Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Pharmaco (N.Z.) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Telephone: 0800 804 079
LOSEC 10 mg Capsules.
LOSEC 20 mg Capsules.
LOSEC 40 mg Capsules.
LOSEC 40 mg MUPS Enteric Coated Tablets.
| Pharmaceutical Form |
|---|
|
LOSEC capsules 10 mg: hard gelatine size 3 capsules with an opaque pink body, marked 10, and an opaque pink cap marked A/OS. Each capsule contains omeprazole 10 mg as enteric coated pellets. LOSEC capsules 20 mg: hard gelatine size 2 capsules with an opaque pink body, marked 20 and an opaque reddish-brown cap marked A/OM. Each capsule contains omeprazole 20 mg as enteric coated pellets. LOSEC capsules 40 mg: hard gelatine size 1 capsules with an opaque, reddish-brown body, marked 40 and an opaque reddish-brown cap marked A/OL. Each capsule contains omeprazole 40 mg as enteric coated pellets. LOSEC MUPS (Multiple Unit Pellet System) tablets 40 mg: Dark red-brown, oblong, biconvex, film-coated tablets engraved with or on one side and 40 mg and a score on the other side. Each tablet contains omeprazole magnesium 41.3 mg (corresponding to omeprazole 40 mg) as enteric coated pellets. [LOSEC MUPS 40 mg are not available in New Zealand]. |
Each capsule contains omeprazole 10 mg, 20 mg or 40 mg.
Each tablet contains omeprazole magnesium 41.3 mg (corresponding to omeprazole 40 mg).
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Omeprazole |
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 |
|---|
|
Capsules: Disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, macrogol (polyethylene glycol), sodium lauryl sulphate, iron oxide (E 172), titanium dioxide (E 171) and gelatine. Tablets: Microcrystalline cellulose, glyceryl monostearate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid co-polymer, sugar spheres, paraffin, macrogol (polyethylene glycol), polysorbate, polyvinylpyrrolidone crosslinked, sodium stearyl fumarate, talc, triethyl citrate, iron oxide (E 172), titanium dioxide (E 171). |
HDPE bottles of 30 capsules.
HDPE bottles of 30 tablets (Not marketed in New Zealand).
Aluminium blisters containing 30 tablets (Not marketed in New Zealand).
Pharmaco (N.Z.) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Telephone: 0800 804 079
Losec 10 mg Capsules: 7 January 1997
Losec 20 mg Capsules: 27 April 1990
Losec 40 mg Capsules: 21 October 1997
Losec MUPS 40 mg Tablets: 15 February 2001
| Drug | Countries | |
|---|---|---|
| LOSEC | Austria, Australia, Brazil, Canada, Cyprus, Spain, Finland, Hong Kong, Ireland, Israel, Italy, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, United Kingdom, South Africa |
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