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Corsodyl Aniseed 0.2% w/v Mouthwash

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General Sale: Non-prescription
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Updated on 13 June 2023

File name

PA678 2 4_Clean proposed PIL Corsodyl Aniseed.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Company Name changed from GSK to Haleon Ireland Ltd.

Updated on 13 June 2023

File name

PA 0678 2 4_Clean SPC Corsodyl Aniseed_M.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Company Name changed from GSK to Haleon Ireland Ltd.

Updated on 13 April 2023

File name

aniseed pil April 2023.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Updated the Section 6 - new Manufacturer, Omega Pharma Germany.

Updated on 17 February 2021

File name

ie-spc-Aniseed mouthwash- reformualtion consolidated-approved-clean-200317BC.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through general sale

Updated on 26 September 2019

File name

Corsodyl Aniseed Mothwash SPC.pdf

Reasons for updating

  • Change to product name

Legal category:Supply through general sale

Updated on 09 August 2019

File name

Corsodyl Aniseed 0.2 w-v Mouthwash label leaflet.pdf

Reasons for updating

  • Change to name of medicinal product
  • Improved presentation of PIL
  • Change to packaging

Updated on 08 August 2019

File name

Corsodyl Aniseed 0.2% w-v Mouthwash SPC.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Supply through general sale

Updated on 28 April 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 28 April 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

A Type II variation (category C.I.4) submitted to align the product SmPC to GSK Global Data Sheet

Updated on 27 April 2016

File name

PIL_12599_284.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 April 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 25 November 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4 Inclusion of excipient warnings for macrogolglycerol hydroxystearate and azo dye Ponceau 4R
Section 4.8 Addition of information regarding the reporting of suspected adverse reactions

Updated on 21 November 2014

Reasons for updating

  • Change to side-effects

Updated on 11 March 2014

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 February 2014

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 October 2010

Reasons for 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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 2 (Qualitative and Quantitative was updated to read as follows:
"Chlorhexidine Digluconate 0.2% w/v
(as Chlorhexidine Digluconate Solution)
 Excipients: Contains Macrogolglycerol hydroxystearate 0.8% w/v
For a full list of excipients, see section .6.1"

Section 6.4 (special precautions for storage): the following was added:"Store in the original container in order to protect from light."

In Section 10 (date of revision of the text) the date was changed to september 2010


Updated on 13 August 2010

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 12 April 2010

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 10

date of text revision is corrected

Updated on 21 July 2009

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 6.1 - replacement of excipient with a comparable excipient

Updated on 15 July 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.2 - Children under 12 warning added
Section 4.4 - Addition of warning re irritation and discoloration
Section 4.8 - Additional warning re tingling and numbness 
Section 4.9 - Addition of alcohol warning for children

Updated on 18 August 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through 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

Ethanol (96%)

Macrogolglycerol Hydroxystearate Ph. Eur.

Anise Oil

Peppermint Oil

Ponceau 4R (E124)

Purified water.

 

 

10 Date of revision of the text

February 2008

Updated on 27 March 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.8  Undesirable Effects
 
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 November 2007

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Supply through general sale

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 15 October 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 October 2006

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

10. Date of Revision of the Text

                            March 2006

Updated on 23 March 2006

Reasons for 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

Legal category:Supply through general sale

Updated on 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale