देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dapsone
Waymade Healthcare Plc
J04BA02
Dapsone
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011000
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Dapsone Tablets 50mg, 100mg x 28’s (UK) 148x210 (Reel Fed) 50971382 Leaflet for Blisters 2438 T. Hull 26/06/19 * 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 UK-Eire-Artwork-Support@accord-healthcare.com 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. FMD info NA (not a carton) No Yes Details DAPSONE ALL STRENGTHS TABLET PIL - UK Black Text safe BBBA5364 G. Worth 27/06/2019 07/08/2019 G. Worth 148 x 210 7.5 pt Accord Barnstaple n/a n/a 3 Version 2 01.11.2017 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. INDEX 1 WHAT DAPSONE TABLETS ARE AND WHAT THEY ARE USED FOR 2 BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 FURTHER 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 may be used for: • leprosy • skin problems • the prevention of malaria in combination with pyrimethamine • the prevention of pneumonia in immunodeficient patients, especially in AIDS patients. 2 BEFORE YOU TAKE DO NOT TAKE Dapsone tablets and TELL your doctor if you: • are ALLERGIC (hypersensitive) to dapsone, any of the other ingredients in the tablet, or to simila पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dapsone 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dapsone BP 100mg 3 PHARMACEUTICAL FORM Dapsone tablets are presented as a white normal convex tablet with a breakline scored on one side. 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 Hypersensitivity to Dapsone. Known hypersensitivity to sulphonamides, sulphones, or any of the excipients. Patients intolerant of frusemide, thiazide diuretics, sulphonylureas or carbonic anhydrase inhibitors may also be intolerant of this medication. Severe anaemia. _Acute _ porphyria पूरा दस्तावेज़ पढ़ें