Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TOPIRAMATE
B & S Healthcare
N03AX11
TOPIRAMATE
100 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Other antiepileptics
Authorised
2006-09-22
PACKAGE LEAFLET: INFORMATION FOR THE USER 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. The name of your medicine is Topamax ® 100mg film-coated tablets but will be referred to as Topamax throughout this leaflet. Please note that this leaflet also contains information about other strengths Topamax ® 25mg and 50mg film-coated tablets. 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 mi Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topamax 100mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg Topiramate Excipient: Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Portugal:_ Yellow, embossed, round tablets imprinted with “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 Lactose monohydrate Pregelatinised starch Carnauba wax Microcrystalline cellulose (E460) Sodium starch glycolate Magnesium stearate Opadry yellow YS-1-6370-G: contains hypromellose, titanium dioxide (E171), polyethylene glycol, yellow iron oxide (E172) and 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 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 in the original package in order to protect from moisture. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 23/07/2015_ _CRN 2162021_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium blister packs of 60 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER B&S Healthcare Unit 4 Bradfield Road Ruislip Middlesex HA4 0NU United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1328/039/003 9 DATE OF FIRST AUTHORISATION/RENE Read the complete document