Hormone replacement therapy (HRT) to eliminate symptoms caused by estrogen deficiency in menopausal women no earlier than 6 months after the last menstruation. Prevention of osteoporosis in postmenopausal women with a high risk of fractures. Femoston should only be used in patients who are intolerant or have contraindications for the use of other medications for the prevention of osteoporosis (see the section “Features of use”). Experience in treating women over 65 yEars and Nose of age is limited.
active substances: dydrogesterone; estradiol;
1 tablet contains micronized dydrogesterone 2.5 mg and micronized estradiol hemihydrate, equivalent to 0.5 mg estradiol;
excipients: lactose monohydrate; hypromellose (HPMC 2910); corn starch; colloidal anhydrous silica; magnesium stearate; film shell Yellow 1 (macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide yellow (E 172)).
Femoston Dosage form
Main physical and chemical properties: round, biconvex yellow tablets, film-coated, with the inscription “379” on one side.
Femoston Pharmacotherapeutic group
Drugs for the treatment of diseases of the genitourinary system and sex hormones. Progestogens in combination with estrogens. Dydrogesterone and estrogen. ATX code G03F A14.
The active ingredient, 17ß-estradiol, is chemically and biologically similar to endogenous human estradiol. Estradiol replaces the loss of estrogen production in menopausal women and relieves menopausal symptoms.
Dydrogesterone is an active oral progestogen, the action of which is comparable to the action of progesterone administered parenterally.
Because estrogen stimulates endometrial growth, estrogen monotherapy increases the risk of endometrial hyperplasia and cancer. The addition of a progestogen to therapy significantly reduces the risk of estrogen-induced endometrial hyperplasia in women with a preserved uterus.
Clinical trial data
Reducing the symptoms of estrogen deficiency and improving the bleeding profile.
A reduction in menopausal symptoms was observed during the first few weeks of treatment.
When taking FEMOSTON® CONTI MINI from 4 weeks of treatment, the reduction in moderate and severe hot flashes was statistically significant compared with placebo. The number of moderate and severe hot flashes continued to decline until the end of the treatment period at 13 weeks. In two studies, amenorrhea (no bleeding or spotting) was seen in 91% and 88% of women, respectively, during the 10th to 12th months of treatment. Irregular bleeding and / or spotting occurred in 10% and 21% of women during the first 3 months of treatment, and in 9% and 12% during the 10-12 months of treatment.
Hormone replacement therapy (HRT) to eliminate the symptoms caused by estrogen deficiency in postmenopausal women, not earlier than 12 months after the last menstrual period.
Hypersensitivity to the active substances or to any of the excipients is known.
Diagnosed in the past or suspected breast cancer.
Estrogen-dependent malignancies (eg, endometrial cancer) have been identified or suspected.
Progestogen-dependent neoplasms (eg meningioma) have been identified or suspected.
Genital bleeding of unknown etiology.
Untreated endometrial hyperplasia.
Venous thromboembolism (deep vein thrombosis, pulmonary embolism) in the past or present.
Presence of thrombophilic disorders (eg protein C, protein S or antithrombin deficiency, see section 4.4).
Acute or recent thromboembolic arterial disease (eg angina, myocardial infarction).
Acute liver disease or a history of liver disease if liver function tests have not returned to normal.