Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydroxychloroquine sulfate
DE Pharmaceuticals
P01BA02
Hydroxychloroquine sulfate
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Hydroxychloroquine Sulfate Film-coated Tablets 200mg x 30, 60 (UK) 296x210 (Reel Fed) 50990014 Leaflet for Blisters 1921 T. Hull 27.03.2020 approved for print/date PROOF ROUND Technical Approval DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: NON PRINTING COLOURS COLOURS 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com G. Worth 31/03/2020 03/04/2020 G. Worth 296x210 9pt Accord Barnstaple n/a n/a HYDROXYCHLOROQUINE 200 MG FILM-COATED TABLETS PACK PIL - UNITED KINGDOM Black Profile BBBA7901 5 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. Version 7 12.02.2020 Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): page 4 page 1 50990014 BBBA7901 PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROXYCHLOROQUINE SULFATE 200MG FILM-COATED TABLETS • You notice yellowing of your skin or your eyes or your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis • Fits • Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue. TELL YOUR DOCTOR OR PHARMACIST IF ANY OF THE FOLLOWING SIDE EFFECTS GET SERIOUS OR LASTS LONGER THAN A FEW DAYS: Very common (affects more than 1 in 10 people) • Stomach pain • Feeling sick. Common (affects 1 to 10 people in a 100 people) • Skin rashes, itching • Being sick, diarrhoea • Loss of appetite (anorexia) • Headache • Changes in mood with uncontrollable laughing or crying. Uncommon (affects 1 to 10 people in a 1,000) • Changes in the colour of your skin or the inside of your nose or mouth • Hair loss or loss of hair colour • Feeling nervous • Ringing in the ear (tinnitus) • Balance Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydroxychloroquine Sulfate 200mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of hydroxychloroquine sulfate Excipient(s) with known effect Each tablet contains 35.5 mg of lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet White to off-white, plain, 9mm, round, biconvex, film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Hydroxychloroquine Sulfate Tablets are recommended for the 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 administ Les hele dokumentet