Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
TOPIRAMATE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N03AX11
TOPIRAMATE 100 mg
FILM-COATED TABLET
TOPIRAMATE 100 mg
POM
ANTIEPILEPTICS
Authorised
2014-07-03
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 is and what it is used for 2. What you need to know before you take Topiramate 3. How to take Topiramate 4. Possible side effects 5. How to store Topiramate 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 • 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. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Topiramate 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 pregnant or could become pregnant (see section “Pregnancy, breast Soma hati kamili
1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Topiramate 25 mg film-coated tablets Topiramate 50 mg film-coated tablets Topiramate 100 mg film-coated tablets Topiramate 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg topiramate. Each film-coated tablet contains 50 mg topiramate. Each film-coated tablet contains 100 mg topiramate. Each film-coated tablet contains 200 mg topiramate. Excepient with known effect: lactose monohydrate. 25 mg tablet contains 21.15 mg lactose monohydrate; 50 mg tablet contains 42.30 mg lactose monohydrate; 100 mg tablet contains 84.60 mg lactose monohydrate; 200 mg tablet contains 61.70 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-ccoated tablet Topiramate 25 mg film-coated tablets: White, circular, biconvex film-coated tablets debossed with ‘E’ on one side and ‘22’ on the other side. Topiramate 50 mg film-coated tablets: Light yellow coloured, circular, biconvex film-coated tablets debossed with ‘E’ on one side and ‘33’ on the other side. Topiramate 100 mg film-coated tablets: Dark yellow coloured, circular, biconvex bevelled edged film-coated tablets debossed with ‘E’ on one side and ‘23’ on the other side. Topiramate 200 mg film-coated tablets: Pink coloured, circular, biconvex, bevelled edged film-coated tablets debossed with ‘E’ on one side and ‘24’ 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. 2 of 24 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 f Soma hati kamili