देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dapsone
Accord-UK Ltd
J04BA02
Dapsone
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011000; GTIN: 5012617005571
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Dapsone, Tablets, 50mg, 100mg, 28s - UK 148x210 (Reel Fed) 51017443 Leaflet for Blisters 8213 RH 17-11-22 * 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. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com DAPSONE ALL STRENGTHS TABLET PIL - UK Black Profile BBBB6113 G. Worth 06/12/2022 08/12/2022 G. Worth 148x210 7.5pt Accord Barnstaple N/A N/A 4 Version 8 15.11.2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAPSONE 50MG AND 100MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT DAPSONE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAPSONE TABLETS 3 HOW TO TAKE DAPSONE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE DAPSONE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT DAPSONE TABLETS ARE AND WHAT THEY ARE USED FOR Dapsone belongs to a group of medicines called antibacterials. It works by stopping the production of folic acid in certain bacteria, therefore stopping them growing. Dapsone tablets may be used for: • lepro पूरा दस्तावेज़ पढ़ें
1 NAME OF THE MEDICINAL PRODUCT DAPSONE TABLETS BP 50mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Dapsone PhEur. Excipients with known effect: Each film-coated tablet contains 7.43 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White uncoated tablets. White, circular, biconvex uncoated tablets impressed "C" on one face and the identifying letters "DP" on either side of a central division line on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) As part of a multi-drug regimen in the treatment of all forms of leprosy. 2) Treatment of dermatitis herpetiformis and other dermatoses. 3) Prophylaxis of malaria in combination with pyrimethamine. 4) Prophylaxis of Pneumocystis carinii pneumonia in immunodeficient subjects, especially AIDS patients. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _Adults and children over 12 years:_ _Multibacillary leprosy (3-drug regimen):_ 100mg daily for at least two years. _Paucibacillary leprosy (2-drug regimen):_ 100mg daily for at least six months. _Malaria prophylaxis:_ 100mg weekly with 12.5mg pyrimethamine. _Dermatitis herpetiformis:_ Initially 50mg daily, gradually increased to 300mg daily if required. Once lesions have begun to subside, the dose should be reduced to a minimum as soon as possible, usually 25-50mg daily, which may be continued for a number of years. Maintenance dosage can often be reduced in patients receiving a gluten-free diet. _Pneumocystis carinii pneumonia:_ In combination with trimethoprim, 50-100mg daily; 100mg twice weekly or 200mg once weekly. _ _ _Children 6-12 years:_ _Multibacillary leprosy (3-drug regimen):_ 50mg daily for at least two years. _Paucibacillary leprosy (2-drug regimen):_ 50mg daily for at least six months. _ _ _Elderly: _ Dosage should be reduced in the elderly where there is an impairment of hepatic function. _Method of Administration _ For oral administration. 4.3 CONTRAINDICATIONS Known hypersensitivity to sulfonamides, sulfones, or पूरा दस्तावेज़ पढ़ें