Therapeutic indications PENTASA indicated for the treatment of mild to moderate exacerbations of ulcerative colitis. For the maintenance of remission of ulcerative colitis. Contraindications PENTASA is contraindicated in: - patients with known hypersensitivity to mesalazine, salicylates or any of the excipients listed in section Undesirable effects The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash. Hypersensitivity reactions and drug fever may occasionally occur, and severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment .