NUROFEN DURANCE Medicated plaster Ref.[110138] Active ingredients: Ibuprofen

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Nurofen Durance 200 mg medicated plaster.

Pharmaceutical Form
Medicated plaster. Colourless, self-adhesive formulation layer mounted onto a 10 cm by 14 cm flexible flesh-coloured woven support, with a release liner.

Qualitative and quantitative composition

Each medicated plaster contains 200 mg of ibuprofen.

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
Adhesive layer: Macrogol 20000 Macrogol 400 Levo-menthol Styrene-Isoprene-Styrene Block Copolymer Polyisobutylene Hydrogenated rosin glycerol ester Liquid paraffin Backing layer: Woven Polyethylene terephthalate (PET) Release liner: Silicone coated Polyethylene Terephthalate (PET)

Pack sizes and marketing

Each sachet is made of composite PET/LDPE/aluminium/LDPE film.

Each sachet contain 2 or 4 medicated plasters. Packs of 2, 4, 6, 8 or 10 medicated plasters.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PA0979/032/018

Date of first authorisation: 30^th June 2017
Date of last renewal: 25^th May 2021

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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