מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
TOPIRAMATE
Clear Pharmacy
N03AX11
TOPIRAMATE
100 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics
Authorised
2011-12-09
PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX® 50 AND 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 “antiepileptic 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 you are able to become pregnant but you are not using effective contraception (see section ‘pregnancy and breast-feeding’ for further information) If you are not sure if the above applies to you, talk to your doctor or pharmacist קרא את המסמך השלם
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: 123 mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets _Product imported from Spain:_ Yellow, round tablets, 9mm in diameter, “TOP” on one side and “100” on the other. 4 CLINICAL PARTICULARS PA0748/012/003 5 PHARMACOLOGICAL PROPERTIES PA0748/012/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Core Tablet:_ Lactose Monohydrate Pregelatinized Starch Microcrystalline Cellulose Sodium Starch Glycolate (Type A) Magnesium Stearate _Film-coating:_ Hypromellose Polyethylene glycol Polysorbate 80 Titanium Dioxide (E171) Iron Oxide (E172) Carnauba wax 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 04/06/2015_ _CRN 2161458_ _page number: 1_ 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer packaging of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25° C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips of 10 tablets in an overlabelled cardboard carton Pack size: 60 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Clear Pharmacy 157-173 Roden Street Belfast BT12 5QA United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1596/058/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 th December 2011 10 DATE OF REVISION OF THE קרא את המסמך השלם