DAKTARIN GOLD 2% CREAM

Active substance: KETOCONAZOLE

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GB-IE - AW_85914

ketoconazole

GOLD 2% Cream

■ This medicine is used to treat Athlete’s Foot, dhobie itch
and sweat rash skin infections.
■ This medicine is for use by adults.
■ 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 ►
■ If you have ever had a bad reaction to any of the
ingredients. For the list of ingredients. See Section 6 ►
■ 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 ►
■ Follow the instructions on how to use this product
carefully. See Section 3 ►
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
Daktarin Gold 2% Cream is a medicine which is used to treat
skin infections which may appear on the feet (Athlete’s Foot),
in the groin area (Dhobie itch/tinea cruris) or between skin
folds (Sweat Rash infected with a yeast infection ‘thrush’).
The cream rapidly relieves the itching which these fungal
infections cause. It also provides long lasting protection from
Athlete’s Foot, as it will continue to work even after you have
stopped using it.
The cream contains the active substance, ketoconazole, which
works by destroying the fungi and yeasts that cause the infection.
If you have Athlete’s Foot, the skin between your toes will be red
and itchy. Your skin may flake and crack and often the infection
causes an unpleasant ‘cheesy’ smell. It is encouraged by moist,
warm conditions and can be recognised by redness, irritation and
itchiness between the toes.
Tinea cruris or Dhobie Itch is a fungal infection that occurs in the
groin area and causes intense itching and inflammation (redness
and soreness). In men, the skin of the scrotum is often affected.

Candidal intertrigo or sweat rash which has been infected with
a yeast infection (‘thrush’) is usually found under the breasts
and where fleshy areas around the waist or under the armpits
become damp with perspiration between the deep folds of
skin. The skin area becomes red and sore and it often looks
like moisture is coming from the surface.
This medicine is for use in adults.

2 Before using this medicine

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

Do not use this medicine…

■ If you have ever had a bad reaction to any of the
ingredients.
If this applies to you, get advice from a doctor or
pharmacist without using Daktarin Gold 2% Cream.

Talk to your doctor or pharmacist…

■ If you recently used a cream, ointment or lotion on your
skin infection that contains a corticosteroid (a group
of medicines that work by reducing inflammation caused
by a variety of skin conditions):
You should continue to apply a mild corticosteroid
(such as hydrocortisone) cream, ointment or lotion in the
morning whilst applying Daktarin Gold 2% cream in the
evening. The mild corticosteroid treatment can then be
gradually stopped over a period of 2 to 3 weeks.
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




You can use Daktarin Gold 2% cream if you are
pregnant or breast-feeding. Do not apply directly to the
breast whilst breast-feeding.
However, always ask your doctor or pharmacist for
advice before using any medicine if you are pregnant
or breast-feeding.
Do not let the cream get into your eyes.

Special warnings about this medicine


Propylene glycol may cause skin irritation.
Cetyl alcohol and stearyl alcohol may cause local skin
reactions (e.g. contact dermatitis).

Some of the ingredients can cause problems




3 How to use this medicine

Each tube of cream is sealed – unscrew the cap and use the
cap to pierce the seal.
For topical use only, which means it is applied directly
to the affected area of skin.
Do not use more often than the stated dose shown in the
table.

Check the tables that follow to see how often to use.







How to apply the cream

■ 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.
■ 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.

For Athlete’s foot (infections between the toes)

Dose
Rub the cream gently between the
toes and surrounding area twice
a day (morning and night) for 1 week.

If Athlete’s Foot is more severe or extensive
(e.g. affecting the sole or sides of the feet), continue
to apply the cream to the affected areas for at least
2 to 3 days after signs of infection have cleared
to prevent them coming back.
If symptoms persist talk to your doctor.

Age
Adults





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For Dhobie itch and Sweat Rash (Candidal
Intertrigo)
Dose
Rub the cream into the affected area
once or twice daily.

Continue treatment for at least 2 to 3 days after signs of
infection have cleared. Treatment may be necessary for
up to 6 weeks. You may feel relief from symptoms quickly but it is important that you continue to use the cream
as described to prevent them from coming back.
If symptoms have not improved within 4 weeks talk
to your doctor.

Age
Adults




If anyone has swallowed this product
If anyone accidentally swallows Daktarin Gold 2% Cream,
contact a doctor or your nearest Accident and Emergency
department (Casualty), taking this leaflet and pack with you.

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

Uncommon: (less than 1 in 100 people but more than
1 in 1000 people are affected)
■ Localised eczema (dermatitis), skin rash, sticky skin,
irritation, prickling sensation, inflammation, discomfort,
dryness, bleeding or other reactions at the application site.
Other effects:


Urticaria also known as hives, where the skin looks
blotchy with white raised wheals (bumps) surrounded
by redness.

If you experience any side-effects not included in this leaflet
or are not sure about anything, talk to your doctor or
pharmacist.
Also you can help to make sure medicines remain as safe
as possible by reporting any unwanted side-effects via
the internet at www.mhra.gov.uk/yellowcard; alternatively
you can call Freephone 0808 100 3352 (available between
10am – 2pm Monday to Friday) or fill in the paper form
available from your local pharmacy.'

5 Storing this medicine

Do not store above 25ºC.
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.
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
to protect the environment.

6 Further information
What's in this medicine?

The active ingredient in 1 g of Daktarin Gold 2% Cream is:
Ketoconazole 20 mg.
Other ingredients are: Propylene glycol, stearyl alcohol, cetyl
alcohol, sorbitan stearate, polysorbate 60, polysorbate 80,
isopropyl myristate, sodium sulphite (E221) and purified water.

What the medicine looks like

Daktarin Gold 2% 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 May 2013.
Daktarin is a registered trade mark.

7 Facts about Athlete’s Foot:

How do you catch Athlete’s Foot?

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 to prevent re-infection

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.





GB-IE - AW_85914
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4 Possible side-effects
Daktarin Gold 2% 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:
Uncommon: (less than 1 in 100 but more than 1 in 1000 people
are affected)
■ Severe allergic reactions including peeling or blistering
of the skin.

If you experience any of the following, stop using
the medicine and talk to your doctor:
Common: (less than 1 in 10 but more than 1 in 100 people are
affected)
Itchiness or redness at the application site.
A skin burning sensation may also occur.



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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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