Esmia (have ulipristal acetate) tablets 5 mg. №28

Description

Esmia Storage:

active substance: ulipristal acetate;

1 tablet contains 5 mg of ulipristal acetate;

Excipients: microcrystalline cellulose, mannitol (E 421), talc, croscarmellose sodium, magnesium stearate.

Esmia Dosage form.

Tablets.

Main physical and chemical properties: round biconvex tablets of white or almost white color with engraving “ES5” on one side.

Pharmacotherapeutic group.

Sex hormones and modulators of the genital system, modulators of progesterone receptors.

ATX code G03X B02.

Pharmacological properties.

Ulipristal acetate is an oral synthetic selective modulator of progesterone receptors, characterized by a tissue-specific partial antiprogesterone effect.

Mechanism of action.

Ulipristal acetate directly affects the endometrium.

Ulipristal acetate has a direct effect on fibroids, reducing their size by inhibiting cell proliferation and inducing apoptosis.

Pharmacodynamics.

Endometrium

If daily use of the drug at a dose of 5 mg begins during the menstrual cycle, in most women (including patients with uterine fibroids) regular menstruation persists, and subsequent do not occur until treatment is stopped.

After treatment, the menstrual cycle is restored during

4 weeks.

Esmia Indication

Ulipristal acetate is indicated for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause and who cannot undergo uterine fibroid embolization and / or surgery or if such treatment has failed.

Contraindication.

• Hypersensitivity to the active substance or to any of the excipients

preparation.

• Pregnancy and breastfeeding.

• Vaginal bleeding of unclear etiology or for reasons unrelated to uterine fibroids.

• Uterine cancer, cervical cancer, ovarian or breast cancer.

• Presence of liver disease.

Overdose.

Data on ulipristal acetate overdose are limited.

A small number of patients the drug was used once in doses up to 200 mg or

50 mg for 10 consecutive days; no serious adverse reactions were reported.