DAKTACORT CREAM

PACKAGE LEAFLET: INFORMATION FOR THE USER

DAKTACORT®

CREAM

(miconazole nitrate / hydrocortisone)

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
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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.
2.
3.
4.
5.
6.

What Daktacort Cream is and what it is used for
What you need to know before you use Daktacort Cream
How to use Daktacort Cream
Possible side effects
How to store Daktacort Cream
Contents of the pack and other information

1. What Daktacort Cream is and what it is
used for
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:
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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.
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Hydrocortisone - a mild ‘topical steroid’ which reduces
inflammation, swelling, redness and itching of the skin.

2. What you need to know before you use
Daktacort Cream
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
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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.
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Warnings and precautions

Talk to your doctor or pharmacist before using Daktacort
Cream if:
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The inflamed skin is on your face. You should not use
Daktacort Cream on your face, unless your doctor has
told you to
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You are using a ‘barrier’ method of contraception. This
includes condoms or diaphragms. This is because
Daktacort cream can damage the latex and stop them
from working properly. Talk to your doctor about using
another type of contraception while you are using this
medicine
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.

3. How to use Daktacort Cream
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
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Children

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.

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

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

Driving and using machines

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

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

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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

How much to apply - adults and children
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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.

If you forget to use Daktacort Cream
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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
Do not use a double dose of cream to make up for a
missed dose

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

4. Possible side effects
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.
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Swelling of the face, lips, tongue or throat, difficulty
swallowing or difficulty breathing
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Hives, 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)
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Skin irritation
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Burning sensation
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Itchy skin
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Irritability

Frequency not known:

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

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: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Daktacort Cream
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KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store the cream in its original packaging in a refrigerator
(2°C to 8°C).
Do not use Daktacort cream after the expiry date which
is stated on the label. The expiry date refers to the last
day of that month.
If your doctor decides to stop your treatment, take any
leftover cream back to the pharmacy.
If your cream appears to be discoloured, or shows any
other signs of deterioration, take them to your
pharmacist who will advise you.
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. Contents of the pack and other
information
What Daktacort Cream contains

The active substances in Daktacort Cream are miconazole
nitrate (2% w/w) and hydrocortisone (1% w/w).
The other ingredients are: macrogol ester, oleoyl
macroglycerides, liquid paraffin, benzoic acid (E210),
disodium edetate, butylated hydroxyanisole (E320) and
purified water.

What Daktacort Cream looks like and contents of
the pack
Daktacort Cream is a white cream available in 30g tubes.

Manufacturer

Manufactured by: Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium
Or
McGregor Cory Ltd., Middleton Close, Banbury, OX16 8RS,
UK.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0536

POM

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(Regulatory)
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following information:
Product name:
DAKTACORT CREAM
Reference No: 21828/0536
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Leaflet issue and revision date: 25.10.17
Daktacort® is a registered trademark of Johnson & Johnson.