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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: 19/01/2012
SPC Calpol Sugar Free Infant Suspension

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 19/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   16-Dec-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company


Implementation of change(s) requested by the National Competent Authority following the assessment of the paracetamol pediatric dosing schedule (section 4.2) with subsequent changes to section 4.4 warnings and precautions.
Updated on 29/07/2008 and displayed until 19/01/2012
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   05/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1: Amendement to excipient detail
Section 6.6: Insertion of information into SPC
Updated on 28/08/2007 and displayed until 29/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   08/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 4.2: dosage information for children aged 6 to 12 years added.
Section 6.5: Pack size of 12 x 5ml added.
 
Updated on 29/06/2007 and displayed until 28/08/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   06/2007
Legal Category:   other

Free-text change information supplied by the pharmaceutical company
Section 6.3  Increase in shelf life of sachets from 2 years to 3 years
Updated on 16/03/2006 and displayed until 29/06/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Updated on 03/09/2004 and displayed until 16/03/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.5 - Nature and contents of container
Updated on 20/06/2003 and displayed until 03/09/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Paracetamol