Postinor

/ Trima

For oral administration: One tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse.
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.
Postinor 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 Postinor does not contraindicate the continuation of regular hormonal contraception.
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.
Paediatric population: There is no relevant use of Postinor for children of prepubertal age in the indication emergency contraception.

Emergency contraceptive.

Hypersensitivity to the active substance or any of the excipients.
Pregnancy and lactation.

Severe hepatic dysfunction. Severe malabsorption syndrome such as Crohn’s disease, might impair the efficacy. Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Severe hepatic dysfunction. Not recommended for use in young women under 16 years of age.

Very common: Headache, Bleeding not related to menses, Nausea, lower abdominal pain, fatigue.
Common: Delay of menses more than 7 days. Irregular bleeding and spotting. Dizziness, headache, diarrhea, vomiting, breast tenderness.
See prescribing information for full details.

The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%.
Drugs suspected of having similar capacity to reduce plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John’s Wort), rifampicin, ritonavir, rifabutin, and griseofulvin.
For women who have used enzyme-inducing drugs in the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraception (i.e. a Cu-IUD) should be considered. Taking a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use a Cu-IUD, although this specific combination (a double dose of levonorgestrel during concomitant use of an enzyme inducer) has not been studied.
Medicines containing levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism.

Pregnancy: Postinor should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the fetus but there are no clinical data on the potential consequences if doses greater than 1.5 mg of levonorgestrel are taken.
Breast-feeding: Levonorgestrel is secreted into breast milk. Potential exposure of an infant to levonorgestrel can be reduced if the breast-feeding woman takes the tablet immediately after feeding and avoids nursing at least 8 hours following Postinor administration.

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.