البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Topiramate
Primecrown 2010 Limited
N03AX; N03AX11
Topiramate
25 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; topiramate
Authorised
2006-09-22
PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX ® 25MG FILM-COATED TABLETS TOPAMAX ® 50MG FILM-COATED TABLETS TOPAMAX ® 100MG FILM-COATED TABLETS (topiramate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 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 Topamax is and what it is used for 2. What you need to know before you take Topamax 3. How to take Topamax 4. Possible side effects 5. How to store Topamax 6. Contents of the pack and other information 1. WHAT TOPAMAX IS AND WHAT IT IS USED FOR Topamax belongs to a group of medicines called ‘anti- epileptic medicines’. It is used: - alone to treat seizures in adults and children over age 6 - with other medicines to treat seizures in adults and children aged 2 years and above - to prevent migraine headaches in adults 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPAMAX DO NOT TAKE TOPAMAX - if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6). - for migraine prevention: if you are pregnant or if you are a woman of childbearing potential unless you are using effective contraception (see section ‘pregnancy and breastfeeding’ for further information). You should talk to your doctor about the best kind of contraception to use while you are taking Topamax. If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topamax. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Topamax if you: - have kidney problems, especially kidney stones, or are getting kidney dialysis - ha اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TOPAMAX 25mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 25 mg of topiramate. Excipient(s) with known effect: also includes lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Portugal and Spain:_ White, round tablets, 6 mm in diameter, “TOP” on one side and “25” on the other. 4 CLINICAL PARTICULARS As per PA0748/012/001 5 PHARMACOLOGICAL PROPERTIES As per PA0748/012/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from Portugal_ CORE TABLET: Lactose Monohydrate Pregelatinised Maize Starch Microcrystalline Cellulose Sodium Starch Glycolate (Type A) Magnesium Stearate FILM-COATING OPADRY White 1 Carnauba wax 1 OPADRY White contains: Hypromellose Macrogol Polysorbate 80 And as colourants, titanium dioxide E171 _Product imported from Spain_ Lactose monohydrate Pregelatinised maize starch 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_ _ _ _0_ _7_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _0_ _3_ _5_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Microcrystalline cellulose (E460) Sodium starch glycolate Magnesium stearate Coating: Carnauba wax Hypromellose Titanium dioxide (E171) Polyethylene glycol Polysorbate 80 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the co اقرأ الوثيقة كاملة