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Indications - Mesalazine is indicated for Treatment of mild to moderately active Ulcerative Colitis & & Crohn’s Disease Maintenance of remission of Ulcerative Colitis Maintenance of remission of Crohn’s disease

Dosage & Administration - Dosage Ulcerative colitis- Adults: Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses. Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily. Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose). Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose). It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg. Administration The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.

Side Effects - The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

Contraindications - Hypersensitivity to salicylates or to any other component of the formulation.

Others - Pregnancy & Lactation It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.