Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.
Emergency contraception does not prevent a pregnancy to occur in every instance, especially if uncertainty about the timing of the unprotected intercourse. In case of doubt (menstrual periods delayed by more than five days or abnormal bleeding at the expected date of menstrual periods, symptoms of pregnancy), it is mandatory to check the absence of pregnancy by performing a pregnancy test.
If the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with NorLevo following the second act of intercourse may therefore be ineffective in preventing pregnancy.
Limited and inconclusive data suggest that there may be reduced efficacy of NorLevo with increasing body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
If pregnancy occurs after treatment with NorLevo, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low as NorLevo prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, NorLevo is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).
NorLevo is not recommended in patients with severe hepatic dysfunction. Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of NorLevo.
Cases of thromboembolic events have been reported after NorLevo intake. The possibility of occurrence of a thromboembolic event should be considered in women with other pre-existing thromboembolic risk factor(s), especially personal or family history suggesting thrombophilia.
After NorLevo intake, menstrual periods are usually of normal abundance and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. It is recommended to have a medical visit to initiate or adapt a method of regular contraception. In case no menstrual period occurs in the next pill-free period following the use of NorLevo after regular hormonal contraception, pregnancy should be ruled out.
Repeated administration within a menstrual cycle is not advisable, because of an undesirable high load of hormones for the patient and the possibility of severe disturbances of the cycle. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.
The use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.
Concomitant use of NorLevo and drugs containing ulipristal acetate is not recommended (see section 4.5).
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.