CLOTRIMAZOLE ATHLETES FOOT CREAM

Active substance: CLOTRIMAZOLE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Clotrimazole Cream 1%
(clotrimazole)

Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you
This medicine is available without
prescription. However, you still need to
use Clotrimazole carefully to get the best
results from it.
• 
Keep this leaflet. You may need to read
it again.
•  your pharmacist if you need more
Ask
information or advice.
•  must contact a doctor if your
You
symptoms worsen or do not improve.
•  you get any side effects, talk to your
If
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1.  hat Clotrimazole is and what it is used for
W
2.  hat you need to know before you
W
use Clotrimazole
H
3.  ow to use Clotrimazole
4.  ossible side effects
P
5.  ow to store Clotrimazole
H
6.  ontents of the pack and other information
C
1. What Clotrimazole is and what it is
used for
The active substance is clotrimazole.
Clotrimazole belongs to a group of medicines
called imidazoles and is an antifungal agent
which fights the cause of fungal skin infections.
Clotrimazole is used to treat fungal skin
infections such as ringworm, athlete's foot,
fungal nappy rash and fungal sweat rash. It
is also used to relieve irritation of the vulva
(external thrush) or the end of the penis, which
may be associated with thrush.
When Clotrimazole is applied to the infected
area of skin it works by destroying the fungus
or yeast which has caused the infection.
If you are unsure whether you (or your baby if
treating nappy rash) have one of these fungal
skin infections, seek the advice of your doctor
or pharmacist.
2. What you need to know before you
use Clotrimazole
Do not use Clotrimazole:
• if you (or your baby if treating nappy rash) are

allergic to clotrimazole
or any of the other
ingredients of this
medicine (listed in section 6), including
cetostearyl alcohol
•  treat nail or scalp infections.
to
Warnings and precautions
Talk to your doctor before using Clotrimazole, if
you have used a cream containing clotrimazole
or a similar medicine before and suffered an
allergic or unpleasant skin reaction. This may
have been a skin rash or itching in the area the
cream was applied.
As with other creams, Clomitrazole may reduce
the effectiveness of rubber contraceptives, such
as condoms or diaphragms. Consequently, if
you are using this cream on the vulva or penis,
you should use alternative precautions for at
least five days after using this product.
Other medicines and Clotrimazole
Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines,
including medicines obtained without a
prescription.
Clotrimazole is not known to interact with any
other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, tell your doctor, midwife or pharmacist
before using Clotrimazole. If you have informed
your doctor or midwife already, follow his/her
instructions carefully.
Driving and using machines
Clotrimazole will not affect your ability to drive
or operate machinery.
Clotrimazole contains cetostearyl alcohol
This medicine contains cetostearyl alcohol
which may cause local skin reactions (e.g. rash,
itching or redness)
3. How to use clotrimazole
Always use this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or
pharmacist if you are not sure.
If you purchased this product without a
prescription, follow these directions closely.
Before use, pierce the tube seal by inverting
• 
the cap over the end of the tube and press.
If
•  the feet are infected, they should be
washed and dried thoroughly, especially
between the toes, before applying the cream.
Clotrimazole should be applied thinly and
• 
evenly to the affected areas, two or three
times daily and rubbed in gently.
The
•  duration of the treatment depends upon
the type of infection. Use the cream for at least

two weeks for candida (thrush) infections or at
least one month for other infections.
•  you have athlete's foot, it may help to use an
If
antifungal dusting powder as well. Ask your
doctor or pharmacist to recommend one.
The symptoms of skin infection, such as itching
or soreness, should improve within a few days
of treatment although signs such as redness
and scaling may take longer to disappear. If
symptoms persist, consult your doctor.
Clotrimazole is for external use only.
Do not put the cream in your mouth or swallow it.
If the cream is swallowed accidentally, tell your
doctor straight away or contact the Accident and
Emergency Department of your nearest hospital.
If you accidentally get cream in your eyes or
mouth, wash immediately with water and
contact your doctor.
If you forget to use Clotrimazole
Apply the cream as soon as possible, then
continue the rest of your treatment as usual.
If you stop using Clotrimazole
Do not suddenly stop using Clotrimazole as
this may cause the symptoms of the infection
to return.
You can help the treatment to work if you
follow these simple self-help tips:
• 
Although the infected area will itch, try not
to scratch. Scratching will damage the
surface of the skin and cause the infection
to spread further.
• 
Keep the affected skin areas clean.
•  particular attention to drying the skin,
Pay
but avoid excessive rubbing.
•  not share towels, bath mats, etc. with
Do
other people as you could spread the
infection to them.
• 
Always wash your hands after treating the
infection to prevent it from spreading.
If you have athlete's foot:
• 
Remember to dry the skin between the
toes thoroughly.
Wash your socks, stockings and tights
• 
thoroughly in hot water to remove any shed
skin or fungal spores
• 
Change your footwear daily if possible.
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.
As with all medicines, some people may be
allergic to the cream. If you or your baby are
allergic, a reaction will occur soon after you start
using it. If you or your baby experience an allergic
reaction, stop using Clotrimazole and tell your
doctor straight away or contact the Accident and

Emergency Department of your nearest hospital.
Signs of an allergic reaction may include:
• Rash
• 
Swallowing or breathing problems
• 
Swelling of the lips, face, throat or tongue
• 
Weakness, feeling dizzy or faint
• Nausea
After you apply the cream you might experience:
• 
Itching, rash, blisters, burning, discomfort,
swelling, irritation or peeling of skin. This may
mean that you are allergic to the cream.
Reporting of side effects
If you or your baby gets 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.
5. How to store clotrimazole
Keep this medicine out of the sight and reach
of children.
Store in a cool dry place.
Do not use this cream after the expiry date
which is stated on the carton after 'EXP'. The
expiry date refers to the last day of that month.
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.
6. Contents of the pack and
other information
What Clotrimazole contains
The active substance is clotrimazole. Each gram
of cream contains 10 mg of clotrimazole (i.e.
1% w/w).
The other ingredients are benzyl alcohol,
polysorbate 60, cetyl esters wax, cetostearyl
alcohol (see section 2 'Clotrimazole contains
cetostearyl alcohol'), octyldodecanol, sorbitan
monostearate and purified water.
What Clotrimazole looks like and contents
of the pack
Clotrimazole Cream 1% is a smooth white
cream and is available in tubes of 20g or 50g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
Manufacturer
Generics [UK] Limited
Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
This leaflet was last revised in: 02/2014

10004860

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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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