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DERMOVATE OINTMENT

Active substance(s): CLOBETASOL PROPIONATE

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10000000141837

2

Package Leaflet: Information for the user

Dermovate Ointment
®

10000000141837

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

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.

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United Kingdom-GBR
Dermovate
N/A
JMF333

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

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:
• frequently relapsing eczema
• psoriasis (thickened patches of inflamed, red skin, often covered by
silvery scales), excluding widespread plaque psoriasis
• lichen planus (a skin disease that causes itchy, reddish-purple,
flat-topped bumps on the wrists, forearms or lower legs)
• discoid lupus erythematosus (a disease of the skin most often
affecting the face, ears and scalp causing scarring and increased
sensitivity of the affected skin to sunlight)
• dermatitis and other skin conditions that have not responded to
milder steroid creams or ointments.

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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 of age

• 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 anus or genitals (penis or vagina)
- infected skin (unless the infection is being treated with an
anti-infective medicine at the same time)
- itchy skin which is not inflamed
- widespread plaque psoriasis, except single lesions.
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.
• make sure that the skin is cleansed before a fresh dressing is
applied to prevent infections.
• you are applying the ointment on broken or damaged skin or within
the skin folds.
• you are applying to a large surface area.
• you have psoriasis, your doctor will want to see you more often.
• you are using for a chronic leg ulcer as you may be at increased risk
of local allergic reaction or infection.
• 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, as Dermovate may
cause skin thinning. Use on the face should be limited to 5 days.
Dressings or bandages should not be used on the face where the
ointment is applied.
If an infection develops during the use of this medicine, talk to your
doctor or pharmacist.
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before using this medicine.
Children
• Do not use this medicine in children under 1 year of age.
• Avoid continuous treatment for a long period of time in infants and
children over 1 year of age, 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.
• Dressings or bandages should not be used on children where the
ointment 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 breast-feeding, think you may be pregnant or
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
If you do use Dermovate when breast-feeding, do not use it on your
breast area to ensure that the baby does not accidentally get
Dermovate in their mouth.
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 once or twice a day.
This may be reduced as your skin begins to get better, or stopped
when it is better. Your doctor may prescribe a weaker steroid for you
to use instead.
• If you are also using an emollient (moisturiser), allow time for
Dermovate to be absorbed into your skin before applying the
emollient.
• This ointment is for use on your skin only.
• Do not use or more than 4 weeks without talking to your doctor. If
you need treatment for a long time, your doctor may decide you
need to use a milder cream or ointment.
• If your skin problem worsens or does not improve within 2 to
4 weeks, talk to your doctor.
• The germs that cause infections like the 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.
• If you are applying the ointment on someone else make sure you
wash your hands after use or wear disposable plastic gloves.

0

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
Number of fingertip units needed
Child’s age
1-2 years
3-5 years
6-10 years

Face
Arm
Leg
and neck and hand and foot


2


2


2
3


Front
2
3


Back
including
buttocks
3

5

Use in children
• Do not use this medicine 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. Your
doctor may want to see the child every week, whilst using the
ointment.
• Dressings or bandages should not be used on children where the
ointment is applied.
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.
Dressings or bandages should not be used on the face where the
ointment is applied. 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.
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.

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)
• skin thinning, stretch marks may develop.
• 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

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• 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
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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Dermovate
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JMF333

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5. How to store Dermovate
• Keep this medicine 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.

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6. Contents of the pack and other information

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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 (see section 2), 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.

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer:
Glaxo Wellcome Operations, Harmire Road, Barnard Castle,
Co. 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 October 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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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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