ASACOL

Swallow whole with water. Do not break, crush or chew the tablets before swallowing.

ADULTS:

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

Maintenance therapy:

Three to six tablets once daily or in divided doses. 4).

CHILDREN:

There is no dosage recommendation.

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, Intracranial hypertension, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, pleurisy, lupus erythematosus-like reactions and rash (including urticaria), drug fever, interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal, nephrolithiasis*.

Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment. 4 for further information Mesalazine may very rarely be associated with an exacerbation of the symptoms of colitis, Stevens Johnson syndrome and erythema multiforme.

4) (frequency unknown). Other side effects observed with sulphasalazine such as depression of sperm count and function, have not been reported with ‘Asacol’. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

1. 3 PHARMACEUTICAL FORM Red-brown, oblong, modified release tablets. 1 Therapeutic indications 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.

2 Posology and method of administration Swallow whole with water. Do not break, crush or chew the tablets before swallowing.

ADULTS:

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

Maintenance therapy:

Three to six tablets once daily or in divided doses. 4).

CHILDREN:

There is no dosage recommendation. 3 Contraindications 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. 4 Special warnings and precautions for use Use in the elderly should be cautious and subject to patients having normal renal function.

g. in toilets cleaned with sodium hypochlorite contained in certain bleaches). 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.

3). 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.

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.