Active substance: MICONAZOLE NITRATE

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GB - 992324
© J-C 2013

Miconazole nitrate and hydrocortisone
Daktacort is a registered trademark

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

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

1 What Daktacort ointment is and what it is used for
Daktacort ointment 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 ointment contains the following
• 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 ointment
Do not use Daktacort ointment if:
• You are allergic to anything in Daktacort
ointment (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 applies to you. If you are not sure,
talk to your doctor or pharmacist before
using Daktacort ointment.

Take special care with Daktacort

Check with your doctor or pharmacist
before using this medicine if:
• The inflamed skin is on your face.
You should not use Daktacort ointment
on your face, unless your doctor has told
you to
• The ointment is to be used by children:
- The ointment should not be used on
young children for long periods of time
(such as every day for several weeks)
- The ointment should not be used on
large areas of a child’s body or under
a baby’s nappy unless your doctor has
told you to
• You are using a ‘barrier’ method
of contraception. This includes condoms
or diaphragms. This is because Daktacort
ointment 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 ointment 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 ointment.

Driving and using machines

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

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

How to apply the ointment

• Each tube of Daktacort ointment 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
ointment to the affected area and rub
it in gently
• Unless the infected skin is on your hands,
wash your hands carefully after applying
the ointment 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
ointment it is preferable to wear cotton
underwear, as Daktacort ointment may
damage some synthetic materials

992324.pdf - Page 1 of 3 - July 26, 2013 - 10:48:16

How much to apply - adults and

• Unless your doctor tells you differently,
apply a small amount of Daktacort
ointment 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 ointment
If anyone accidentally swallows Daktacort
ointment, 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 ointment
• Apply the next dose of ointment as usual
and keep using it as your doctor has
told you
• Do not use a double dose of ointment
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 - 992324

4 Possible side effects
Like all medicines this medicine can cause
side effects, although not everybody gets
Stop using Daktacort ointment and tell
your doctor straight away if you notice
the following. You may need medical
• Sudden swelling of the face, lips, tongue,
wheezing or shortness of breath
• Severe irritation or reddening of the skin
where the ointment 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 (may affect
up to 1 in 100 people)
• Skin irritation
• Burning sensation
• Itchy skin
• Hives (also known as nettle rash
or urticaria)
• Irritability

Not known (frequency cannot be
estimated from the available data):
• 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 any side effects talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet.

5 How to store Daktacort ointment
Keep the product out of the reach and sight
of children.
Store the ointment in its original packaging.
Do not store above 25°C.
Do not use Daktacort ointment after the
expiry date which is stated on the packaging.
The expiry date refers to the last day of that

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
ointment are miconazole nitrate (2% w/w)
and hydrocortisone (1% w/w).
The other ingredients are liquid paraffin
and polyethylene.

What Daktacort ointment looks
like and contents of the pack

Daktacort ointment is a white odourless,
fatty ointment 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 ointment is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium
McGregor Cory Ltd, Middleton Close,
Banbury, OX16 4RS, UK

992324.pdf - Page 2 of 3 - July 26, 2013 - 10:48:16

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.