Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Tillotts Pharma GmbH, Warmbacher Strasse 80, DE- 79618 Rheinfelden, Germany
Asacolon is indicated in adults, children above 6 years and adolescents:
For the treatment of mild to moderate acute ulcerative colitis. For the maintenance of remission of ulcerative colitis.
For the maintenance of surgically-induced remission of Crohn’s Disease.
Induction of remission: 2.4 g (3 tablets) per day once daily or in divided doses. If required the dose may be increased to 4.8 g (6 tablets) per day in divided doses. Above 2.4 g daily in divided doses only. The dosage can be adjusted in accordance with the response to the treatment.
Maintenance of remission: 1.6 to 2.4 g (2 to 3 tablets) per day once daily or in divided doses.
Maintenance of remission: 2.4 g (3 tablets) per day once daily or in divided doses.
The normal adult dose can be taken unless liver or renal function is severely impaired (see section 4.3 and 4.4). No studies have been carried out in older people.
There is only limited documentation for an effect in children (age 6-18 years).
Oral.
The tablets must be swallowed whole preferably with some liquid before food intake.
They must not be chewed, crushed or broken before swallowing.
If one or more doses have been missed, the next dose is to be taken as usual.
There is little data on overdose (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive.
3 years.
Do not store above 25ºC.
Store in the original package in order to protect from moisture.
Blister strips of aluminium foil and PVC, and outer cardboard carton containing 90 tablets per pack.
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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