Janssen-Cilag Ltd

Change to section 5.2 - Pharmacokinetic properties

Addition of more detailed information on absorption, distribution and metabolism

Change to section 4.8 – Undesirable effects

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

Change to section 10 – Date of revision of the text

Updated to 22 May 09

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

Change to section 9 Date of first authorisation/renewal of authorisation

Product licence renewal granted 12^th December 2008

Change to section 10 – Date of revision of the text

12 December 2008

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 section 10 – Date of revision of the text

4^th April 2008

Change to section 7 – Marketing Authorisation Holder

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

Change to section 8 – Marketing Authorisation Numbers

Change to section 9 – Date of Renewal of Authorisation

Change to section 10 – Date of revision of the text

    4^th April 2008

Change to section 1 –Name of the medicinal product

Gyno-Daktarin 20mg/g cream

Change to section 2 – quantitative and qualitative composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg miconazole nitrate)

For a full list of excipients, see section 6.1.

Change to section 6.5 – Nature and Contents of Container

Tube containing 15 g, 40 g or 78 g of cream.

The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap.

The cream is supplied with disposable cardboard vaginal applicators.

*Not all pack sizes are marketed.

Change to section 6.1 – List of Excipients

 PEG-6, PEG-32 and glycol stearate
 Oleoyl macroglycerides

Change to section 10 – Date of revision of the text

 14^thDec 2007

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 cream should not be used concurrently with a latex condom or latex”

Change to section 10 – Date of revision of the text

27 February 2007