Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SULFASALAZINE
B & S Healthcare
500 Milligram
Tablets Gastro-Resistant
2010-01-25
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. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet _Product imported from the Italy:_ 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. IRISH MEDICINES BOARD ________________________ Read the complete document