البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Topiramate
IMED Healthcare Ltd.
N03AX; N03AX11
Topiramate
100 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; topiramate
Authorised
2016-03-11
PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX 50 MG FILM-COATED TABLETS TOPAMAX 100 MG 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 - have a history of blood and body fluid abnormality (m اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topamax 100mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 100 mg of topiramate. Excipients 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 Slovakia and the Netherlands:_ Description of the product Yellow, round tablets, 9 mm in diameter, “TOP” on one side and “100” on the other. 4 CLINICAL PARTICULARS As per PA0748/012/003 5 PHARMACOLOGICAL PROPERTIES As per PA0748/012/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS CORE TABLET: Lactose Monohydrate Pregelatinized Maize Starch Microcrystalline Cellulose Sodium Starch Glycolate (Type A) Magnesium Stearate FILM-COATING: OPADRY Yellow1 Carnauba Wax 1OPADRY Yellow contains: Hypromellose Macrogol Polysorbate 80 As a colourant, titanium dioxide E171 and iron oxide yellow E172 6.2 INCOMPATIBILITIES Not applicable. 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_ _2_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _3_ _2_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store the tablets in the original package to protect from moisture. 6.5 NA اقرأ الوثيقة كاملة