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EUMOVATE OINTMENT

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

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10000000147136
Package Leaflet: Information for the User

10000000147136

Eumovate Ointment
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.
Warnings 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. Dressing or bandages should not be
used on the face where the ointment 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 ointment on broken skin or within the skin folds.
• you are applying near eyes or on eyelids, as cataracts or glaucoma
may result if the ointment repeatedly enters the eye.
• you experience blurred vision or other visual disturbances.
• 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 this product comes into contact with dressings, clothing and bedding
the fabric can be easily ignited with a naked flame. You should keep
away from fire when using this product.
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 are 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.

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 ointment 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 ointment 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 ointment
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 ointment but still use an adult finger to measure out the
fingertip unit. This picture shows one fingertip unit.

GSK-GBR-Barnard Castle-UKBAR
Do not worry if you find you need a little more or less than this. It is
only a rough guide.
For a child
Child’s
age
3-6 months

Number of fingertip units needed
Face
Arm
Leg
and
and
and
Front
neck
hand
foot

Back
including
buttocks

1

1



1



1-2 years





2

2

3

3-5 years



2

3

3



2







5

6-10 years

United Kingdom-GBR
Eumovate
N/A
JMF333

Offset

• 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 ointment to your face if your doctor tells you
to. The ointment should not be used for too long as the skin on your
face thins easily. Do not let the ointment 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 ointment, 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.

White paper
1
K

0

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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 ointment, 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 ointment is applied
• a feeling of burning, irritation or itching where the ointment 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
Not Known (frequency cannot be estimated from the available data)
• blurred vision
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.

5. How to store Eumovate
• 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.

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 liquid paraffin and white soft paraffin.
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 ointment.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT
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:

8pt
8.4pt
100%
8pt
No

3 Unless you are meant to apply the ointment to your hands as a part
of the treatment, wash them again after using the ointment.
For an adult

Please be ready to give the following information:
Product name
Eumovate Ointment
Reference number
10949/0037
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in June 2017
Trade marks are owned by or licensed to the GSK group
of companies
© 2017 GSK group of companies or its licensor

Pharma code Ref. No. 640

0800 198 5000 (UK Only)

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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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