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: 17/11/2010
SPC Anadin Extra 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 17/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   02-Sep-2010
Legal Category:   P, GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

To add a pack size of 10 tablets and to update the registered details of the drum container, including the container materials (HDPE), technical dimensions and specifications.
Updated on 06/05/2010 and displayed until 17/11/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Apr-2010
Legal Category:   P, GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change in Marketing Authorisation Holder name and address
Updated on 15/05/2008 and displayed until 06/05/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   18-Apr-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update of section 4.8  re Hypersensitivity warnings following MHRA letter of 27/09/07
Updated on 12/02/2008 and displayed until 15/05/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   02/2008
Legal Category:   GSL/P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

To update the SMPC to bring in line with other Wyeth Products containing the same active ingredients
Updated on 06/12/2007 and displayed until 12/02/2008
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   11/2007
Legal Category:   GSL/P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 
 
Increase of shelf life from 24th months to 36 months.
Updated on 22/10/2007 and displayed until 06/12/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   07/2006
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

One line got missed out of the description of the pharmaceutical form ie:
 
White, capsule shaped tablet with a break bar on one side, with the letter "A" and "E" debossed on the other.
Updated on 24/07/2006 and displayed until 22/10/2007
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   07/2006
Legal Category:   GSL/P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 
section 4.9 overdose amended to reflect changes to symptoms and management of active substances (Aspirin/Paracetamol/Caffeine)
 
Updated on 22/03/2006 and displayed until 24/07/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/12/2004 and displayed until 22/03/2006
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

 
   paracetamol
   caffeine
   acetylsalicylic acid