Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: myHealthbox
topiramate
Milpharm Limited
N03AX11
topiramate
100mg
Film-coated tablets
Oral use
60 film-coated tablets
POM - Prescription Only Medicine
APL Swift Services (Malta) Limited
antiepileptics, other antiepileptics, antimigraine preparations
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 generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment.
Authorised
2014-06-19
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 Topiramate Milpharm is and what it is used for 2. What you need to know before you take Topiramate Milpharm 3. How to take Topiramate Milpharm 4. Possible side effects 5. How to store Topiramate Milpharm 6. Contents of the pack and other information Topiramate belongs to a group of medicines called “antiepileptic 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 DO NOT TAKE TOPIRAMATE MILPHARM • 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, breast-feeding and fertility” for further information). If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Milpharm. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Topiramate Milpharm if you: • have kidney problems, especially kidney stones, or are getting kidney dialysis • have a history of blood and body fluid abnormality (metabolic acidosis). • have liver problems • have eye problems, especially glaucoma • have a growth problem • are on a high fat diet (ketogenic diet) • are Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topiramate Milpharm 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg topiramate. Excepient with known effect: lactose monohydrate. 100 mg tablet contains 84.60 mg lactose monohydrate; For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Dark yellow coloured, circular, biconvex bevelled edged film-coated tablets debossed with ‘E’ on one side and ‘23’ 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 generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION General It is recommended that therapy be initiated at a low dose followed by titration to an effective dose. Dose and titration rate should be guided by clinical response. It is not necessary to monitor topiramate plasma concentrations to optimize therapy with topiramate. On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with Topiramate Milpharm may require adjustment of the dose of Topiramate M Belgenin tamamını okuyun