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Forest Laboratories UK Limited
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL, UK
Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
Medical Information e-mail: medinfo@forest-labs.co.uk
Summary of Product Characteristics last updated on medicines.ie: 06/05/2010
SPC Infacol

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 06/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf-life has changed due to the extension of the shlef-life and addition of a use by date, this section should now read as below:

As packaged for sale: 3 years
After first opening: 28 days

Section 10 - Date of revision of text has changed due to the update, this should now read:

March 2010.
Updated on 16/10/2009 and displayed until 06/05/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   13-Oct-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
The change in the address of the MA holder has been approved via a type 1A variation.

Please amend section 7 to read;

7 MARKETING AUTHORISATION HOLDER

Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL.
Updated on 01/09/2006 and displayed until 16/10/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
In section 2 the name of the active ingredient has changed from simethicone to simeticone.  The ingredient itself has not changed.
 
Section 10 has been updated to August 2006, to reflect the date of the change to section 2.
Updated on 26/07/2006 and displayed until 01/09/2006
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 6.6 - Special precautions for disposal and other handling
  • 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:   06/2006
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 1
 
The name of the product has changed from 'Infacol' to 'Infacol 40mg/ml Oral Suspension'.
 
Section 2
 
The wording 'For excipients, see section 6.1' has been added.
 
Section 3
 
The wording 'Orange flavoured, colourless, translucent suspension' has been added.
 
Section 6.6
 
The wording has been changed from 'Not stated' to 'No special requirements'.
 
Section 9
 
The date of renewal has been updated to '27th February 2006'.
 
Section 10
 
The date of revision of text has been updated to 'June 2006'.
Updated on 02/08/2004 and displayed until 26/07/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/08/2003 and displayed until 02/08/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 18/08/2003 and displayed until 26/08/2003
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 17/06/2003 and displayed until 18/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Simethicone