Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Laboratoire HRA Pharma, 200 avenue de Paris, 92320 CHATILLON, France
Emergency contraception within 72 hours after an unprotected sexual intercourse or in case of failure of a contraceptive method.
The treatment necessitates the intake of one tablet. The efficacy of the method is higher the sooner after the unprotected intercourse the treatment is initiated. Therefore, the tablet must be taken as soon as possible, preferably within 12 hoursafter the unprotected intercourse, and no longer than 72 hours (3 days) after the intercourse.
Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5).
NorLevo can be taken at any moment during the menstrual cycle.
If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.
After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, cervical cap) until the next menstrual periods resume. The use of NorLevo does not contraindicate the continuation of regular hormonal contraception.
There is no relevant use of NorLevo for children of prepubertal age in the indication emergency contraception.
Oral use.
Serious 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.
5 years.
Keep the blister in the outer carton in order to protect from light.
PVC/PE/PVDC/Aluminium blister of 1 tablet.
Pack sizes with 1 tablet and 5, 10, 25 or 50 tablets as hospital packs only.
Not all pack sizes may be marketed.
No special requirements.
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