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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 22/10/2010
SPC Corsodyl 0.2% w/v Mint Mouthwash

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 22/10/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 2 (Qualitative and Quantitative Composition)  the following was added:

"Excipients: Contains Macrogolglycerol Hydroxystearate 0.8% w/v

            For a full list of excipients, see section 6.1."

In section 6.4 (Special precautions for storage) the following was added: "Store in the original container in order to protect from light" was added

In Section 10 the date of revision was changed to September 2010
Updated on 15/07/2009 and displayed until 22/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   18-Jun-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Updated doseage recommendation for children
Section 4.4 - Addtion of special warnings (soreness, swelling or irritation of the mouth - see a health care professional; discoloration of the teeth and tongue)
Section 4.8 - Addition of numbness and tingling as adverse effects
Section 4.9 - Addition of alchohol warning for children who overdose
Updated on 18/08/2008 and displayed until 15/07/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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:   02/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

4.8 Undesirable effects

Irritative skin reactions

Irritative skin reactions to chlorhexidine preparations can occasionally occur. Generalised allergic reactions to chlorhexidine have been reported but are extremely rare.

 

Generalised reactions

Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

 

6.1 List of excipients

Sorbitol 70% (non-crystallising)

Ethanol (96%)

Macrogolglycerol hydroxystearate

Peppermint oil

Purified water

 

9 Date of first authorisation/renewal of the authorisation

30 September 1976/ 10 January 2005

 

10 Date of revision of the text

February 2008
Updated on 27/03/2008 and displayed until 18/08/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2006
Legal Category:   GSL

Free-text change information supplied by the pharmaceutical company
The last sentence of section 4.8 of the SPC, which begins with "Generalised allergic reactions" should be deleted and a new heading should be added, so that the end of section 4.8 reads as follows:

Irritative skin reactions

Irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions

Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.
Updated on 30/11/2007 and displayed until 27/03/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   03/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
SECTION 4.1
"Also for use in a post-periodontal surgery or treatment regimen to promote gingival healing."
Updated on 27/10/2006 and displayed until 30/11/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

10. Date of Revision of the Text

                            March 2006
Updated on 23/03/2006 and displayed until 27/10/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.8 - Undesirable effects
  • 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 9 - Date of renewal of authorisation
Updated on 26/06/2003 and displayed until 23/03/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Chlorhexidine digluconate