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Active substance: MICONAZOLE NITRATE

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S655 LEAFLET Daktacort 20150917


(hydrocortisone and miconazole nitrate)
Your medicine is known as Daktacort cream and will be referred to
as Daktacort cream throughout the following leaflet.

Elderly patients
Medicines like Daktacort cream can cause thinning of the skin when
used for a long time without a break. Because thinning of the skin
happens naturally in older people, this medicine should be used
sparingly for no more than a few weeks in elderly patients. Only use
it for as long as your doctor tells you.
Other medicines and Daktacort cream

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Keep this leaflet. You may need to read it again

In particular, tell your doctor if you are taking;

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

Medicines that thin your blood (anticoagulants) such as
warfarin. Your doctor may want to check that the anticoagulants
are still working properly

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before using this medicine.

1. What Daktacort cream is and what it is used for
2. What you need to know before you use Daktacort cream

Driving and using machines

3. How to use Daktacort cream

Daktacort cream is not likely to affect you being able to drive or use
any tools or machines.

4. Possible side effects
5. How to store Daktacort cream
6. Contents of the pack and other information

Daktacort cream contains

Benzoic acid (E210) and butylated hydroxyanisole (E320),
which can mildly irritate the skin, eyes and mucosal membranes

Daktacort cream is a medicine which is used to treat inflamed
conditions of the skin such as eczema and dermatitis which may be
caused by infection with certain fungi and bacteria.
The cream contains the following ingredients:

Miconazole nitrate - an antifungal which works by destroying
both the fungus that causes the infection and some of the
associated bacteria which may also be present
Hydrocortisone - a mild ‘topical steroid’ which reduces
inflammation, swelling, redness and itching of the skin

Do not use Daktacort cream if:

You are allergic to miconazole nitrate, hydrocortisone, any of
the other ingredients of this medicine (listed in section 6) or to
other similar antifungal medicines

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
How to apply the cream

Each tube of Daktacort cream is sealed. Use the cap to pierce
the tube

Wash the infected area and dry it well

As many skin conditions are infectious, you should keep a towel
and flannel for your own use. Do not share them so that you do
not infect anyone else

Apply a small amount of Daktacort cream to the affected area
and rub it in gently until the cream has disappeared

Unless the infected skin is on your hands, wash your hands
carefully after applying the cream to avoid spreading the
infection to other parts of the body or to other people. Clothing
which comes into contact with the infected areas should be
washed and changed frequently. If your underwear is likely to
come into contact with Daktacort cream, it is preferable to wear
cotton underwear, as Daktacort cream may damage some
synthetic materials

You have any other skin problems such as cold sores, herpes,
chicken pox or shingles. Only use it for the skin problem that
you showed the doctor

Do not use this medicine if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before using
Daktacort cream.

How much to apply - adults and children

Unless your doctor tells you differently, apply a small amount of
Daktacort cream to the affected area 2 or 3 times each day

If your skin problem does not improve in 7 days, tell your doctor

Warnings and precautions
Talk to your doctor or pharmacist before using Daktacort if:

The inflamed skin is on your face. You should not use Daktacort
cream on your face, unless your doctor has told you to

You are using a ‘barrier’ method of contraception. This includes
condoms or diaphragms. This is because Daktacort cream can
damage the rubber and stop them from working properly. Talk
to your doctor about using another type of contraception while
you are using this medicine

If you swallow Daktacort cream
If anyone accidentally swallows Daktacort cream, contact a doctor
or go to your nearest hospital casualty department straight away.
If you forget to use Daktacort cream

The cream should not be used on young children for long periods of
time (such as every day for several weeks). The cream should not
be used on large areas of a child’s body or under a baby’s nappy
unless your doctor has told you.

Do not apply the missed dose of cream

Apply the next dose of cream as usual and keep using the
cream as your doctor has told you

Keep this medicine away from your eyes. If you get any cream in
your eyes, rinse with water straight away. Keep your eyes open
when you rinse.

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 medicine, ask
your doctor or pharmacist.



Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop using Daktacort cream and tell your doctor straight away
if you notice the following. You may need medical treatment.

What Daktacort cream contains

Each gram contains 20 mg of the active ingredient, miconazole
nitrate (2% w/w), and 10mg of the active ingredient
hydrocortisone (1% w/w/)

Daktacort Cream also contains the following inactive
ingredients: Tefose 63, labrafil M1944 CS, paraffin liquid,
benzoic acid, butylated hydroxyanisole, disodium edetate and
purified water.

Sudden swelling of the face, lips, tongue, wheezing or
shortness of breath

Severe irritation or reddening of the skin where the cream has
been used, or other signs of severe allergy
Tell your doctor or pharmacist if you notice or suspect any of
the following side effects:

What Daktacort cream looks like and contents of the pack

Uncommon side effects (affects fewer than 1 in 100 people)

Daktacort Cream is a white cream.

Skin irritation

Daktacort Cream is available in a 15g tube.

Burning sensation

Itchy skin

Product Licence holder

Hives (also known as nettle rash, or urticaria)


Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.

Frequency not known:

Lighter patches of skin

Sensitivity reactions (such as rash) at the application site.
Inflammation (contact dermatitis). If this occurs stop using the

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.


Store in a refrigerator (2-8°C).

Do not use the cream after the expiry date printed on the
packet. Always return any medicine that you do not use to your

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

This product is manufactured by Famar ABE, 49km Athens-Lamia,
Avlona, Attica, Greece.

PL: 19488/0655

Leaflet revision date: 17 September 2015
Daktacort is a registered trade mark of Janssen-Cilag, UK.
S655 LEAFLET Daktacort 20150917

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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.