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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: 14/06/2011
SPC Gaviscon Peppermint Chewable 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 14/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   31-May-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company


Harmonisation of text

Inclusion of the following in section 4.4 "

Take special care if you are over 40 years and have never suffered with heartburn and acid indigestion before.


Removal of the following text in section 4.6
"Nevertheless, taking into account the presence of calcium carbonate (see Section 5.3) it is recommended to limit the treatment duration as much as possible.

Section 4.8 - addtion of tabulated undesirable effects, and the deletion of the following; 

Very rarely (≤1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic and anaphylactoid reactions.
Updated on 08/01/2010 and displayed until 14/06/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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:   22-Dec-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
All sections updated as part of license renewal
Updated on 15/05/2007 and displayed until 08/01/2010
Reasons for adding or updating:
  • 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 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:
  • Change to section 6.1 - List of excipients
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   09/2005
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.8 amended to add reference to anaphylactic and anaphylactoid reactions.
Section 6.1 amended to add the excipients copovidone and acesulfame potassium.
Section 6.4 amended to change the storage condition "Do not store above 30°.
Section 6.5 amended to add more pack sizes.
Updated on 16/05/2005 and displayed until 04/08/2006
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 10/08/2004 and displayed until 16/05/2005
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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