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DAKTACORT HYDROCORTISONE CREAM

Active substance: MICONAZOLE NITRATE

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GB - AW_104125

Hydrocortisone acetate, miconazole nitrate

®

■ 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.
■ 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 have ever had a bad reaction to any of the
ingredients. For the list of ingredients. See Section 6 c
■ Speak to your doctor:
■ If you suffer from any of the conditions mentioned in
Section 2 c
■ 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.
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.
If you have a fungal infection without any symptoms
of inflammation, an antifungal medication without
hydrocortisone acetate may be more appropriate.
Ask your doctor or pharmacist if you are in doubt.
This medicine is for use in adults and children aged 10 years
and over.

2 Before using this medicine

Talk to your doctor or pharmacist if you are
taking…

■ If you have ever had a bad reaction to any of the
ingredients.
■ 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 or under dressings.
■ 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…

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.

!

■ Oral anticoagulants (drugs used to thin the blood, such
as warfarin).
If you are not sure about any of the medicines you are
taking, show the bottle or pack to your pharmacist.

!

!

!

If you are pregnant or breast-feeding



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

Do not let the cream get into your eyes. Rinse with
water straight away.
If you experience any irritation or sensitivity to the
cream, stop using this medicine.
Do not use for more than 7 days.

Special warnings about this medicine







Some of the ingredients can cause problems





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.

3 How to use this medicine

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.



How to apply the cream







turn over c

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.

AW_104125.pdf - Page 1 of 3 - May 29, 2015 - 10:40:57

Dose

AW_104125.pdf - Page 2 of 3 - May 29, 2015 - 10:40:57

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

CRR: 318137
Ref: AW_104125 15-0141
Date: 29/05/2015
B/1/006/v1 (145 x 260mm)

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).

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

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

4 Possible side-effects

!

!

Adults and children Put a small amount of the cream on
aged 10 years and
the affected area twice daily. Rub it in
over
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

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.

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

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

5 Storing this 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.

Reporting of side-effects

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.

GB - AW_104125
15-0141

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.

How do you catch Athlete’s Foot?

7 Facts about Athlete’s Foot:

This leaflet was revised June 2015.
Daktacort is a registered trade mark.

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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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