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DERMOVATE SCALP APPLICATION

Active substance(s): CLOBETASOL PROPIONATE / CLOBETASOL PROPIONATE

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12000000108435

Package Leaflet: Information for the user

12000000108435

Dermovate Scalp Application
®

GSK-ContractMfg-Eur-Deu-GermanyAspen-Bad Oldesloe

clobetasol propionate

1. What Dermovate is and what it is
used for
Dermovate Scalp Application (called ‘Dermovate’ in
this leaflet) contains a medicine called clobetasol
propionate. It belongs to a group of medicines called
steroids. It helps to reduce swelling and irritation.
Dermovate is used to help reduce the redness and
itchiness of certain scalp problems. These include
frequently relapsing dermatoses and psoriasis that
have not responded to milder steroid creams,
ointments, lotions or scalp applications.

2. What you need to know before you
use Dermovate
Do not use Dermovate:
• if you are allergic (hypersensitive) to clobetasol
propionate or any of the other ingredients of
this medicine (listed in Section 6)
• if you have a skin infection on your scalp
• on a child under 1 year of age.
Do not use if any of the above apply to you. If
you are not sure, talk to your doctor or
pharmacist before using Dermovate.
Warnings and precautions
Talk to your doctor or pharmacist before using
your medicine if:
• you have previously had an allergic reaction
with another steroid.
• you are applying the liquid under an airtight
dressing. These dressings make it easier for the
active ingredient to pass through the skin. It is
possible to accidentally end up using too much.
Do not bandage or otherwise cover the treated
scalp area, unless directed to do so by your doctor.
• If directed to cover the treated area with a
dressing, make sure that the skin is cleansed before
a fresh dressing is applied to prevent infections.
• you have psoriasis, your doctor will want to
see you more often.
• you are applying the liquid to broken,
damaged or thin skin.
• you are applying to a large surface area.
If an infection develops during the use of this
medicine talk to your doctor or pharmacist.
Be very careful not to get the liquid in your eyes.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.

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Children
• Do not use this medicine on a child under the
age of 1 year.
• Avoid continuous treatment for a long period
of time in children over the age of 1 year, as
their skin is thinner than adults and as a result
may absorb larger amounts.
• Use on children should be limited to a few
days and reviewed weekly.
• Dressings or bandages should not be used on
children where the scalp application is applied.
Other medicines and Dermovate
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 become pregnant or are planning to
have a baby ask your doctor or pharmacist for
advice before taking this medicine.

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3. How to use Dermovate
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 put Dermovate on your scalp in
the morning and at night. This may be reduced
as your scalp problem begins to get better, or
stopped when it is better.
• For use on your skin of your scalp only.
• Do not use it more often than prescribed or
use it for a long time (such as every day for
many weeks or months). If you need
treatment for a long time, your doctor may
decide you need to use a milder treatment.
• The germs that cause infections like warm and
moist conditions under dressings. If directed to
cover the treated area with a dressing, always clean
the skin before a fresh dressing is put on to help
prevent infection of the skin beneath the dressing.
• Be very careful not to get the liquid in your
eyes. Do not touch your eyes until you have
washed your hands.
• If you wash or shampoo your hair it should be
dried before applying the liquid.
• If you are applying the scalp application on
someone else make sure you wash your hands
after use or wear disposable plastic gloves.
• This product is flammable. Keep the liquid
away from open fire and flames and all
sources of ignition, including smoking,
during application and immediately after
you’ve used it.
• Do not dry your hair with a hairdryer.
Guidance on how to apply the liquid
1 Wash your hands.
2 Unscrew the bottle cap and place the nozzle
directly on the scalp that needs treating.
3 Gently squeeze the bottle to cover the area
with a thin and even layer of liquid.
4 You can rub this liquid in, but you don’t have to.
Your scalp will feel cool until the liquid has dried.
5 Wash your hands again.
6 Do not exceed the prescribed amount.
Use in children
• Do not use this medicine on children under
1 year of age.

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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 Dermovate is and what it is used for
2 What you need to know before you use
Dermovate
3 How to use Dermovate
4 Possible side effects
5 How to store Dermovate
6 Contents of the pack and other information

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop using Dermovate and tell your doctor
immediately if:
• you find that your scalp problem gets worse,
you develop a generalised rash or your skin
becomes swollen during treatment. You may
be allergic to the scalp application, 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
the treatment and is known as pustular psoriasis.
Other side effects you may notice when
using Dermovate include:
Common (may affect up to 1 in 10 people)
• a feeling of burning, pain, irritation or itching
where the scalp application is applied.
Uncommon (may affect up to 1 in 100 people)
• skin thinning, this may cause stretch marks
• blood vessels under the surface of your skin
may become more noticeable.
Very Rare (may affect up to 1 in 10,000 people)
Use of Dermovate for a long period of time, or use
under an airtight dressing, may cause the
following symptoms:
• increased weight
• moon face, rounding of the face
• obesity
• skin thinning
• skin wrinkling
• skin dryness
• changes to the colour of your skin
• increased body hair
• hair loss/lack of hair growth/damaged looking hair
Other very rare skin reactions that may occur are:
• allergic reaction at the site of application
• worsening of condition
• application site irritation/pain
• redness
• rash or hives
• if you have psoriasis you may get raised
bumps with pus under the skin.
• This can happen very rarely during or after
treatment and is known as
• pustular psoriasis
• skin infection
• acne
In children, also look out for the following symptoms:
• delayed weight gain
• slow growth

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Very rare side effects that may show up in blood tests
or when your doctor gives you a medical examination:
• a decrease in the level of the hormone cortisol
in your blood
• increased levels of sugar in your blood or urine
• high blood pressure
• cloudy lens in the eye (cataract)
• increased pressure in the eye (glaucoma)
• weakening of the bones through gradual loss
of mineral (osteoporosis);
• additional tests may be needed after your medical
examination to confirm if you have this condition
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.

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GSK-ContractMfg-Eur-Deu-GermanyAspen-Bad Oldesloe

United Kingdom-GBR
Dermovate
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5. How to store Dermovate

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• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date
which is stated on the bottle label or carton
after (EXP). The expiry date refers to the last
day of that month.
• Do not store above 30°C.
• Do not use this bottle for more than 3 months
after first opening it.
• Keep the container tightly closed when not in
use. Contents are flammable. Keep away from
all sources of fire, flame and heat. Do not
leave in direct sunlight.
• 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.

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6. Contents of the pack and other
information
What Dermovate contains
• The active ingredient is clobetasol propionate.
Each 1 g contains 0.5 mg of clobetasol
propionate (0.05% w/w).
• The other ingredients are carbomer, isopropyl
alcohol, sodium hydroxide and purified water
What Dermovate looks like and contents of
the pack
Within each carton is a specially designed plastic
bottle with a nozzle and cap that contains 30 or
100 ml of a sticky liquid.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer:
Aspen Bad Oldesloe GmbH, Industriestrasse
32-36, 23843 Bad Oldesloe, Germany
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:

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• It is especially important in children not to
exceed the prescribed amount.
• A course of treatment for a child should not
normally last more than a few days, unless your
doctor has told you to use it for longer. The
doctor may want to see the child every week
whilst using Dermovate scalp application.
If you use more Dermovate than you should
If you apply too much or if accidentally
swallowed, it could make you ill. Talk to your
doctor or go to hospital as soon as possible.
If you forget to use Dermovate
If you forget to apply your scalp application, 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.
Do not apply extra Dermovate to make up for a
missed dose.
If you stop using Dermovate
If you use Dermovate 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.

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Dermovate Scalp
Application
Reference number 10949/0046
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in November 2016.
Dermovate is a registered trade mark of the
GSK group of companies
© 2016 GSK group of companies. All rights reserved.
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Aspen Bad Oldesloe
Additional Information Panel
Replacement: 12000000105679

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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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