Femoston 1 tablet, 28pcs

Composition

1 tablet contains:

Active ingredient:

estradiol 1 mg;

excipients:

lactose monohydrate,

hypromellose,

corn starch,

colloidal silicon dioxide,

magnesium stearate

Shell composition:

Opadry OY-1-7000 white.

Tablets of gray color, round, biconvex, with an embossed ” S ” above the “dlt” icon on one side, “379” – on the other side; the core of the tablet is white (14 pcs. in a blister).

1 tablet contains:

active ingredients:

estradiol 1 mg,

didrogesterone 10 mg;

excipients:

lactose monohydrate,

hypromellose,

corn starch,

colloidal silicon dioxide,

magnesium stearate.

Shell composition:

Opadry OY-8243 grey.

Pharmacological action

Pharmacodynamics

Estradiol-estrogen, which is part of Femoston, is identical to human endogenous estradiol. Estradiol makes up for the lack of estrogens in the female body after menopause and provides effective treatment of psychoemotional and vegetative climacteric symptoms: hot flashes, increased sweating, sleep disorders, 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, soreness during sexual intercourse). Hormone replacement therapy (HRT) with Femoston prevents postmenopausal bone loss caused by estrogen deficiency. Taking Femoston leads to a change in the lipid profile in the direction of lowering the level of total cholesterol and LDL and increasing HDL.

Didrogesterone is a progestogen that is effective when taken orally, which fully ensures the onset of the endometrial secretion phase, thereby reducing the risk of endometrial hyperplasia and/or carcinogenesis, which increases against the background of estrogens. Didrogesterone has no estrogenic, androgenic, anabolic or glucocorticosteroid activity.

The combination of 1 mg of estradiol with didrogesterone is a modern low-dose HRT regimen.

After oral use, micronized estradiol is easily absorbed. It is metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Estrone and estradiol glucuronides are mainly excreted in the urine.

Didrogesterone is rapidly absorbed from the gastrointestinal tract after oral use. Completely metabolized. The main metabolite is 20-dihydrodirogesterone, which is present in the urine mainly as a glucuronic acid conjugate. Complete elimination of didrogesterone occurs after 72 hours.

Indications

• hormone replacement therapy for disorders caused by estrogen deficiency in perimenopausal women (not earlier than 6 months after the last menstrual period) or in postmenopausal women;
• prevention of postmenopausal osteoporosis in women with a high risk of fractures with intolerance or contraindications to the use of other medications.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation. If pregnancy occurs during treatment with the drug, therapy should be stopped immediately.

Contraindications

• established or suspected pregnancy;
• breastfeeding;
• diagnosed or suspected breast cancer, breast cancer history;
• diagnosed or suspected estrogen-dependent malignant tumors;
• vaginal bleeding of unknown etiology;
• previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, thromboembolism of the pulmonary vessels);
• active or recent arterial embolism;
• acute liver disease, and liver disease in history (up to the normalization of laboratory parameters of liver function);
• untreated endometrial hyperplasia;
• hypersensitivity to any component of the drug;
• porphyria.

Caution — Patients who are receiving HRT and have the following conditions (currently or in the past) should be closely monitored by a doctor:

• leiomyoma of the uterus, endometriosis;
• thrombosis or their risk factors in history;
• the risk factors for estrogen-dependent tumors (e. g. breast cancer in mothers of patients);
• arterial hypertension;
• benign tumor of the liver;
• diabetes mellitus;
• cholelithiasis;
• epilepsy;
• migraine or severe headache;
• endometrial hyperplasia in history;
• systemic lupus erythematosus;
• bronchial asthma;
• renal failure;
• otosclerosis.
• After consultation with the doctor, the drug should be discontinued in cases such as: :
• the appearance of jaundice or deterioration of liver function;
• a strong rise in blood pressure;
• a migraine-like attack detected for the first time;
• pregnancy;
• manifestation of any contraindication.

Side effects

From the blood and lymphatic system: very rare (

From the nervous system: headache, migraine (in 1-10%); sometimes (in 0.1–1%) — dizziness, nervousness, depression, changes in libido; very rarely — chorea.

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

From the gastrointestinal tract: nausea, abdominal pain, flatulence; very rarely — vomiting.

From the liver and biliary tract: sometimes-cholecystitis; rarely (in 0.01–0.1%) — impaired liver function, sometimes accompanied by asthenia, malaise, jaundice or abdominal pain.

From the skin and subcutaneous fat: sometimes-allergic reactions, rash, urticaria, pruritus, peripheral edema; very rarely-chloasma, melasma, erythema polymorphic, erythema nodosum, hemorrhagic purpura, angioedema.

From the reproductive system and mammary glands: breast tenderness, breakthrough bleeding, pelvic pain; sometimes-changes in cervical erosion, changes in secretion, dysmenorrhea; rarely-breast enlargement, premenstrual-like syndrome.

Other: changes in body weight; sometimes-vaginal candidiasis, breast carcinoma, increased leiomyoma in size; rarely-contact lens intolerance, increased corneal curvature; very rarely-exacerbation of porphyria.

Interaction

Drugs that are inducers of microsomal liver enzymes (barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) can weaken the estrogenic effect of Femoston.

Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, can play the role of inducers when taken simultaneously with steroid hormones. Herbal preparations containing St. John’s wort can stimulate the exchange of estrogens and progestogens.

Interactions of didrogesterone with other drugs are unknown.

The patient should inform the doctor about the medications that she is currently taking or was taking before prescribing Femoston.

How to take, course of use and dosage

Inside, preferably at the same time of day, regardless of food intake-1 tablet a day without a break. Femoston 1/10 is taken according to the following scheme: in the first 14 days of the 28-day cycle, take 1 white tablet daily (from half a package with an arrow marked with the number “1”) containing 1 mg of estradiol, in the remaining 14 days — 1 gray tablet daily (from half a package with an arrow marked with the number “2”) containing 1 mg of estradiol and 10 mg of didrogesterone.

Patients who do not stop menstruating are recommended to start treatment on the first day of the menstrual cycle (1st day of the onset of menstruation).

Patients with irregular menstrual cycles should start treatment after 10-14 days of progestogen monotherapy.

Patients who have had their last menstrual period more than 1 year ago can start treatment at any time.

Overdose

Overdose may cause symptoms such as nausea, vomiting, breast tension, dizziness, abdominal pain, drowsiness/weakness, and withdrawal bleeding. Treatment-symptomatic

Description

There are two types of film-coated tablets. Tablets coated with a white film color, round, biconvex, with the inscription “379” on one side; on the break – a white rough surface Tablets coated with a gray film color, round, biconvex, with the inscription “379” on one side; on the break – a white rough surface.

Special instructions

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history and conduct a general and gynecological examination in order to identify possible contraindications and conditions that require precautionary measures. 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 mammary gland examination and / or mammography in accordance with accepted standards, taking into account clinical indications. The use of estrogens may affect the results of the following laboratory tests: determination of glucose tolerance, study of thyroid and liver function.

Generally recognized risk factors for thrombosis and thromboembolism associated with HRT include a history of thromboembolic complications, severe forms of obesity (body mass index greater than 30 kg/m2), and systemic lupus erythematosus. There is no general consensus on the role of varicose veins in the development of thromboembolism.

The risk of developing deep vein thrombosis in the lower extremities may temporarily increase with prolonged immobilization, extensive injuries, or surgery. In cases where prolonged immobilization is necessary after surgery, the possibility of temporarily stopping HRT 4-6 weeks before surgery should be considered.

When considering HRT in patients with recurrent deep vein thrombosis or thromboembolism treated with anticoagulants, the benefits and risks of HRT should be carefully evaluated.

If thrombosis develops after the start of HRT, the drug should be discontinued. 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, dyspnoea, visual impairment.

There are data showing a slight increase in the detection rate of breast cancer in women who have received HRT for a long time (more than 10 years). The likelihood of breast cancer diagnosis increases with the duration of treatment and returns to normal 5 years after HRT is discontinued.

Patients who have previously received HRT using only estrogenic drugs should be especially carefully examined before starting treatment in order to detect possible endometrial hyperstimulation. Breakthrough uterine bleeding and blurred 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 established. If the 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 women are recommended to use non-hormonal contraceptives.

It does not affect the ability to drive a car or other mechanisms.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

: Didrogesterone, Estradiol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For menopausal women, For postmenopausal women

Indications

Osteoporosis, Menopause