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 400 mg

Pharmaceutical form:

VAGINAL CAPSULE

Composition:

MICONAZOLE NITRATE 400 mg

Prescription type:

POM

Therapeutic area:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-12-29

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
GYNO-DAKTARIN 400MG
VAGINAL CAPSULE
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 vaginal capsule is and what it is used for
2.
What you need to know before you use Gyno-Daktarin vaginal capsules
3.
How to use Gyno-Daktarin vaginal capsule
4.
Possible side effects
5.
How to store Gyno-Daktarin vaginal capsule
6.
Contents of the pack and other information
1
WHAT GYNO-DAKTARIN VAGINAL CAPSULE IS AND WHAT IT IS USED FOR
The name of your medicine is Gyno-Daktarin 400mg vaginal capsules. It
is called ‘Gyno-
Daktarin vaginal capsule’ or just ‘capsule’ in this leaflet.
Gyno-Daktarin vaginal capsule is for use in adults.
Gyno-Daktarin vaginal capsules is a white to off-white, egg-shaped
pessary. When inserted into
the vagina it releases a medicine called miconazole nitrate. This
belongs to a group of medicines
called ‘anti-fungals’
Gyno-Daktarin vaginal capsules is used for infections of the vagina.
Signs of these infections
include itching, redness and white discharge.
Gyno-Daktarin vaginal capsules 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
Page 2 of 6
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 (_Cand

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gyno-Daktarin 400 mg vaginal capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg miconazole nitrate.
Also contains ethyl parahydroxybenzoate (E215) and sodium propyl
parahydroxybenzoate (E217)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal capsule, soft
White to off-white egg shaped soft vaginal capsule containing a white
to cream coloured
hydrophobic mass.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult females only.
For
the
local
treatment
of
vulvo-vaginal
Candida
infections,
including
those
with
super
infectiondue to susceptible gram-positive bacteria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gyno-Daktarin vaginal capsule is for vaginal administration.
Adults (aged 18 years and older)
Once daily before bedtime, insert one vaginal capsule deeply into the
vagina. This is best done in
the reclining position. Repeat this procedure for 3 days. The
treatment can be repeated if necessary.
Complete the entire treatment even if symptoms (e.g., pruritus and
leukorrhea) have disappeared or
menstruation begins.
In case of severe infections it may be advisable to prescribe a 6-day
treatment course right from the
start.
Paediatrics (aged under 18 years)
The safety and efficacy of Gyno-Daktarin vaginal capsule in children
and adolescents has not been
studied.
4.3
CONTRAINDICATIONS
Gyno-Daktarin vaginal capsule is contraindicated in individuals with a
known hypersensitivity to
miconazole/miconazole nitrate, other imidazole derivatives or another
ingredient of the soft vaginal
capsule.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Severe hypersensitivity reactions, including anaphylaxis and
angioedema, have been reported
during treatment with Gyno-Daktarin vaginal capsule and with other
miconazole formulations (see
section 4.8). If a reaction suggesting hypersensitivity or irritation
should occur, the treatment
should be discontinued.
Appropriate therapy is indicated when the se