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DAKTACORT 2%/1% W/W OINTMENT

Active substance(s): HYDROCORTISONE / MICONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - 665955
© J-C 2015

2% / 1% w/w ointment
Miconazole nitrate and hydrocortisone
Daktacort is a registered trademark

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

• 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 What Daktacort ointment is and what
it is used for
2 What you need to know before you
use Daktacort ointment
3 How to use Daktacort ointment
4 Possible side effects
5 How to store Daktacort ointment
6 Contents of the pack and other
information

1 What Daktacort ointment is and what it is used for
The name of your medicine is Daktacort
2% / 1% w/w ointment. It is called Daktacort
ointment in this leaflet.
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
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 What you need to know before you use Daktacort
ointment
Do not use Daktacort ointment 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.
• 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.

Warnings and Precautions

Talk to your doctor or pharmacist before
using this Daktacort ointment if:
• The inflamed skin is on your face.
You should not use Daktacort ointment
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
ointment 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 ointment in your eyes, rinse
with water straight away. Keep your eyes
open when you rinse.

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.

Other medicines and Daktacort
ointment

Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines. This includes
medicines that you buy without a prescription
or herbal medicines.
In particular, tell your doctor if you are
taking;
• 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 taking this medicine.

Driving and using machines

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

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

3 How to use Daktacort ointment
Always use this medicine exactly as your
doctor has told you. Daktacort ointment is
for use on your skin only. 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

How much to apply - adults and
children

• 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 to use Daktacort
ointment

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

© J-C 2015

GB - 665955

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop using Daktacort ointment and tell
your doctor straight away if you notice
the following. You may need medical
treatment.
• Swelling of the face, lips, tongue or
throat, difficulty swallowing or difficulty
breathing
• Hives (also known as nettle rash or
urticaria), 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
• 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
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
By reporting side effects you can help
provide more information on the safety
of this medicine.

5 How to store Daktacort ointment
Keep this medicine out of the sight and
reach of children.
Store the ointment in its original packaging.
Store at or below 25oC.
Do not use this medicine after the expiry
date which is stated on the carton and
tube. The expiry date refers to the last day
of that month.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other information
What Daktacort ointment contains
The active substances 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.
Marketing Authorisation Holder:
Janssen-Cilag Ltd., 50-100 Holmers
Farm Way, High Wycombe, Bucks HP12
4EG, UK
Manufacturer:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium
OR
McGregor Cory Ltd, Middleton Close,
Banbury, OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in October 2015.

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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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