Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Rowex Ltd, Bantry, Co. Cork
Emazole 20 mg Gastro-Resistant Tablets.
| Pharmaceutical Form |
|---|
|
Gastro-resistant tablet. 20 mg: Light pink oval film-coated tablet. |
Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium dihydrate).
Excipient(s) with known effect: Each 20 mg gastro-resistant tablet contains 12.90 mg – 14.76 mg sucrose and 0.81 mg glucose.
For the 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 |
|---|
|
Tablet core: Sucrose Tablet coating: Hypromellose |
Aluminium/aluminium blisters and aclar/aluminium blisters with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 100 × 1 gastro-resistant tablets.
HDPE bottles with PP cap and desiccant with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 250 gastro-resistant tablets.
Not all pack sizes may be marketed.
Rowex Ltd, Bantry, Co. Cork
PA0711/158/001
Date of first authorisation: 8th April 2009
Date of last renewal: 2nd April 2014
| Drug | Countries | |
|---|---|---|
| EMAZOLE | Ireland, Malta, Singapore |
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