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Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. 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. 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 are recommended to use a non-hormonal EC emergency contraceptioni.

Cu-IUD or take a double dose of levonorgestrel i. Levonorgestrel 1. After using emergency contraception it is recommended to use a local barrier method e. The use of levonorgestrel does not contraindicate the continuation of regular hormonal contraception. There is no relevant use of levonorgestrel for children of prepubertal age in the indication emergency contraception. 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 levonorgestrel, 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 fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, levonorgestrel is not recommended for patients who are at risk of ectopic pregnancy history of salpingitis or of ectopic pregnancy.

Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of levonorgestrel.

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This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. After levonorgestrel 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.

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If no withdrawal bleed occurs in the next pill-free period following the use of levonorgestrel 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. Limited and inconclusive data suggest that there may be reduced efficacy of Levonorgestrel 1.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI. Levonorgestrel 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.


The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Drugs suspected of having similar capacity to reduce plasma levels of levonorgestrel include barbiturates including primidonephenytoin, carbamazepine, herbal medicines containing Hypericum perforatum St. John's Wortrifampicin, ritonavir, rifabutin, 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. Taking a double dose of levonorgestrel i. Medicines containing levonorgestrel may increase the risk of cyclosporine toxicity due to possible inhibition of cyclosporin metabolism. Levonorgestrel 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.

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 Levonorgestrel administration. Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date.

Although there are no fertility data in the long term, after treatment with levonorgestrel a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after levonorgestrel EC use. No studies on the effect on the ability to drive and use machines have been performed. Frequency of adverse reactions. From Post-marketing surveillance additionally, the following adverse events have been reported:. Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www. 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. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest.

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Levonorgestrel is not effective once the process of implantation has begun. Both meta-analyses excluded intake later than 72 hours after unprotected intercourse i. At the recommended regimen, levonorgestrel is not expected to induce ificant modification of blood clotting factors, and lipid and carbohydrate metabolism.

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A prospective observational study showed that out of treatments with levonorgestrel emergency contraceptive tablets, seven women became pregnant resulting in an overall failure rate of 2. The failure rate in women under 18 years 2. The of a pharmacokinetic study carried out with 16 healthy women showed that following ingestion of one tablet of Levonorgestrel 1.

Side effects

Levonorgestrel is bound to serum albumin and sex hormone binding globulin SHBG. Only about 1. The biotransformation follows the known pathways of steroid metabolism, thelevonorgestrel is hydroxylated by liver enzymes mainly by CYP3A4 and itsmetabolites are excreted after glucuronidation by liver glucuronidase enzymes. Seesection 4. After reaching maximum serum levels, the concentration of levonorgestrel decreased with a mean elimination half-life of about 26 hours.

Levonorgestrel is not excreted in unchanged form but as metabolites. Levonorgestrel metabolites are excreted in about equal proportions with urine and faeces.

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The clinical relevance of these data is unclear. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity and carcinogenicity potential, beyond the information included in other sections of the SmPC. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Help us improve emc by letting us know which of the following best describes you. Toggle .

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Search emc: Enter medicine name or company Start typing to retrieve search suggestions. Continue typing to refine. Active ingredient levonorgestrel.

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Name of the medicinal product 2. Qualitative and quantitative composition 3. Pharmaceutical form 4. Clinical particulars 4. Pharmacological properties 5. Pharmaceutical particulars 6. Marketing authorisation holder 8. Marketing authorisation s 9. Date of revision of the text.

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This information is intended for use by health professionals. Each tablet contains 1. For a full list of excipients, see section 6. 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. Paediatric population There is no relevant use of levonorgestrel for children of prepubertal age in the indication emergency contraception. Hypersensitivity to the active substance or to any of the excipients listed in section 6. Pregnancy Levonorgestrel should not be given to pregnant women.

Breast-feeding Levonorgestrel is secreted into breast milk. Fertility Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date.