Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OLSALAZINE SODIUM
UCB Pharma Limited
500 Milligram
Tablets
2000-05-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dipentum 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg olsalazine sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A yellow capsule-shaped tablet debossed with ‘D500’ on one side and a score line on the other. The score line is only to faciiltate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild to moderate ulceration colitis with or without corticosteroids. The drug may also be used in the long-term maintenance of remission of ulcerative colitis. It is particularly useful where patients cannot tolerate sulphasalazine because of sulpha intolerance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Recommended dosage schedules To be taken in divided dose, with meals. Acute mild disease Adults including the elderly: Commence on 1 gram daily in divided doses depending on patient responses titrate dosage upwards to the maximum of 3 g daily over 1 week. Concomitant oral or rectal steroids may be used. In the event of drug related diarrhoea occurring, it may be transient. If it is not, the dose may be reduced; where diarrhoea continues despite this reduction the drug should be stopped. A single dose should not exceed 1 g Long-term maintenance _Adults including the elderly_: One tablet may be taken twice daily with food. _Children and infants_: No specific recommendations are made. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/09/2011_ _CRN 2100353_ _page number: 1_ 4.3 CONTRAINDICATIONS Patients hypersensitive to olsalazine or other salicylates or any of the ex Read the complete document