국가: 몰타
언어: 영어
출처: Malta Medicines Authority
TOPIRAMATE
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgium
N03AX11
TOPIRAMATE 200 mg
FILM-COATED TABLET
TOPIRAMATE 200 mg
POM
ANTIEPILEPTICS
Authorised
2006-12-20
Page 1 of 11 PACKAGE LEAFLET _ _ Page 2 of 11 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 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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). Migraine prevention - You must not use Topamax if you are pregnant. - If you are a woman who is able to become pregnant, you must not take Topamax, unless you use highly effective contraception (birth control) during your treatment. See below under ‘Pregnancy and breast-feeding – Important advice for 전체 문서 읽기
Page 1 of 27 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 27 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Topamax 25 mg film-coated tablets Topamax 50 mg film-coated tablets Topamax 100 mg film-coated tablets Topamax 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 25 mg of topiramate. One tablet contains 50 mg of topiramate. One tablet contains 100 mg of topiramate. One tablet contains 200 mg of topiramate. Excipients with known effect: also includes lactose monohydrate: One 25 mg tablet contains 30.85 mg lactose monohydrate One 50 mg tablet contains 61.70 mg lactose monohydrate One 100 mg tablet contains 123.40 mg lactose monohydrate One 200 mg tablet contains 43.50 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 25 mg: White round tablets, 6 mm in diameter, “TOP” on one side, “25” on the other side. 50 mg: Light yellow round tablets, 7 mm in diameter, “TOP” on one side, “50” on the other side. 100 mg: Yellow round tablets, 9 mm in diameter, “TOP” on one side, “100” on the other side. 200 mg: Salmon round tablets, 10 mm in diameter, “TOP” on one side, “200” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures. Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalisation or primary generalised tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Page 3 of 27 Topiramate is indicated in adults for the prophylax 전체 문서 읽기