Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
TOPIRAMATE
LTT Pharma Limited
N03AX11
TOPIRAMATE
100 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics
Authorised
2014-06-20
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. WHAT IS IN THIS LEAFLET: What Topamax is and what it is used for What you need to know before you take Topamax How to take Topamax Possible side effects How to store Topamax Contents of the pack and other information 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 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 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 Læs hele dokumentet
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. Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Spain_ Yellow, round tablet, 9 mm in diameter, marked ‘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 Pregelatinised maize starch Microcrystalline cellulose Sodium starch glycolate (Type A) Magnesium stearate FILM-COATING: OPADRY Yellow 1 Carnauba Wax 1 OPADRY contains: Hypromellose Macrogol Polysorbate 80 Titanium dioxide (E171) Iron oxide yellow (E172) 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/01/2017_ _CRN 2186661_ _page number: 1_ 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 Do not store above 25 o C. Store the tablets in the original package to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack of an aluminium/aluminium foil in strips. Pack sizes of 60 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER LTT Pharma Limited Unit 18, Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1562/111/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE Læs hele dokumentet