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Reckitt Benckiser Ireland Limited

7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 15/12/2017
SPC Nurofen Express Maximum Strength 400mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Sep-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Renewal date: Date of last renewal: 10th August 2016

Date of revision of text: September 2017
Updated on 16/08/2017 and displayed until 15/12/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Aug-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.2, 4.3, 4.4, 4.5, 4.8, 5.1 updated with Article 31 text.
Section 4.4 and 4.8 updated with Chicken pox warning.
Section 10 date of revision of text updated.
Updated on 10/10/2014 and displayed until 16/08/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   19-Sep-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Update in relation to Article 45
Updated on 12/02/2014 and displayed until 10/10/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   31-Jan-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 2.0 excipients updated
Section 4.4 cardiovascular & cerebrovascular effects reworded
Updated on 16/03/2012 and displayed until 12/02/2014
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   12-Mar-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Included the following in section 6.1:

Red printing ink*

 

*(containing:  Shellac, iron oxide red (E172),propylene glycol (E1520), ammonium hydroxide (E257) , and simethicone)

Updated on 22/06/2011 and displayed until 16/03/2012
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Ibuprofen sodium dihydrate