Corsodyl Mint 0.2% w/v Mouthwash * General Sale: Non-prescription
Company:
GlaxoSmithKline Consumer Healthcare (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 February 2021
File name
ie-pil-mint-redesign-approved-201207bc_1613644127.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to packaging
Updated on 17 February 2021
File name
ie-spc-mint-approved-200519BC_1613581818.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Updated on 26 September 2019
File name
Corsodyl Mint Mouthwash SPC_1569503901.pdf
Reasons for updating
- Change to product name
Legal category:Supply through general sale
Updated on 09 August 2019
File name
Corsodyl Mint 0.2 w-v Mouthwash label-leaflet_1565279466.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 Mint 0.2% w-v Mouthwash SPC_1565275710.pdf
Reasons for updating
- Change to product name
Legal category:Supply through general sale
Updated on 22 June 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 2: Editorial change
Section 4.2: Editorial changes to the sub-headings.
Section 4.4: Editorial changes to the sub-heading of Paediatric population
Section 10: Date of revision has been amended.
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
- 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
Updated on 27 April 2016
File name
PIL_12575_71.pdf
Reasons for updating
- New PIL for new product
Updated on 09 March 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 5.2 - Pharmacokinetic properties
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to joint SPC covering all presentations
Free text change information supplied by the pharmaceutical company
Section 1 – inclusion of details for all other strengths (combined SmPC created)
Section 2 – inclusion of details for all other strengths (combined SmPC created)
Section 3 - inclusion of details for all other strengths (combined SmPC created)
Section 4.1 – replaced “essential” with “primary” before “hypertension”.
Section 4.2 – minor editorial changes
Section 4.4 – inclusion of “co-trimoxazole also known as trimethoprim/sulfamethoxazole” under subheading “Hyperkalaemia” and minor editorial and formatting changes.
Section 4.8 – minor editorial changes.
Section 5.2 – minor editorial changes.
Section 8 – inclusion of details for all other strengths (combined SmPC created)
Section 10 – update to date of revision of text.
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 11 March 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
- Section 6.5 – addition of 90 tablet blister pack
- Section 10 – update to date of revision
Updated on 24 December 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.1
· Minor formatting to paragraph 1 to move the ‘the’ to the start of each bullet point
· Art 31 wording update
§ cross referencing
§ amendment to heart failure indication
Section 4.2
· formatting updates
· Art 31 wording update
§ cross referencing,
§ update to posology in heart failure section to include addition of information on co-adminstration of Atacand tablets with an ACE-inhibitor
Section 4.3
· Art 31 wording
§ addition of contraindication with Aliskiren
Section 4.4
· Art 31 wording
§ Dual blockade of renin-angiotensin-aldosterone system added
· Information added to concomitant therapy with an ACE-inhibitor in heart failure
· Updated information on kidney transplantation.
Section 4.5
· Art 31 update
§ Information on dual blockade of the RAAS system through combined use of ACE-inhibitors compared to single agents and frequency of adverse events.
Section 4.8
· minor formatting, addition of commas into frequencies in the first paragraph
· updated to include reflect the name change of the HPRA
Section 5.1
· Art 31 update
§ addition of trial data - ONTARGET and VA NEPHRON-D
Section 6.3
· formatting
Section 10
· Updated date of revision
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 - how to report a side effect
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.8 Addition of information regarding the reporting of suspected adverse reactions
Updated on 02 January 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Section 2: Change “the” è “a”
Section 3: “halves” è “doses”
Section 4.1: New bullet: Treatment of hypertension in children and adolescents aged 6 to <18 years.
Section 4.2: A large new sub-section titled “Paediatric Population” is added in “Posology in Hypertension” section.
A small change in section Paediatric population just deleting hypertension and (as information has now been added re hypertension).
Section 4.3: A cross ref to where the excipients are listed is added and a Contraindication in Children aged below 1 year (with a cross reference) is added.
Section 4.4: A new section titled Use in paediatric patient, including patients with renal impairment is added and extra paragraphs in sections on Hypotension and Pregnancy.
Section 4.5: A new section titled Paediatric population is added.
Section 4.6: Title is updated and Lactation heading is changed to Breastfeeding.
Section 4.8: A new section titled Paediatric population is added.
“adult” is added to the section on Treatment of Heart Failure (because there is now info on paeds elsewhere in the SmPC).
A new section titled Reporting of suspected adverse reactions is added.
Section 4.9: “in an adult” has been added to the first paragraph (because there is now info on paeds elsewhere in the SmPC)
Section 5.1 Some headings have been added for clarity.
A new sub-section titled Paediatric population - hypertension is added.
Section 5.2: A new section titled Paediatric population is added.
Section 5.3: A new paragraph is added about neonatal and juvenile rats and a new paragraph about renal development.
Updated on 22 June 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 6.5
Update to list of pack sizes
Section 10
Date of Revision changed to 15th June 2012
Updated on 22 December 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 2 - Update to be in line with CMC harmonised wording
Section 3 - Update to be in line with CMC harmonised wording
Section 6.1 – update to list of excipients for details related to iron oxide
Section 10 - Date of revision changed to 9th December 2011
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
"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 July 2009
Reasons for 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
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 August 2008
Reasons for 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
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
Sorbitol 70% (non-crystallising)
Ethanol (96%)
Macrogolglycerol hydroxystearate
Peppermint oil
Purified water
9 Date of first authorisation/renewal of the authorisation
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
Irritative skin reactions
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
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 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 23 May 2003
Reasons for updating
- New SPC for medicines.ie