Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Topiramate
PCO Manufacturing Ltd.
N03AX; N03AX11
Topiramate
100 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; topiramate
Authorised
2007-03-16
_ _ _ _ _ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER TOPAMAX ® 25 MG FILM-COATED TABLETS TOPAMAX ® 50 MG FILM-COATED TABLETS TOPAMAX ® 100 MG FILM-COATED TABLETS TOPAMAX ® 200 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 breast-feeding ‟ 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 apply 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 k Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 17 January 2020 CRN009FTF Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topamax 100 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 100 mg of Topiramate Excipients with known effect: also contains lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-Coated Tablet. _Product imported from Greece,France, Spain, The Netherlands and Lithuania:_ Yellow, embossed, round tablets imprinted with “TOP”on one side and “100”on the other. 4 CLINICAL PARTICULARS As per PA22612/013/003 5 PHARMACOLOGICAL PROPERTIES As per PA22612/013/003 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 Yellow contains: Hypromellose Macrogol Polysorbate 80 And as colourant, titanium dioxide (E171) and Iron oxide yellow (E172) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE Health Products Regulatory Authority 17 January 2020 CRN009FTF Page 2 of 2 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 (blister or bottle) in order to protect from moisture. Keep the bottle tightly closed to protect the tablets from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Opaque plastic containers containing 60 tablets or Al-PVC/ALU-ALU blisterpacks containing 28 or 60 tablets. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/196/003 9 DATE OF FIRST AUTHORISATION/RENEWA Διαβάστε το πλήρες έγγραφο