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DERMOVATE 0.05% W/V SCALP APPLICATION

Active substance: CLOBETASOL PROPIONATE

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Package Leaflet: Information for the User

Dermovate® 0.05% w/v Scalp Application
(clobetasol propionate)
The name of your medicine is Dermovate
0.05%w/v scalp application but will be referred to
as Dermovate throughout this leaflet.

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.

Read all of this leaflet carefully before you
start using this medicine.

Pregnancy and breast-feeding

Keep this leaflet. You may need to read it
again.

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

If you have any further questions, ask your
doctor or pharmacist.

3. How to use Dermovate

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.
2.
3.
4.
5.
6.

What Dermovate is and what it is used for
Before you use Dermovate
How to use Dermovate
Possible side effects
How to store Dermovate
Further information

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. 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)
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.

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 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
gloves.
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.

Take special care with Dermovate

3. Gently squeeze the bottle to cover the area
with a thin and even layer of liquid.

Check with your doctor or pharmacist before
using your medicine if:

4. You can rub this liquid in, but you don’t have
to.

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
much.
you have psoriasis, your doctor will want to
see you more often.

5. Your scalp will feel cool until the liquid has
dried.
6. Wash your hands again.

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

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

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
time.

One millilitre of this topical solution contains
0.5 mg of clobetasol propionate as the active
ingredient.

If you stop using Dermovate

Also includes carbomer, isopropyl alcohol,
sodium hydroxide and purified water.

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 scalp problem gets worse or
becomes swollen during treatment. You may
be allergic to the scalp application, have an
infection or need other treatment.

Other side effects you may notice when
using Dermovate include:

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
solution
Manufacturer: Aspen Bad Oldesloe GmbH,
Germany.
Procured from within the EU and repackaged
by the Product Licence holder: B&S
Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU
Dermovate 0.05%w/v Scalp Application

A feeling of burning, irritation or itching where
the scalp application is applied.

PL No: 18799/1453

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.

Leaflet date: 17.09.2014

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:
Thinning of your skin that may also damage
more easily.
Weight gain, rounding of the face and high
blood pressure. These are more likely to
happen in infants and children.
Reporting of side effects
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: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 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.

POM

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. 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.

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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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