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DAKTACORT CREAM

Active substance(s): HYDROCORTISONE / MICONAZOLE NITRATE / HYDROCORTISONE / MICONAZOLE NITRATE / HYDROCORTISONE / MICONAZOLE NITRATE

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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.







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:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Daktacort Cream
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 rubber 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




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

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

If you swallow Daktacort Cream

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.

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.

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.


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.

Daktacort Cream Contains



3. How to use Daktacort Cream

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)



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.





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

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

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Skin irritation
Burning sensation
Itchy skin
Hives (also known as nettle rash, or urticaria)
Irritability

Frequency not known:

Other Formats

Reporting of side effects

Please be ready to give the following information:
Product name
Daktacort Cream
Reference number
21828/0536




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 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.

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.

Leaflet issue and revision date: 09.02.15
Daktacort® is a registered trademark of Johnson & Johnson.

5. How to store Daktacort Cream









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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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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