Gyno-Daktarin 2% vaginal cream

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:

20mg/1gram

Pharmaceutical form:

Vaginal cream

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 5012674030219

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. It
is called
Gyno-Daktarin cream in this leaflet.
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’.
It is used for infections of the vagina and the skin around the
vagina. Signs of
these infections include itching, redness and white discharge.
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 can become a problem due to:

Recent use of antibiotics

Pregnancy

Use of oral

Summary of Product characteristics

OBJECT 1
GYNO-DAKTARIN 20MG/G CREAM
Summary of Product Characteristics Updated 11-May-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Gyno-Daktarin 20mg/g vaginal cream
2. Qualitative and quantitative composition
Miconazole nitrate 2% w/w.
(Each gram of cream contains 20mg miconazole nitrate)
Excipients: Each gram of cream contains 2mg benzoic acid and 5
micrograms of butylated
hydroxyanisole.
For a 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
For the local treatment of vulvovaginal candidosis and superinfections
due to gram-positive bacteria.
4.2 Posology and method of administration
Gyno-Daktarin vaginal cream is for vaginal administration.
Adults (aged 18 years and older)
Administer the contents of one applicator (about 5g of cream) once
daily deeply into vagina for 10 – 14
days or twice daily for 7 days. For vulvitis the cream should be
applied topically twice daily. Continue the
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 vaginal cream in children and
adolescents has not been studied.
4.3 Contraindications
Gyno-Daktarin vaginal 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 vaginal cream 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 cream does not stain skin or clothes.
The concurrent use of latex condoms or diaphragms with vaginal
an