Corsodyl Mint 0.2% w/v Mouthwash

  • Name:

    Corsodyl Mint 0.2% w/v Mouthwash

  • Company:
    info
  • Active Ingredients:

    Chlorhexidine digluconate

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/19

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Summary of Product Characteristics last updated on medicines.ie: 26/9/2019

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Andrews Liver Salts Effervescent Powder Active Ingredients Citric Acid (Anhydrous), Magnesium sulfate (dihydrate), Sodium Hydrogen Carbonate
Medicine Name Corsodyl Aniseed 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl 1% w/w Dental Gel Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl Freshmint 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl Mint 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Day Nurse Capsules Active Ingredients Paracetamol, Pholcodine, Pseudoephedrine Hydrochloride
Medicine Name Duofilm Cutaneous Solution Active Ingredients Lactic Acid, Salicylic Acid
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Medicine Name Excedrin 250 mg /250 mg /65 mg film-coated tablets Active Ingredients Aspirin, Caffeine, Paracetamol
Medicine Name Flixonase Allergy Relief Nasal Spray Active Ingredients Fluticasone Propionate
Medicine Name Lamisil 1% w/w Cream Active Ingredients Terbinafine hydrochloride
Medicine Name Lamisil AT Cream Active Ingredients Terbinafine hydrochloride
Medicine Name Lamisil Once 1% cutaneous solution Active Ingredients Terbinafine hydrochloride
Medicine Name Nicotinell Cool Mint 2mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Cool Mint 4mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 2mg medicated chewing-gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 4mg Medicated Chewing-Gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Mint 1mg Compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
Medicine Name Nicotinell Mint 2mg compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
Medicine Name Nicotinell TTS 10, 7 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 20, 14 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 30, 21 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Night Nurse Capsules Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Night Nurse Cold Remedy Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Oilatum Cream Active Ingredients Light Liquid Paraffin, White Soft Paraffin
1 - 0 of 53 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 26 September 2019 SmPC

Reasons for updating

  • Change to product name

Legal category: Supply through general sale

Updated on 9 August 2019 PIL

Reasons for updating

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

Updated on 8 August 2019 SmPC

Reasons for updating

  • Change to product name

Legal category: Supply through general sale

Updated on 22 June 2017 PIL

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 SmPC

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

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

Updated on 28 April 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 27 April 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 March 2016 PIL

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 SmPC

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 PIL

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 PIL

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 SmPC

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 4.4 Inclusion of excipient warnings for macrogolglycerol hydroxystearate
Section 4.8 Addition of information regarding the reporting of suspected adverse reactions

Updated on 2 January 2014 PIL

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 titledPaediatric 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 PIL

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 PIL

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 SmPC

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

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 July 2009 SmPC

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 4.2 - 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 August 2008 SmPC

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

30 September 1976/ 10 January 2005

 

10 Date of revision of the text

February 2008

Updated on 27 March 2008 SmPC

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

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 SmPC

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 27 October 2006 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 23 May 2003 PIL

Reasons for updating

  • New SPC for medicines.ie