Daktarin 2% w/w Cutaneous Powder
- Name:
Daktarin 2% w/w Cutaneous Powder
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/01/18

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Johnson & Johnson (Ireland) Ltd
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Company Products
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 17 June 2019 SPC
Reasons for updating
- File format updated to PDF
Legal category: Supply through pharmacy only
Updated on 25 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 25 January 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 23 January 2018 SPC
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 SPC
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 SPC
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
Hypersensitivity to the active substance, other imidazole derivatives or to any of the excipients listed in section 6.1.
Section 4.4
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 Powder must not come into contact with the mucosa of the eyes.
Miconazole PRAC updates SNAS 1409
Section 4.8- addition of AE reporting details
Updated on 18 November 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Addition of information on reporting a side effect.
Updated on 24 June 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 18 April 2013 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 12 August 2010 PIL
Reasons for updating
- Change of manufacturer
Updated on 2 November 2009 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 29 October 2009 SPC
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
Updated on 12 May 2009 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
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 Cutaneous Powder from Daktarin Powder
|
2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
Addition of 20mg/g
Full statement added: For a full list excipients, see section 6.1. |
6.1 |
List of excipients |
E number added to talc Name corrected : Silica, colloidal anhydrous |
9. |
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
Renewal of product licence March 2008 |
10. |
DATE OF REVISION OF THE TEXT |
Changed to May 2009 November 2006
|
Updated on 11 May 2009 PIL
Reasons for updating
- Change to date of revision
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to storage instructions
Updated on 4 October 2007 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Updated on 11 April 2006 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 20 March 2006 SPC
Reasons for updating
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category: Supply through pharmacy only
Updated on 5 October 2005 PIL
Reasons for updating
- Change of manufacturer
- Correction of spelling/typing errors
Updated on 22 September 2005 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
Updated on 22 September 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 5 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only