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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/04/2012
SPC Gyno-Daktarin 1200 mg vaginal capsule

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 5.2 - Revised statement of apparent elimination half-life
Change to section 10 - 17 April 2012
Updated on 13/04/2012 and displayed until 23/04/2012
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 5.3: New statement
Change to section 10: 29 March 2012  
Updated on 08/03/2012 and displayed until 13/04/2012
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
change to appearance of vaginal capsule.

from 'White'  to 'White to off white'
Updated on 03/01/2012 and displayed until 08/03/2012
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   21-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 Changed from 5 years to 24 months
Section 6.4 Changed from ‘Do not store above 25°C’ to ‘Do not store above 30°C’
Section 10: 21st December 2011
Updated on 07/08/2009 and displayed until 03/01/2012
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   23-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 5.2 - Pharmacokinetic properties

Addition of more detailed information on absorption, distribution and metabolism
Updated on 02/06/2009 and displayed until 07/08/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.8 – Undesirable effects

Addition of tabulated adverse events reported during single blind clinical trials and postmarketing experience

Change to section 10 – Date of revision of the text

Updated to 22 May 09
Updated on 26/03/2009 and displayed until 02/06/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 5.1 - Pharmacodynamic properties

Addition of : Pharmacotherapeutic classification

Change to section 10 – Date of revision of the text

Change to March 2009
Updated on 03/11/2008 and displayed until 26/03/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 2 – quantitative and qualitative composition

Addition of ‘For a full list of excipients’

Change to section 3 – pharmaceutical form

Addition of ‘egg-shaped ‘ in the description

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

Change in heading to:

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Changed to, No special requirements

Change to section 10 – Date of revision of the text

Changed to 29th October 2008
Updated on 06/05/2008 and displayed until 03/11/2008
Reasons for adding or updating:
  • 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 4.9 - Overdose
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

Change

eMC - Summary of Change Details Per Section

 

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

Miconazole administered systemically is known to inhibit CYP3A4/2C9.  Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely.  In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.  The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.

 

Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin cream since the constituents of the cream may damage the latex. (see section 4.4). 

 

Change to section 4.6 – Pregnancy and Lactation

Addition of headings ‘Pregnancy’  and ‘Lactation’

Change to section 4.9 - Overdose
Treatment

In the event of accidental ingestion of large quantities, an appropriate method of gastric emptying may be used if considered appropriate.

 

Change to section 7 – Marketing Authorisation Holder

 Change to High Wycombe address

Change to section 10 – Date of revision of the text

21sth April 2008
Updated on 21/06/2007 and displayed until 06/05/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

Gyno-Daktarin vaginal capsules are for intravaginal administration.

Adults and Elderly

One soft vaginal capsule to be inserted high in the vagina at bedtime, as a single dose. This is best done in the reclining position.

Children

Not recommended.

Date of revision of the text
18th June 2007
Updated on 11/05/2007 and displayed until 21/06/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 – Special Warnings and Precautions for Use

“General hygienic measures should be observed to control sources of infection and reinfection” text removed

 

Addition of  “The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents.  Therefore Gyno-Daktarin vaginal capsules should not be used concurrently with a latex condom or latex”

Change to section 10 – Date of revision of the text

27 February 2007
Updated on 07/11/2006 and displayed until 11/05/2007
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

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 26/07/2006 and displayed until 07/11/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
Date of revision of text on the SPC:   01/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

1          NAME OF THE MEDICINAL PRODUCT

Gyno-Daktarin 1200 mg vaginal capsule
Updated on 30/04/2004 and displayed until 26/07/2006
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/04/2004 and displayed until 30/04/2004
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 29/08/2001 and displayed until 29/04/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 29/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  miconazole nitrate