Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydroxychloroquine sulfate
A A H Pharmaceuticals Ltd
P01BA02
Hydroxychloroquine sulfate
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5025903008910
SmPC fragment 1. NAME OF THE MEDICINAL PRODUCT Hydroxychloroquine Sulfate 200mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hydroxychloroquine Sulfate 200mg Film-coated Tablet: Each film- coated tablet contains Hydroxychloroquine Sulfate 200mg 3. PHARMACEUTICAL FORM Film - coated tablet. White, approximately 9.5mm circular, biconvex, film-coated tablets debossed with 200 on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight. _Paediatric population_ Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly) The minimum effective dose should be employed. This dose should not exceed 6.5mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200mg or 400mg per day. In patients able to receive 400mg daily: Initially 400mg daily in divided doses. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 400mg daily if the response lessens. Paediatric population The minimum effective dose should be employed and should not exceed 6.5mg/kg/day based on ideal body weight. The 200mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg. Each dose should be taken with a meal or glass of milk Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light. The tablets are for oral administration. 4.3 CONTRAINDICATIONS - known hypersensitivity to 4-aminoquinolin Lesen Sie das vollständige Dokument