PIZOTIFEN Film-coated tablet Ref.[9288] Active ingredients:

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

PIZOTIFEN TABLETS BP 0.5mg.

Pharmaceutical Form

Film-coated tablet.

Cream film-coated, round, biconvex tablets embossed “0.5” on one side.

Qualitative and quantitative composition

Each tablet contains 0.725mg of Pizotifen hydrogen malate equivalent to 0.500mg of Pizotifen base.

Also contains Lactose.

For a full list of excipients, see section 6.1.

List of Excipients

Tablet core contains:

Povidone
Lactose monohydrate
Maize starch
Magnesium stearate
Microcrystalline cellulose (E460)

Film-coat contains:

Hypromellose
Medium Chain Triglycerides
Titanium Dioxide (E171)
Yellow Iron Oxide (E172)
Black Iron Oxide (E172)

Pack sizes and marketing

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

The product may also be supplied in blister packs in 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 5-7g/M2 PVC compatible heat seal lacquer on the reverse side.

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

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0142/0446

December 1998

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