Therapeutic indications
Emergency contraception within 72 hours of unprotected sex or if a contraceptive method has failed.
Posology and method of administration
Treatment requires taking a tablet. The effectiveness of the treatment is all the greater when it is started quickly after unprotected intercourse. Therefore, the tablet should be taken as soon as possible, if possible within 12 hours after unprotected intercourse, and within 72 hours (3 days) after intercourse at the latest.
NORLEVO can be taken at any time of the cycle.
If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately. After using emergency contraception, it is recommended to use a local contraceptive method (condom, spermicide, cervical cap) until the next period returns.
The use of NORLEVO does not contraindicate the continuation of regular hormonal contraception.
Contraindications
Hypersensitivity to levonorgestrel or to any of the excipients.
Special warnings and precautions for use
Emergency contraception is an occasional method; it should in no case be a substitute for regular contraception. This method does not prevent pregnancy in all cases, especially if the date of unprotected intercourse is uncertain. Limited and inconclusive data suggest that NORLEVO has decreased efficacy 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 sex, regardless of the woman's body weight or BMI. If in doubt (more than five days late for a period or abnormal bleeding on the due date, pregnancy symptoms), it is imperative to verify the absence of pregnancy by a pregnancy test. If the woman has already had unprotected first intercourse in the same cycle which is more than 72 hours old, fertilization linked to this first intercourse is possible. Treatment with NORLEVO after a second intercourse may therefore be ineffective in preventing pregnancy. If pregnancy occurs after taking NORLEVO, the possibility of an ectopic pregnancy should be considered. The absolute risk of an ectopic pregnancy is low because NORLEVO prevents ovulation and fertilization. Ectopic pregnancy can continue despite the onset of uterine bleeding. Therefore, NORLEVO is not recommended in women at risk of ectopic pregnancy (history of salpingitis or ectopic pregnancy).
NORLEVO is not recommended in severe hepatic impairment. Severe malabsorption syndromes, for example Crohn's disease, may decrease the effectiveness of NORLEVO. Cases of thromboembolic events have been reported with the use of NORLEVO. The possibility of a thromboembolic event occurring should be taken into account in women with other pre-existing thromboembolic risk factors, and in particular a personal or family history suggesting thrombophilia. After taking NORLEVO 1.5 mg, your period is usually normal, abundantly and usually happens when you expect it to be, but sometimes it is a few days early or late. It is recommended to consult a doctor to start or readjust regular contraception. If your period does not occur at the end of the oral contraceptive pack after taking NORLEVO, the possibility of pregnancy should be ruled out.
It is not recommended to use NORLEVO more than once in the same menstrual cycle due to the high level of hormones and the possibility of severe disturbances in the menstrual cycle. A woman using repeated emergency contraception should be advised to choose a long-term contraceptive method. The use of emergency contraception does not dispense with precautions to be taken against sexually transmitted diseases. The concomitant use of NORLEVO and medicinal products containing ulipristal acetate is not recommended (see section 4.5).
This medicine contains lactose monohydrate. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome.
Pregnancy and breast feeding
Pregnancy
This medicine cannot interrupt an ongoing pregnancy. If this contraception fails with continued pregnancy, the results of epidemiological studies indicate that progestins do not pose a risk of malformation to the fetus. If levonorgestrel greater than 1.5 mg is taken, the consequences in children are not known.
Feeding with milk
Levonorgestrel is excreted in milk. It is therefore recommended to breast-feed immediately before taking NORLEVO tablets and not to breast-feed for at least 8 hours after taking NORLEVO.
Fertility A rapid return to fertility is likely after taking NORLEVO for emergency contraception; therefore, regular hormonal contraception should be continued or started as soon as possible after taking NORLEVO to prevent future pregnancy.
Clinical experience does not indicate any effect on fertility in humans after taking NORLEVO. Likewise, preclinical studies do not show a deleterious effect on fertility in animals (see section 5.3).
Side effects
The SPC table shows the frequency of side effects reported after taking 1.5 mg of levonorgestrel in clinical studies *.
Nervous system disorders: Dizziness, Headache,
Gastrointestinal disorders: Nausea, Abdominal pain, Diarrhea Vomiting,
Reproductive system and breast disorders: Pelvic pain, Breast tension, Delayed periods, Heavy periods, Bleeding, Dysmenorrhea General disorders and administration site conditions These side effects usually resolve within 48 hours after taking NORLEVO. Breast tightness, spotting and irregular bleeding are reported in 30 percent of women and may continue until their next period, which may be delayed.
reactions such as pharyngeal / facial edema and skin reactions have been reported after taking NORLEVO. Cases of thromboembolic events have been reported in the postmarketing period (see section 4.4). Reporting of suspected adverse reactions The reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for Medicines and Health Products Safety (Ansm) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.
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