PENTASA Suppository Ref.[6972] Active ingredients: Mesalazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Ferring Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

Product name and form

Pentasa 1g Suppositories.

Pharmaceutical Form

Suppository.

White to tan, spotted, oblong suppository.

Qualitative and quantitative composition

Each suppository contains mesalazine 1g.

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

Povidone
Macrogol 6000
Magnesium stearate
Talc

Pack sizes and marketing

Each suppository is individually packed in double aluminium foil and presented in cartons of 28 suppositories.

Marketing authorization holder

Ferring Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1009/006/002

Date of first authorisation: 21 December 1992
Date of last renewal: 21 December 2007

Drugs

Drug Countries
PENTASA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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