HYTRIN Tablet Ref.[8192] Active ingredients: Terazosin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2024  Publisher: Amdipharm UK Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom

Product name and form

Hytrin 2 mg Tablets.

Terazosin 2 mg Tablets.

Pharmaceutical Form

Yellow, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

Qualitative and quantitative composition

Each tablet contains 2 mg of terazosin as monohydrochloride dihydrate.

Excipients with known effect:

Lactose (127.28 mg).

For a full list of excipients, see section 6.1.

Active Ingredient

Although the exact mechanism of the hypotensive action is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha-adrenoceptors. Terazosin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

List of Excipients

Lactose
Maize starch
Pregelatinised starch
Purified talc
Magnesium stearate
Purified water
Dye yellow (quinolone yellow, E104)

Pack sizes and marketing

Tablets in a blister pack. The 2 mg tablets are supplied in a pack of 28 tablets. Blisters are packaged in a carton with a package insert.

Starter Pack for Hypertension:

The 2 mg tablets form part of a starter pack of 28 tablets which also contains 7 x 1 mg tablets. Blisters are packaged in a carton with a package insert.

Starter pack for BPH:

Tablets in a blister pack. The starter pack consists of 7 x 1 mg, 14 x 2 mg and 7 x 5 mg tablets. The blisters, of PVC/PVdC, are heat sealed with 20 micron hard tempered aluminium foil and packaged in a carton with a pack insert.

Marketing authorization holder

Amdipharm UK Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom

Marketing authorization dates and numbers

PL 20072/0029

23/12/1986

Drugs

Drug Countries
HYTRIN Ecuador, Hong Kong, Ireland, Israel, Netherlands, Poland, Singapore, Turkey, United Kingdom

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