Gyno-Daktarin 1200 mg vaginal capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Miconazole nitrate

Available from:

Janssen-Cilag Ltd

ATC code:

G01AF; G01AF04

INN (International Name):

Miconazole nitrate

Dosage:

1200 milligram(s)

Pharmaceutical form:

Vaginal capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Imidazole derivatives; miconazole

Authorization status:

Not marketed

Authorization date:

1989-06-09

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GYNO-DAKTARIN
® 1200 MG 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 capsule
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 1200 mg vaginal capsule. 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 capsule 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 ‘antifungals’.
Gyno-Daktarin vaginal capsule is used for infections of the vagina.
Signs of
these infections include itching, redness and white discharge.
Gyno-Daktarin vaginal capsule 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

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 1200 mg vaginal capsule.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1200 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
superinfection due 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)
One soft vaginal capsule inserted high into the vagina before retiring
at night. This is
best done in the reclining position.
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
Health Products Regulatory Authority
19 November 2018
CRN008LPD
Page 2 of 8
Gyno-Daktarin vaginal capsule 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 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 sexual partner is also
infected.
The concurrent use of latex condoms or diaphragms with vaginal
anti-infective
preparations may decrease the effectiveness of latex co