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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 14/03/2011
SPC Anadin Extra

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 14/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   30-Jul-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
reference to children replaced with adolescents.
Updated on 10/08/2010 and displayed until 14/03/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


7. MARKETING AUTHORISATION HOLDER

Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.

(formally Wyeth Consumer Healthcare)
Updated on 20/10/2009 and displayed until 10/08/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
Date of revision of text on the SPC:   28-Aug-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
During renewal most of the changes were to improve clarity and reability. 
Section 1: the product name was changed in line with EU guidance. 
Section 3: the pharmaceutical form now clarifies if the tablet is breakable for ease of swallowing.
Section 6.1: excipients are classified according to tablet core and tablet coat
Section 6.3: shelf life is stated in years rather then months. 
Section 4.3: contraindications are listed on seperate lines for clarity. Breastfeeding is cross referenced to section 4.6 
Section 5.1 the ATC code has been added.   
 
Updated on 20/05/2009 and displayed until 20/10/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   08-Jan-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.5 Interactions with other medicinal products
Experimental data suggests that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. No firm conclusion can be made from this data in relation to regular us of ibuprofen and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

Section 5.1 Pharmacological Properties
Experimental data suggests that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. No firm conclusion can be made from this data in relation to regular us of ibuprofen and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Updated on 15/10/2008 and displayed until 20/05/2009
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Variation to update section 4.3, 4.4, 4.5, & 4.8 of the SPC as regards cardiovascular, dermatological, gastrointestinal  & reproductive toxicity
Updated on 12/12/2006 and displayed until 15/10/2008
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   12/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Amend section 6.3
Shelf -life increased to 36 months
Updated on 23/08/2006 and displayed until 12/12/2006
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   08/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.5: Delete polypropylene pack
Updated on 15/07/2005 and displayed until 23/08/2006
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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 31/03/2005 and displayed until 15/07/2005
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Updated on 17/12/2004 and displayed until 31/03/2005
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 30/05/2003 and displayed until 17/12/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Paracetamol
  Caffeine
  Acetylsalicylic acid (Aspirin)