Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
sodium valproate, Quantity: 200 mg
Arrotex Pharmaceuticals Pty Ltd
Sodium valproate
Tablet, enteric coated
Excipient Ingredients: purified talc; triethyl citrate; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; povidone; magnesium stearate; citric acid; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; indigo carmine; sunset yellow FCF; allura red AC; polyvinyl alcohol; macrogol 3350; xanthan gum; lecithin
Oral
100 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: Round, purple, coated, biconvex tablet, approximately 9.7 mm in diameter; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-06-30
VALPREASE ® 1 VALPREASE _Sodium Valproate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Valprease. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of your taking Valprease against the benefits they expect it will have for you. PLEASE READ THIS LEAFLET VERY CAREFULLY BEFORE YOU START TO TAKE YOUR VALPREASE, EVEN IF YOU HAVE episodes of overactivity, elation or irritability. Valprease may be used alone or in combination with other medicines to treat your condition. Your doctor, however, may have prescribed Valprease for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Valprease is addictive. This medicine is available only with a doctor's prescription. • known or suspected of having a genetic problem causing a mitochondrial disorder. • you are pregnant, unless your doctor has determined no alternative treatment works for you. If you are a girl or woman of childbearing age, you must not take Valprease unless you use an effective method of birth control (contraception) at all times during your treatment with Valprease. Do not stop taking Valprease or your contraception until you have discussed this with your doctor. Your doctor will advise you further (see TAKEN VALPREASE BEFORE. 'Before you start to take it'). IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VALPREASE IS USED FOR Valprease is a medicine used to for the treatment of epilepsy in adults and children. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Valprease belongs to a group of medicines called anticonvulsants. These medicines are thought to work by controlling brain chemica Lees het volledige document
1 AUSTRALIAN PRODUCT INFORMATION – VALPREASE (SODIUM VALPROATE) ENTERIC COATED TABLETS 1 NAME OF THE MEDICINE Sodium valproate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Valprease tablets come in two strengths and contain either 200 mg or 500 mg of sodium valproate. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM VALPREASE 200 A purple, round, coated, biconvex tablet, approximately 9.7 mm in diameter. VALPREASE 500 A purple, round, coated, biconvex tablet, approximately 13 mm in diameter. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE AND METHOD OF ADMINISTRATION Valprease tablets may be given twice daily. Valprease tablets should preferably be taken with or after food; it must be swallowed whole, if necessary with a little water. Valprease 500 mg enteric coated is recommended for patients requiring high dosages. Valprease may take several days to show an initial effect and in some cases may take from two to six 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. 2 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 monitored. Above 40 mg/kg/day, clinical chemistr Lees het volledige document