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

Source: Health Products Regulatory Authority (IE)  Revision Year: 2026  Publisher: JNTL Consumer Health I (Ireland) Ltd., Block 5, High Street, Tallaght, Dublin 24, Ireland

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

One film coated tablet contains domperidone 10 mg.

For a full list of excipients, see section 6.1.

Active Ingredient

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 potato starch
Povidone
Magnesium stearate
Hydrogenated vegetable oil
Sodium laurilsulfate
Hypromellose

Pack sizes and marketing

Blister packs of aluminium foil/PVC containing 10 and 20 tablets, packed in a cardboard carton.

Not all pack sizes may be marketed.

Marketing authorization holder

JNTL Consumer Health I (Ireland) Ltd., Block 5, High Street, Tallaght, Dublin 24, Ireland

Marketing authorization dates and numbers

PA 23490/022/002

Date of first authorisation: 5th October 2007
Date of last renewal: 5th October 2012

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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