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CLOBETASONE BUTYRATE 0.05% W/W CREAM

Active substance(s): CLOBETASONE BUTYRATE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

EUMOVATE® CREAM/
CLOBETASONE BUTYRATE 0.05% w/w CREAM
(Clobetasone butyrate)
Patient Information Leaflet

This product is available as the above names, but will be referred to throughout this leaflet as Eumovate.
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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

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.

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).

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

TVT CHECKED

DATE:
DATE:
26/08/14
6464/1512D

DATE OF PROOF:

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.

CODE:

DT

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.

ARTWORKER:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0269

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.

Eumovate cream

PRE-PRESS NO.:

WARNING!

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.

PRODUCT:

CUSTOMER: Waymade

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.

PROOF HISTORY:
v.2 - waymade - 26/08/14

Leaflet Flat Size = 148 x 400

- 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.

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

Face and neck:
2½ fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including
the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including
the foot):
6 fingertip units.
One foot:
2 fingertip units.

Colour
Swatch

Black

WARNING!

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

For a child
Number of fingertip units needed
Leg
and
foot

Front

Back
including
buttocks

3-6
months

1

1



1



1-2
years





2

2

3

3-5
years



2

3

3



6-10
years

2







5

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.

WARNING!

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.

DATE:

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.

26/08/14
DATE OF PROOF:

5. HOW TO STORE EUMOVATE
• Keep out of the sight and reach of children.
• Do not use after the expiry date on the tube or carton (Exp). The expiry date refers to the last day of that
month.
• Eumovate cream/Clobetasone Butyrate 0.05% w/w cream should not be stored above 25°C.
• If the cream becomes discoloured or shows any other signs of deterioration, you should ask your doctor or
pharmacist before using it.
• 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.

TVT CHECKED

DT
ARTWORKER:

DATE:

05-0269
PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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.

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

6464/1512D
CODE:

Eumovate cream
PRODUCT:

CUSTOMER: Waymade

6. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Eumovate cream/Clobetasone Butyrate 0.05% w/w cream. It contains the active
ingredient, Clobetasone butyrate 0.05% w/w in a white cream base.
Eumovate cream/Clobetasone Butyrate 0.05% w/w cream also contains the following:
glyceryl monostearate, cetostearyl alcohol, dimethicone, glycerol, Arlacel 165, chlorocresol, sodium citrate,
citric acid, beeswax substitute and purified water.
Eumovate cream/Clobetasone Butyrate 0.05% w/w cream is available as tubes of 30g.
POM

PL No: 6464/1512

This product is manufactured by Glaxo Operations UK Ltd, Barnard Castle, Co Durham, UK and procured
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 26.08.2014
Eumovate is a registered trademark of the Glaxo Wellcome Group
More Information
If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you.

Colour
Swatch

Black

You may be able to find out more information from books in public libraries.

000-0000D

WARNING!

Arm
and
hand

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Face
and
neck

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

PROOF HISTORY:
v.2 - waymade - 26/08/14

Leaflet Flat Size = 148 x 400

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Childs
age

Expand view ⇕

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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