Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Omeprazole 10mg Gastro-resistant Capsules.
| Pharmaceutical Form |
|---|
|
Gastro-resistant capsules, hard. Hard gelatine capsules of size 3, Opaque yellow cap and body containing white to off-white spherical pellets. |
Each capsule contains 10mg omeprazole.
Excipient with known effect: Contains sucrose, see section 4.4.
Each 10mg omeprazole capsule contains 51 to 58mg of sucrose.
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 |
|---|
|
Sugar spheres (consisting of corn starch and sucrose) Capsules consist of gelatin and contain the colours quinoline yellow (E104) and titanium dioxide (E171). |
OPA/Aluminium/PVC: Aluminium blister; OPA/Aluminium/PVC: PET/Aluminium blister:
Pack sizes: 7’s, 10’s, 14’s, 15’s, 20’s, 21’s, 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 90’s, 98’s, 100’s
HDPE tablet containers with a PP closure incorporating a LDPE capsule containing silica gel dessicant:
Pack size: 30, 90
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
PL 00142/0516
22.03.2002
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