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Package Leaflet: Information for the User

Dermovate® 0.05% w/v Scalp Application
(clobetasol propionate)
you are applying to thin skin or on children as
Read all of this leaflet carefully before you
their skin is thinner than adults and as a result
start using this medicine because it
may absorb larger amounts. Use on children
contains important information for you.
should be limited to a few days and reviewed
Keep this leaflet. You may need to read it
Dressing or bandages should not be used on
children where the scalp application is applied.
If you have any further questions, ask your
doctor or pharmacist.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
using this medicine.
them, even if their signs of illness are the
Pregnancy, breast-feeding and fertility
same as yours.
If you are pregnant or are breast-feeding, think
If you get any side effects, talk to your doctor
you may become pregnant or are planning to
or pharmacist. This includes any possible side
have a baby ask your doctor or pharmacist for
effects not listed in this leaflet. See section 4.
advice before taking this medicine.
The name of your medicine is Dermovate
Other medicines and Dermovate
0.05%w/v scalp application but will be referred to
Tell your doctor or pharmacist if you are taking,
as Dermovate throughout this leaflet.
have recently taken or might take any other
What is in this leaflet:
medicine, especially if you are taking ritonavir and
itraconazole medications.
1. What Dermovate is and what it is used for
2. What you need to know before you use
3. How to use Dermovate
3. How to use Dermovate
Always use this medicine exactly as your doctor
4. Possible side effects
has told you. Check with your doctor or
5. How to store Dermovate
pharmacist if you are not sure.
6. Contents of the pack and other information

Using this medicine

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 eczema 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 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
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
you have psoriasis, your doctor will want to
see you more often.
you are applying the liquid to broken skin or
within the skin folds.
you are applying to a large surface area.

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 so always
clean the skin before a fresh dressing is put on.
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
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
5. Your scalp will feel cool until the liquid has
6. Wash your hands again.
7. It is important not to exceed the prescribed

Use in children

Reporting of side effects

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 get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:
By reporting side effects, you can help provide
more information on the safety of this medicine.

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

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 product, 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 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

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
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 scalp
application 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
Bones can become thin, weak and break
Cloudy lens in the eye (cataract) or increased
pressure in the eye (glaucoma)
Increased blood sugar levels or sugar in the
High blood pressure

5. How to store Dermovate
Keep out of the sight and reach of children.
Do not use Dermovate after the expiry date on
the bottle label or carton (Exp). The expiry
date refers to the last day of that month.
Keep away from naked flames, fires or
artificial heat as the liquid is flammable.
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
What Dermovate contains
One millilitre of this topical solution contains
0.5 mg of clobetasol propionate as the active
Also includes carbomer, isopropyl alcohol,
sodium hydroxide and purified water.

What Dermovate looks like and contents of
the pack
The scalp application is contained in a 50ml
polyethylene squeeze bottle with a polyethylene
nozzle and a tamper evident cap.
Each bottle of scalp application contains 50ml of
Manufacturer: Aspen Bad Oldesloe GmbH,
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%w/v Scalp Application
PL No: 18799/1453
Leaflet date: 18.08.2015
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.