DERMOVATE 0.05% SCALP APPLICATION

Active substance: CLOBETASOL PROPIONATE

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Package Leaflet: Information for the User
®

Dermovate 0.05% Scalp
Application
(clobetasol propionate)
Read all of this leaflet carefully before you
start using this medicine.
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. 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.
The name of your medicine is Dermovate
0.05% Scalp Application but will be referred to
as Dermovate throughout this leaflet.
In this leaflet:
1. What Dermovate is and what it is used
for
2. Before you use Dermovate
3. How to use Dermovate
4. Possible side effects
5. How to store Dermovate
6. Further 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 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.

Take special care with Dermovate
Check with your doctor or pharmacist before
using your medicine if:
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.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using
this medicine if you are pregnant, might
become pregnant or are breast-feeding.
3. How to use 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.

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 to.

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
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.
If you stop using Dermovate
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:
A feeling of burning, irritation or itching
where the scalp application is applied.
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.
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 the month.
Do not store above 25°C.
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. Further information
What Dermovate contains
Each ml of the topical solution contains
0.05%w/w clobetasol propionate.
Also includes carbomer 980 NF, isopropyl
alcohol, sodium hydroxide and purified water.
What Dermovate looks like and contents of
the pack
The scalp application is contained in
apolyethylene squeeze bottle with a
polyethylene nozzle and a tamper evident
cap. Each bottle contains 100ml of clear
colourless solution.
Manufactured by: Aspen Bad Oldesloe
GmbH, Industriestrasse 32-36, 23843 Bad
Oldesloe, Germany.
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% Scalp Application
PL No: 18799/2075
POM
Leaflet date: 17.09.2014
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

Package Leaflet: Information for the User

Clobetasol propionate 0.05%
Scalp Application
Read all of this leaflet carefully before you
start using this medicine.
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. 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.
The name of your medicine is Clobetasol
propionate 0.05% Scalp Application but will
be referred to as Clobetasol throughout this
leaflet.
In this leaflet:
1. What Clobetasol is and what it is used for
2. Before you use Clobetasol
3. How to use Clobetasol
4. Possible side effects
5. How to store Clobetasol
6. Further information
1. What Clobetasol is and what it is used
for
Clobetasol contains a medicine called
clobetasol propionate. It belongs to a group of
medicines called steroids. It helps to reduce
swelling and irritation.
Clobetasol 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 Clobetasol
Do not use Clobetasol:
if you are allergic (hypersensitive) to
clobetasol propionate or any of the other
ingredients of Clobetasol (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 Clobetasol.

Take special care with Clobetasol
Check with your doctor or pharmacist before
using your medicine if:
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.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using this medicine.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using
this medicine if you are pregnant, might
become pregnant or are breast-feeding.
3. How to use Clobetasol
Always use Clobetasol 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 Clobetasol 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.

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 to.

5. Your scalp will feel cool until the liquid has
dried.

6. Wash your hands again.
If you use more Clobetasol 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 Clobetasol
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.
If you stop using Clobetasol
If you use Clobetasol 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, Clobetasol can cause side
effects, although not everybody gets them.
Stop using Clobetasol 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 Clobetasol include:
A feeling of burning, irritation or itching
where the scalp application is applied.
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.
Side effects if you use Clobetasol 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 Clobetasol
Keep out of the sight and reach of children.
Do not use Clobetasol after the expiry date on
the bottle label or carton (Exp). The expiry
date refers to the last day of the month.
Do not store above 25°C.
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. Further information
What Clobetasol contains
Each ml of the topical solution contains
0.05%w/w clobetasol propionate.
Also includes carbomer 980 NF, isopropyl
alcohol, sodium hydroxide and purified water.
What Clobetasol looks like and contents of
the pack
The scalp application is contained in
apolyethylene squeeze bottle with a
polyethylene nozzle and a tamper evident
cap. Each bottle contains 100ml of clear
colourless solution.
Manufactured by: Aspen Bad Oldesloe
GmbH, Industriestrasse 32-36, 23843 Bad
Oldesloe, Germany.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK
Clobetasol proprionate 0.05% Scalp
Application
PL No: 18799/2075
POM
Leaflet date: 17.09.2014
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

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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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