UNWANTED-72 Tablet

Emergency contraception within 72 hours of unprotected sexual intercourse of failure of a contraceptive method.

Dosage and Administration

1 tablet to be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse.

If vomiting occurs within 3 hours of taking the tablet, another tablet should be taken immediately.

Levonorgestrel Tablet 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 barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Levonorgestrel Tablet does not contraindicate the continuation of regular hormonal contraception.

Paediatric population: Levonorgestrel Tablet is not recommended in children.

Oral use.

Hypersensitivity to the active substance or any of the excipients.

The most commonly reported undesirable effect was nausea.

Nervous system disorders: Headache, Dizziness

Gastrointestinal disorders: Nausea, Lower abdominal pain, Diarrhoea, Vomiting.

Reproductive system and breast disorders: Bleeding not related to menses *, Delay of menses more than 7 days **, Irregular menstruation, and Breast tenderness.

* Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 7 days of the expected time.

** If the next menstrual periods is more than 5 days overdue, pregnancy should be excluded.

The metabolism of Levonorgestrel is enhanced by concomitant use of liver enzyme inducers.

Drugs suspected of having the capacity to reduce the efficacy of levonorgestrel containing medication include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John’s Wort), rifampicin, ritonavir, rifabutin, griseofulvin.

Levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism.

Contraindicated. See the package insert about the details.

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.

Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Levonorgestrel following the second act of intercourse may therefore be ineffective in preventing pregnancy If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded.

If pregnancy occurs after treatment with Unwanted-72, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low, as Levonorgestrel prevents ovulation and fertilization. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, Levonorgestrel is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).

Levonorgestrel Tablet is not recommended in patients with severe hepatic dysfunction.

Severe malabsorption syndromes, such as Crohn’s disease, might impair the efficacy of Levonorgestrel..

After Levonorgestrel Tablet intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. Women should be advised to make a medical appointment to initiate or adopt a method of regular contraception. If no withdrawal bleed occurs in the next pill-free period following the use of Levonorgestrel Tablet after regular hormonal contraception, pregnancy should be ruled out.

Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle.

Levonorgestrel Tablet is not as effective as a conventional regular method of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.

Use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.

Unwanted-72 contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives.

The precise mode of action of Levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilization if intercourse has taken place in the preovulatory phase, when the likelihood of fertilization is the highest. It may also cause endometrial changes that discourage implantation. Levonorgestrel is not effective once the process of implantation has begun.

Levonorgestrel is not expected to induce significant modification of blood clotting factors, and lipid and carbohydrate metabolism.