DAKTARIN 20mg/g Oral Gel
- Name:
DAKTARIN 20mg/g Oral Gel
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/20
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Johnson & Johnson (Ireland) Ltd
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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 18 November 2020 PIL
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
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
Updated on 27 September 2018 PIL
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
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 10 - Date of revision of the text
Updated on 24 November 2017
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 24 November 2017 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - 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 PIL
Reasons for updating
- New PIL for new product
Updated on 23 November 2017 PIL
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 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
Updated on 21 July 2017 PIL
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 SPC
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
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 9 January 2017 PIL
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 SPC
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 SPC
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 PIL
Reasons for updating
- Change of contraindications
- Change to side-effects
Updated on 28 October 2015 PIL
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 SPC
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
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 7 September 2015 SPC
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 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 SPC
Reasons for updating
- Change to section 4 - Clinical particulars
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 15 October 2013 PIL
Reasons for updating
- Change to dosage and administration
Updated on 18 April 2013 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 12 July 2011 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 12 July 2011 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
Updated on 22 October 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 1 June 2010 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
Section 8: Change to PA number PA 823/59/3
Updated on 28 May 2010 PIL
Reasons for updating
- Change of licence holder
Updated on 18 November 2009 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 6 May 2008 PIL
Reasons for updating
- Change to marketing authorisation holder address
Updated on 29 April 2008 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
|
|
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 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 12 July 2006 SPC
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 PIL
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 8 June 2006 SPC
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 PIL
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 SPC
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 4 April 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 9 August 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through pharmacy only
Updated on 28 April 2004 SPC
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 5 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only