LEVONELLE

1). If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately. e. 5). Levonelle 1500 can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. 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 Levonelle 1500 for children of prepubertal age in the indication emergency contraception. Method of administration For oral administration.

The most commonly reported undesirable effect was nausea. System Organ Class Frequency of adverse reactions Very common (≥ 1/10) Common (≥1/100 to <1/10) Nervous system disorders Headache Dizziness Gastrointestinal disorders Nausea Abdominal pain lower Diarrhoea Vomiting Reproductive system and breast disorders Bleeding not related to menses* Delay of menses more than 7 days ** Menstruation irregular Breast tenderness General disorders and administration site conditions Fatigue * Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 5-7 days of the expected time.

** If the next menstrual period is more than 5 days overdue, pregnancy should be excluded. From Post-marketing surveillance additionally, the following adverse events have been reported: Gastrointestinal disorders Very rare (<1/10,000): abdominal pain Skin and subcutaneous tissue disorders Very rare (<1/10,000): rash, urticaria, pruritus, Reproductive system and breast disorders Very rare (<1/10,000): pelvic pain, dysmenorrhoea General disorders and administration site conditions Very rare (<1/10,000): face oedema Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 (previous history of salpingitis or of ectopic pregnancy). Levonorgestrel is not recommended in patients with severe hepatic dysfunction.

Severe malabsorption syndromes, such as Crohn’s disease, might impair the efficacy of levonorgestrel. This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

After Levonelle 1500 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 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.

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