TRANDOLAPRIL Capsules Ref.[7130] Active ingredients: Trandolapril

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.

Product name and form

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.

Qualitative and quantitative composition

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
Cellulose, microcrystalline
Lactose monohydrate
Starch, pregelatinised maize
Silica, colloidal anhydrous
Magnesium stearate

Capsules shell of 0.5 mg:

Gelatin
Titanium dioxide (E171)
Erythrosine (E127)
Sunset yellow (E110)
Quinoline yellow (E104)

Capsules shell of 1 mg:

Gelatin
Titanium dioxide (E171)
Erythrosine (E127)
Sunset yellow (E110)

Capsules shell of 2 mg:

Gelatin
Titanium dioxide (E171)
Erythrosine (E127)
Sunset yellow (E110)

Capsules shell of 4 mg:

Gelatin
Titanium dioxide (E171)
Erythrosine (E127)
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Herts EN6 1TL, U.K.

Marketing authorization dates and numbers

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

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