Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial, Estate, Dublin 13, Ireland
Odrik 1mg Hard Capsules.
| Pharmaceutical Form |
|---|
|
Hard Capsule (capsule). Opaque red/orange capsule. |
Each hard capsule contains 1.0 mg of trandolapril.
Excipients: Each hard capsule contains 55.5mg lactose monohydrate.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Trandolapril |
Trandolapril is a prodrug, which is rapidly, non-specifically hydrolysed to its potent, long-acting active metabolite, trandolaprilat (other metabolites are inactive) and acts as an orally-active angiotensin converting enzyme inhibitor (ACE inhibitor) without a sulphydryl group. In addition to inhibition of plasma ACE, trandolapril has been experimentally shown to inhibit tissue ACE (particularly vascular, cardial and adrenal). The clinical relevance of tissue ACE inhibition has not been established in humans. |
| List of Excipients |
|---|
|
Maize starch |
PVC/PVDC/Aluminium blister strips containing 7, 28 or 56 capsules.
Not all pack sizes may be marketed.
Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial, Estate, Dublin 13, Ireland
PA2010/005/002
Date of first authorisation: 25 November 1992
Date of last renewal: 25 November 2007
| Drug | Countries | |
|---|---|---|
| ODRIK | France, Ireland, Tunisia |
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