Gyno-Daktarin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MICONAZOLE NITRATE

Available from:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC code:

G01AF04

INN (International Name):

MICONAZOLE NITRATE 20 mg/g

Pharmaceutical form:

VAGINAL CREAM

Composition:

MICONAZOLE NITRATE 20 mg/g

Prescription type:

POM

Therapeutic area:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-12-29

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 c

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gyno-Daktarin 20 mg/g vaginal cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w
Each gram of cream contains 20 mg miconazole nitrate.
Excipients with known effect
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 52 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.
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.
2
Absorption of the antifungal may occur through denuded mucosa. To date
there have been no reports of
systematic adverse effects following a single dose.
Appropr