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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: 31/01/2012
SPC Nurofen Cold and Flu Film-Coated 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 31/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Jan-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Change in revision of text from June 2009 to January 2012.  No other changes made to the content of the SmPC
Updated on 29/11/2011 and displayed until 31/01/2012
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


Section 10  - change in the revision date
Updated on 03/09/2009 and displayed until 29/11/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1  - product name has been updated to Nurofen Cold and Flu Film-Coated Tablets, Ibuprofen 200mg, Pseudoephedrine Hydrochloride 30mg

Section 2 - Quantity of sunset yellow per tablet has been included 

Section 4.5 - Addition of following information -
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly.  However, the limitations of these data and the uncertainties regarding the extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional use (see section 5.1)

Section 5.1 - addition of the following text -
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly.  In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use. 

Section 6.1 - deletion of one of the printing inks

Section 6.4 - inclusion of the statement "Store in the original package in order to protect from moisture"

Section 9 - update date of renewal

Section 10 - update of revision date
Updated on 25/08/2008 and displayed until 03/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Addition of NSAID warnings
Updated on 28/08/2007 and displayed until 25/08/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Transfer of MA to Reckitt Benckiser Ireland Ltd. and change of PA number
Updated on 24/05/2006 and displayed until 28/08/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 26/08/2003 and displayed until 24/05/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/06/2003 and displayed until 26/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ibuprofen
  Pseudoephedrine Hydrochloride