Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Herts EN6 1TL, U.K.
Trandolapril 0.5 mg capsules, hard.
Trandolapril 1 mg capsules, hard.
Trandolapril 2 mg capsules, hard.
Trandolapril 4 mg capsules, hard.
| Pharmaceutical Form |
|---|
|
Capsule, hard. Each capsule contains a white to almost white powder. 0.5 mg: light scarlet/rich yellow capsules. 1 mg: light scarlet/light orange capsules. 2 mg: light scarlet/light scarlet capsules. 4 mg: light swedish orange/ light scarlet capsules. |
Each 0.5 mg capsule contains: 0.5 mg trandolapril.
Each 1 mg capsule contains: 1 mg trandolapril.
Each 2 mg capsule contains: 2 mg trandolapril.
Each 4 mg capsule contains: 4 mg trandolapril.
Excipients with known effect:
Each capsule contains 24 mg lactose monohydrate.
Each 0.5 mg, 1 mg, 2 mg capsule also contains 1.26 mg Sunset yellow (E110).
For the 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 |
|---|
|
Dimeticone Capsules shell of 0.5 mg: Gelatin Capsules shell of 1 mg: Gelatin Capsules shell of 2 mg: Gelatin Capsules shell of 4 mg: Gelatin |
Blister (PVC/PE/PVDC/Al).
0.5 mg, 1 mg, 2 mg and 4 mg: 14, 20, 28, 30, 50, 56, 84, 90 and 100 capsules.
Not all pack sizes may be marketed.
Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Herts EN6 1TL, U.K.
0.5 mg: PL 04569/0817
1 mg: PL 04569/0818
2 mg: PL 04569/0819
4 mg: PL 04569/0820
21 February 2008 / 08 January 2013
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
