MECOLZINE Gastro-resistant tablet Ref.[50654] Active ingredients: Mesalazine

Source: Web Search  Publisher: FAES FARMA, S.A., C/Mรกximo Aguirre, 14, 48940 Leioa (Bizkaia), Spain

Product name and form

Mecolzine 500 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablets.

Oblong tablets of 17.9 mm of length and 8.3 mm of diameter, with homogeneous gastro-resistant orange coloured coating.

Qualitative and quantitative composition

Each tablet of Mecolzine 500 mg gastro-resistant tablets contains 500 mg of mesalazine.

Excipient with known effect: Each tablet contains 2.13 mmols of sodium (49 mg).

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

Sodium carbonate, anhydrous
Glycine
Povidone
Cellulose, microcrystalline
Croscarmellose sodium
Silica, colloidal anhydrous
Calcium stearate
Methacrylic acid polymer – ethyl acrylate copolymer (1:1)
Methacrylic acid polymer – methyl methacrylate copolymer (1:1)
Methacrylic acid polymer – methyl methacrylate copolymer (1:2)
Dibutyl sebacate
Talc
Titanium dioxide (E-171)
Macrogol
Yellow iron oxide (E-172)
Red iron oxide (E-172)

Pack sizes and marketing

Aluminium/Aluminium blister packed in cartons containing 100 tablets.

Marketing authorization holder

FAES FARMA, S.A., C/Mรกximo Aguirre, 14, 48940 – Leioa (Bizkaia), Spain

Marketing authorization dates and numbers

MA1278/00101

Date of first authorisation: 14/11/2019

Drugs

Drug Countries
MECOLZINE Cyprus, Ecuador, Malta

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