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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: 29/03/2011
SPC Gaviscon Advance Oral 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 29/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Sep-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
10 Date of revision of the text

amended from July 2009 to September 2009 (to relfect that of schedule)
Updated on 03/09/2009 and displayed until 29/03/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

  • Section 2: Dosage per 5ml and 1ml added
  • Section 4.2: Extra instructions added, If symptoms do not improve...
  • Section 4.4: Statement deleted, If symptoms do not improve...
  • Section 4.6: Delete statement about limiting treatment
  • Section 4.7:statement updated
  • Section 5.2: PK properties updated
  • Section 6.1:Sodium Hydroxide (for pH adjustment)
  • Section 6.5: nature of container contents updated
  • Section 6.6: waste diposal istructions added
Updated on 15/05/2007 and displayed until 03/09/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to marketing authorisation holder address
Date of revision of text on the SPC:   02/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
SECTION 1.  Name of medicinal product changed to Gaviscon Advance Oral Suspension.
 
SECTION 2.  Excipients: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) added to this section.
 
SECTION 4.1.  Wording of therapeutic indications modified.
 
SECTION 4.3  Contraindications wording modified.
 
SECTION 4.6.  Additional recommendation added to pregnancy and lactation section to limit treatment duration as much as possible due to presence of calcium carbonate.
 
SECTION 6.1.  Ingredients of fennel flavour added:  fennel anethol and benzyl alcohol.
 
SECTION 6.3  Shelf life after opening extended to 6 months.
 
SECTION 7.  Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Updated on 30/06/2005 and displayed until 15/05/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 10/08/2004 and displayed until 30/06/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/06/2003 and displayed until 10/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Sodium Alginate
  Potassium hydrogen carbonate