Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Levonorgestrel
Imbat Limited
G03AC; G03AC03
Levonorgestrel
1.5 milligram(s)
Tablet
Product not subject to medical prescription
Progestogens; levonorgestrel
Authorised
2012-03-02
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER NORLEVO ® 1.5MG TABLET levonorgestrel Your medicine is available using the above name but will be referred to as NorLevo throughout this leaflet. 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 is and what it is used for 2. What you need to know before you use NorLevo 3. How to use NorLevo 4. Possible side effects 5. How to store NorLevo 6. Contents of the pack and other information 1. WHAT NORLEVO 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 be pregnant for one of the following reasons: if you have had sexual intercourse without contraception; if Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NorLevo 1.5 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.5mg levonorgestrel. Excipients: lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Italy:_ White round biconvex tablet engraved with code NL 1.5 on one face. 4 CLINICAL PARTICULARS As per PA1166/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA1166/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Maize starch Povidone Colloidal anhydrous silica Magnesium stearate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Keep the blister in the outer carton in order to protect from light. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _9_ _8_ _8_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Blister strip of 1 tablet in an over labelled carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2, North Ring Business Park Santry Dublin 9 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA 1151/177/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Dat Les hele dokumentet