phase in the endometrium. Dydrogesterone reduces the risk of endometrial hyperplasia and/or carcinogenesis, increased under the influence of estrogen. Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticoid activity.

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

Before prescribing or restarting 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 requiring the necessary precautions. During treatment with Femoston®, 1/5 of women are recommended to be examined periodically (the frequency and nature of the examinations are determined individually).

Breast examination and/or mammography are carried out in accordance with accepted standards, taking into account clinical indications.

Femoston® 1/5 is prescribed to women who have been 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 a break in taking the pills.

The use of estrogens may affect the results of the following laboratory tests: glucose tolerance testing, thyroid and liver function tests.

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

Generally recognized risk factors for thrombosis and thromboembolism while taking HRT are a history of thromboembolic complications, severe forms of obesity (body mass index more than 30 kg/m2) and systemic lupus erythematosus. There is no generally accepted opinion regarding 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, temporary cessation of HRT should be considered 4–6 weeks before surgery.

When deciding on HRT in patients with recurrent deep vein thrombosis or thromboembolism receiving anticoagulant treatment, its benefits and risks must be carefully assessed.

If thrombosis develops after starting HRT, Femoston® 1/5 should be discontinued. The patient should be informed of the need to consult a doctor if the following symptoms occur: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, blurred vision.

There is data demonstrating a slight increase in the incidence of breast cancer in women receiving long-term (more than 10 years) hormone replacement therapy. Detection of breast cancer may be due to early diagnosis, the 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 stopping HRT.

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

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

Femoston® 1/5 is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives.

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

Instructions for use FEMOSTON® 1/5 CONTI (FEMOSTON® 1/5 CONTI)

The drug is prescribed to postmenopausal women only if there are symptoms that adversely affect the quality of life:

• hot flashes, increased sweating, sleep disturbance, increased nervous excitability, dizziness, headache, involution of the skin and mucous membranes, especially the mucous membranes of the genitourinary system (dryness and irritation of the vaginal mucosa, pain during sexual intercourse). Therapy should be continued as long as the benefit of taking the drug outweighs the risk of side effects, and it is necessary to strive to prescribe the drug in the minimum effective dose. Aim should be made to achieve the shortest duration of treatment. Experience with the drug in women over 65 years of age is limited.

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history and conduct a general and gynecological examination of the patient in order to identify possible contraindications and conditions requiring precautions. During treatment with Femoston® 1/5 conti, it is recommended to conduct periodic examinations, the frequency and nature of which are determined individually, but at least once a year, based on the collected medical history, clinical and laboratory parameters. It is advisable to conduct examination of the mammary glands, incl. mammography. Women should be informed about those possible changes in the mammary glands that need to be reported to their doctor.

The use of estrogens may affect the results of the following laboratory tests:

• determination of glucose tolerance, study of thyroid and liver functions.

In order to timely diagnose endometrial hyperplasia, it is advisable to conduct an ultrasound and, if necessary, a histological (cytological) examination.

In the first months of treatment with the drug, breakthrough bleeding and/or acyclic menstrual-like bleeding from the vagina may occur. If such bleeding appears some time after the start of therapy or continues after cessation of treatment, its cause should be determined. An endometrial biopsy may be performed to rule out malignancy.

If the patient has a history of thromboembolism (including family history), as well as a history of recurrent miscarriage, it is necessary to conduct a hemostasis study. Until a thorough assessment of the factors for the possible development of thromboembolism or the initiation of anticoagulant therapy, HRT is not used.

The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, major trauma, or surgery. If long-term immobilization is necessary after surgery, HRT should be discontinued 4-6 weeks before. before surgery, resumption of the drug is possible after the woman has fully recovered her motor activity.

If thrombosis develops after initiation of therapy, HRT should be discontinued.

The patient should consult a doctor if any of the symptoms indicating a possible thromboembolism (pain or swelling of the lower extremities, sudden pain in the chest, dyspnea, blurred vision) appear.

In women receiving HRT for a long time, the incidence of breast cancer diagnosis increases, which returns to the original level within 5 years after cessation of therapy. During HRT, there may be an increase in the density of breast tissue during mammography, which can make it difficult to diagnose breast cancer.

An increase in the risk of ovarian cancer when using estrogen-progestin drugs for HRT has not been proven.

Estrogens can cause fluid retention, which may adversely affect patients with impaired cardiac or renal function.

In women with triglyceridemia, during HRT, in very rare cases, there may be a significant increase in the concentration of triglycerides in the blood plasma, which contributes to the development of pancreatitis.

Estrogens increase the content of thyroid-binding globulin, which leads to a general increase in the concentration of circulating thyroid hormones (the concentrations of free hormones T3 and T4 usually do not change). Serum levels of other binding proteins (corticoid binding globulin, sex hormone binding globulin) may also be increased, resulting in increased concentrations of circulating corticosteroids and sex hormones. The concentrations of free or biologically active hormones do not change. It is possible to increase the concentration of other plasma proteins (angiotensinogen/renin substrate, α-l-antitrypsin, ceruloplasmin).

Taking Femoston® 1/5 conti should be discontinued if contraindications are identified and/or if the following conditions occur:

• jaundice and/or liver dysfunction;
• significant increase in blood pressure;
• the appearance of a migraine-like attack against the background of HRT;
• in case of relapse or aggravation of the severity of the above diseases or conditions.

Femoston® 1/5 conti is not a contraceptive.

The patient should inform the doctor about the medications she is taking during HRT or was taking before prescribing Femoston® 1/5 conti.

Impact on the ability to drive vehicles and operate machinery

Femoston® 1/5 conti does not affect the ability to drive vehicles and operate machinery.

Femoston tablets of two types of film 1 mg/1 mg+10 mg pack cont cell/pack card x28

Trade name: Femoston International name: (not specified) ( (not specified))

Release form: film-coated tablets (blisters) / 2 types of tablets included: estradiol 1 mg - 14 pcs. and estradiol 1 mg + dydrogesterone 10 mg - 14 pcs.)

Composition: dydrogesterone 10 mg, estradiol 1.03/2.06 mg [equiv. 1/2 mg estradiol] - dydrogesterone + estradiol tablets, estradiol hemihydrate 1.03/2.06 mg [equiv. 1/2 mg estradiol] - estradiol tablets

Pharmacological group: antimenopausal agent

Pharmacological group according to ATK: G03FB08 (Dydrogesterone and estrogens)

Pharmacological action: antimenopausal, reducing bone resorption of calcium during menopause, estrogenic, gestagenic,

Description: Yellow tablets, intended for the next 14 days of a 28-day cycle, contain 2 mg of 17-beta estradiol and 10 mg of dydrogesterone.

Indications: Hormone replacement therapy for disorders caused by the menopause, as well as during menopause resulting from surgical intervention (psychovegetative disorders, disorders of the genitourinary system, atrophic processes on the skin, androgenization phenomena), as well as the prevention and treatment of postmenopausal osteoporosis and cardiovascular vascular diseases. Treatment of menstrual disorders (amenorrhea, etc.)

Dosage regimen: Femoston is taken 1 tablet. per day without a break. After the 28-day cycle, the next cycle of treatment should begin immediately. For patients whose menstruation has not stopped, it is recommended to begin treatment on the first day after the start of menstruation. For patients with irregular menstruation, it is advisable to carry out progesterone monotherapy for 10-14 days before starting treatment (“chemical curettage”). For postmenopausal patients (the last menstruation was observed more than 12 months ago), treatment can begin at any time. While taking Femoston, menstrual-like discharge may be observed during the first days of the start of a new cycle. These menstrual-like reactions are regular, predictable, light and painless.

Contraindications: Known or suspected breast cancer, endometrial cancer or other hormone-dependent neoplasms. Acute or chronic liver diseases. History of liver disease, if deviations from the norm according to functional studies remain. Acute venous thromboembolic disorders. Pathological genital bleeding of unknown etiology. Pregnancy and lactation period. Hypersensitivity to one of the ingredients of the drug.

Side effects: In the first months of treatment, a feeling of tension in the mammary glands may be observed. Rarely, headache and slight swelling may occur. These symptoms are transient. There have been reports of skin reactions.

Special instructions: Before carrying out HRT, it is necessary to conduct a general somatic and gynecological examination. A mammogram is advisable. HRT, as a rule, is not prescribed for more than a year without a repeat general medical (including gynecological) examination. Mammography is recommended every 1-2 years. In case of sudden acyclic uterine bleeding, pathological results of a gynecological examination, it is necessary to conduct an endometrial examination. Femoston is not a contraceptive drug. Perimenopausal patients should be advised not to use hormonal contraceptives. Unlike synthetic estrogens, estradiol is a natural hormone and practically does not cause thromboembolic disorders. However, trauma and surgery can increase the risk of thrombosis. Patients with diagnosed or suspected epilepsy, migraine, heart failure, arterial hypertension, porphyria, hemoglobinopathies, otosclerosis, as well as a history of cerebrovascular accidents and thromboembolic disorders should be under strict medical supervision during HRT.

Particular caution should be exercised when treating patients with uterine leiomyoma and endometriosis, since estrogens can affect these conditions. Femoston does not affect the ability to drive a car or operate machines and mechanisms.

Interaction: Regular use of a number of drugs that increase the activity of liver enzymes and enhance the biotransformation of estrogens may reduce the effect of estradiol. These drugs include barbiturates, phenytoin, carbamazepine, rifampicin.

Drug registration number: P No. 011361/01

Date of registration (re-registration) of the drug: December 28, 2004