MESASAL Enteric-coated tablet Ref.[50305] Active ingredients: Mesalazine

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2022  Publisher: Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

Product name and form

MESASAL Mesalazine enteric-coated tablets.

Pharmaceutical Form

MESASAL 250 mg enteric-coated tablets are round, biconvex and tan coloured.

Qualitative and quantitative composition

Each enteric-coated tablet contains 250 mg of mesalazine as the active ingredient.

Excipients of known effect: contains 23.9 mg elemental sodium per 250 mg tablet.

For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.

Chemical structure

Chemical name: 5-amino-2-hydroxybenzoic acid

Molecular weight: 153.1

CAS Number: 89-57-6

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

The enteric-coated tablets also contain: calcium stearate, colloidal anhydrous silica, glycine, iron oxide red, iron oxide yellow, macrogol 6000, methacrylic acid copolymer, microcrystalline cellulose, povidone, purified talc, sodium carbonate, titanium dioxide and triethyl citrate.

Pack sizes and marketing

Container type: blister pack (PVC/PVDC/Al).

Pack sizes: 100

Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG)

AUST R 289132 – MESASAL mesalazine 250mg enteric-coated tablet blister pack.

Marketing authorization holder

Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

Marketing authorization dates and numbers

250 mg: 16/08/2017

Drugs

Drug Countries
MESASAL Australia, South Africa

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