STOPINOR Tablet Ref.[115617] Active ingredients: Levonorgestrel

Method of administration

For oral administration.

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.

Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception is recommended to use a non-hormonal EC (emergency contraception), 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).

Levonorgestrel 1.5 mg tablets 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 levonorgestrel does not contraindicate the continuation of regular hormonal contraception.

Paediatric population

There is no relevant use of levonorgestrel for children of prepubertal age in the indication emergency contraception.

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.

36 months.

Store at controlled room temperature 20°C to 25°C.

Primary Packing: 1 tablets Alu/PVC Blister.

Secondary Packing: 1 such blisters packed in printed carton along with the pack insert.

None.