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DAKTACORT HYDROCORTISONE CREAM

Active substance(s): HYDROCORTISONE ACETATE / MICONAZOLE NITRATE

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Hydrocortisone acetate, miconazole nitrate

®

Sweat rash (candida intertrigo, or ‘thrush’ of the skin folds) is a sore,
itchy red rash found in areas where the skin rubs together e.g. below or
between the breasts, underarms, tops of legs or the groin or other skin
areas.

Athlete’s Foot is a fungal skin infection causing soreness, itching and
flaking between the toes or on the soles or sides of the feet.

Ask your doctor or pharmacist if you are in doubt.
This medicine is for use in adults and children aged 10 years and over.

If you have a fungal infection without any symptoms of inflammation,
an antifungal medication without hydrocortisone acetate may be more
appropriate.

This medicine is used to treat inflamed sweat rash and Athlete’s Foot
skin infections.
This medicine is for use by adults and children aged 10 years and over.

■ If you are allergic to the active substance, other similar antifungal
medicines or any of the other ingredients of this medicine (listed in
section 6)
■ If you have any other skin problems such as cold sores, acne,
herpes, chicken pox, or shingles.
■ If your skin is broken.
■ On large areas of your body, under dressings, or baby’s nappies.
■ For more than 7 days.
■ On your face, eyes or mucous membranes.
■ On the anal or genital area, unless your doctor has told you to.
■ If it is for a child under 10 years of age, unless your doctor has told
you to.
■ To treat ringworm, unless your doctor has told you to.
■ To treat any other infections which occur as a result of your
original infection, unless your doctor has told you to.
If this applies to you, get advice from a doctor or pharmacist
without using Daktacort Hydrocortisone Cream.

X Do not use this medicine…

2 Before using this medicine

Do not use this medicine:
■ There are some people who should not use this medicine.
To find out if you are one of them. See Section 2 c
■ If you are allergic to the active substance, other similar antifungal
medicines or any of the other ingredients of this medicine
(listed in section 6) c
c

This medicine is suitable for most adults and children but a few
people should not use it. If you are in any doubt, talk to your doctor or
pharmacist.

Speak to your doctor:
If you suffer from any of the conditions mentioned in Section 2
If you are taking any other medicines. See Section 2 c



Follow the instructions on how to use this product carefully.
See Section 3 c

Now read this whole leaflet carefully before you use this medicine.
Keep the leaflet: you might need it again.

1 What the medicine is for
Daktacort Hydrocortisone Cream is a medicine which is used to treat
inflamed sweat rash or Athlete’s Foot.
The cream contains the following ingredients:
Hydrocortisone acetate is a mild ‘topical steroid’ which reduces
inflammation, swelling, redness and itching of the skin.
Miconazole nitrate is an antifungal which works by destroying both the
fungus that causes the infection and some of the associated bacteria
which may also be present.

!

!

Elderly patients

How to apply the cream



3 How to use this medicine

Dose

If you forget to use the medicine

If anyone accidentally swallows Daktacort Hydrocortisone Cream,
contact a doctor or your nearest Accident and Emergency
department (Casualty), taking this leaflet and pack with you.

If anyone has swallowed this product

Adults and children
Put a small amount of the cream on the
aged 10 years and over
affected area twice daily. Rub it in gently
until the cream has disappeared.
Do not use for more than 7 days.
If symptoms persist talk to your doctor.

!





Age

i Adults and children aged 10 years and over

■ Wash the infected area and dry it well. As many skin conditions are
contagious, you should keep a towel and flannel for your own use
and not share it so that you do not infect anyone else.
■ Apply the cream onto the infected area and surrounding skin.
■ 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. Similarly, clothing which comes
into contact with the infected areas, such as socks, should be
washed and changed frequently.
It is preferable to wear cotton underwear if it is likely to come into
contact with the cream, as the cream may damage some synthetic
materials.

Check the table that follows to see how much medicine to use.
■ For topical use only, which means it is applied directly to the
affected area of skin.
Do not use more than the stated dose shown in the table.

Medicines like Daktacort Hydrocortisone 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 up to 7 days.

Oral anticoagulants (drugs used to thin the blood, such as warfarin).

Talk to your doctor or pharmacist if you are taking…



Ask your doctor or pharmacist for advice before using this
medicine if you are pregnant or breast-feeding.

Some of the ingredients can cause problems

■ Avoid contact with the eyes. If contact occurs rinse with water
straight away.
■ Daktacort can cause severe allergic reactions. You must be
aware of the signs of an allergic reaction while you are taking
Daktacort. See ‘Possible side-effects’
■ Do not use for more than 7 days.
■ If you are using a 'barrier' method of contraception (condoms
or diaphragms) you should avoid contact with the cream, as
the ingredients might damage the rubber so that pregnancy or
sexually transmitted diseases might not be prevented.

Special warnings about this medicine



If you are pregnant or breast-feeding

If you are not sure about any of the medicines you are taking, show the
bottle or pack to your pharmacist.

!

!

!

■ Benzoic acid (E210) can mildly irritate the skin, eyes and
mucosal membranes.
■ Butylated hydroxyanisole (E320) may cause local skin reactions
(e.g. contact dermatitis), or irritation to the eyes and mucous
membranes.

!

If you forget to use a dose, use the next dose when needed.
Do not use a double dose.

4 Possible side-effects

Daktacort Hydrocortisone Cream can have side-effects, like all
medicines, although these don’t affect everyone and are usually mild.

If you experience any of the following, stop using the
medicine and seek immediate medical help:

Frequency not known:
■ Severe allergic reactions including swelling of the face, lips, tongue or
throat.
■ Light headedness, generalised itch, wheezing or difficulty in breathing.
If you experience any of the following, stop using the medicine and
talk to your doctor:
Uncommon (affects fewer than 1 in 100 people):
■ Skin irritation, burning sensation, itchy skin, hives (also known as
nettle rash or urticaria).
Frequency not known:
■ Sensitivity reactions at the site of application, skin rash, redness,
inflammation or lighter patches of skin.
Other effects which occur are listed below:
Uncommon:
■ Irritability in children.

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.

turn over c

Daktacort Hydrocortisone Cream is a white cream available in a 15 g tube.
Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B2340, Beerse, Belgium.
This leaflet was revised November 2015.
Daktacort is a registered trade mark.

What the medicine looks like

The active ingredients in 1 g of Daktacort
Hydrocortisone Cream are: Miconazole nitrate 20 mg and
Hydrocortisone acetate equivalent to 10 mg of hydrocortisone.
Other ingredients are: Macrogol 6-32 stearate, glycol stearate, oleoyl
macrogolglycerides, liquid paraffin, butylhydroxyanisole, benzoic acid,
disodium edetate, sodium hydroxide and purified water.

What’s in this medicine?

6 Further information

How do you catch Athlete’s Foot?

Keep the product out of the sight and reach of children.
Do not use your medicine after the date shown as the expiry date on the
packaging.
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.

If you want to avoid the vicious circle of re-infection, here are a few
helpful hints.
■ Spray inside your shoes and socks with fungicidal powder before
putting them on.
■ Don’t wear the same pair of shoes every day. This helps reduce the
build-up of sweat which provides the moisture on which the fungus
thrives.
■ Avoid synthetic footwear. Choose cotton socks and leather shoes
which allow your feet to breathe.
■ Avoid sharing towels or footwear.
■ Avoid walking barefoot in changing rooms.
■ Dry thoroughly between your toes and keep toenails short as this
reduces the number of places fungi can grow.

How to prevent re-infection

It’s extremely infectious so anyone can pick it up, especially people
sharing communal changing rooms and showers.
Once the fungal spores have been transferred onto the feet, they thrive
in the warm, moist areas between the toes. The skin soon becomes
inflamed and itchy with flaking or cracking occurring.
The infected flakes of skin are then shed onto the floor or into the socks
and shoes by walking or friction.
Someone else will be easily infected if they step on these flakes, or
if they share towels or footwear with someone who has already got
Athlete’s Foot.
What is more, even if you’ve already got rid of your Athlete’s Foot, it’s
very easy to re-infect yourself. The spores can live on or in your shoes
or socks and if you don’t change them regularly, or treat them with
antifungal powders or spray powders, the Athlete’s Foot soon returns.

7 Facts about Athlete’s Foot:

5 Storing this medicine

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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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