PROCHLORPERAZINE Tablets Ref.[8282] Active ingredients: Prochlorperazine

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

PROCHLORPERAZINE TABLETS BP 5mg.

Pharmaceutical Form

White to off-white, uncoated tablets.

White to off-white, circular, flat bevelled-edge uncoated tablets impressed “C” on one face and the identifying letters “Z and P” on either side of a central division line on the reverse.

Qualitative and quantitative composition

Each tablet contains 5mg Prochlorperazine Maleate PhEur.

Excipients with known effect: Each 5mg tablet contains 61.00mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Prochlorperazine

Prochlorperazine belongs to the phenothiazine group. Prochlorperazine has a wide range of activity arising from its depressant actions on the CNS and its alpha-adrenergic blocking and weaker anti-muscarinic properties. It inhibits dopamine and prolactin-release-inhibitory factor, thus stimulating the release of prolactin.

List of Excipients

Also contains:

Lactose monohydrate
Magnesium stearate
Maize starch
Microcrystalline cellulose (E460)

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

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

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

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

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

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 50,000.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0142/0312

Date of first authorisation: 6th May 1992

Date of latest renewal: 6th May 1997

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