Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sulfasalazine
Alliance Healthcare (Distribution) Ltd
A07EC01
Sulfasalazine
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01050100
SALAZOPYRIN EN-TABS 500MG TABLETS (sulfasalazine) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE 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. * If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your medicine is called Salazopyrin EN-tabs 500mg Tablets but will be called Salazopyrin EN-tabs throughout this leaflet. IN THIS LEAFLET: What Salazopyrin EN-tabs are and what they are used for Before you take Salazopyrin EN-tabs How to take Salazopyrin EN-tabs Possible side effects How to store Salazopyrin EN-tabs Further information WHAT SALAZOPYRIN EN-TABS ARE AND WHAT THEY ARE USED FOR The active substance in Salazopyrin EN-tabs is sulfasalazine which is an anti-inflammatory drug and belongs to a group of medicines called aminosalicylates. Your doctor may give you Salazopyrin EN-tabs to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis. INFLAMMATORY BOWEL DISEASE The main forms of inflammatory bowel disease are Ulcerative Colitis and Crohn’s disease. Although the diseases have some features in common, there are some important differences. Ulcerative Colitis is an inflammatory disease which affects only the large bowel (colon and back passage). The lining of the bowel becomes inflamed (red and swollen) and symptoms include abdominal pain and diarrhoea (which may contain blood and mucus). Salazopyrin EN-tabs are used to control the flare-ups of ulcerative colitis. They may also be used at lower doses to prevent more flare-ups of ulcerative colitis. Crohn’s disease is an inflammatory disease which may affect any part of the digestive system from the mouth to the anus, but it most commonly affects the last part of the small bowel and the first par Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SULAZINE EC Sulfasalazine 500 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500.00 mg Sulfasalazine For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant Tablets Oval-shaped, orange, bi-convex tablets engraved ‘SULAZINE EC’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Induction and maintenance of remission of ulcerative colitis; treatment of active Crohn’s disease 2. Treatment of rheumatoid arthritis which has failed to respond to non- steroidal anti-inflammatory drugs (NSAIDs) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gastro-resistant tablets should be used where there is gastro-intestinal intolerance of plain tablets. They should not be crushed or broken. The dose is adjusted according to the severity of the disease and the patient’s tolerance to the drug, as detailed below. 1. Ulcerative colitis: Adults and Elderly: • _Severe attacks: _ 2-4 tablets four times a day, which may be given in conjunction with steroids as part of an intensive management regime. Rapid passage of the tablets may reduce the effect of the drug. Night-time interval between doses should not exceed 8 hours. When remission occurs, maintenance therapy should be commenced. • _Moderate attacks: _ 2-4 tablets four times a day may be given in conjunction with steroids • _Mild attacks: _ 2 tablets four times a day with or without steroids • _Maintenance therapy: _ With induction of remission gradually reduce dose to 4 tablets per day. The dosage should be continued indefinitely to avoid relapse, since discontinuation even several years after an acute attack is associated with a four-fold increase in risk of relapse. Children over 2 years: Adjust the dose in proportion to bodyweight • Acute attack or relapse: 40-60 mg/kg per day • Maintenance therapy: 20-30 mg/kg per day Sulfasalazine suspension may provide a more flexible dosage form. 2. Crohn’s disease In active Crohn Đọc toàn bộ tài liệu