BRUFEN Film-coated tablet Ref.[50856] Active ingredients: Ibuprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Brufen 400mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

A white, pillow-shaped, film-coated tablet.

Qualitative and quantitative composition

Each Brufen tablet contains 400 mg of ibuprofen.

Excipient(s) with known effect: each tablet contains 26.7mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Colloidal anhydrous silica
Sodium laurilsulfate
Magnesium stearate
Opadry white (containing hypromellose, titanium dioxide and talc)
or
Hypromellose
Plus
Talc
Plus
Opaspray white M-1-7111B (contains: Titanium Dioxide (E171) and Hypromellose)

Pack sizes and marketing

Blister pack comprising of transparent polyvinyl chloride (PVC) or polyvinyl chloride/polyvinylidene (PVC/PVDC) film with aluminium foil backing.

Pack size 60 tablets.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/002/001

Date of first authorisation: 14 April 1975
Date of last renewal: 14 April 2010

Drugs

Drug Countries
BRUFEN Albania, Austria, Australia, Cyprus, Estonia, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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