Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
VALPROATE SODIUM
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
N03AG01
VALPROATE SODIUM 300 mg
PROLONGED-RELEASE TABLET
VALPROATE SODIUM 300 mg
POM
ANTIEPILEPTICS
Withdrawn
2006-01-18
1 PACKAGING ADMINISTRATION : SANOFI AMBARÈS - FRANCE LIBELLÉ : NOT EPILIM CHR CP DC RL GB ITEM CODE 555731 CREATION DATE 03/06/2014 COUNTRY GRANDE BRETAGNE CODE LAETUS 1068 BASED ON 529153 BY D. PAPON FORMAT 170X210 DC COLOR 2 ARTICLE NOTICE DC MODIFICATION DATE 12/02/2015 BRAND MARK LOGO ........... FONTS OCEAN SANS PRO SAN PROFF N° 10 BY I. SOURBE COUBTRY REQUIREMENT CRGB - V1 – 05 /2012 FONT SIZE 8 PT THIS ARTWORK PROOF INDICATES COLOUR POSITION ONLY. PLEASE REFER TO PANTONE COLOUR FORMULA USED COLOR PRINTABLE: NO PRINTABLE COLOR: PANTONE REFLEX BLUE ET PANTONE BLACK-> TRIANGLE PLAN PACKAGE LEAFLET: INFORMATION FOR THE USER EPILIM® CHRONO 200MG, 300MG AND 500MG CONTROLLED RELEASE TABLETS sodium valproate IS THIS LEAFLET HARD TO SEE OR READ? PHONE 0845 372 7101 FOR HELP This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects 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 further questions, please 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 you get any side effects, talk to your doctor or pharma- cist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Epilim Chrono is and what it is used for 2. What you need to know before you take Epilim Chrono 3. How to take Epilim Chrono 4. Possible side effects 5. How to store Epilim Chrono 6. Co Đọc toàn bộ tài liệu
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS _▼_ _ _This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Epilim Chrono 300 Controlled Release 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Constituents Each tablet contains 199.8mg Sodium Valproate and 87.0mg Valproic Acid equivalent to 300mg sodium valproate. 3. PHARMACEUTICAL FORM Prolonged Release Tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of generalised, partial or other epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epilim Chrono Controlled Release Tablets are for oral administration. Epilim Chrono is a prolonged release formulation of Epilim which reduces peak concentration and ensures more even plasma concentrations throughout the day. Epilim Chrono may be given once or twice daily. The tablets should be swallowed whole and not crushed or chewed. Daily dosage requirements vary according to age and body weight. In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other conventional or prolonged release formulations on an equivalent daily dosage basis. _ _ _Dosage _ Usual requirements are as follows: Adults Dosage should start at 600mg daily increasing by 200mg at three-day intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day, ie 20- 30mg/kg/day body weight. Where adequate control is not achieved within this range the dose may be further increased to 2500mg per day. Page 2 of 17 Children over 20kg Initial dosage should be 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20-30mg/kg body weight per day. Where adequate control is not achieved within this range the dose may be increased to 35mg/kg body weight per day. Đọc toàn bộ tài liệu