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Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 15/11/2011
SPC Gaviscon Advance Tablets

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 15/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   04-Nov-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Included the date of last renewal:  05th January 2010

10.       DATE OF REVISION OF THE TEXT
amended to November 2011 
Updated on 15/05/2007 and displayed until 15/11/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   02/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 4.1  Therapeutic Indications has been modified slightly.
 
Section 4.3  Contraindication in relation to hypersensitivity to ingredients has been reworded
 
Section 4.6  Pregnancy and Lactation.  An additional statement that duration of treatment should be limited as much as possible due to the presence of calcium carbonate.
 
Section 6.1  Excipients have been updated. 
 
Section 6.5.  Additional pack size of 60 tablets.  Expansion of description of 20 and 60 container.
 
Section 7.  Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Updated on 04/08/2006 and displayed until 15/05/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Sodium Alginate
  Potassium Bicarbonate