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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 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 29/01/2010 and displayed until 19/01/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   25-Jan-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Post renewal commitments to include preclinical safety data.Inclusion of anaphylaxis warning, frutose intolerance warning. Inclusion of pharmacokinetic data in nursing mothers.Details on risk factors associated with paracetamol. Inclusion of ATC codes.
Updated on 03/11/2008 and displayed until 29/01/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   11/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Renewal change - list of excipients updated to include E-numbers, sachet presentation removed from the SPC and the renewal date updateed to 01/04/08.
Updated on 25/08/2008 and displayed until 03/11/2008
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

Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.
Updated on 28/08/2007 and displayed until 25/08/2008
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:   08/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 4.2 Dosage information on infants 3 months to 1 year added
Section 4.4 Warning - "If your child is taking any other medicine, consult your doctor or pharmacist before taking this product" added.
Updated on 16/03/2006 and displayed until 28/08/2007
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
Updated on 10/06/2003 and displayed until 03/09/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Paracetamol