Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
sodium valproate, Quantity: 500 mg
Sanofi-Aventis Australia Pty Ltd
Sodium valproate
Tablet, enteric coated
Excipient Ingredients: citric acid monohydrate; hypromellose; polyvinyl acetate phthalate; diethyl phthalate; purified talc; hyprolose; titanium dioxide; povidone; magnesium stearate; amaranth aluminium lake; calcium silicate; indigo carmine aluminium lake; stearic acid; macrogol 6000
Oral
20 tablets, 100 tablets, 10 tablets
(S4) Prescription Only Medicine
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. Mania: For the treatment of mania where other therapy has proved inadequate or is inappropriate
Visual Identification: Circular biconvex enteric coated tablet with a lilac matt finish; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2017-07-11
VALPRO EC V a l p r o E C 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 VALPRO EC? Valpro EC contains the active ingredient sodium valproate. Valpro EC is used to treat epilepsy in adults and children. For more information, see Section 1. Why am I using Valpro EC? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VALPRO EC? Do not use if you have ever had an allergic reaction to Valpro EC or any of the ingredients listed at the end of the CMI. 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 Valpro EC? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Valpro EC 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 VALPRO EC? • 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 instructions can be found in Section 4. How do I use Valpro EC? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VALPRO EC? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Valpro EC. • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine. • If you become pregnant while you are taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly or lower the dosage, without checking with your doctor. • Do not take more than the recommended dose unless your doctor tells you to. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how Valpro EC affects you. • Children should not ride a bike, climb Lees het volledige document
valpro-ec-ccdsv31-34-35-piv12-30aug22 Page 1 of 36 AUSTRALIAN PRODUCT INFORMATION VALPRO ® EC200, VALPRO ® EC500 (SODIUM VALPROATE) ENTERIC-COATED TABLETS 1 NAME OF THE MEDICINE Sodium valproate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Enteric-coated tablets, Sodium valproate 200 mg. Enteric-coated tablets, Sodium valproate 500 mg. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Tablets, 200 mg (lilac, enteric-coated) Tablets, 500 mg (lilac enteric-coated) 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. _MANIA _ For the treatment of mania where other therapy has proved inadequate or is inappropriate. 4.2 DOSE AND METHOD OF ADMINISTRATION Valpro EC tablets may be given twice daily. Valpro EC should preferably be taken with or after food: the enteric-coated tablet (lilac) must be swallowed whole, if necessary with a little water. Valpro EC 500 mg enteric-coated tablets are recommended for patients requiring high doses. valpro-ec-ccdsv31-34-35-piv12-30aug22 Page 2 of 36 Valpro EC may take several days to show an initial effect and in some cases may take from 2 to 6 weeks to exhibit its maximum effect. _EPILEPSY _ Monotherapy Usual requirements are as follows: Adults Dosage should start with 600 mg daily increasing by 200 mg/day at three-day intervals until control is achieved. This is generally within the range 1,000 to 2,000 mg/day, (i.e. 20 to 30 mg/kg/day). Where adequate control is not achieved within this range the dose may be further increased to 2,500 mg/day. Children > 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 to 30 mg/kg/day. Children < 20 kg 20 mg/kg/day: in severe cases this may be increased but only in patients in whom plasma valproic acid levels can be Lees het volledige document