BRUFEN 400 mg Tablet Ref.[50856] Active ingredients: Ibuprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2024  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Brufen Tablets 400 mg.

Pharmaceutical Form

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

Qualitative and quantitative composition

Each Brufen tablet contains 400 mg Ibuprofen.

Excipient with known effect: 26.67 mg 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

Extragranular excipients:

Opaspray white M-1-7111B*
Dry colour dispersion, white 06A28611**

* Opaspray white M-1-7111B comprises industrial methylated spirit, purified water, hypromellose 2910 and titanium dioxide.

** or combination of Opaspray white M-1-7111B, hypromellose and talc

NB industrial methylated spirit and purified water are removed during the drying process

Pack sizes and marketing

Blister pack comprising of transparent polyvinyl chloride (PVC) with aluminium foil backing – pack size 60 tablets or 100 tablets.

Blister pack comprising of transparent polyvinyl chloride (PVC) film coated on one face with polyvinylidene chloride (PVDC) with aluminium foil backing – pack size 60 or 100 tablets.

Not all pack sizes are marketed.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0006

04/03/2009

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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