Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
OLSALAZINE SODIUM
Atnahs Pharma UK Limited
A07EC; A07EC03
OLSALAZINE SODIUM
500 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; olsalazine
Marketed
2014-09-26
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Прочетете целия документ