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DERMOVATE 0.05% SCALP APPLICATION

Active substance(s): 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% 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

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


1. What Dermovate is and what it is used for
Dermovate contains a medicine called clobetasol propionate. It
1. How to store Dermovate
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

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.
Contact your doctor if you experience blurred vision or
other visual disturbances.
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.

Not Known (frequency cannot be estimated from the
available data)
 blurred vision
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information
on the safety of this medicine.

4. Possible side effects

5. How to store Dermovate

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





Keep out of the sight and reach of children.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the
liquid is flammable.
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 shows any sign of
deterioration, seek the advice of your pharmacist.
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
The active ingredient in Dermovate is clobetasol propionate.
Each ml of the topical solution contains 0.05%w/w clobetasol
propionate.
The other ingredients are carbomer 980 NF, isopropyl alcohol,
sodium hydroxide and purified water.
What Dermovate looks like and contents of the pack
Dermovate is available 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: 10.01.2018
POM
Dermovate is a registered trademark of Glaxo Group Ltd.
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% 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

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


1. What Clobetasol is and what it is used for
Clobetasol contains a medicine called clobetasol propionate. It
1. How to store Clobetasol
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.






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.
Contact your doctor if you experience blurred vision or
other visual disturbances.
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.

Not Known (frequency cannot be estimated from the
available data)
 blurred vision
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information
on the safety of this medicine.

4. Possible side effects

5. How to store Clobetasol

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





Keep out of the sight and reach of children.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the
liquid is flammable.
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 shows any sign of
deterioration, seek the advice of your pharmacist.
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
The active ingredient in Clobetasol is clobetasol propionate.
Each ml of the topical solution contains 0.05%w/w clobetasol
propionate.
The other ingredients are carbomer 980 NF, isopropyl alcohol,
sodium hydroxide and purified water.
What Clobetasol looks like and contents of the pack
Clobetasol is available 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: 10.01.2018
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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