Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
HYDROXYCHLOROQUINE SULPHATE
Clear Pharmacy
P01BA02
HYDROXYCHLOROQUINE SULPHATE
200 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Aminoquinolines
Authorised
2011-06-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Plaquenil 200mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg hydroxychloroquine sulphate. Excipient: lactose monohydrate 35.25mg per tablet. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from the UK:_ White, round, film-coated tablets with HCQ on one side and 200 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plaquenil tablets are recommended for the treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Plaquenil tablets are for oral administration. 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. 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. The 400mg tablet should not be used in adults with an ideal body weight of less than 62kg. Children: 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 35kg IRISH MEDICINES BOARD ___________________________ Soma hati kamili