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DAKTARIN 20mg/g Oral Gel

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    Updated

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Miconazole

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

  • updated_daktarin_oral_gel_40g.jpeg

Updated on 29 November 2024

File name

ie-leaflet-daktarin-oral-gel-2376.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 November 2024

File name

ie-spc-v15-daktarin-oral-gel-2376.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 10 August 2023

File name

PIL.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 10 August 2023

File name

ie-spc-clean-rfi3-2263.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 18 November 2020

File name

ie-mockup-leaflet-2096.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 18 November 2020

File name

DKF02 2096 SPC 13.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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • 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 27 September 2018

File name

ie-mockup-leaflet-1770.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 27 September 2018

File name

DKF02 1770 SPC V12.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 24 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 24 November 2017

Reasons for updating

  • 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 - how to report a side effect
  • 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

Type II (Cat C.I.4) variation for the above-mentioned product to update the SPC following HPRA request for variation application.

The safety changes are proposed to sections 4.3, 4.4, 4.5, & 4.8 of the SPC in line with the HPRA request.

Updated on 23 November 2017

File name

PIL_9525_840.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 August 2017

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

Legal Entity has been changed to Johnson & Johnson (Ireland) Ltd, PA number updated to PL 330/048/003

Updated on 21 July 2017

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 13 January 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Text that has been highlighted and underlined has been added, text that has been highlighted and struck through has been removed:

4.1 Therapeutic Indications

In the management,

 

including prophylaxis, of fungal infections of the oral

 

cavity and gastro

 

‐intestinal tract in adults and paediatric patients 4 months and older.

 

Miconazole is effective against some Gram positive bacteria in adults and

paediatric patients 4 months and older, including Streptococcus pyrogenes,

Staphylococcus aureus and Erysipelothrix.

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

 22 December 2016

Updated on 09 January 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision

Updated on 19 January 2016

Reasons for updating

  • 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 4.4

 

 

 

It is important to take into consideration the variability of the maturation of the swallowing reflex in infants, especially when giving Daktarin Oral Gel to infants between the ages of 4-6 months

changed to:

Serious skin reactions (e.g. Toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported in patients receiving Daktarin Oral Gel (see Adverse Reactions). It is recommended that patients be informed about the signs of serious skin reactions, and that use of Daktarin Oral Gel be discontinued at the first appearance of skin rash.

 

It is important to take into consideration the variability of the maturation of the swallowing reflex in infants, especially when giving Daktarin Oral Gel to infants between the ages of 4-6 months.

Section 4.8

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

Updated on 11 November 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.3.      Contraindications

 

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



4.4.      Special Warnings and Precautions for Use

 

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

PRAC updates, SNAS 1409

Updated on 10 November 2015

Reasons for updating

  • Change of contraindications
  • Change to side-effects

Updated on 28 October 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 October 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.1 - clarification to age group in first sentence

In the management, including prophylaxis, of fungal infections of the oral cavity and gastro-intestinal tract in adults and paediatric patients 4 months and older.

 

Miconazole is effective against some Gram positive bacteria in adults and paediatric patients 4 months and older, including Streptococcus pyrogenes, Staphylococcus aureus and Erysipelothrix.

Updated on 07 September 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2 - QRD updates

Section 4.1

Miconazole is effective against some Gram positive bacteria in adults and paediatric patients 4 months and older, including Streptococcus pyrogenes, Staphylococcus aureus and Erysipelothrix.
Inclusion of age details. 


Section 4.2 - inclusion of information on the measuring spoon.

Section 4.4 - inclusion of the follwoing text

It is important to take into consideration the variability of the maturation of the swallowing reflex in infants, especially when giving miconazole gel to infants between the ages of 4-6 months.

Also due to the risk of choking, the gel must not be applied to the nipple of a breast-feeding woman for administration to an infant.



Section 4.5 - editorial changes
Section 4.6 - inclusion of text in red

It is not known whether miconazole or its metabolites are  excreted in human milk. Caution should be exercised when prescribing Daktarin Oral Gel to nursing mothers


Section 4.7 - QRD updates

Section 4.8 - substantial changes to this section, please refer to the SPC

Section 4.9 - deletion of the following paragraph

In the event of accidental ingestion of large quantities of Daktarin an appropriate method of gasrtic emptying may be used, if considered necessary. (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction.)

Updated on 16 October 2013

Reasons for updating

  • Change to section 4 - Clinical particulars

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Reduction in age range from 6 months to 4 months.

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 12 July 2011

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: Revised to provide adverse drug reactions identified from clinical trials and adverse drug reactions first identified from post-marketing experience; reference to Daktarin Oral Gel and Tablets Clinical Overview, and Cumulative Review of Post-Marketing Reports of Tongue Discoloration, Stomatitis, Dysgeusia, Burning Sensation and Dyspnea

Updated on 12 July 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 October 2010

Reasons for updating

  • Change to side-effects

Updated on 01 June 2010

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

Section 7: Change to McNeil Healthcare (Ireland) Limited, Airton road, Tallaght, Dublin 24.
Section 8: Change to PA number PA 823/59/3 

Updated on 28 May 2010

Reasons for updating

  • Change of licence holder

Updated on 18 November 2009

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

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of;

 

Excipients-contains Ethanol 96% 7.59 mg/g

 

For a full list of excipients, see 6.1

 

 

 

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Renewal  date changed to 10 Jul 2009

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to  30 October 2009

 

Updated on 16 November 2009

Reasons for updating

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

Updated on 06 May 2008

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 29 April 2008

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

Change to section 6.3 – Shelf Life

 3 years.

Change to section 10 – Date of revision of text

 February 2008

 

Updated on 15 February 2008

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

Change to section 6.3 - changed from 5 years to 3 years.
Change to section 10 - changed from April 2006 to February 2008

Updated on 12 July 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 2 - qualitative and quantitative composition

The statement ‘Each gram contains 20 mg miconazole’ has been added.

Change to section 3 - pharmaceutical form

The description of the product is added as White homogeneous gel having an orange taste.

Change to section 6. 5 - Nature and Contents of Container

A fuller description of the tube and dosing spoon is added.  The spoon is shown to have ¼ and ½ spoon measures, not just the ½ spoon (2.5 ml) dose.

Change to section 9 - Date of Renewal of Authorisation

The date of renewal has been altered to 2004

Correction of spelling/typing errors, including correction of the SPC headings

Updated on 12 July 2006

Reasons for updating

  • Change of active ingredient
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 08 June 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 20 September 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 September 2005

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 04 April 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 28 April 2004

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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only