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Motilium 10mg Film-coated Tablets (2012)

Product Name and Form

Motilium / Domperidone 10 mg film-coated tablets.

Pharmaceutical form

Film-coated tablets – white to faintly cream coloured, circular, biconvex tablets.

Qualitative and Quantitative Composition

One film-coated tablet contains domperidone maleate 12.72 mg equivalent to domperidone 10 mg.

For excipients, see 6.1.

List of excipients

Lactose monohydrate
Maize starch
Microcrystalline cellulose
Pregelatinised starch
Povidone K90
Magnesium stearate
Silicon dioxide
Polysorbate 20
Hypromellose
Propylene glycol

Pack sizes and Marketing

Blister packs consisting of aluminium foil and PVC genotherm clear glass.

Pack sizes of 4, 10, 28, 30 and 100 tablets.

HDPE (Duma) containers

Pack size 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Winthrop Pharmaceuticals UK Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom

Trading as:

Winthrop Pharmaceuticals
PO Box 611
Guildford
Surrey
GU1 4YS

Or trading as:

Zentiva
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

01 July 2007

Marketing authorization number:

PL 17780/0300