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DERMOVATE 0.05% SCALP APPLICATION

Active substance(s): CLOBETASOL PROPIONATE / 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 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.
The name of your medicine is Dermovate 0.05%w/v
scalp application but will be referred to as Dermovate
throughout this leaflet.

What is in this leaflet:
1
2
3
4
5
6

What Dermovate is and what it is used for
What you need to know before you use Dermovate
How to use Dermovate
Possible side effects
How to store Dermovate
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 scalp problems. These include
frequently relapsing dermatoses and psoriasis that have
not responded to milder steroid creams, ointments,
lotions or scalp applications.

2. What you need to know before you use

Children






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 are breast-feeding, think you may
become pregnant or are planning to have a baby ask
your doctor or pharmacist for advice before taking this
medicine.

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





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)
 if you have a skin infection on your scalp
 on a child under 1 year of age.
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 much. Do not bandage
or otherwise cover the treated scalp area, unless
directed to do so by your doctor.
 If directed to cover the treated area with a dressing,
make sure that the skin is cleansed before a fresh
dressing is applied to prevent infections.
 you have psoriasis, your doctor will want to see you
more often.
 you are applying the liquid to broken, damaged or
thin skin.
 you are applying to a large surface area.
If an infection develops during the use of this medicine
talk to your doctor or pharmacist.
Be very careful not to get the liquid in your eyes. If you
are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using this medicine.

Do not use this medicine on a child under the age of
1 year.
Avoid continuous treatment for a long period of time
in children over the age of 1 year, as their skin is
thinner than adults and as a result may absorb larger
amounts.
Use on children should be limited to a few days and
reviewed weekly.
Dressings or bandages should not be used on
children where the scalp application is applied.








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. 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.
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
2
3
4
5
6

Wash your hands.
Unscrew the bottle cap and place the nozzle directly
on the scalp that needs treating.
Gently squeeze the bottle to cover the area with a
thin and even layer of liquid.
You can rub this liquid in, but you don’t have to. Your
scalp will feel cool until the liquid has dried.
Wash your hands again.
Do not exceed the prescribed amount.

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 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.

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 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 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 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 scalp application is applied.

Uncommon (may affect up to 1 in 100 people)



skin thinning, this may cause stretch marks
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
 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, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. You can also report any 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 solution after the expiry date which is
stated on the carton and bottle label after 'Exp'. The
expiry date refers to the last day of that month.
 If the solution becomes discoloured or show any signs
of deterioration, seek the advice of your pharmacist.
 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. Contents of the pack and other

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 a polyethylene
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 18799/2075
Leaflet date: 22.02.2017
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.
You may also be able to find out more information from
books in public libraries.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

Package Leaflet: Information for the user

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

What is in this leaflet:
1
2
3
4
5
6

What Clobetasol is and what it is used for
What you need to know before you use Clobetasol
How to use Clobetasol
Possible side effects
How to store Clobetasol
Contents of the pack and other 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
frequently relapsing dermatoses and psoriasis that have
not responded to milder steroid creams, ointments,
lotions or scalp applications.

Children






Other medicines and Clobetasol
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 are breast-feeding, think you may
become pregnant or are planning to have a baby ask
your doctor or pharmacist for advice before taking this
medicine.

3. How to use Clobetasol
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





2. What you need to know before you use

Clobetasol
Do not use Clobetasol:


if you are allergic (hypersensitive) 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 of age.
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.

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 much. Do not bandage
or otherwise cover the treated scalp area, unless
directed to do so by your doctor.
 If directed to cover the treated area with a dressing,
make sure that the skin is cleansed before a fresh
dressing is applied to prevent infections.
 you have psoriasis, your doctor will want to see you
more often.
 you are applying the liquid to broken, damaged or
thin skin.
 you are applying to a large surface area.
If an infection develops during the use of this medicine
talk to your doctor or pharmacist.
Be very careful not to get the liquid in your eyes. If you
are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using this medicine.

Do not use this medicine on a child under the age of
1 year.
Avoid continuous treatment for a long period of time
in children over the age of 1 year, as their skin is
thinner than adults and as a result may absorb larger
amounts.
Use on children should be limited to a few days and
reviewed weekly.
Dressings or bandages should not be used on
children where the scalp application is applied.










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. 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.
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
2
3
4
5
6

Wash your hands.
Unscrew the bottle cap and place the nozzle directly
on the scalp that needs treating.
Gently squeeze the bottle to cover the area with a
thin and even layer of liquid.
You can rub this liquid in, but you don’t have to. Your
scalp will feel cool until the liquid has dried.
Wash your hands again.
Do not exceed the prescribed amount.

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 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 Clobetasol.

If you use more Clobetasol 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 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. Do not apply
extra Clobetasol to make up for a missed dose.

If you stop using Clobetasol
If you use Clobetasol 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 Clobetasol 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 psoriasis.

Other side effects you may notice when using
Clobetasol 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 people)



skin thinning, this may cause stretch marks
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 Clobetasol 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
 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, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. You can also report any 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 solution after the expiry date which is
stated on the carton and bottle label after 'Exp'. The
expiry date refers to the last day of that month.
 If the solution becomes discoloured or show any signs
of deterioration, seek the advice of your pharmacist.
 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. Contents of the pack and other

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 a polyethylene
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 propionate 0.05% Scalp Application;
PL 18799/2075
Leaflet date: 22.02.2017
POM
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 information from
books in public libraries.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

Expand Transcript

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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