Country: Malta
Language: English
Source: Medicines Authority
TOPIRAMATE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N03AX11
TOPIRAMATE 100 mg
FILM-COATED TABLET
TOPIRAMATE 100 mg
POM
ANTIEPILEPTICS
Withdrawn
2010-06-21
PACKAGE LEAFLET: INFORMATION FOR THE USER TALOPAM 25 MG FILM-COATED TABLETS TALOPAM 50 MG FILM-COATED TABLETS TALOPAM 100 MG FILM-COATED TABLETS TALOPAM 200 MG FILM-COATED TABLETS Topiramate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Talopam is and what it is used for 2. Before you take Talopam 3. How to take Talopam 4. Possible side effects 5. How to store Talopam 6. Further information. 1. WHAT TALOPAM IS AND WHAT IT IS USED FOR Talopam is a medicine to treat epilepsy. Talopam is used for the treatment of epilepsy in patients where seizures start in a limited part of the brain (known as partial seizures) and/or with generalised tonic-clonic seizures (grand mal). Talopam can be used alone or in addition to a treatment with other anti-epileptic drugs. Talopam is also used to prevent frequently recurring migraine headaches in adults when earlier treatment with other medicinal products was not effective. 2. BEFORE YOU TAKE TALOPAM DO NOT TAKE TALOPAM - if you are allergic (hypersensitive) to topiramate, soya, peanuts or any of the other ingredients of Talopam - for the indication prophylaxis of migraine if you are pregnant or if you are a woman with child bearing potential and you are not using an effective method of contraception (see pregnancy). TAKE SPECIAL CARE WITH TALOPAM Check with your doctor or pharmacist before using this medicine if you have ever had: - problems with your liver. Your doctor may want to give you a lower do Read the complete document
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Talopam 25 mg film-coated tablets Talopam 50 mg film-coated tablets Talopam 100 mg film-coated tablets Talopam 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate. Topiramate 50 mg, 100 mg and 200 mg Film-coated Tablets contain the following excipient: Lecithin (contains soya oil). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Talopam 25 mg: film-coated tablet, white, round, biconvex, 6 mm diameter with V1 marked on it. Talopam 50 mg: film-coated tablet, light yellow, round, biconvex, 8 mm diameter with V3 marked on it. Talopam 100 mg: film-coated tablet, yellow, round, biconvex, 10 mm diameter with V4 marked on it. Talopam 200 mg: film-coated tablet, salmon-coloured, oval, biconvex, 9.2-18.3 mm in size with V5 marked on it. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults and adolescents aged 12 years and older: Monotherapy of epileptic patients with partial onset seizures and/or generalised tonic-clonic seizures. Adults and adolescents aged 12 years and older: Adjunctive therapy for epileptic patients with partial onset seizures and/or generalised tonic-clonic seizures. Adults: Second line treatment for migraine prophylaxis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that the dose should be titrated gradually to the therapeutic level in order to avoid dose dependent undesirable effects. Estimation of plasma levels is not necessary for optimisation of Topiramate therapy. For doses not realisable/practicable with t Read the complete document