Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Sodium valproate 40 mg/mL
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Sodium valproate 40 mg/mL
200 mg/5mL
Syrup
Active: Sodium valproate 40 mg/mL Excipient: Cherry flavour 17.40.0740 Ponceau 4R Purified water Saccharin sodium Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Sorbitol Sucrose
Bottle, glass, 300 mL
Prescription
Prescription
Sanofi Chimie
Epilepsy: Primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). Partial (focal) epilepsy either alone or as adjuvant therapy.
Package - Contents - Shelf Life: Bottle, glass, - 300 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 300 mL - 36 months from date of manufacture stored at or below 30°C
1977-10-11
Epilim® 1 EPILIM ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING EPILIM? Epilim contains the active ingredient sodium valproate. Epilim is used to treat epilepsy in adults and children and bipolar disorder in adults. For more information, see Section 1. Why am I using Epilim? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE EPILIM? Do not use if you have ever had an allergic reaction to Epilim or any of the ingredients listed at the end of the CMI. EPILIM CAN SERIOUSLY HARM AN UNBORN CHILD WHEN TAKEN DURING PREGNANCY. IF YOU ARE A FEMALE ABLE TO HAVE A BABY, YOU MUST USE AN EFFECTIVE METHOD OF BIRTH CONTROL (CONTRACEPTION) DURING YOUR ENTIRE TREATMENT WITH EPILIM. RISK OF PATERNAL EXPOSURE, RISK OF NEURODEVELOPMENT DISORDERS IN CHILDREN BORN TO MEN TREATED WITH VALPROATE CANNOT BE EXCLUDED. ENSURE THAT YOUR DOCTOR HAS ADVISED YOU OF THE RISKS, ALTERNATIVE TREATMENT OPTIONS, OR IF REMAINING ON EPILIM THE NEED FOR EFFECTIVE CONTRACEPTION. SCHEDULE AN URGENT APPOINTMENT WITH YOUR DOCTOR IF YOU WANT TO BECOME PREGNANT OR IF YOU THINK YOU BECAME PREGNANT. DO NOT STOP TAKING EPILIM UNLESS YOUR DOCTOR TELLS YOU TO, AS IT MAY BE DANGEROUS FOR YOU. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Epilim? in the full CMI and read the patient guide available electronically through QR code on the carton (www.sanofi.com.au/valproate) 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Epilim and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE EPILIM? • Your doctor will tell you how much to take. This may depend on your age, your condition and whether or not you are taking any other medicines. More in Läs hela dokumentet
epilim-ccdsv38-dsv28-24nov23 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Epilim 100 crushable tablet, 100 mg Epilim EC modified release tablet, 200 mg Epilim EC modified release tablet, 500 mg Epilim Syrup, 200 mg/5 mL Epilim Liquid oral solution (sugar free), 200mg/5mL 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Epilim 100 Crushable Tablets contain 100 mg sodium valproate. Epilim EC Modified Release Tablets contain 200 mg sodium valproate. Epilim EC Modified Release Tablets contain 500 mg sodium valproate. Epilim Syrup, each 5 mL of syrup contains 200 mg sodium valproate. Excipients of known effects: sucrose, saccharin sodium and sorbitol. Epilim Liquid Oral Solution (sugar free), each 5mL of liquid contains 200 mg sodium valproate. Excipients of known effects: saccharin sodium, sorbitol solution (70%) (non-crystallising), sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Crushable tablet, 100 mg (white, scored). Modified release tablet, 200 mg (lilac, enteric-coated). Modified release tablet, 500 mg (lilac enteric-coated). Syrup, 200 mg/5 mL (red, cherry flavoured). Oral solution sugar free liquid, 200 mg/5 mL (red, cherry flavoured) epilim-ccdsv38-dsv28-24nov23 Page 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _EPILEPSY _ Primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic- clonic grand mal seizures). Partial (focal) epilepsy either alone or as adjuvant therapy. In women of child bearing potential effective contraception must also be prescribed. _BIPOLAR DISORDER _ For the treatment of manic episodes, maintenance and prophylactic treatment of bipolar disorder when other treatments have failed. In women of child bearing potential effective contraception must also be prescribed. The safety and efficacy of sodium valproate for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years. 4.2 DOSE AND METHOD Läs hela dokumentet