Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
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 TRUSTAN 40 mg is a pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and |
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. |
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.
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
TRUSTAN 20 mg: 45/11.4.3/0777
TRUSTAN 40 mg: 45/11.4.3/0778
10 April 2014
| Drug | Countries | |
|---|---|---|
| TRUSTAN | South Africa |
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