ALTOSEC Capsule Ref.[115191] Active ingredients: Omeprazole
Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686
Product name and form
ALTOSEC 20 mg capsules.
| Pharmaceutical Form |
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Capsules. ALTOSEC 20 are hard gelatine capsules with an opaque pink body and opaque reddish- brown cap. The body is marked 20 and the cap |
in black. The capsule contains white to lightly beige enteric-coated granules.Qualitative and quantitative composition
Each capsule of ALTOSEC 20 contains 20 mg omeprazole.
Contains sugar: Lactose anhydrous 8 mg, mannitol 142,5 mg.
For full list of excipients, see section 6.1.
| Active Ingredient |
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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 |
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Disodium hydrogen phosphate dihydrate |
Pack sizes and marketing
14 or 28 capsules are packed into a white high-density polyethylene bottle sealed with a white polypropylene screw cap with a safety ring together with a white low-density polyethylene desiccant capsule. The bottle is placed in an outer cardboard carton together with a leaflet.
14 or 28 capsules are packed into polyvinyl chloride blister strips sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.
Not all pack sizes may be marketed.
Marketing authorization holder
Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686
Marketing authorization dates and numbers
32/11.4.3/0087
23 October 1998
Drugs
| Drug | Countries | |
|---|---|---|
| ALTOSEC | South Africa |
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