Femoston pills 2/10mg №28

Coated tablets

Composition

1 tablet, film coated, contains: estradiol 2 mg, didrogesteron 10 mg.
Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, Magnesium stearate.
Film shell: opadry OY-8734 orange: hypromellose, macrogol 400, titanium dioxide (E171), iron dye yellow oxide (E172), iron dye red oxide (E172).

28 pcs.

Mechanism of action

Femoston - hormone replacement therapy.
Estradiol, which is part of the drug Femoston is identical to the endogenous human estradiol, which is the most active estrogen. Estradiol compensates for the lack of estrogen in the female body after menopause and provides effective treatment of psycho-emotional, vegetative and urogenital menopausal symptoms.
Replacement hormone therapy (HRT) with Femoston 1/5 conty prevents bone loss in the postmenopausal period.
The drug Femoston leads to a change in the lipid profile in the direction of lowering the level of total cholesterol and low-density lipoproteins and increasing high-density lipoproteins.
Didrogesterone - progestogen, effective when taken orally.It does not possess androgenic, estrogenic, anabolic or glucocorticoid activity. During HRT, the inclusion of didrogesterone provides a complete secretory transformation of the endometrium, thereby reducing the risk of developing hyperplasia and / or endometrial cancer, which is increased under the influence of estrogens.

Indications and usage

- Hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women.
- Prevention of postmenopausal osteoporosis in women with a high risk of fractures with intolerance or contraindications to the use of other drugs.

Contraindications

- Established or suspected pregnancy and lactation.
- Diagnosed or suspected breast cancer.
- Breast cancer in history.
- Diagnosed or suspected progestogen-dependent neoplasms.
- Diagnosed or suspected estrogen-dependent malignant tumors, including endometrial cancer, including in the anamnesis.
- Bleeding from the vagina of unknown etiology.
- Thromboembolic diseases at present or in history, including: myocardial infarction, deep vein thrombosis, pulmonary embolism.
- Violation of cerebral circulation.
- Acute or chronic liver disease in the present or in history (before normalization of laboratory parameters of liver function).
- Untreated endometrial hyperplasia.
- Porphyria.
- Hypersensitivity to the drug.
- Galactose intolerance, lactase deficiency, glucose malabsorption syndrome, galactose.

Pregnancy and Breastfeeding

The drug is contraindicated for use during pregnancy and lactation (breastfeeding). If pregnancy occurs during treatment with femoston, therapy should be immediately discontinued.

Dosage and administration

For the purpose of HRT and prevention of osteoporosis: inside in continuous mode, 1 pill per day (preferably at the same time of day), regardless of the meal. The duration of therapy is determined by the ratio of the benefits and risks to the health of a woman and the severity of estrogen deficiency.
Prevention of postmenopausal osteoporosis It is necessary to carry out taking into account the individual tolerance of the drug and possible effects on bone mass, which are dose-dependent.

Special notes

The drug is prescribed in postmenopausal women only if there are symptoms that adversely affect the quality of life: "hot flushes", increased sweating, sleep disturbance, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes, especially mucous urogenital system (dryness and irritation of the vaginal mucosa, pain during intercourse).Therapy should continue as long as the benefits of taking the drug outweigh the risk of side effects, and you should strive to prescribe the minimum therapeutically effective doses of the drug. You should strive to achieve the shortest duration of treatment.
Experience with the use of the drug in women over 65 is limited.
Medical examination: Before the appointment or renewal of HRT, a complete medical and family history should be collected and a general and gynecological examination of the patient should be carried out in order to identify possible contraindications and conditions requiring compliance with precautionary measures. During treatment with Femoston 1/5 konti, it is recommended to conduct periodic examinations, the frequency and nature of which is determined individually, but at least 1 time per year, based on the collected history, clinical and laboratory parameters. It is advisable to conduct a study of the mammary glands, incl. mammography. Women should be informed about the possible changes in the mammary glands, which are required to inform the attending physician. The use of estrogens may affect the results of the following laboratory tests: determination of glucose tolerance, an examination of the functions of the thyroid gland and the liver.
Endometrial hyperplasia: for the purpose of timely diagnosis, it is advisable to conduct an ultrasound (US) screening, if necessary, to conduct a histological (cytological) study.
Bloody issues: Breakthrough bleeding and / or acyclic menstrual bleeding from the vagina may occur during the first months of drug treatment. If such bleeding occurs some time after the start of therapy or continues after stopping treatment, their cause should be established. It is possible to conduct an endometrial biopsy to exclude a malignant neoplasm.
In the presence of thromboembolism in history Patients (including family), as well as with the usual miscarriage in history, it is necessary to conduct a study of hemostasis. Until a thorough assessment of the factors for the possible development of thromboembolism or the start of anticoagulant therapy, HRT is used. The risk of thrombosis of deep veins of the lower extremities may temporarily increase with prolonged immobilization, extensive injuries or surgical interventions. If necessary, long-term immobilization after surgical interventions should stop HRT 4-6 weeks before the operation, the resumption of the drug is possible after the full restoration of the physical activity of the woman. If thrombosis develops after initiation of therapy, HRT should be abolished. You should contact your doctor if any of the symptoms indicate a possible thromboembolism (pain or swelling of the lower extremities, sudden chest pain, dyspnea, visual impairment).
Breast and ovarian cancer: in women who received long-term HRT, increases the frequency of diagnosis of breast cancer, which returns to the initial level within 5 years after discontinuation of therapy. On the background of HRT, there may be an increase in the density of breast tissue during mammography, which may make it difficult to diagnose breast cancer. An increase in the risk of ovarian cancer with the use of estrogen drugs for HRT has not been proven.
Other states: Estrogens can cause fluid retention, which can adversely affect the condition of patients with impaired cardiac and renal function. In women with triglyceridemia in the background of HRT in very rare cases, there may be a significant increase in plasma triglyceride concentration, which contributes to the development of pancreatitis. Estrogens increase the content of thyroid-binding globulin, which leads to an overall increase in the concentration of circulating thyroid hormones (concentrations of free hormones T C and T 4 usually do not change). Levels of other serum binding proteins (corticoid binding globulin, sex hormone binding globulin) may also increase, leading to an increase in the concentration of circulating corticosteroids and sex hormones. Concentrations of free or biologically active hormones do not change.It is possible to increase the concentration of other plasma proteins (substrate angiotensinogen / renin, a-1-antitrypsin, ceruloplasmin).

Femoston estrogenic effect of the drug is reduced while reception with medicinal preparations which are inducers of microsomal liver enzymes anticonvulsants (barbiturates, phenytoin, Carbamazepine , oxcarbazepine, topiramate , felbamate), antimicrobial agents (rifampicin, rifabutin, nevirapine, efavirenz); with herbal preparations containing Hypericum perforatum (Hypericum perforatum).
The estrogenic effect of the drug Femoston may be enhanced while taking microsomal liver enzymes (ritonavir, nelfinavir) with inhibitor drugs. The interaction of didrogesterone with other drugs is not known. The patient should inform the doctor about the drugs that she takes during HRT or took before the appointment of the drug Femoston.

Symptoms: estradiol and didrogesterone - substances with low toxicity. No cases of overdose have been reported. Theoretically, in the case of an overdose, symptoms such as nausea, vomiting, drowsiness, and dizziness may occur.
Treatment: symptomatic.

The drug should be stored at a temperature not higher than 30 ° C.