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Corsodyl 1% w/w Dental Gel

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Pharmacy Only: Non-prescription
  • dentalgel.png

Updated on 08 February 2024

File name

PL 446730062_cropped carton label Corsodyl Gel.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Addition of Tingling / numbness of the mouth to section 2 of the PIL / Product label. 

Updated on 13 June 2023

File name

PA0678 2 1_Clean proposed Carton Corsodyl Gel_M.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 1_ Clean SPC Corsodyl Dental Gel_M.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Company Name changed from GSK to Haleon Ireland Ltd.

Updated on 08 April 2022

File name

ie-spc-Dental Gel-approved 16-Apr-2021.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category:Supply through pharmacy only

Updated on 26 October 2021

File name

ie-spc-Dental Gel-approved 16-Apr-2021.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

Updated on 19 April 2021

File name

ie-pil-approved-210416.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 19 April 2021

File name

ie-spc-corsodyl dental gel-approved-210416.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

Updated on 17 February 2021

File name

ie-spc-dental gel-approved-200519BC.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Updated on 23 July 2018

File name

uk-mockup-label-gel-carton-proposed.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 11 May 2016

File name

PIL_12574_361.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 May 2016

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 29 April 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 29 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

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

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 03 February 2016

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

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 10 March 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 Addition of information on how to report a side effect

Updated on 06 March 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 25 February 2014

Reasons for updating

  • Change of manufacturer

Updated on 22 October 2010

Reasons for updating

  • 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2 (Qualitative and Quantitative composition) as follows was updated as follows:


"Chlorhexidine Digluconate 1.0% w/w  (as Chlorhexidine Digluconate Solution)

Excipients: Contains Macrogolglycerol Hydroxystearate1% w/w

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

Section 9 (date of Authorisation/Renewal of the Authorisation) was updated to read as follows:
"29 April 1975/ 10 January 2010"

Section 10 (Date of Revision) was changed to September 2010.

Updated on 13 August 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 - Updated warnings for children
Section 4.4 - Updated adverse effects eg irritation/discoloration
Section 4.8 - Addition of numbness and and tingling

Updated on 19 August 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8

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.

 

Section 9

29 April 1975/ 10 January 2005

 

Section 10

February 2008

Updated on 27 March 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 4.8 - Undesirable Effects
 

The second sentence in section 4.8 of the SPC, which currently reads "Generalised allergic reactions to chlorhexidine have been reported but are extremely rare" should be deleted and replaced with the following: "Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare."

Updated on 15 October 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 March 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 pharmacy only

Updated on 19 January 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only