Salicylates.

Mesalazine

Asacol 400mg MR Tablets - Modified ReleaseTablets - Red-brown, oblong tablets marked 'PG 400'. Asacol 800mg MR Tablets - Modified ReleaseTablets - Red-brown, oblong tablets marked 'PG 800'.

Asacol 400mg MR Tablets - 400 mg mesalazine (5-aminosalicylic acid) per tablet. Asacol 800mg MR tablets - Each tablet contains 800 mg of mesalazine (active substance) and 152.75 mg of lactose monohydrate (excipient).

Ulcerative Colitis:- For the treatment of mild to moderate acute exacerbations. For the maintenance of remission. Crohn's ileo-colitis: - For the maintenance of remission.

Oral: Acute disease: Six tablets a day in divided doses, with concomitant corticosteroid therapy where clinically indicated. Maintenance therapy: Three to six tablets a day in divided doses.

There is no dosage recommendation.

The normal adult dosage may be used unless renal function is impaired (See Special Precautions).

A history of sensitivity to salicylates or renal sensitivity to sulphasalazine. Confirmed severe renal impairment (GFR less than 20 ml/min). Children under 2 years of age.

Use in the elderly should be cautious and subject to patients having normal renal function.

Renal disorder: Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N-acetyl-5-aminosalicylic acid. In rats, large doses of mesalazine injected intravenously produce tubular and glomerular toxicity. Asacol should be used with extreme caution in patients with confirmed mild to moderate renal impairment. Patients on mesalazine should have renal function monitored, (with serum creatinine levels measured) prior to treatment start. Renal function should then be monitored periodically during treatment, for example every 3 months for the first year, then 6 monthly for the next 4 years and annually thereafter, based on individual patient history. Physicians should take into account risk factors such as prior and concomitant medications, duration and severity of disease and concurrent illnesses. Treatment with mesalazine should be discontinued if renal function deteriorates. If dehydration develops, normal electrolyte and fluid balance should be restored as soon as possible.

Serious blood dyscrasias have been reported very rarely with mesalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasia.

'Asacol' Tablets should not be given with lactulose or similar preparations, which lower stool pH and may prevent release of mesalazine.

Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions

The side effects are predominantly gastrointestinal, including nausea, diarrhoea and abdominal pain. Headache has also been reported.

There have been rare reports of leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, alopecia, peripheral neuropathy, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, lupus erythematosus-like reactions and rash (including urticaria), drug fever, interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal. Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

Mesalazine may very rarely be associated with an exacerbation of the symptoms of colitis, Stevens Johnson syndrome and erythema multiforme.

Other side effects observed with sulphasalazine such as depression of sperm count and function, have not been reported with 'Asacol'.

Procter & Gamble

(POM)

08 June 2009