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Active substance: MICONAZOLE NITRATE

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S655 LEAFLET Daktacort 20130207


(hydrocortisone and miconazole nitrate)

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

Your medicine is known as Daktacort cream and will be referred to
as Daktacort cream throughout the following leaflet.
Read all of this leaflet carefully before you start using this

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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours

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
or pharmacist

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

If you are pregnant or breast-feeding
Ask your doctor for advice before using this medicine if you are
pregnant or breast-feeding. Your doctor will decide if you can use
Daktacort cream.
Driving and using machines
Daktacort cream is not likely to affect you being able to drive or use
any tools or machines.

In this leaflet:

Important information about some of the ingredients of
Daktacort cream

1. What Daktacort cream is and what it is used for

2. Before you use Daktacort cream

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

3. How to use Daktacort cream
4. Possible side effects


5. How to store Daktacort cream

Always use Daktacort cream exactly as your doctor has told you.
Daktacort cream is for use on your skin only. You should check with
your doctor or pharmacist if you are not sure.

6. Further information

How to apply the cream

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.

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

Wash the infected area and dry it well

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

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

Hydrocortisone - a mild ‘topical steroid’ which reduces
inflammation, swelling, redness and itching of the skin

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

The cream contains the following ingredients:

Do not use Daktacort cream if:

You are allergic to anything in Daktacort cream (listed in section
6 below)

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 apply to you. If you are
not sure, talk to your doctor or pharmacist before using Daktacort

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

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

Take special care with Daktacort cream
Check with your doctor or pharmacist before using this medicine if:

If you forget a dose

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

Do not apply the missed dose of cream

The cream is to be used by children:

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

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

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

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.

Like all medicines Daktacort cream 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.

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:

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

Skin irritation

Burning sensation

Itchy skin

Hives (also known as nettle rash, or urticaria)


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

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


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.

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.

What Daktacort cream looks like and contents of the pack
Daktacort Cream is a white cream.
Daktacort Cream is available in a 15g tube.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.
This product is manufactured by Famar ABE, 49km Athens-Lamia,
Avlona, Attica, Greece.

PL No: 19488/0655

Leaflet revision date: 7 February 2013
Daktacort is a registered trade mark of Janssen-Cilag, UK.
S655 LEAFLET Daktacort 20130207

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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.