TUMSIGON Hard gelatine capsule Ref.[115170] Active ingredients: Omeprazole

Source: Health Products Regulatory Authority (ZA)  Publisher: Dezzo Trading 392 (Pty) Ltd, Jespan Centre, Corner Garrick and Flagtail Street, Extension 8, Lenasia, 1821, South Africa

Product name and form

TUMSIGON 20 mg capsules.

Pharmaceutical Form

Hard gelatine capsules.

Size 2 hard gelatin capsules with a dark blue body and a light blue cap, containing white to almost white uniformly rounded enteric-coated pellets. “TUMSIGON” is printed on both the shells with white ink.

Qualitative and quantitative composition

Each capsule contains:

Omeprazole 20 mg

Preservatives:

Methylparaben 0,15 % m/m
Propylparaben 0,04 % m/m
Contains sugar.

Each TUMSIGON capsule:

Contains sucrose 165,95 mg and lactose anhydrous 2,99 mg.

Contains sweetener mannitol 55,90 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

List of Excipients

Content:

Sugar pellets (consisting of sucrose and purified water)
Mannitol
Lactose anhydrous
Purified talc
Sodium lauryl sulfate
Povidone/Polyvinyl pyrrolidone (PVPK-30)
Anhydrous disodium hydrogen phosphate
Sucrose (sugar)
Hypromellose phthalate/Hydroxypropyl methylcellulose phthalate (HPMCP-55)
Cetyl alcohol
Titanium dioxide

Capsule shell:

Gelatine
Methylparaben (preservative)
Propylparaben (preservative)

Cap – light blue

Brilliant blue (CI 42090)
Erythrosine (CI 45430)
Quinoline yellow (CI 47005)
Titanium dioxide (CI 77891)
Carmosine (CI 14720)

Body – dark blue

Brilliant blue (CI 42090)
Carmosine (CI 14720)
Erythrosine (CI 45430)
Quinoline yellow (CI 47005)
Titanium dioxide (CI 77891)

White printing ink:

Absolute alcohol
Isopropyl alcohol
Shellac dewaxed powder
Titanium dioxide

Pack sizes and marketing

6 capsules in aluminium strip pack:

5 of these strips in one carton i.e. 30 capsules pack.

7 capsules in aluminium strip pack:

4 of these strips in one carton i.e. 28 capsules per pack.

10 capsules in aluminium strip pack:

3 of these strips in one carton i.e. 30 capsules per pack. or 10 of these strips in one carton i.e. 100 capsules per pack.

14 capsules in aluminium strip pack:

1 of these strips in one carton i.e. 14 capsules per pack or 2 of these strips in one carton i.e. 28 capsules per pack.

Not all pack sizes may be marketed.

Marketing authorization holder

Dezzo Trading 392 (Pty) Ltd, Jespan Centre, Corner Garrick and Flagtail Street, Extension 8, Lenasia, 1821, South Africa

Drugs

Drug Countries
TUMSIGON South Africa

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