DAKTACORT CREAM

Active substance: MICONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB-IE - 992325
© J-C 2013

cream
Miconazole nitrate and hydrocortisone
Daktacort is a registered trademark

Read all of this leaflet carefully
before you start using this
medicine.

• 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

In this leaflet
1 What Daktacort cream is and what
it is used for
2 Before you use Daktacort cream
3 How to use Daktacort cream
4 Possible side effects
5 How to store Daktacort cream
6 Further 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:
• 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

2 Before you use Daktacort cream
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 cream.

Take special care with Daktacort
cream

Check with your doctor or pharmacist
before using this medicine if:
• The inflamed skin is on your face.
You should not use Daktacort cream
on your face, unless your doctor has
told you to
• The cream is to be used by 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
• 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

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.

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.
• 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 breastfeeding

Ask your doctor for advice before using this
medicine if you are pregnant or breastfeeding. 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.

Important information about
some of the ingredients
of Daktacort cream

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

3 How to use 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.

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

992325.pdf - Page 1 of 3 - July 24, 2013 - 06:55:09

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.

If you forget a dose

• 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 product, ask your doctor
or pharmacist.

© J-C 2013

GB-IE - 992325

4 Possible side effects
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.

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
medicine
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 pharmacist.

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)
• Irritability

5 How to store Daktacort cream
Keep the product out of the reach and sight
of children.
Store the cream in its original packaging
in a refrigerator.
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.

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 substances in Daktacort
cream are miconazole nitrate (2% w/w)
and hydrocortisone (1% w/w).
The other ingredients are PEG-6,
PEG-32 and glycol stearate, oleoyl
macroglycerides, mineral oil, benzoic acid,
sodium edetate, butylated hydroxyanisole
and purified water.

What Daktacort cream looks like
and contents of the pack

Daktacort cream is a white cream available
in a 30 g tube.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe, Bucks,
HP12 4EG, UK
Daktacort cream is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close,
Banbury, OX16 4RS, UK

992325.pdf - Page 2 of 3 - July 24, 2013 - 06:55:09

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in July 2013.

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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.

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