EZINELLE Tablet Ref.[49677] Active ingredients: Levonorgestrel

Posology

One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1).

If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately. The patient should seek advice from her doctor, nurse, family planning clinic or pharmacist.

Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5).

Ezinelle can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.

After using emergency contraception it is recommended to use a local barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the next menstrual period starts. The use of Ezinelle does not contraindicate the continuation of regular hormonal contraception.

Paediatric population

Ezinelle is not recommended in children. There is no relevant use of Ezinelle for children of prepubertal age in the indication emergency contraception. Ezinelle is not recommended for use by young women under 16 years of age without medical supervision.

Method of administration

Ezinelle should be taken orally.

Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.

3 years.

This medicinal product does not require any special storage conditions.

Blister composed of PVC film coated with PVDC and aluminium foil.

Pack size: 1 tablet.

No special requirements.