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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 14/06/2011
SPC Calpol Infant Suspension Sachets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14/06/2011 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:   06-Jun-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update sections 4.2 (Posology and administration) and 4.4 (Special warnings) to include paediatric posology requested by MHRA with regards to paracetamol containing products.
Updated on 02/06/2010 and displayed until 14/06/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-May-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The reason for both changes is: Update of section 3 to include the detail ‘A pink strawberry flavoured suspension’
Updated on 08/09/2009 and displayed until 02/06/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Nature of change: To update Section 2 (Qualitative and Quantitative Composition) of the SPC by

deleting the reference standard of the excipient and the quantitative composition

of those excipients not having a known effect, with consequential up-date of

section 4.4 of the SPC.
Updated on 27/08/2009 and displayed until 08/09/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Aug-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Nature of changes

4.1 - to include the conditions which can be relieved by taking the finished product, bringing it in line with other paracetamol products for children

4.8 to update this section to include anaphylactic reactions as an adverse effect of paracetamol which occurs very rarely.

 

4.4, 4.7,6.1, 6.4, 6.6, 9. In addition update to several sections of the SPC bringing it in line with the QRD template.

 
Updated on 16/03/2009 and displayed until 27/08/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   25-Feb-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


licence renewal

Updated on 18/02/2009 and displayed until 16/03/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   15-Apr-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 19/05/2008 and displayed until 18/02/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   15-Apr-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To change the name and address of the Marketing Authorisation Holder from PCH, Walton Oaks to McNeil Products Limited, Maidenhead.
Updated on 09/11/2007 and displayed until 19/05/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  paracetamol