EUMOVATE CREAM

Active substance: CLOBETASONE BUTYRATE

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8
10000000094432

Pharmacode Ref No is: 74

GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

10000000094432

Package Leaflet: Information for the User

Eumovate Cream

Eumovate

®

1

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.

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 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.
• 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 are applying to thin skin such as the face or on
children as their skin is thinner than adults and as a
result may absorb larger amounts.
• dressing or bandages should not be used on children
or 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.
• use on children should be limited to 7 days.
• you accidently swallow. Rinse the mouth out with
plenty of water and contact a doctor or pharmacist for
advice immediately.

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).

K

JMF032

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.

Front of Leaflet
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GSK-GBR-Barnard Castle-UKBAR
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.

United Kingdom-GBR
Eumovate
1

5. How to store Eumovate

Number of fingertip units needed
Child’s
age
3-6
months

Face Arm
and and
neck hand

Leg
and
foot

Back
Front including
buttocks

1

1



1



1-2
years





2

2

3

3-5
years



2

3

3



6-10
years

2







5

• If the condition does not improve within 7 days,
consult your doctor. Continuous daily treatment for
longer than 4 weeks is not recommended.
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.
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.

4. Possible side effects

K

6. Contents of the pack and
other 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 Glaxo Wellcome UK Ltd,
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.
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:

JMF032

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 2013
Eumovate is a registered trademark of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies. All rights
reserved.

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

Pharmacode Ref No is: 74

For a child

• Keep 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 to protect the environment.

10000000094432

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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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