| Asacol® Suppositories 250 mg & 500 mg |
| Asacol Suppositories contain 250 or 500 mg mesalazine per suppository. |
| Opaque, beige suppositories, containing 250 mg or 500 mg mesalazine. |
The suppositories are particularly appropriate in patients with distal disease.
For the maintenance of remission of ulcerative colitis.
| ADULTS: Suppositories 250 mg: Three to six suppositories a day in divided doses, with the last dose at bedtime. Suppositories 500 mg: A maximum of three suppositories a day in divided doses, with the last dose at bedtime. ELDERLY: The normal adult dosage may be used unless renal function is impaired (see section 4.4). CHILDREN: There is no dosage recommendation. |
| A history of sensitivity to salicylates or renal sensitivity to sulphasalazine. Confirmed severe renal impairment (GFR <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 (see section 4.3). 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. |
| Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions (see section 4.4) |
| No information is available with regard to teratogenicity; however, negligible quantities of mesalazine are transferred across the placenta and are excreted in breast milk following sulphasalazine therapy. Use of Asacol during pregnancy should be with caution, and only if the potential benefits are greater than the possible hazards. Asacol should, unless essential, be avoided by nursing mothers. |
| Not applicable. |
| 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. |
| There is no specific antidote. |
| 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. |
| There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. |
| Witepsol W45 (Hard Fat). |
| Not applicable. |
| Suppositories 250 mg: 4 years. Suppositories 500 mg: 3 years. |
| Store below 25°C. Protect from light. |
| Cartoned plastic moulds (OP), each containing 20 suppositories (250 mg) or 10 suppositories (500 mg). |
| For rectal administration. |
| Procter & Gamble Pharmaceuticals UK Ltd. Rusham Park Whitehall Lane Egham Surrey TW20 9NW United Kingdom |
| Asacol Suppositories 250 mg 00364/0075 Asacol Suppositories 500 mg 00364/0076 |
| Asacol Suppositories 250 mg 20.4.88/21.05.2002 Asacol Suppositories 500 mg 22.3.90/21.05.2002 |
| October 2002 |
| POM. |
Link to this document from your website: http://emc.medicines.org.uk/medicine/11571/SPC/Asacol Suppositories 250mg & 500mg
Dear Ms Henning
We have investigated your complaint and as per the discussion with our COO this afternoon we can advise as follows:
Asacol suppositories requires a motivation from your doctor as our protocols do not automatically allow for the approval of Asacol suppositories in your condition. We have e-mailed you, as well as your doctor a copy of the letter from Medicine Management today, indicating the motivation request. We can further advise that we are trying to contact your doctor in order to obtain the required motivation, and will provide you with feedback once we are able to speak to him.
We would like to note that to date the doctor has not yet completed the application form as sent to him by yourself and the authorisation process thus far was done on the basis of receiving the prescription and application form.
We trust you find the above in order.
Kind Regards
Yvonne Govender
Special Cases & Clinical Support
Medshield Medical Scheme Administration
Fax: 011 399 2466
Email:
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