Gyno-Daktarin 1200mg vaginal capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Miconazole nitrate

Available from:

Janssen-Cilag Ltd

ATC code:

G01AF04

INN (International Name):

Miconazole nitrate

Dosage:

1.2gram

Pharmaceutical form:

Vaginal capsule

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 5012674030301

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_)

Summary of Product characteristics

OBJECT 1
GYNO-DAKTARIN 1200 MG VAGINAL CAPSULE
Summary of Product Characteristics Updated 17-Dec-2015 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Gyno-Daktarin 1200 mg vaginal capsule
2. Qualitative and quantitative composition
Each capsule contains 1200 mg miconazole nitrate
For 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
For the local treatment of vulvovaginal candidosis and superinfections
due to Gram-positive bacteria.
4.2 Posology and method of administration
Gyno-Daktarin vaginal capsules are for intravaginal administration.
Adults (aged 18 years and older)
One soft vaginal capsule to be inserted high in the vagina at bedtime,
as a single dose. 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
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.
Gyno-Daktarin vaginal capsules do not stain skin or clothes.
The concurrent use of latex condoms or diaphragms with vaginal
anti-infective preparations may decrease
the effectiveness of latex contraceptive agents. Therefore
Gyno-Daktarin vaginal capsules should not be
used concurrently with a latex condom or latex diaphragm.
4.5 In