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McNeil Healthcare (Ireland) Ltd
Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 02/11/2010
SPC Actifed 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 02/11/2010 and displayed until Current
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   19-Oct-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Changes to sections 4.3, 4.4 & 4.5 to include standard sympathomimetic warnings.
Updated on 24/03/2009 and displayed until 02/11/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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:   03/2009
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
 Renewal changes to PIL:

Inclusion of API and strength in product name.
Inclusion of excipients in the composition section
Inclusion of breakbar descripion in tablet
Inclusion of E numbers in excipient list       
Inclusion of "not all pack sizes are marketed" in container closure system
Revision of renewal date 
Updated on 11/03/2008 and displayed until 24/03/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

To change the MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland.
Updated on 18/06/2003 and displayed until 11/03/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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