Country: Ċipru
Lingwa: Grieg
Sors: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
TOPIRAMATE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N03AX11
TOPIRAMATE
50MG
FILM COATED TABLETS
TOPIRAMATE (0097240794) 50MG
ORAL USE
Εθνική Διαδικασία
TOPIRAMATE
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) ALU/ALU (300051601) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 60 TABS IN BLISTER(S) ALU/ALU (300051602) 60 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) ALU/ALU (300051603) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 200 TABS IN BLISTER(S) ALU/ALU (300051604) 200 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) PVC/PVDC-ALU (300051605) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 60 TABS IN BLISTER(S) PVC/PVDC-ALU (300051606) 60 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) PVC/PVDC-ALU (300051607) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 200 TABS IN BLISTER(S) PVC/PVDC-ALU (300051608) 200 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
PACKAGE LEAFLET: INFORMATION FOR THE USER PIRALEPS 25 MG FILM-COATED TABLETS PIRALEPS 50 MG FILM-COATED TABLETS PIRALEPS 100 MG FILM-COATED TABLETS PIRALEPS 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. 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 Piraleps is and what it is used for 2. What you need to know before you take Piraleps 3. How to take Piraleps 4. Possible side effects 5. How to store Piraleps 6. Contents of the pack and other information 1. WHAT PIRALEPS IS AND WHAT IT IS USED FOR Piraleps 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 age 2 years and above to prevent migraine headaches in adults 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIRALEPS DO NOT TAKE PIRALEPS 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 breastfeeding’ for further information). You should talk to your doctor about the best kind of contraception to use while you are taking Piraleps. If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Piraleps. WARNINGS AND PRECAUTIONS 1 Talk to your doctor or pharmacist before taking Piraleps if you: have kidney problems, especially k Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Piraleps 25 mg Film-coated tablets Piraleps 50 mg Film-coated tablets Piraleps 100 mg Film-coated tablets Piraleps 200 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg tablet contains 25 mg of Topiramate. Each 50 mg tablet contains 50 mg of Topiramate. Each 100 mg tablet contains 100 mg Topiramate. Each 200 mg tablet contains 200 mg Topiramate. Excipients with known effect 25 mg tablet contains 47. 960 mg lactose monohydrate; 50 mg tablet contains 95.920 mg lactose monohydrate; 100 mg tablet contains 191.840 mg lactose monohydrate; 200 mg tablet contains 124.505 mg lactose monohydrate; For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. For 25 mg strength: White, round, embossed film-coated tablets with ‘T’ logo engrave on one side and ‘25’ on the other side. For 50 mg strength: Orange, round, embossed film-coated tablets with ‘T’ logo engraved on one side and ‘50’ on the other side. For 100 mg strength: Yellow, round, embossed film-coated tablets with ‘T’ logo engraved on one side and ‘100’ on the other side. For 200 mg strength: Pink, round, embossed tablets with ‘T’ logo engraved on one side and ‘200’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1 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 ADMINISTRATIO Aqra d-dokument sħiħ