NUROFEN Coated tablet Ref.[50876] Active ingredients: Ibuprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Nurofen 200 mg Coated Tablets.

Pharmaceutical Form

Coated tablet.

White round sugar-coated tablet with ‘NUROFEN’ imprinted in black.

Qualitative and quantitative composition

Each tablet contains Ibuprofen 200 mg.

Excipients with known effect: Sucrose 116.1mg per tablet.

For a 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

Tablet Core:

Sodium Citrate
Croscarmellose Sodium
Stearic Acid
Colloidal anhydrous silica
Sodium Laurilsulphate

Tablet Coat:

Sucrose
Talc
Carmellose Sodium
Titanium Dioxide
Acacia spray dried
Macrogol 6000
Black Printing Ink (iron oxide black (E172), propylene glycol (E1520), shellac)

Pack sizes and marketing

A push through laminate blister tray consisting of opaque, white 250 micron PVC/40 gsm PVdC heat-sealed to 20 micron aluminium foil and containing 4, 6 or 12 tablets. The blister trays are packed into cardboard cartons, containing 4, 6, 10, 12, 14, 18, 20, 22, 24, 30, 36, 40 or 48 tablets.

A push through laminate blister tray consisting of opaque, white 250 micron PVC heat-sealed to 20 micron aluminium foil and containing 4, 6 or 12 tablets.

The blister trays are packed into cardboard cartons, containing 4, 6, 10, 12, 14, 18, 20, 22, 24, 30, 36, 40 or 48 tablets.

An HDPE bottle fitted with an HDPE cap that is internally wadded with expanded polyethylene, containing 12, 14, 18, 20, 22, 24, 30, 36, 40 or 48 tablets.

Not all pack sizes or types may be marketed.

Marketing authorization holder

Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0979/032/006

Date of first authorisation: 17th December 2004
Date of last renewal: 17th December 2009

Drugs

Drug Countries
NUROFEN Austria, Cyprus, Germany, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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