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Corsodyl 1% w/w Dental Gel

  • Name:

    Corsodyl 1% w/w Dental Gel

  • Company:
    info
  • Active Ingredients:

    Chlorhexidine digluconate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/07/18

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Summary of Product Characteristics last updated on medicines.ie: 29/4/2016
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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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 Mint 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
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Medicine Name Nicotinell Fruit 4mg Medicated Chewing-Gums Active Ingredients Nicotine-polacrilin
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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
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1 - 0 of 52 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 23 July 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 11 May 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 29 April 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 29 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 - 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 PIL

Reasons for updating

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

Updated on 3 February 2016 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 July 2015 SmPC

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 SmPC

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 6 March 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 25 February 2014 PIL

Reasons for updating

  • Change of manufacturer

Updated on 22 October 2010 SmPC

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 PIL

Reasons for updating

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

Updated on 15 July 2009 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

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 March 2006 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only