There is no specific antidote.
3 years
Not applicable.
Witepsol W45 (Hard Fat).
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), 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.
Rarely, local irritation may occur after administration of rectal dosage forms containing mesalazine.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Mesalazine is one of the two components of sulphasalazine, the other being sulphapyridine. It is the latter which is responsible for the majority of the side effects associated with sulphasalazine therapy whilst mesalazine is known to be the active moiety in the treatment of ulcerative colitis. Asacol consists only of this active component which is delivered directly by the suppositories.
The suppository is designed to deliver mesalazine directly to the proposed site of action in the distal bowel.
February 2016
Allergan Pharmaceuticals International Limited
Clonshaugh Industrial Estate
Coolock
Dublin 17
Ireland
Store below 25°C. Protect from light.
Cartoned plastic moulds (OP), each containing 20 suppositories.
PL 45496/0003
Not applicable.
For rectal administration.
20th April 1988 / 21st May 2002
