DERMOVATE CREAM

Active substance: CLOBETASOL PROPIONATE

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10000000050300

Package Leaflet: Information for the User

Dermovate® Cream
clobetasol propionate
Read all of this leaflet carefully before you
start using this medicine.
• 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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Dermovate is and what it is used for
2 Before you use Dermovate
3 How to use Dermovate
4 Possible side effects
5 How to store Dermovate
6 Further information

1 What Dermovate is
and what it is used for
Dermovate 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 skin problems. These
skin problems include eczema, psoriasis and
dermatitis that have not responded to milder
steroid creams or ointments.

2 Before you use Dermovate
Do not use Dermovate:
• if you are allergic (hypersensitive) to
clobetasol propionate or any of the other
ingredients of Dermovate (listed in Section 6)
• on a child under 1 years old
• to treat any of the following skin problems, it
could make them worse:
- acne
- severe flushing of skin on and around your
nose (rosacea)
- spotty red rash around your mouth
(perioral dermatitis)
- itching around your back passage or
private parts - unless your doctor has told
you to do so
- viral infections, such as cold
sores, herpes or chicken pox
- fungal infections, such as
ringworm, athletes foot or
thrush
- skin blisters or sores that are
caused by an infection.
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.
Take special care with Dermovate
Check with your doctor or pharmacist
before using your medicine if:
• 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.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using
this medicine if you are pregnant, might become
pregnant or are breast-feeding.

3 How to use Dermovate
Always use Dermovate exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Using this medicine
• You usually apply a thin layer of Dermovate
1 or 2 times a day. This may be reduced as
your skin begins to get better, or stopped
when 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). If you need treatment for a long
time, your doctor may decide you need to
use a milder cream or ointment
• The germs that cause infections like warm
and moist conditions under dressings so
always clean the skin before a fresh dressing
is put on.
• 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 in
2 to 4 weeks, talk to your doctor.
Guidance on how to apply the cream
1 Wash your hands.
2 Gently rub the correct amount of cream into
the skin until it has all disappeared. You can
measure how much Dermovate to use with
your fingertip. 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
You should find that:
• two fingertips of cream will cover both hands
or one foot
• three fingertips of cream will cover one arm
• six fingertips of cream will cover one leg
• fourteen fingertips of cream will cover the
front and back of the body.
Do not worry if you find you need a little more or
a little less than this. It is only a rough guide.

• Weight gain, rounding of the face and high
blood pressure. These are more likely to
happen in infants and children.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Dermovate

For a child
• Do not use it on children under 1 years of
age.
• The smaller the child the less you will need to
use.
• A child of 4 years needs about a third of the
adult amount.
• A course of treatment for a child should not
normally last more than 5 days - unless your
doctor has told you to use it for longer. The
doctor may want to see the child every week,
whilst using the cream.
If you have psoriasis
If you have thick patches of psoriasis on your
elbows or knees, your doctor may suggest
applying the cream under an airtight dressing. It
will only be at night to help the cream to start
working. After a short period of time you will
then apply the cream as normal.
If you apply Dermovate to your face
You should only apply the cream to your face if
your doctor tells you to. It should not be used for
more than 5 days, as the skin on your face thins
easily. Do not let the cream get into your
eyes. If it does, wash it out with plenty of water.
If you use more Dermovate than you should
If, by mistake on a few occasions you use more
than you should, do not worry. 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 Dermovate
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 Dermovate
If you use Dermovate regularly make sure you
talk to your doctor before you stop using it.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Dermovate can cause side
effects, although not everybody gets them.
Stop using Dermovate and tell your doctor
as soon as possible if:
• you find that your skin problem gets worse or
become swollen during treatment. You may
be allergic to the cream, have an infection or
need other treatment.
Other side effects you may notice when
using Dermovate include:
• A feeling of burning, irritation or itching
where the cream is applied.
• If you have psoriasis you may get raised
bumps with pus under the skin. This can
happen during or after the treatment and is
known as pustular psoriasis.
Side effects if you use Dermovate for a long
time, or you use a lot each time you apply it, or
you apply it under an airtight dressing or a
nappy:
• Stretch marks may develop.
• Veins under the surface of your skin may
become more noticeable.
• Increased hair growth and changes in skin
colour.
• Thinning of your skin that may also damage
more easily.

• Keep out of the reach and sight of children.
• Do not use Dermovate 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 Further 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 cetostearyl alcohol,
glyceryl monostearate, arlacel 165, beeswax
substitute 6621, propylene glycol,
chlorocresol, sodium citrate, citric acid and
purified water.
What Dermovate looks like and contents of
the pack
Within each carton is a tube with a plastic screw
cap, which contains either 30 or 100 g of cream.
Marketing Authorisation Holder and
Manufacturer
Product licence held by GlaxoSmithKline UK,
Stockley Park West, Uxbridge, Middlesex
UB11 1BT
Manufactured by Glaxo Wellcome Operations,
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. 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.
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the
following information:
Product name
Dermovate Cream
Reference number
10949/0025
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet date: November 2007
Dermovate is a registered trademark
of the GlaxoSmithKline group of
companies
© 2007 GlaxoSmithKline group of
companies

10000000050300

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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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