MOTILIUM Film-coated tablet Ref.[6806] Active ingredients: Domperidone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Motilium 10 mg film-coated tablets.

Pharmaceutical Form

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

Qualitative and quantitative composition

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

Excipients with known effect:

Each film-coated tablet contains 53.88mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Domperidone

Domperidone is a dopamine antagonist with anti-emetic properties, Domperidone does not readily cross the blood-brain barrier. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary.

List of Excipients

Lactose monohydrate
Maize starch
Microcrystalline cellulose
Pregelatinised starch
Povidone K90
Magnesium stearate
Silica colloidal hydrated
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

Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom

Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 17780/0300

01 July 2007

Drugs

Drug Countries
MOTILIUM Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Spain, France, Hong Kong, Ireland, Israel, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, South Africa

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