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EUMOVATE CREAM

Active substance(s): CLOBETASONE BUTYRATE / CLOBETASONE BUTYRATE / CLOBETASONE BUTYRATE

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Package leaflet: Information for the user

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10000000143213
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Eumovate
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JMF333

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Eumovate® Cream
clobetasone butyrate

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• 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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1 What Eumovate is and what it is used for
2 What you need to know before you use Eumovate
3 How to use Eumovate
4 Possible side effects
5 How to store Eumovate
6 Contents of the pack and other 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, nappy rash or insect bites.
• help reduce inflammation of the outer ear.

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2. What you need to know
before you use Eumovate
Do not use Eumovate:
• if you are allergic to clobetasone butyrate or any
of the other ingredients of this medicine (listed
in section 6)
• to treat any of the following skin problems, it
could make them worse:
- infected skin (unless the infection is being
treated with an anti-infective medicine at the
same time)
- acne
- severe flushing of skin on and around your
nose (rosacea)
- itchy skin which is not inflamed
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.
Warning and precautions
Talk to your doctor or pharmacist before using
Eumovate if:
• you have previously had an allergic reaction
with another steroid
• using for a chronic leg ulcer as you may be at
increased risk of local allergic reaction or
infection
• you have been advised by your doctor to use
this medicine under an occlusive dressing
(including a child’s nappy). Make sure that the
skin is cleansed before a fresh dressing is
applied to prevent infections. Occlusive
dressings (including a child’s nappy) make it
easier for the active ingredient to pass through
the skin, making it possible to accidentally use
too much.
• you are applying to thin skin such as the face,
as skin is thinner and may absorb larger
amounts. Dressings or bandages should not be
used on the face where the cream is applied.
• you are applying to the face over a long period
of time as it may cause skin thinning.
• you have psoriasis, your doctor will want to
see you more often.
• you are applying the cream on broken skin or
within the skin folds.
• you are applying near eyes or on eyelids, as
cataracts or glaucoma may result if the cream
repeatedly enters the eye.
• you accidentally swallow a large amount of
Eumovate, rinse the mouth out with plenty of
water and contact a doctor or pharmacist for
advice immediately.
• if an infection develops (see section 4, Possible
side effects)

Children
• Treatment in children under 12 years of age
should not normally exceed 7 days.
• Prolonged daily treatment in children can affect
their growth. Continuous daily treatment for
longer than 4 weeks is not recommended.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.
Other medicines and Eumovate
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicine, especially if you are taking ritonavir
and itraconazole medications.
Pregnancy, breast-feeding and fertility
If you are pregnant, or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Eumovate Cream contains chloroscresol and
cetostearyl alcohol
Eumovate cream contains chlorocresol which may
cause allergic reactions and cetostearyl alcohol
which may cause local skin reactions (e.g. contact
dermatitis).
3. How to use Eumovate
Always use this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

Using this medicine
• You usually apply Eumovate up to 2 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 using an emollient (moisturising)
preparation allow time for Eumovate to be
absorbed after each application before
applying the emollient.
• 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 after
4 weeks talk to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Apply a thin layer to the affected area(s) and
gently rub into the skin until it has all
disappeared. You can measure how much
Eumovate to use with your fingertip. For
children you will need to use less cream but still
use an adult finger to measure out the fingertip
unit. 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

Do not worry if you find you need a little
more or less than this. It is only a rough
guide.

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For a child

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Number of fingertip units needed
Child’s
age

GSK-GBR-Barnard Castle-UKBAR

3-6
months

United Kingdom-GBR
Eumovate
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5. How to store Eumovate

Face Arm Leg
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and and and Front including
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1-2
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3-5
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6-10
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5

• Keep

this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date
which is stated on the tube or carton after
(EXP). The expiry date refers to the last day of
that month.
• Do not store above 25°C.
• 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

• Do not use on children younger than 12 years
unless advised by a doctor.
• If the condition worsens or does not improve
within 7 days, consult a doctor.
• Once the condition improves, reduce both the
amount applied and the frequency of application
to the minimum necessary to relieve symptoms.
• Do not use every day for more than 4 weeks at
a time.
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 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.

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
monohydrate 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 g or 100 g of cream.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Glaxo Wellcome UK Ltd, Stockley Park West,
Uxbridge, Middlesex UB11 1BT

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 as your
condition may get worse if stopped suddenly.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Manufacturer
Glaxo Operations UK Ltd, Harmire Road,
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.
You may be able to find out more information
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:

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop using Eumovate and tell your doctor
immediately if:
• you find that your skin condition gets worse,
you develop a generalised rash or your skin
becomes swollen during treatment. You may
be allergic to the cream, have an infection or
need other treatment.
• you have psoriasis and 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: may affect up to 1 in 10,000 people
• an increased risk of skin infection.
• an allergic skin reaction where the cream is
applied.
• a feeling of burning, irritation or itching where
the cream is applied.
• rash, itchy bumpy skin or redness of the skin.
• 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
• delayed weight gain or slowing of growth in
children
• bones can become thin, weak and break easily
• cloudy lens in the eye (cataract) or increased
pressure in eye (glaucoma)
• increased blood sugar levels or sugar in the urine
• high blood pressure
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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.

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.
This leaflet was last revised in August 2016.
Eumovate is a registered trade mark of the
GSK group of companies.
© 2016 GSK group of companies. All rights
reserved.

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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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