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DERMOVATE 0.05% CREAM

Active substance(s): CLOBETASOL PROPIONATE

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Package Leaflet: Information for the User
®

Dermovate 0.05% Cream
(clobetasol propionate)

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 of the side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.



dressing or bandages should not be used on children or on
the face where the cream is applied.

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 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 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.

The name of your medicine is Dermovate 0.05% Cream but will be
referred to as Dermovate throughout this leaflet.

Dermovate Cream contains propylene glycol, cetostearyl
alcohol and chlorocresol
Propylene glycol may cause skin irritation. Cetostearyl alcohol may
cause local skin reactions (eg. contact dermatitis). Chlorocresol
may cause allergic reactions.

What is in this leaflet:

3. How to use Dermovate

1.
2.
3.
4.
5.
6.

What Dermovate is and what it is used for
What you need to know before you use Dermovate
How to use Dermovate
Possible side effects
How to store Dermovate
Contents of the pack and other 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, lichen planus, discoid lupus, dermatitis and other skin
conditions that have not responded to milder steroid creams or
ointments.

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)
on a child under 1 year 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
infected skin (unless the infection is being treated with an
anti-infective medicine at the same time)
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 Dermovate.

Warnings and precautions
Talk to your doctor or pharmacist before using Dermovate if:
• you have previously had an allergic reaction with another
steroid.
• 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.
• using for a chronic leg ulcer as you may be at increased risk of
local allergic reaction or infection.
• you are applying to a large surface area 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. Use on children should be limited to 5 days
and reviewed weekly. Use on the face should be limited to 5
days.

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 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. 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
Dermovate 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 aged 1 – 10
Child’s
age
1-2
years
3-5
years
6-10
years




Number of fingertip units needed
Face
Arm
Leg
Front
and
and
and
neck
hand
foot


2
2

Back
including
buttocks
3



2

3

3



2







5

Do not use it on children under 1 year of age.
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 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 be limited to only 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 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 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 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 Dermovate and tell your doctor immediately if:
• you find that your skin problem 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 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 cream
is applied.
Uncommon (may affect up to 1 in 100 people)
• Stretch marks may develop.
• Veins under the surface of your skin may become more
noticeable.
Rare (may affect up to 1 in 1,000 people)
• An increased risk of infection
• An allergic skin reaction where the cream is applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your skin and it may also damage or
wrinkle more easily
• An increase or reduction in hair growth or hair loss and
changes in skin colour.








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
the 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 Dermovate





Keep out of the sight and reach 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. Contents of the pack and other information
What Dermovate contains



The cream contains: the active ingredient – clobetasol
propionate 0·05% w/w
a preservative - chlorocresol - in a base containing cetostearyl
alcohol, glyceryl monostearate, Arlacel 165, beeswax
substitute, propylene glycol, sodium citrate, citric acid and
purified water.

Warning:
This product contains propylene glycol, which may cause skin
irritation.

What Dermovate looks like and contents of the pack
The cream is a smooth white translucent cream packaged in a
collapsible tube with a white screw cap. The cream is available in
25g tubes.
Manufactured by: Glaxo Wellcome Operations, Greenford,
Middlesex, UB6 0NN, U.K. Ltd, England.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

Dermovate 0.05% Cream
PL 18799/1451

POM

Leaflet Date: 30.03.2015
Dermovate is a registered trademark of GlaxoSmithKline group of
companies
More Information
If you have any questions or are not sure about anything, ask your
doctor or pharmacist who will advise you.
You may also be able to find out more from books in public
libraries.

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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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