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EUMOVATE 0.05%CREAM

Active substance(s): CLOBETASONE BUTYRATE / CLOBETASONE BUTYRATE

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Package leaflet: Information for the user

Eumovate® 0.05% 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.
The name of your medicine is Eumovate 0.05% Cream but
will be referred to as Eumovate throughout this leaflet.
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 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 chlorocresol 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).
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.

For a child

5. How to store Eumovate
Keep out of the sight and reach of children.
Do not use the cream after the expiry date which is
stated on the carton and tube label after 'Exp'. The
expiry date refers to the last day of that month.
Do not store above 25°C.
If the cream becomes discoloured or shows any signs
of deterioration, seek the advice of your pharmacist.
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.

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.
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
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 any 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..

What Eumovate contains
Each 1g of cream contains 0.5mg clobetasone
butyrate (0.05% w/w).
Other ingredients are: a preservative, chlorocresol in a
base containing glyceryl monostearate, cetostearyl
alcohol, beeswax substitute 6621, arlacel 165,
dimethicone, glycerol, sodium citrate, citric acid
monohydrate and purified water.
What Eumovate looks like and contents of the pack
Eumovate is a white, smooth cream contained in a white
aluminium tube, with a grey band near the cap end and is
available in tubes containing 25g of cream.
Manufactured by: Glaxo Operations U.K. Ltd, UK.
Procured from within EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Eumovate 0.05% Cream; PL 18799/1458
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.
Leaflet date: 24.11.2016
Eumovate is a registered trademark of the
GlaxoSmithKline group of companies.

POM

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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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