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EUMOVATE 0.05%CREAM

Active substance(s): 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

2.

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.

4.

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 reaction (e.g. Contact dermatitis)
local
contact dermatitis).
3. skin
Howreactions
to use (e.g.
Eumovate
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if c
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.

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.

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 a little
less than this. It is only a rough guide.
For a child

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
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..

5. How to store Eumovate
Keep out of the sight and reach 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.

6. Contents of the pack and other information
What Eumovate contains
Each 1 g 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 cream 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, England
Procured from within EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU
Eumovate 0.05% Cream, PL No: 18799/1458

POM

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.
Leaflet date: 08.04.2016
Eumovate is a registered trademark of the
GlaxoSmithKline group of companies

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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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