ASACOLON Gastro-resistant tablet Ref.[50879] 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 800mg Gastro-resistant Tablets.

Pharmaceutical Form

Gastro-resistant tablet.

The tablets are reddish to brownish and oblong-shaped.

Qualitative and quantitative composition

Each gastro resistant tablet contains: 800mg mesalazine.

Excipient with known effect: 152.8mg lactose, see section 4.4.

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

Lactose monohydrate
Sodium starch glycolate
Magnesium stearate (E572)
Talc (E553b)
Povidone

Film Coating:

Methacrylic acid-methyl methacrylate copolymer (1:2)
Talc
Triethyl citrate
Yellow pigment (ferric oxide) (E172)
Macrogol 6000
Red pigment (ferric oxide) (E172)

Pack sizes and marketing

Blister strips of aluminium foil and PVC, and outer cardboard carton containing 90 tablets per pack.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA2018/001/002

Date of first authorisation: 07 February 2003
Date of last renewal: 07 February 2008

Drugs

Drug Countries
ASACOLON Ireland, Malta

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