Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sulfadiazine
Waymade Healthcare Plc
J01EC02
Sulfadiazine
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010800
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends • Removed pre-print L.I.No. from front side (pg1/2) PACKAGE LEAFLET: INFORMATION FOR THE USER SULFADIAZINE 500MG TABLETS SULFADIAZINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Sulfadiazine 500mg Tablets. In the rest of this leaflet it is called Sulfadiazine Tablets. IN THIS LEAFLET: 1. What Sulfadiazine Tablets are and what they are used for 2. Before you take Sulfadiazine Tablets 3. How to take Sulfadiazine Tablets 4. Possible side effects 5. How to store Sulfadiazine Tablets 6. Further information 1. WHAT SULFADIAZINE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Sulfadiazine Tablets is sulfadiazine, which belongs to a group of medicines called sulphonamides. These are antibiotics that work by preventing the growth and multiplication of bacteria that cause infections. Sulfadiazine Tablets are used in the treatment of a wide range of infections including food poisoning and meningitis. 2. BEFORE YOU TAKE SULFADIAZINE TABLETS DO NOT TAKE SULFADIAZINE TABLETS IF YOU: • are allergic to sulfadiazine or sulphonamides or any of the other ingredients contained in Sulfadiazine Tablets (see list under heading ‘What Sulfadiazine Tablets contain’ in section 6) • have a kind of meningitis caused by meningococcus bacteria unless your doctor decides it is appropriate • suffer from severe liver or kidney problems • have jaundice (yellowing of the skin and/or whites of the eyes) or blood Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sulfadiazine 500mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sulfadiazine BP 500mg 3 PHARMACEUTICAL FORM Tablet Sulfadiazine tablets are plain white, biconvex tablets, with CP on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sulfadiazine is a short-acting sulphonamide with bacteriostatic activity against a broad spectrum of organisms. _Gram-positive _- particularly group _A Streptococci _and some strains of _Streptococcus pneumoniae, Bacillus ant hracis, Nocardia _(especially _N.asteroides) _and, to a lesser extent, _Staphylococci _and _Clostridium _ _perfringens. _ _ _ _Gram-negative _- _Haemophilus influenzae _and _H.ducreyi _are often sensitive, sensitivity varies among the _enterobacteriae-Escherichia _coli, _Klebsiella, _ _proteus, Salmonella _and _Serratia _and _Vibrio cholerae _are sometimes sensitive. Other organisms reported to be sensitive include, _Actinomyces spP., Brucella, _ _Calymmatobacterium granulomatis, Legionella, Yersinia pestis, Chlamydia, _ _Pseudomonas pseudomallei. _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Adults and elderly _ The initial dose is usually 2-4 grams followed by a maintenance dose of up to 4 grams daily in divided doses for a maximum of seven days. Dosage reduction may be necessary in renal impairment. _Children _ Initially 75mg/kg, followed by a maintenance dose of 150mg/kg daily in divided doses. Maximum of 6 grams daily. Sulphonamides should not be used for initial treatment of meningococcal meningitis although oral Sulfadiazine may be substituted for parenteral penicillin once susceptibility to sulphonamides has been established. 4.3 CONTRAINDICATIONS Known hypersensitivity to any sulphonamide. Severe renal or hepatic failure. Acute porphyria. Jaundice or blood disorders. Neonates _ _ Concomitant use with clozapine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution in elderly, renal or hepatic impairment_ _and jaundice. Use with caution in patients Read the complete document