NEXIUM Gastro-resistant tablet

Active ingredients: Esomeprazole

Product name and form

Nexium 20 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablet.

A light-pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A / EH on the other side.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 22.3 mg esomeprazole magnesium trihydrate equivalent to 20 mg esomeprazole.

Excipient(s) with known effect: Each gastro-resistant tablet contains 28 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+ K+ -ATPase – the acid pump and inhibits both basal and stimulated acid secretion.

List of Excipients

Glycerol monostearate 40-55
Hyprolose
Hypromellose
Iron oxide (reddish-brown and yellow) (E172)
Magnesium stearate
Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent
Cellulose microcrystalline
Synthetic paraffin
Macrogols
Polysorbate 80
Crospovidone
Sodium stearyl fumarate
Sugar spheres (sucrose and maize starch)
Talc
Titanium dioxide (E171)
Triethyl citrate

Pack sizes and marketing

  • Polyethylene bottle with a tamper-proof, polypropylene screw cap equipped with a desiccant capsule.
  • Aluminium blister package.Bottles of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140(5x28) tablets.

Blister packs in wallet and/or carton of 3, 7, 7x1, 14, 15, 25x1, 28, 30, 50x1, 56, 60, 90, 98, 100x1, 140 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization dates and numbers

PL 17901/0068

Date of first authorisation: 10 March 2005
Date of latest renewal: 10 March 2010

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States