Pfizer Consumer Healthcare

Vanwall Road, Maidenhead, Berks, SL6 4UB
Telephone: +44(0)1628 692 002
Fax: +44(0)1628 414 728
Medical Information Direct Line: 0845 111 0151
Medical Information e-mail: carelineuk@pfizer.com
Customer Care direct line: 0845 111 0151
Medical Information Fax: +44(0)1628 414 728

Summary of Product Characteristics last updated on the eMC: 08/04/2011
SPC Anadin Ibuprofen 200mg Tablets

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

Updated on 08/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update to SPC side effects following renewal of licence.  

During this procedure a number of side effects were added to the SmPC (abdominal distension,  haematuria, interstitial nephritis, nephritic syndrome, proteinuria).

 
Updated on 06/05/2010 and displayed until 08/04/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
  • Company name change or merger
  • Change to MA holder contact details
Date of revision of text on the SPC:   27-Apr-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to Marketing Authorisation Holder name and address.
Updated on 03/02/2009 and displayed until 06/05/2010
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   29-Dec-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Low-dose aspirin warnings from MHRA (4.5 and 5.1)
Updated on 22/10/2007 and displayed until 03/02/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change of printing ink code + revision date of April 2007
Updated on 13/03/2007 and displayed until 22/10/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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:   02/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

UPdate of cardiovascular safety warnings for NSAIDs
Updated on 17/03/2006 and displayed until 13/03/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 12/01/2005 and displayed until 17/03/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   ibuprofen