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DAKTACORT 2% / 1% W/W CREAM

Active substance(s): HYDROCORTISONE / MICONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - AW_113958
© J-C 2016

2% / 1% w/w cream
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 cream is and what
it is used for
2 What you need to know before you
use Daktacort cream
3 How to use Daktacort cream
4 Possible side effects
5 How to store Daktacort cream
6 Contents of the pack and other
information

1 What Daktacort cream is and what it is used for
The name of your medicine is Daktacort
2% / 1% w/w cream. It is called Daktacort
cream in this leaflet.
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 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
• 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.

Warnings and precautions

Talk to your doctor or pharmacist before
using Daktacort if:
• The inflamed skin is on your face.
You should not use Daktacort cream
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
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.

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;
• 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

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

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

• 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

• 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

• 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.

© J-C 2016

GB - AW_113958

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.
• Swelling of the face, lips, tongue or throat,
difficulty swallowing or difficulty breathing
• 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)
• Skin irritation
• Burning sensation
• Itchy skin
• Irritability

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
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 cream
Keep this medicine out of the sight and
reach of children.
Store the cream in its original packaging
in a refrigerator (2°C – 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.

Do not throw away any medicines 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 are miconazole
nitrate (2% w/w) and hydrocortisone
(1% w/w).

Manufacturer:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium

The other ingredients are PEG-6,
PEG-32 and glycol stearate, oleoyl
macroglycerides, liquid paraffin, benzoic
acid (E210), disodium edetate, butylated
hydroxyanisole (E320) and purified water.

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.

What Daktacort cream looks like
and contents of the pack

This leaflet was last revised in April 2016.

Daktacort cream is a white cream available
in a 30 g tube.
Marketing Authorisation Holder:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe, Bucks,
HP12 4EG, UK

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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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