Gyno-Daktarin 20mg/g vaginal cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Miconazole nitrate

Available from:

Janssen Sciences Ireland UC

ATC code:

G01AF04

INN (International Name):

Miconazole nitrate

Dosage:

20 milligram(s)/gram

Pharmaceutical form:

Vaginal cream

Therapeutic area:

miconazole

Authorization status:

Marketed

Authorization date:

1992-11-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GYNO-DAKTARIN
® 20 MG/G VAGINAL CREAM
Miconazole nitrate
Gyno-Daktarin is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or pharmacist

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 What Gyno-Daktarin cream is and what it is used for
2 What you need to know before you use Gyno-Daktarin cream
3 How to use Gyno-Daktarin cream
4 Possible side effects
5 How to store Gyno-Daktarin cream
6 Contents of the pack and other information
1 WHAT GYNO-DAKTARIN CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Gyno-Daktarin 20 mg/g vaginal cream.
In this leaflet it is called Gyno-Daktarin cream.
Gyno-Daktarin cream is for use in adults.
Gyno-Daktarin cream contains a medicine called miconazole nitrate.
This belongs to a group of
medicines called ‘antifungals’.
Gyno-Daktarin cream is used for infections of the vagina and the skin
around the vagina. Signs
of these infections include itching, redness and white discharge. The
infections, such as thrush
(_Candida_), are caused by fungi and yeasts.
Gyno-Daktarin cream works by destroying the fungus that causes the
infection and some of the
bacteria which may also be present.
Your sexual partner may also need to be treated. Ask your doctor for
advice.
ABOUT VAGINAL THRUSH
Vaginal thrush is a very common problem affecting women of all ages.
It has nothing to do
with poor hygiene. It is often caused by a fungus (_Candida albicans_)
that is present in
everybody. The fungus is normally kept in check by the body’s
defences.
Sometimes the fungus can b

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2020
CRN00C0PG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gyno-Daktarin 20mg/g vaginal cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w
Each gram of cream contains 20 mg miconazole nitrate.
Excipients: Each gram of cream contains 2 mg benzoic acid.
15 g: This medicine contains 30 mg benzoic acid in each tube of 15 g
cream which is equivalent to 2 mg/g cream.
40 g: This medicine contains 80 mg benzoic acid in each tube of 40 g
cream which is equivalent to 2 mg/g cream.
78 g: This medicine contains 156 mg benzoic acid in each tube of 78 g
cream which is equivalent to 2 mg/g cream.
Each gram of cream contains 0.052 mg of butylated hydroxyanisole.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal cream.
The cream is white and homogeneous.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gyno-Daktarin is for the local treatment of vulvo-vaginal candidosis
and superinfection due to susceptible Gram-positive
bacteria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gyno-Daktarin cream is for vaginal administration.
Adults (aged 18 years and older):
The contents of two applicators (10 g of cream) inserted high into the
vagina at night for 7 days.
Alternatively, the contents of one applicator inserted high into the
vagina at night for 14 days.
Continue the full 7 or 14 day course of treatment even after pruritus
and leukorrhoea have disappeared or menstruation begins.
Paediatrics (aged under 18 years)
The safety and efficacy of Gyno-Daktarin cream in children and
adolescents has not been studied.
4.3 CONTRAINDICATIONS
Gyno-Daktarin cream is contraindicated in individuals with a known
hypersensitivity to miconazole/miconazole nitrate, 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
Gyno-Daktarin cream and