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DAKTARIN INTENSIV CREAM

Active substance(s): KETOCONAZOLE

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Transcript
CREAM

KETOCONAZOLE

This medicine is used to treat Athlete’s Foot and dhobie
itch.
■ 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.


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1 What the medicine is for
Daktarin Intensiv Cream is a medicine which is used to treat
skin infections which may appear on the feet (Athlete’s Foot)
or in the groin area (Dhobie Itch/tinea cruris). 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 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




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.

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

3 How to 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 Intensiv Cream.

Check the tables below to see how often to use.
■ 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.

Talk to your doctor or pharmacist…

How to apply the cream

Do not use this medicine…


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 Intensiv cream in the
evening. The mild corticosteroid treatment can then be
gradually stopped over a period of 2 to 3 weeks.
■ If you are a diabetic you should visit your healthcare
professional for regular check ups as diabetes can
increase the risk of foot problems.
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 Intensiv 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.


Special warnings about this medicine


Wash the infected area and dry it well (especially between
the toes). 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 thinly 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 Athletes Foot (infections between the toes)
Age
Adults

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 have not improved within 7 days talk to
your doctor.

Do not let the cream get into your eyes.

turn over ▶

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INTENSIV

Some of the ingredients can cause problems

scrotum is often affected.
This medicine is for use in adults.

Age
Adults

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.

If anyone has swallowed this product
If anyone accidentally swallows Daktarin Intensiv 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

Uncommon: (less than 1 in 100 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 sideeffects 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

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

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.

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

6 Further information

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

4 Possible side-effects

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.

What's in this medicine?

The active ingredient in 1 g of Daktarin Intensiv Cream is
prescription strength: 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 Intensiv Cream is a white cream available in a 5 g,
15 g or 30 g tube. Not all pack sizes may be marketed.
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.

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For Dhobie Itch (Jock Itch)

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.
11/0222
GB - AW_85913

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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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