ELLA TABLET 30MG

Prescription Only

Drug type: Therapeutic

ATC code: G03AD02

Dosage form: TABLET

Route of administration: ORAL

Active ingredient: Ulipristal acetate; Ulipristal acetate

4.1 Therapeutic indications

Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Pregnancy.

4.2 Posology and method of administration

Posology

The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.

The tablet can be taken with or without food.

If vomiting occurs within 3 hours of Ella intake, another tablet should be taken.

Ella can be taken at any moment during the menstrual cycle.

Pregnancy should be excluded before Ella is administered.

Special populations

Renal or hepatic impairment:

In the absence of specific studies, no specific dose recommendations for Ella can be made.

Severe hepatic impairment:

In the absence of specific studies, Ella is not recommended.

Children and adolescents:

A limited number of women under 18 years were included in clinical trials of Ella.

Method of administration