国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Levonorgestrel
Laboratoire HRA Pharma
G03AD; G03AD01
Levonorgestrel
1.5 milligram(s)
Tablet
Product not subject to medical prescription
Emergency contraceptives; levonorgestrel
Not marketed
2005-08-26
PACKAGE LEAFLET: INFORMATION FOR THE USER NORLEVO 1.5 MG TABLET Levonorgestrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or family planning clinic told you. - Keep this leaflet. You may need to read it again. - Ask your doctor, pharmacist or family planning clinic, if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NorLevo 1.5 mg tablet is and what it is used for 2. What you need to know before you use NorLevo 1.5 mg tablet 3. How to use NorLevo 1.5 mg tablet 4. Possible side effects 5. How to store NorLevo 1.5 mg tablet 6. Contents of the pack and other information 1. WHAT NORLEVO 1.5 MG TABLET IS AND WHAT IT IS USED FOR NorLevo is an oral emergency contraceptive. WHAT IS EMERGENCY CONTRACEPTION? Emergency contraception is a rescue method intended to prevent pregnancy after unprotected intercourse or in case of failure of a contraceptive method. WHEN SHOULD EMERGENCY CONTRACEPTION BE USED? This contraceptive method should be used as soon as possible, preferably within 12 hours and no later than a period of 72 hours (3 days), after unprotected sexual intercourse or failure of a contraceptive method. It is more effective if you take it as soon as possible after unprotected sex. NorLevo can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking NorLevo, it will not stop you from becoming pregnant. NorLevo has been shown to prevent 52% to 85% of expected pregnancies. If you suspect that you may become pregnant for one of the following reasons: if you have had sexual intercourse without contraception; if you have forgotten to take your contraceptive pill on 阅读完整的文件
Health Products Regulatory Authority 17 September 2019 CRN008LNM Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NORLEVO® 1.5 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.5 mg levonorgestrel. Excipient with known effect: each tablet contains 90.90 mg lactose monohydrate. For the full list of excipients, see section6.1. 3 PHARMACEUTICAL FORM Tablet. White, round biconvex tablet engraved with code NL 1.5 on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours after an unprotected sexual intercourse or in case of failure of a contraceptive method. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. _Paediatric population_ There is no relevant use of NorLevo for children of prepubertal age in the indication emergency contraception. Method of administration Oral use. 4.3 CONTRAINDICATIONS Hypersensitivityto the active substance or to any of the excipients listed in 阅读完整的文件