البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Sulfasalazine
Pfizer Healthcare Ireland
A07EC; A07EC01
Sulfasalazine
500 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; sulfasalazine
Marketed
1977-04-01
Page 1 of 8 2022-0082309 PACKAGE LEAFLET: INFORMATION FOR THE USER SALAZOPYRIN ® EN-TABS 500 MG Gastro-resistant tablets sulfasalazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Salazopyrin EN-tabs are and what they are used for 2. What you need to know before you take Salazopyrin EN-tabs 3. How to take Salazopyrin EN-tabs 4. Possible side effects 5. How to store Salazopyrin EN-tabs 6. Contents of the pack and other information 1. 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 inflammation caused by rheumatoid arthritis or 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 i اقرأ الوثيقة كاملة
Health Products Regulatory Authority 13 June 2023 CRN00DKZ7 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salazopyrin® EN Tabs 500 mg Gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of sulfasalazine Excipient with known effect: Salazopyrin En-Tabs 500mg contains 5 mg propylene glycol in each tablet. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet Orange/Yellow, oval-shaped tablets with ‘KPh’ imprinted on one side and ‘102’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Induction and maintenance of remission of ulcerative colitis; treatment of active Crohn’s disease. Treatment of rheumatoid arthritis which has failed to respond to non-steroidal and anti-inflammatory drugs (NSAIDs). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Salazopyrin EN-Tabs 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 of the drug, as detailed below. (a) Ulcerative Colitis ADULTS AND THE ELDERLY _Severe attacks_: 2 to 4 tablets, four times a day, 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. The night-time interval between doses should not exceed 8 hours. _Moderate attacks_: 2 to 4 tablets, four times per day may be given in conjunction with steroids. _Mild attacks_: 2 tablets, four times per day, may be taken with or without steroids. _Maintenance Therapy_: With induction of remission, reduce the dose gradually to 4 tablets per day. This dosage should be continued indefinitely, since discontinuance even several years after an acute attack is associated with a four-fold increase in relapse. PAEDIATRIC POPULATION The dose is reduced in proportion to body weight. _Acute attack or relapse_: 40-60 mg/kg/per day. _Maintenance Dosage_: 2 اقرأ الوثيقة كاملة