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Daktarin 2% w/w Cream

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Miconazole Nitrate

    *Additional information is available within the SPC or upon request to the company

  • updated_daktarin_cream_30g.jpeg

Updated on 29 April 2024

File name

ie-pil-daktarin-cream-2381.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 29 April 2024

File name

ie-spc-v10-Daktarin-Cream-2381.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 07 December 2020

File name

ie-mockup-leaflet-clean-2095.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 07 December 2020

File name

ie-spc-clean-2095.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 23 July 2020

File name

ie-mockup-leaflet-clean-2072.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 17 June 2019

File name

DKD02 1656 SPC V8.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 25 January 2018

File name

PIL_9516_528.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 January 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 23 January 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

 

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.

Updated on 19 January 2016

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

Section 4.8

 

 

Angioedema moved from SOC "Immune System Disorders" to Skin and "subcutaneous Tissue Disorders"

Updated on 19 November 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3 - Addition of the underlined text:

Hypersensitivity to the active substance, other imidazole derivatives or to any of the excipients listed in section 6.1.

Section 4.4 - addition of the following text 

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole topical formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Daktarin Cream must not come into contact with the mucosa of the eyes.


Section 4.8  - Additional of adverse event reporting details

(Miconazole PRAC updates, SNAS 1409)

Updated on 18 November 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 24 June 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Additonal side effects and revised overdosage section.

Updated on 16 October 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to directions for use.

Updated on 15 October 2013

Reasons for updating

  • Change to dosage and administration

Updated on 18 April 2013

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 October 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 4.4, the following excipient warning has been added:
Benzoic acid (E210) can mildly irritate the skin, eyes and mucosal membranes.
Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucosa membranes.

In Section 6.1, the Macrogol content has been clarified:
Macrogol 6 (PEG 6)
Macrogol 32 (PEG 32)

Updated on 12 August 2010

Reasons for updating

  • Change of manufacturer

Updated on 29 October 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

MA Holder changed to McNeil Healthcare Ireland Limited. MA Number changed to PA 823/59/1

     

Updated on 23 October 2009

Reasons for updating

  • Change to MA holder contact details

Updated on 13 May 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

1.

NAME OF THE MEDICINAL PRODUCT

Changed to Daktarin  2% w/w Cream

 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of :   Excipients; contains 0.2% w/w benzoic acid (E210) and 0.005% w/w butylated hydroxyanisole (E320)

 

Addition of Full statement added: For a full list excipients, see section 6.1.

6.1

List of excipients

 

Name change: unsaturated polyglycolysed glycerides to oleoylmacroglycerides

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Renewal of product licence  31 March 2008

10.

DATE OF REVISION OF THE TEXT

 

Changed to May 2009

 
 

Updated on 11 May 2009

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 19 January 2009

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 19 January 2009

Reasons for updating

  • PIL re-instated

Updated on 20 March 2006

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 20 March 2006

Reasons for updating

  • Change to drug interactions
  • Change to side-effects

Updated on 17 May 2005

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 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through pharmacy only

Updated on 31 March 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only