GYNO-DAKTARIN 20MG/G CREAM
Active substance(s): MICONAZOLE NITRATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gyno-Daktarin 20mg/g Cream
Your medicine is known as “Gyno-Daktarin 20mg/g Cream” but will
be referred to as “Gyno-Daktarin cream” throughout the following
Read all of this leaflet carefully before you start using this
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 GynoDaktarin 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 flannel or towel. This will stop
them from getting your infection.
Keep this leaflet. You may need to read it again
Taking other medicines
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
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.
If you get side effects and they become serious or if you notice
any side effects not listed in this leaflet, please tell your doctor
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
In this leaflet
Medicines for diabetes, taken by mouth
1. What Gyno-Daktarin cream is and what it is used for
Medicines that act on the heart and blood vessels called
‘calcium channel blockers’ such as dihydropyridines and
4. Possible side effects
Medicine for epilepsy called phenytoin
5. How to store Gyno-Daktarin cream
Medicines to lower cholesterol called lovastatin or simvastatin
6. Further information
Tell your doctor before taking, or if you are already taking any of the
above. They may need to alter your treatment.
2. Before you use Gyno-Daktarin cream
3. How to use Gyno-Daktarin cream
1. WHAT GYNO-DAKTARIN CREAM IS AND WHAT IT IS USED
The name of your medicine is Gyno-Daktarin cream.
Gyno-Daktarin cream contains a medicine called miconazole
nitrate. This belongs to a group of medicines called ‘antifungals’.
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.
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.
Talk to your doctor before using this medicine if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
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
Important information about some of the ingredients of
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:
The cream contains benzoic acid and butylated hydroxyanisole.
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.
Recent use of antibiotics
Use of oral contraceptives
Do not swallow the cream
For infections of the vagina
Wearing tight clothing
Your doctor may suggest treatment over 7 to 14 days:
Over use of hot baths and bath additives
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
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
Your doctor will tell you how much cream to use and for how long
you should use it.
Not wearing tight clothing
Inserting the cream with an applicator
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
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
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 (figure 1)
Unscrew the filled 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
Push the plunger firmly but gently. Empty the cream into your
vagina by pushing the plunger as far as it will go (figure 2)
If you get side effects and they become serious or if you notice any
other side effects not listed in this leaflet, please tell your doctor or
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE GYNO-DAKTARIN CREAM
Remove the applicator and put it in the bin with your household
Always wash your hands with soap and water after using the
The cream does not stain your skin or clothes but you may want
to use a sanitary towel
KEEP OUT OF THE SIGHT AND REACH 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 to
protect the environment.
For infections outside the vagina
Apply the cream to the affected area twice each a day
Lightly cover the skin around your vagina with a thin, even layer
Always wash your hands with soap and water after using the
Your doctor will tell you how often and for how long to use the
When to stop using Gyno-Daktarin cream
Keep using the cream until the course is finished, even during your
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
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gyno-Daktarin cream can cause side effects,
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
Severe irritation or reddening of the skin, swelling of the face,
lips tongue or throat, light headedness, wheezing or difficulty
breathing or other signs of allergy during the first few days of
treatment. This only happens in a small number of people.
Other side effects:
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
Skin rash or hives (also known as nettle rash or urticaria)
Low stomach pains (pelvic cramps)
Infection of urine or pain in passing urine
Feeling sick (nausea)
Redness of the face
6. FURTHER INFORMATION
What Gyno-Daktarin cream contains
The active substance is miconazole nitrate. Each gram of
cream contains 20mg of miconazole nitrate.
Other ingredients are: tefose, labrafil, mineral oil, butylated
hydroxyanisole, benzoic acid and purified water.
What Gyno-Daktarin cream looks like and contents of the pack
Gyno-Daktarin cream is available in a 78g aluminium tube with a
white screw cap containing white smooth, homogenous cream and
16 single use applicators in a separate cardboard box contained in
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
This product is manufactured by Famar AEB, 49Km Avlonas,
PL No: 19488/1720
Leaflet revision date: 29 April 2014
Gyno-Daktarin is a registered trademark of Janssen - Cilag.
S1720 LEAFLET Gyno-daktarin 20140429
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.