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

Product name and form

Asacolon 1000 mg Suppository.

Pharmaceutical Form

Suppository.

Light beige coloured, torpedo-shaped suppositories dimension of 33 × 11 mm.

Qualitative and quantitative composition

Each suppository contains 1000 mg mesalazine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mesalazine

Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, but appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

List of Excipients

Hard fat

Pack sizes and marketing

Container (strip): PVC/polyethylene film.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Tillotts Pharma GmbH, Warmbacher Strasse 80, DE- 79618 Rheinfelden, Germany

Marketing authorization dates and numbers

PA2018/005/001

Date of first authorisation: 29th January 2021

Drugs

Drug Countries
ASACOLON Ireland, Malta

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