Description

Contraindicated in patients with- Hypersensitivity to the active substance or to any of the excipients. Pregnancy and breastfeeding. Genital bleeding of unknown aetiology or for reasons other than uterine fibroids. Uterine, cervical, ovarian or breast cancer.

Pregnancy Category X. Ulipristal acetate is contraindicated during pregnancy. Ulipristal acetate is excreted in human milk and is not recommended.

Ulipristal acetate should only be prescribed after careful diagnosis and Pregnancy should be precluded prior to treatment. Contraception: Concomitant use of progestagen-only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended. Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non-hormonal contraceptive method is recommended during treatment. Endometrial Changes: Endometrial Thickening or Progesterone receptor modulator Associated Endometrial Changes (PAEC). Ulipristal acetate has a specific pharmacodynamic action on the endometrium. An increase in thickness of the endometrium may occur. The thickness of the endometrium decreases to baseline levels upon treatment cessation. If the endometrial thickening persists beyond 3 months following the end of treatment and return of menstruations, this may need to be investigated as per usual clinical practice to exclude underlying conditions. Bleeding Pattern: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician. Asthma Patients: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.

Hepatic Impairment: Ulipristal acetate is not recommended in patients with severe hepatic impairment unless the patient is closely monitored. Renal Impairment: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate. In the absence of specific studies, ulipristal acetate is not recommended for patients with moderate and severe renal impairment unless the patient is closely monitored.

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.

Drugs acting on the Uterus

Keep protected from light & moisture, store below 25° C. Keep out of reach of children.