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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 Fastmelts

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 19/05/2008 and displayed until 19/01/2012
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
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
From:
Calpol Fastmelts 250mg Paracetamol Orodispersible Tablets
To:
Calpol Six Plus Fastmelts 250mg Paracetamol Orodispersible Tablets
Updated on 19/09/2007 and displayed until 19/05/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   07/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 6.1
 
"colloidal anhydrous silica" changed to "silica hydrophobic colloidal anhydrous"
Updated on 28/08/2007 and displayed until 19/09/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   08/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 6.1 Excipenty name amended: Colloidal Anhydrous Silica.
Section 6.4 Deleted phrase "Do not store above 30C"
Updated on 20/12/2006 and displayed until 28/08/2007
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
Date of revision of text on the SPC:   12/2006
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 1 - "Orodispersible" added to name
Section 2 - Excipients added
Section 3 - Description inserted
Section 6.1 -  E numbers added
 
Updated on 18/06/2003 and displayed until 20/12/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Paracetamol