EUMOVATE CREAM

Active substance: CLOBETASONE BUTYRATE

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10000000051022

Package Leaflet: Information for the User

Eumovate® Cream
clobetasone butyrate
Read all of this leaflet carefully before
you start using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Eumovate is and what it is used for
2 Before you use Eumovate
3 How to use Eumovate
4 Possible side effects
5 How to store Eumovate
6 Further information

1 What Eumovate is
and what it is used for
Eumovate contains a medicine called
clobetasone butyrate. It belongs to a group of
medicines called steroids. It helps to reduce
swelling and irritation.
Eumovate is used to:
• help reduce the redness and itchiness of
certain skin problems. It is used for mild skin
problems or to keep your skin problem
under control. These skin problems include
eczema, dermatitis or insect bites.
• help reduce inflammation of the outer ear.

2 Before you use Eumovate
Do not use Eumovate:
• if you are allergic (hypersensitive) to
clobetasone butyrate or any of the other
ingredients of Eumovate (listed in Section 6)
• to treat any of the following skin problems,
it could make them worse:
- viral infections, such as cold sores, herpes
or chicken pox
- fungal infections, such as ringworm,
athletes foot or thrush
- skin blisters or sores that are caused by
an infection.
Do not use if any of the above apply
to you. If you are not sure, talk to
your doctor or pharmacist before
using Eumovate.
Take special care with Eumovate
Check with your doctor or
pharmacist before using your
medicine if:
• you are applying the cream under
an airtight dressing, including a
child’s nappy. These dressings
make it easier for the active
ingredient to pass through the
skin. It is possible to accidentally
end up using too much cream.
• you have psoriasis, your doctor will want to
see you more often.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using
this medicine if you are pregnant, might
become pregnant or are breast-feeding.

3 How to use Eumovate
Always use Eumovate exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Using this medicine
• You usually apply Eumovate up to 4 times a
day. This may be reduced as your skin
begins to get better.
• This cream is for use on your skin only.
• Do not use on large areas of the body for a
long time (such as every day for many weeks
or months) - unless your doctor tells you to.
• If you are applying the cream on someone
else make sure you wash your hands after
use or wear disposable plastic gloves.
• If your skin problem does not improve, talk
to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Gently rub the correct amount of cream
into the skin until it has all disappeared.
You can measure how much Eumovate to
use with your fingertip. This picture shows
one fingertip unit.

3 Unless you are meant to apply the cream to
your hands as a part of the treatment, wash
them again after using the cream.
For an adult
You should find that:
• two fingertips of cream will cover both
hands or one foot
• three fingertips of cream will cover one arm
• six fingertips of cream will cover one leg
• fourteen fingertips of cream will cover the
front and back of the body.
Do not worry if you find you need a little more
or a little less than this. It is only a rough guide.

5 How to store Eumovate
• Keep out of the reach and sight of children.
• Do not use Eumovate after the expiry date
on the tube or carton (Exp). The expiry date
refers to the last day of that month.
• Do not store above 25°C.
• 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.
For a child
• The smaller the child the less you will need
to use.
• A child of 4 years needs about a third of the
adult amount.
• A course of treatment for a child should not
normally last more than 7 days - unless your
doctor has told you to use it for longer.
If you apply Eumovate to your face
You should only apply the cream to your face if
your doctor tells you to. The cream should not
be used for too long as the skin on your face
thins easily. Do not let the cream get into
your eyes.
If you use more Eumovate than you should
If, by mistake on a few occasions you use more
than you should, do not worry. If you apply a
lot or if a lot is accidentally swallowed, it could
make you ill. Talk to your doctor or go to
hospital as soon as possible.
If you forget to use Eumovate
If you forget to apply your cream, apply it as
soon as you remember. If it is close to the time
you are next meant to apply it, wait until this
time.
If you stop using Eumovate
If you use Eumovate regularly make sure you
talk to your doctor before you stop using it.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Eumovate can cause side
effects, although not everybody gets them.
Stop using Eumovate and tell your doctor
as soon as possible if:
• you find that your skin condition gets worse
or becomes swollen during treatment. You
may be allergic to the cream, have an
infection or need other treatment.
• you have psoriasis you may get raised
bumps with pus under the skin. This can
happen during or after treatment and is
known as pustular psoriasis.
Other side effects you may notice when
using Eumovate include:
Very rare (affects less than 1 in 10,000 people)
• A feeling of burning, irritation or itching
where the cream is applied.
Other very rare side effects if you use Eumovate
for a long time, you use a lot each time you
apply it, or you apply it under an airtight
dressing or a nappy:
• Increased hair growth and changes in skin
colour
• Thinning of your skin and it may also
damage more easily
• Weight gain, rounding of the face and high
blood pressure. These are more likely to
happen in infants and children.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

6 Further information
What Eumovate contains
• The active ingredient is clobetasone
butyrate. Each 1 g contains 0.5 mg of
clobetasone butyrate (0.05% w/w).
• The other ingredients are glycerol, glycerol
monostearate, cetostearyl alcohol, beeswax
substitute 6621, Arlacel 165, dimeticone 20,
chlorocresol, sodium citrate, citric acid and
purified water.
What Eumovate looks like and contents of
the pack
Within each carton is a tube with a plastic
screw cap, which contains either 30 or 100 g of
cream.
Marketing Authorisation Holder
and Manufacturer
Product licence held by GlaxoSmithKline UK,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufactured by Glaxo Wellcome Operations,
Barnard Castle, Durham DL12 8DT
More Information
If you have any questions or are not sure about
anything, ask your doctor or pharmacist who
will advise you. Other sources of information
are:
National Eczema Society, Hill House,
Highgate Hill, London N19 5NA
The Psoriasis Association, 2 Queensbridge,
Northampton, NN4 7BF
You may also be able to find out more from
books in public libraries.
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Eumovate Cream
Reference number
10949/0035
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet date: November 2007
Eumovate is a registered trademark
of the GlaxoSmithKline group of
companies
© 2007 GlaxoSmithKline group of
companies

10000000051022

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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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