DERMOVATE OINTMENT

Active substance: CLOBETASOL PROPIONATE

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10000000104130

Package Leaflet: Information for the User

Dermovate® Ointment
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 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

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 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 ointment 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 ointment.
you have psoriasis, your doctor will want
to see you more often.
you are applying the ointment 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 ointment 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.

dressing or bandages should not be used on children or on
the face where the ointment 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 planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Dermovate Ointment contains propylene glycol
Propylene glycol may cause skin irritation.

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 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 it is better.
This ointment 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 ointment 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 ointment
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 ointment
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 ointment to your
hands as a part of the treatment, wash them again after
using the ointment.
For an adult

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

An increase or reduction in hair growth or hair loss and
changes in skin colour.
Thinning of your skin that 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
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.

For a child aged 1 – 10
Number of fingertip units needed
Child’s
age

Face Arm
and and
neck hand

Leg
and
foot

Back
Front including
buttocks

1-2 years





2

2

3

3-5 years



2

3

3



6-10 years

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 ointment.
If you have psoriasis
If you have thick patches of psoriasis on your elbows or knees,
your doctor may suggest applying the ointment under an
airtight dressing. It will only be at night to help the ointment
to start working. After a short period of time you will then
apply the ointment as normal.
If you apply Dermovate to your face
You should only apply the ointment to your face if your
doctor tells you to. It should be limited to 5 days, as the
skin on your face thins easily. Do not let the ointment
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 ointment, 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 ointment, 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
ointment 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 ointment 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

5. How to store Dermovate
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the tube or carton after (Exp). The expiry date
refers to the last day of that month.
Do not store above 30°C.
Do not throw away 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.

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 propylene glycol, sorbitan
sesquioleate and white soft paraffin.
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 ointment.
Marketing Authorisation Holder and Manufacturer
Product licence held by Glaxo Wellcome UK Ltd,
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.
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:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Dermovate Ointment
Reference number
10949/0028
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in: August 2014
Dermovate is a registered trade mark of the
GSK group of companies
© 2014 GSK group of companies. All rights
reserved.

10000000104130

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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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