Gyno-Daktarin 20mg/g vaginal cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Miconazole nitrate

Available from:

Janssen-Cilag Ltd

ATC code:

G01AF04

INN (International Name):

Miconazole nitrate

Dosage:

20 milligram(s)/gram

Pharmaceutical form:

Vaginal cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

miconazole

Authorization status:

Marketed

Authorization date:

1987-11-06

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 ca

Summary of Product characteristics

Health Products Regulatory Authority
19 November 2018
CRN008LPD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gyno-Daktarin 20mg/gvaginal 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 2mg benzoic acid and 5
micrograms 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.
Health Products Regulatory Authority
19 November 2018
CRN008LPD
Page 2 of 8
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 with other
miconazole
formulations (see section 4.8). If a reaction suggesting
hypersensitivity or irritation
should occur, the treatment should be discontinued.
Absorption of the antifungal may occur through denuded mucosa. To date
there
have been no reports of systematic adverse e