TRUSTAN Gastric resistant tablet Ref.[50546] Active ingredients: Esomeprazole

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

Product name and form

Trustan 20 mg Gastric resistant tablets.

Trustan 40 mg Gastric resistant tablets.

Pharmaceutical Form

Gastric resistant tablets.

TRUSTAN 20 mg is a light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and on the other side.

TRUSTAN 40 mg is a pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and on the other side.

Qualitative and quantitative composition

Each tablet of TRUSTAN 20 mg contains 20 mg esomeprazole (as magnesium trihydrate) in the form of a multiple unit pellet system (MUPS).

Each tablet of TRUSTAN 40 mg contains 40 mg esomeprazole (as magnesium trihydrate in the form of a multiple unit pellet system (MUPS).

TRUSTAN 20 mg:

Contains sugar: Sucrose 28 mg.

TRUSTAN 40 mg:

Contains sugar: Sucrose 30 mg.

For full list of excipients, see section 6.1.

Active Ingredient Description
Esomeprazole

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

Crospovidone, glycerol monostearate, hypromellose, hydroxypropylcellulose, iron oxide, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, macrogol, polysorbate 80, synthetic paraffin, sugar spheres (sucrose and maize starch), sodium stearyl fumarate, talc, triethyl citrate, titanium dioxide.

Pack sizes and marketing

White HDPE bottles (with desiccated, white, screw type caps, with or without child resistance and a tamper proof ring) of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100 tablets. The bottles are packed in a cardboard carton.

PVC/aluminium blister packages of 3, 7, 14, 15, 28, 30, 50, 56, 60, 98, 100 tablets.

The blisters are packed in a cardboard carton.

Not all packs or pack sizes may be marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

Marketing authorization dates and numbers

TRUSTAN 20 mg: 45/11.4.3/0777
TRUSTAN 40 mg: 45/11.4.3/0778

10 April 2014

Drugs

Drug Countries
TRUSTAN South Africa

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