HYDRAZALINE Film-coated tablet Ref.[8218] Active ingredients: Hydralazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

HYDRALAZINE 25mg TABLETS BP.

Pharmaceutical Form

Film-coated tablet.

Ivory, circular, biconvex film-coated tablets impressed “C” on one face and the identifying letters “HY” on the reverse.

Qualitative and quantitative composition

Each tablet contains 25mg Hydralazine Hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Hydralazine

Hydralazine is a direct acting vasodilator which exerts its effects principally on the arterioles. Its precise mode of action is not known.

List of Excipients

The tablet core contains:

Polyvidone
Disodium edetate
Microcrystalline cellulose (E460)
Magnesium stearate

The coating contains:

Hypromellose (E464)
Titanium dioxide (E171)
Lactose monohydrate
Macrogol
Glycerol triacetate (E1518)
Iron oxide (E172)

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene containers and snap-on polyethylene lids.

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: 250ยตm white rigid PVC. Surface printed 20ยตm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Polyethylene container with a polypropylene lid.

Pack size: 56s

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/0499

Date of first authorisation: 6th March 2001
Date of latest renewal: 19th March 2009

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