ASACOLON Suppository Ref.[50882] Active ingredients: Mesalazine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Tillotts Pharma GmbH, Warmbacher Strasse 80, DE- 79618 Rheinfelden, Germany

4.1. Therapeutic indications

Treatment of acute mild to moderate ulcerative colitis limited to the rectum (ulcerative proctitis).

4.2. Posology and method of administration

Posology

Adults and older people

One Mesalazine 1000 mg Suppository once daily (equivalent to 1000 mg mesalazine daily) inserted into the rectum.

Paediatric population

There is little experience and only limited documentation for an effect in children.

Method of administration

For rectal administration only.

Asacolon 1000 mg Suppositories should be administered preferably at bedtime.

Treatment with Asacolon 1000 mg Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.

Duration of treatment

The duration of use is determined by the physician.

4.9. Overdose

There are rare data on overdosage (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.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store in the original container in order to protect contents from light.

Do not store above 30°C.

6.5. Nature and contents of container

Container (strip): PVC/polyethylene film.

Package sizes: 10, 20, 30, 60, 90.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.