PENTASA Prolonged release granules Ref.[50877] Active ingredients: Mesalazine

Source: Health Products Regulatory Authority (IE)  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 Sachet 2g prolonged-release granules.

Pharmaceutical Form

Prolonged release granules.

White-grey to pale white-brown granules.

Qualitative and quantitative composition

Each sachet contains mesalazine 2 g.

For a 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

Ethylcellulose
Povidone

Pack sizes and marketing

Polyester/Aluminium/LD polyethylene sachet.

Pack sizes: 1 × 60, 1 × 120, 1 × 10 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA1009/006/006

Date of first authorisation: 19th December 2007
Date of last renewal: 28th February 2011

Drugs

Drug Countries
PENTASA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, 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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