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Gyno-Daktarin 20 mg/g vaginal cream

*
Pharmacy Only: Prescription

  • Company:

    Janssen Sciences Ireland

  • Status:

    Discontinued

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Miconazole Nitrate

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

Updated on 24 December 2020

File name

IE-Gyno-Daktain-SPC C16-23Dec20-clean EDMS-ERI-147547446 V9.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Quantitative declaration of excipient butylated hydroxyanisole corrected in section 2.

Updated on 21 August 2020

File name

IE-Gyno-Daktain-SPC C15-17Aug20-Clean EDMS-ERI-147547446_7.0.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated in line with the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’

Updated on 21 August 2020

File name

IE-Gyno-Daktain-PIL C11-17Aug20-clean_EDMS-ERI-147547229_5.0.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Updated to implement the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’

Updated on 12 April 2019

File name

IE-Gyno-Daktarin-C10-29mar19-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

IE-Gyno-Daktain-C14-29mar19-Clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 21 November 2018

File name

Gyno-Daktarin SPC cream-C13-V02-clean.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.9       Overdose

Symptoms

Gyno-Daktarin cream is intended for local application and not for oral use.

In case of accidental ingestion, vomiting and diarrhoea may occur.no problems are expected.

Treatment

In case the event of accidental ingestion of large quantities, the treatment is symptomatic and use appropriate supportive care. See also Section 4.5, Interactions with other medicinal products and other forms of interaction.

Updated on 15 January 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 January 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.8 angioneurotic edema has been removed from Immune system disorders and angioedema has been added in Skin and subcutaneous tissue disorders

Updated on 20 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$04.3.      Contraindications$0$0Gyno-Daktarin cream iscontraindicated in individuals with a known hypersensitivity to miconazole/miconazolenitrate, other imidazole derivatives or other ingredients in the formulation to any of the excipients listed insection 6.1.$0$04.4       Special warnings andprecautions for use$0$0Severe hypersensitivity reactions, including anaphylaxis and angioedema,have been reported during treatment with Gyno-Daktarin cream and with othermiconazole formulations (see section 4.8).If a reaction suggesting hypersensitivity or irritation should occur,the  treatment should be discontinued.$0$0If local irritation or an allergic reaction occurs, the treatment should be discontinuedAbsorption of the antifungal mayoccur through denuded mucosa. To date there have been no reports of systematicadverse effects following a single dose.$0$0$0$0Appropriate therapy is indicated when the sexualpartner is also infected.$0$0Gyno-Daktarin cream does not stain skin or clothes.$0$0The concurrent use of latex condoms or diaphragms withvaginal anti-infective preparations may decrease the effectiveness of latexcontraceptive agents.  ThereforeGyno-Daktarin cream should not be used concurrently with a latex condom orlatex diaphragm.$0$0Gyno-Daktarin cream contains benzoic acid, which is mildly irritant to the skin, eyes andmucous membranes, and butylated hydroxyanisole, which may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes.$0$0$0

Updated on 19 November 2015

File name

PIL_10874_30.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 November 2015

Reasons for updating

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

Updated on 28 July 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • 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
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2: Wording added regarding use in paediatrics
4.3: miconazole nitrate and other imidazole derivatives added
4.6: 'Lactation' changed to 'breastfeeding'
4.8: Update of reporting of adverse events wording
4.9: not for oral use. Reference to gastric emptying removed
10: 25 July 2014

Updated on 25 July 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 12 June 2013

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3.    Contraindications

Gyno-Daktarin cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredients of in the formulation.

Updated on 31 May 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8-Correction of typographical errors

Section 10- 24 May 2013

Updated on 18 October 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4: Addition of excipient warning statements
Change to section 10: 15 October 2012

Updated on 16 October 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 07 March 2012

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 5.2:  Change to information on Metabolism and Excretion

Change to section 10: 01 March 2012 

Updated on 04 August 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 11 April 2008

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:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

 Minor changes to the frequency of adverse events in table 1. Addition of Table 2 adverse events. Postmarketing advesre events was table 2 now table 3

 

 

Change to section 9 – Date of Renewal of Authorisation

 

Change to section 10 – Date of revision of the text

3rd April 2008

 

 

 

Updated on 11 April 2008

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Correction of spelling/typing errors
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision

Updated on 14 March 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 7 - address changed to 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Change to section 10 - Changed to March 2008

Updated on 14 March 2008

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 21 November 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 1. - Gyno-Daktarin 20 mg/g cream changed to Gyno-Daktarin 20 mg/g vaginal cream.
Change to section 2. - Added: Excipients: Each gram of cream contains 2mg benzoic acid and 5 micrograms of butylated hydroxyanisole.
Change to section 6.1. - Macrogol 6-32 stearate and glycol stearate changed to Macrogol ester.
Change to section 6.2. - None known changed to Not applicable.
Change to section 9. - 4 April 1977/20 August 2004 changed to 6th November 1987/6th November 2007.
Change to section 10. - December 2006 changed to November 2007.
 
 

Updated on 21 November 2007

Reasons for updating

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

Updated on 05 January 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 1 – trade name

NAME OF THE MEDICINAL PRODUCT

Addition of strength

Change to section 2 – quantitative and qualitative composition

Addition of standard statement

Change to section 4.2 – Posology and |Method of Administration

Changed for clarification

Change to section 4.4 – Special Warnings and Precautions for Use

Update warnings

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Update interactions

Change to section 4.6 – Pregnancy and Lactation

Update warnings

Change to section 4.8 – Undesirable effects

Update undesirable effects

Change to section 4.9 - Overdose

Update information

Change to section 5.1 - Pharmacodynamic properties

Update information

Change to section 5.2 - Pharmacokinetic properties

Update information

Change to section 5.3 - Preclinical Safety Data

Update information

Change to section 6.5 – Nature and Contents of Container

Updated

Change to section 6.6 –  Instructions for use, handling and disposal

Update headings

Change to section 9 – Date of Renewal of Authorisation

Update dates

Change to section 10 – Date of revision of text

Update dates

Updated on 05 January 2007

Reasons for updating

  • Change of active ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Correction of spelling/typing errors
  • Change to date of revision

Updated on 15 November 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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
  • Change to separate SPCs covering individual presentations

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1.

NAME OF THE MEDICINAL PRODUCT

X

 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

X

 

6.5

Nature and contents of container

Change to this section to remove reference to the fingerstall as it will no longer be included in the pack.

10.

DATE OF REVISION OF THE TEXT

 

November 2006

 

 

 

Change to separate SPCs covering individual presentations                                                                                                                                                                                                      

X

 

Updated on 09 May 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)