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GYNO-DAKTARIN 20 MG/G CREAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2014

20 mg/g cream
Miconazole nitrate
Gyno-Daktarin is a registered trademark

Read all of this lea et carefully
before you start using this
medicine.

• Keep this lea et. 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours
• If you get side e ects and they become
serious or if you notice any side e ects
not listed in this lea et, please tell your
doctor or pharmacist

In this lea et
1 What Gyno-Daktarin cream is and
what it is used for
2 Before you use Gyno-Daktarin
cream
3 How to use Gyno-Daktarin cream
4 Possible side e ects
5 How to store Gyno-Daktarin cream
6 Further information

1 What Gyno-Daktarin cream is and what it is used for
The name of your medicine is
Gyno-Daktarin 20 mg/g 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.
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 a ecting 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 contraceptives
• Wearing tight clothing
• Over use of hot baths and bath
additives
You can prevent infections coming back
by:
• Washing the infected area in the
morning and evening with plain, warm
water. It is important that you dry
thoroughly
• Wiping backwards (away from the
vagina) after visiting the toilet
• Not using medicated and perfumed
bath additives
• Not wearing tight clothing

2 Before you use Gyno-Daktarin cream
Do not use Gyno-Daktarin cream if:
• You are allergic to anything in the
cream (listed in section 6 below)
Do not use this medicine if this applies
to you. If you are not sure, talk to your
doctor or pharmacist before using
Gyno-Daktarin cream.

Take special care with
Gyno-Daktarin cream

Check with your doctor or pharmacist
before using this medicine:
• If you are using a ‘barrier’ method of
contraception. This includes condoms
or diaphragms. This is because
Gyno-Daktarin cream can damage the
rubber and stop them working properly.
Talk to your doctor about using another
type of contraception while you are
using this medicine
Do not allow other people to use your
annel or towel. This will stop them from
getting your infection.

Children and adolescents

Gyno-Daktarin cream is not
recommended for use in children or
adolescents under the age of 18.

Taking other medicines

Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines. This includes medicines
that you buy without a prescription or
herbal medicines.

In particular tell your doctor if you are
taking:
• Medicines to thin the blood
(anticoagulants) such as warfarin.
Your doctor will need to check that the
anticoagulant is working properly
• Medicines for diabetes, taken by mouth
• Medicines that act on the heart and
blood vessels called ‘calcium channel
blockers’ such as dihydropyridines and
verapamil
• Medicine for epilepsy called phenytoin
• Medicines to lower cholesterol called
lovastatin or simvastatin
Tell your doctor before taking, or if you
are already taking any of the above.
They may need to alter your treatment.

Pregnancy and breast-feeding

Please tell your doctor before using
Gyno-Daktarin cream if you are
pregnant, think you may be pregnant
or might become pregnant.
You may still be able to use
Gyno-Daktarin cream if your doctor
thinks you need to.
Talk to your doctor before using this
medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

Important information about
some of the ingredients of
Gyno-Daktarin cream

• The cream contains benzoic acid
(E210) and butylated hydroxyanisole
(E320). These can irritate your skin,
eyes, eyelids, mouth and nostrils if they
come into contact with them

3 How to use Gyno-Daktarin cream
Always use this medicine exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.

Using the cream

• Each tube of Gyno-Daktarin cream is
sealed. You will need to use the cap to
pierce the seal.
• Do not swallow the cream

For infections of the vagina

Your doctor may suggest treatment over
7 to 14 days:
• 7 day course - insert the cream into
the vagina twice each day for 7 days
• 10 to 14 day course - insert the cream
into the vagina once each day for 10 to
14 days
Your doctor will tell you how much cream
to use and for how long you should use it.

© J-C 2014

3 How to use Gyno-Daktarin cream (continued)
Inserting the cream with an
applicator
• Remove the cap from the tube. Use
the top of the cap to pierce the metal
seal on the cap
• Screw the yellow end of the applicator
with the green band onto the tube
• Squeeze the tube so that the
applicator barrel pushes the plunger
to the stop mark ( gure 1)
1

• Unscrew the lled applicator and
replace the cap on the tube
• Lie down with your knees bent and
spread apart. Insert the yellow end
of the applicator with the green band
well into your vagina
• Push the plunger rmly but gently.
Empty the cream into your vagina by
pushing the plunger as far as it will go
( gure 2)
2

For infections outside the vagina

• Apply the cream to the a ected area
twice each a day
• Lightly cover the skin around your
vagina with a thin, even layer of cream
• Always wash your hands with soap and
water after using the cream
Your doctor will tell you how often and for
how long to use the cream.

When to stop using
Gyno-Daktarin cream

Keep using the cream until the course is
nished, even during your period.
Do this, even if the redness, itching and
discharge go away before the end of the
course.

If you swallow Gyno-Daktarin
cream

If a large amount of cream is eaten or
swallowed talk to a doctor or go to the
nearest hospital casualty department
straight away.

If you forget a dose

• Don’t worry, apply the next dose of
cream as usual and keep using the
cream as your doctor has told you
• Do not use a double dose of cream
to make up for a missed dose

• Remove the applicator and put it in
the bin with your household rubbish
• Always wash your hands with soap
and water after using the cream
• The cream does not stain your skin
or clothes but you may want to use
a sanitary towel

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4 Possible side e ects
Like all medicines, Gyno-Daktarin cream
can cause side e ects, although not
everybody gets them.
Stop using Gyno-Daktarin cream and
tell your doctor straight away if you
notice the following. You may need
medical treatment.
• Severe irritation or reddening of the
skin, swelling of the face, lips, tongue
or throat, light headedness, wheezing
or di culty breathing or other signs of
allergy during the rst few days of
treatment. This only happens in a small
number of people.

Other side e ects:
• Local irritation (around or inside the
vagina), itching or burning sensation
of the treated area. This is much milder
than an allergic reaction. Tell your
doctor or pharmacist if these feelings
continue
• Skin rash or hives (also known as nettle
rash or urticaria)
• Stomach pain
• Low stomach pains (pelvic cramps)
• Headache
• Infection of urine or pain in passing urine
• Vaginal bleeding
• Feeling sick (nausea)
• Redness of the face
Reporting of side e ects,
If you get any side effects talk to your
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
doctor, pharmacist or nurse. This
includes any possible side e ects not
includes any possible side effects report
listed in this lea et. You can alsonot
side einects leaflet. You can Yellow Card
listed this directly via the also report
Scheme at:directly via the Yellow Card
side effects www.mhra.gov.uk/yellowcard
By reporting side e ects you can help
Scheme at: www.mhra.gov.uk/yellowcard
provide more information oncan help
By reporting side effects you the safety
of this medicine.
provide more information on the safety
of this medicine.

5 How to store Gyno-Daktarin cream
Keep out of the reach and sight of
children. Do not store above 25°C.
Do not use Gyno-Daktarin cream:
• After the expiry date which is stated on
the packaging. The expiry date refers to
the last day of that month
• If the tube seal is missing or broken
• If the cream is not white in colour

Medicines should not be disposed of via
wastewater or household waste.
Ask your pharmacist how to dispose of
medicines no longer required.
These measures will help protect the
environment.

6 Further information
The active substance in Gyno-Daktarin
cream is miconazole nitrate.
Gyno-Daktarin cream contains
2% miconazole nitrate.

Gyno-Daktarin cream is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium

The other ingredients are puri ed
water, PEG-6, PEG-32, glycol stearate,
oleoyl macroglycerides, liquid para n,
benzoic acid (E210) and butylated
hydroxyanisole (E320).

OR

What Gyno-Daktarin cream looks
like and contents of the pack
Gyno-Daktarin cream comes in an
aluminium tube containing 78 g of white
cream.

The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe, Bucks,
HP12 4EG, UK

McGregor Cory Ltd, Middleton Close,
Banbury, Oxfordshire OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in
February 2014.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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