Corsodyl 1% w/w Dental Gel
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
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
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
"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 4.4 - 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
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
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