Femoston (estradiol) coated tablets 1 mg/10 mg. №56

Description

Femoston (estradiol) Composition
estradiol tablet

active substance: estradiol;

1 tablet contains micronized estradiol hemihydrate, which is equivalent to estradiol 1 mg or 2 mg;

excipients: lactose monohydrate, hypromellose (HPMC 2910), corn starch, colloidal silicon dioxide, magnesium stearate;

film coating: Opadry® Y-1-7000 white (hypromellose (HPMC 2910), polyethylene glycol 400, titanium dioxide (E 171)) – for tablets containing 1 mg of estradiol;

Opadry® OY-6957 pink (hypromellose (HPMC 2910), polyethylene glycol 400, talc, iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E 171)) – for tablets, containing 2 mg of estradiol;

estradiol and dydrogesterone tablet

active ingredients: estradiol; dydrogesterone;

1 tablet contains micronized estradiol hemihydrate, which is equivalent to 1 mg estradiol or 2 mg micronized dydrogesterone 10 mg;

Femoston (estradiol) excipients:

lactose monohydrate, hypromellose (HPMC 2910), corn starch, colloidal silicon dioxide, magnesium stearate;

film coating: Opadry® II gray 85F27664 (polyethylene glycol 3350, talc (E 553b), polyvinyl alcohol, black iron oxide (E172), titanium dioxide (E 171)) – for tablets containing 1 mg of estradiol and 10 mg of dydrogesterone;

Opadry® OY-02B22764 yellow (hypromellose (HPMC 2910), polyethylene glycol 400, talc, iron oxide yellow (E172), titanium dioxide (E 171)) – for tablets containing 2 mg estradiol and 10 mg dydrogesterone.

Femoston (estradiol) Dosage form
Film-coated tablets.

Basic physical and chemical properties:

a tablet that contains 1 mg of estradiol: round, biconvex, film-coated, white tablet with the marking “379” on one side, diameter 7 mm and weight of the tablet approximately 144 mg;

a tablet that contains 1 mg estradiol and 10 mg dydrogesterone: round, biconvex, film-coated, gray tablet marked “379” on one side, 7 mm in diameter and weight of the tablet approximately 144 mg.

Pharmacotherapeutic group
Drugs for the treatment of diseases of the genitourinary system and sex hormones. Combination preparations containing progestogens and estrogens for sequential use.

ATX code G03F B08.

Pharmacodynamics
Estradiol

The active ingredient 17ß-estradiol is chemically and biologically similar to the natural female sex hormone estradiol. It replaces the loss of production of its own estrogen in menopausal women and relieves menopausal symptoms.

Estrogens prevent bone loss after menopause or oophorectomy.

Dydrogesterone

Dydrogesterone is an orally active progestogen with a comparable effect to parenteral progesterone.

Due to the fact that estrogens stimulate endometrial growth, if progestogen is not used, they increase the risk of endometrial hyperplasia and carcinoma. The addition of progestogen to therapy significantly reduces estrogen-induced risk in women with a preserved uterus.

Clinical trial data

Reducing the symptoms of estrogen deficiency and improving the bleeding profile.

A decrease in menopausal symptoms was observed during the first few weeks of treatment.

Indications

Hormone replacement therapy (HRT) to eliminate symptoms caused by estrogen deficiency in women in the menopausal period no earlier than 6 months after the last menstruation.
Prevention of osteoporosis in postmenopausal women at high risk of fractures. Femoston® should be used in patients only in case of intolerance or contraindications to the use of other drugs for the prevention of osteoporosis (see section “Peculiarities of use”).
Experience in treating women over 65 years of age is limited.

Contraindications

Has been diagnosed with past, present or suspected breast cancer;
Established or suspected estrogen-sensitive tumors (eg, endometrial cancer);
established or suspected progestogen-sensitive tumors (eg meningiomas);
vaginal bleeding of unknown origin;
untreated endometrial hyperplasia;
venous thromboembolism, present or in history (deep vein thrombosis, pulmonary embolism);
the presence of thrombophilic disorders (for example, a deficiency of protein C, protein S or antithrombin, see the section “Peculiarities of use”);
acute or recent thromboembolic disease of the arteries (eg angina pectoris, myocardial infarction);
a history of acute liver disease or liver disease if liver function tests have not returned to normal;
known hypersensitivity to active ingredients or to any of the drug excipients.
porphyria.