מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Topiramate
Janssen-Cilag Ltd
N03AX11
Topiramate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 5012946026087
1 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 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 ston קרא את המסמך השלם
OBJECT 1 TOPAMAX 100MG TABLETS Summary of Product Characteristics Updated 28-Sep-2022 | Janssen-Cilag Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 includes lactose monohydrate: One 100 mg tablet contains 123.40 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Yellow round tablets, 9 mm in diameter, “TOP” on one side, “100” 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 generali קרא את המסמך השלם