Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium valproate
Sanofi
N03AG01
Sodium valproate
40mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 5013417101173
Découpe 303429 - 429 1 PACKAGE LEAFLET: INFORMATION FOR THE USER EPILIM 200MG/5ML LIQUID sodium valproate IS THIS LEAFL ET HARD TO SEE OR READ? PHONE 0845 372 7101 FOR HELP ▼ This medicine is subject to additional monitoring. This will allow quick identifi cation of new safety information. You can help by reporting any side eff ects you may get. See the end of section 4 for how to report side eff ects. WARNING EPILIM LIQUID, SODIUM VALPROATE, CAN SERIOUSLY HARM AN UNBORN BABY WHEN TAKEN DURING PREGNANCY. IF YOU ARE A FEMALE ABLE TO HAVE A BABY YOU SHOULD USE AN EFF ECTIVE METHOD OF BIRTH CONTROL (CONTRACEPTION) WITHOUT INTERRUPTION DURING YOUR ENTIRE TREATMENT WITH EPILIM LIQUID. YOUR DOCTOR WILL DISCUSS THIS WITH YOU BUT YOU MUST ALSO FOLLOW THE ADVICE IN SECTION 2 OF THIS LEAFL ET. SCHEDULE AN URGENT APPOINTMENT WITH YOUR DOCTOR IF YOU WANT TO BECOME PREGNANT OR IF YOU THINK YOU ARE PREGNANT. DO NOT STOP TAKING EPILIM LIQUID UNLESS YOUR DOCTOR TELLS YOU TO AS YOUR CONDITION MAY BECOME WORSE. IF YOU ARE A PARENT OR CAREGIVER OF A FEMALE CHILD TREATED WITH EPILIM LIQUID, YOU MUST ALSO READ SECTION 2 OF THIS LEAFL ET CAREFULLY AND CONTACT YOUR CHILD’S DOCTOR ONCE THEY EXPERIENCE THEIR FI RST PERIOD. READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. You may need to read it again • If you have any 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 eff ects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET 1. What Epilim Liquid is and what it is used for 2. What you need to know before you take Epilim Liquid 3. How to take Epilim Liquid 4. Possible side eff ects 5. How to store Epilim Liquid 6. Contents of the pack and other information 1. WHAT EPILIM LIQ Đọc toàn bộ tài liệu
OBJECT 1 EPILIM LIQUID Summary of Product Characteristics Updated 11-May-2018 | SANOFI 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 Liquid/Sodium Valproate 200 mg/5 ml Liquid 2. Qualitative and quantitative composition Each 5 ml of liquid contains Sodium Valproate 200.0 mg. 3. Pharmaceutical form Liquid 4. Clinical particulars 4.1 Therapeutic indications In the treatment of generalised, partial or other epilepsy. 4.2 Posology and method of administration Epilim Liquid is for oral administration. Daily dosage requirements vary according to age and body weight. Epilim Liquid may be given twice daily. Epilim Liquid should not be diluted. In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other Epilim conventional or prolonged release formulations on an equivalent daily dosage basis. _Dosage_ Usual requirements are as follows: Adults Dosage should start at 600 mg daily increasing by 200 mg at three-day intervals until control is achieved. This is generally within the dosage range 1000 mg – 2000 mg per day, i.e. 20 – 30 mg/kg/day body weight. Where adequate control is not achieved within this range the dose may be further increased to 2500 mg per day. Children over 20 kg Initial dosage should be 400 mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20 – 30 mg/kg body weight per day. Where adequate control is not achieved within this range the dose may be increased to 35 mg/kg body weight per day. Children under 20 kg 20 mg/kg of body weight per day; in severe cases this may be increased but only in patients in whom plasma valproic acid levels can be monitored. Above 40 mg/kg/day, clinical chemistry and haematological parameters should be monitored. Us Đọc toàn bộ tài liệu