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DERMOVATE CREAM CLOBETASOL PROPIONATE CREAM

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500885/PL1d

Package Leaflet: Information for the User

Dermovate Cream
®

(clobetasol propionate)
The name of your medicine is Dermovate Cream.
Throughout this leaflet it will be referred to as Dermovate.

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 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 of the side effects, talk to your doctor
or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

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.

What is in this leaflet:
1 What Dermovate is and what it is used for
2 What you need to know before you use Dermovate
3 How to use Dermovate
4 Possible side effects
5 How to store Dermovate
6 Contents of the pack and other information

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Dermovate Cream contains propylene glycol,
cetostearyl alcohol and chlorocresol
Propylene glycol may cause skin irritation. Cetostearyl
alcohol may cause local skin reactions (eg. contact
dermatitis). Chlorocresol may cause allergic reactions.

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 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 skin problems. These skin problems
include eczema, psoriasis, lichen planus, discoid lupus,
dermatitis and other skin conditions that have not
responded to milder steroid creams or ointments.










2. What you need to know
before you use Dermovate



You usually apply a thin layer of Dermovate 1 or 2 times
a day. This may be reduced as your skin begins to get
better, or stopped when better.
This cream is for use on your skin only.
Do not use on large areas of the body 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 cream or ointment
The germs that cause infections like warm and moist
conditions under dressings so always clean the skin
before a fresh dressing is put on.
If you are applying the cream on someone else
make sure you wash your hands after use or wear
disposable plastic gloves.
If your skin problem does not improve in 2 to 4 weeks,
talk to your doctor.

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)
on a child under 1 year old
to treat any of the following skin problems, it could
make them worse:
- acne
- severe flushing of skin on and around your nose
(rosacea)
- spotty red rash around your mouth (perioral
dermatitis)
- itching around your back passage or private parts
- infected skin (unless the infection is being treated
with an anti-infective medicine at the same time)
- itchy skin which is not inflamed

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.

Warning and precautions
Talk to your doctor or pharmacist before
using Dermovate if:
• you have previously had an allergic
reaction with another steroid
• you are applying the cream under an
airtight dressing, including a child’s
nappy. These dressings make it easier
for the active ingredient to pass through
the skin. It is possible to accidentally
end up using too much cream.
• you have psoriasis, your doctor will
want to see you more often.
• you are applying the cream on broken
skin or within skin folds.
• using for a chronic leg ulcer as you may
be at increased risk of local allergic
reaction or infection.
• you are applying to a large surface area or within the
skin folds.
• you are applying near eyes or on eyelids, as cataracts
or glaucoma may result if the cream repeatedly
enters the eye.
• you are applying to thin skin such as the face or on
children as their skin is thinner than adults and as a
result may absorb larger amounts. Use on children
should be limited to 5 days and reviewed weekly. Use
on the face should be limited to 5 days.
• dressing or bandages should not be used on children
or on the face where the cream is applied.

Guidance on how to apply the cream
1
2

Wash your hands.
Apply a thin layer to the affected area(s) and gently
rub into the skin until it has all disappeared. You
can measure how much Dermovate to use with
your fingertip. For children you will need to use less
cream but still use an adult finger to measure out the
fingertip unit. This picture shows one fingertip unit.

3

Unless you are meant to apply the cream to your
hands as a part of the treatment, wash them again
after using the cream.

For an adult
Face and neck:
2½ fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including
the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including
the foot):
6 fingertip units.
One foot:
2 fingertip units.

Do not worry if you find you need a little more or less
than this. It is only a rough guide.
Continued overleaf




For a child aged 1 – 10

Child’s
age
1–2 years
3-5 years
6-10 years




Number of fingertip units needed
Face
Arm
Leg
and
and
and
Front
neck
hand
foot


2
2

2
3
3
2




Back
including
buttocks
3

5

Do not use it 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 5 days - unless your doctor has told
you to use it for longer. The doctor may want to see
the child every week, whilst using the cream.

If you have psoriasis
If you have thick patches of psoriasis on your elbows or
knees, your doctor may suggest applying the cream under
an airtight dressing. It will only be at night to help the
cream to start working. After a short period of time you
will then apply the cream as normal.




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.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Dermovate






If you apply Dermovate to your face
You should only apply the cream to your face if your
doctor tells you to. It should be limited to only 5 days as
the skin on your face thins easily. Do not let the cream
get into your eyes. If it does, wash it out with plenty
of water.

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



Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the tube or carton after (Exp). The expiry
date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment
If you notice any sign of deterioration or discolouration
of the cream consult your pharmacist.

6. Contents of the pack and
other information

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.

What Dermovate contains

If you forget to use Dermovate



If you forget to apply your cream, 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.



The active ingredient is clobetasol propionate.
Each 1 g contains 0.5 mg of clobetasol propionate
(0.05% w/w).
The other ingredients are cetostearyl alcohol, glyceryl
monostearate, arlacel 165, beeswax substitute 6621,
propylene glycol, chlorocresol, sodium citrate, citric
acid monohydrate and purified water.

If you stop using Dermovate

What Dermovate looks like and contents of the pack

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.

Within each carton is a tube of white cream, which is sealed
and capped with a white plastic screw cap and pointer for
breaking the seal. Each tube contains 30g of cream.

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 skin problem gets worse, you
develop a generalised rash or your skin becomes
swollen during treatment. You may be allergic to the
cream, 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 cream is applied.

Uncommon (may affect up to 1 in 100 people)



Stretch marks may develop.
Veins under the surface of your skin may become
more noticeable.

Product Licence Holder
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd both at
St James’ House, 8 Overcliffe, Gravesend, Kent,
DA11 0HJ.
Manufacturer
Industrial Farmaceutica Cantabria S.A, Carretera de
Cazona-Adarzo, S/N, Santander ES-39011, Spain.
Dermovate Cream
PL No: 18067/0306

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 be able to find out more information from books
in public libraries.
Other formats
To request a copy of this leaflet in Braille, large
print or audio please call 01622 690172.
th

Leaflet date: 5 January 2015.
Dermovate® is a registered trademark of the GlaxoSmithKline
group of companies.

Rare (may affect up to 1 in 1,000 people)








An increased risk of infection
An allergic skin reaction where the cream 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 children

500885/PL1d

500887/PL1d

Package Leaflet: Information for the User

Clobetasol Propionate Cream
The name of your medicine is Clobetasol Propionate Cream.
Throughout this leaflet it will be referred to as 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 of the side effects, talk to your doctor
or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Clobetasol Propionate is and what it is used for
2 What you need to know before you use Clobetasol
Propionate
3 How to use Clobetasol Propionate
4 Possible side effects
5 How to store Clobetasol Propionate
6 Contents of the pack and other information

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before using this medicine.
Other medicines and Clobetasol Propionate
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 breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Clobetasol Propionate Cream contains propylene
glycol, cetostearyl alcohol and chlorocresol
Propylene glycol may cause skin irritation. Cetostearyl
alcohol may cause local skin reactions (eg. contact
dermatitis). Chlorocresol may cause allergic reactions.

3. How to use Clobetasol Propionate
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 Propionate is
and what it is used for
Clobetasol Propionate contains a medicine called
clobetasol propionate. It belongs to a group of medicines
called steroids. It helps to reduce swelling and irritation.
Clobetasol Propionate is used to help reduce the redness
and itchiness of certain skin problems. These skin problems
include eczema, psoriasis, lichen planus, discoid lupus,
dermatitis and other skin conditions that have not
responded to milder steroid creams or ointments.

2. What you need to know
before you use Clobetasol Propionate










You usually apply a thin layer of Clobetasol Propionate
1 or 2 times a day. This may be reduced as your skin
begins to get better, or stopped when better.
This cream is for use on your skin only.
Do not use on large areas of the body 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 cream or ointment
The germs that cause infections like warm and moist
conditions under dressings so always clean the skin
before a fresh dressing is put on.
If you are applying the cream on someone else
make sure you wash your hands after use or wear
disposable plastic gloves.
If your skin problem does not improve in 2 to 4 weeks,
talk to your doctor.

Do not use Clobetasol Propionate:





if you are allergic (hypersensitive) to clobetasol
propionate or any of the other ingredients of this
medicine (listed in Section 6)
on a child under 1 year old
to treat any of the following skin problems, it could
make them worse:
- acne
- severe flushing of skin on and around your nose
(rosacea)
- spotty red rash around your mouth (perioral
dermatitis)
- itching around your back passage or private parts
- infected skin (unless the infection is being treated
with an anti-infective medicine at the same time)
- itchy skin which is not inflamed

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 Propionate.

Guidance on how to apply the cream
1
2

Wash your hands.
Apply a thin layer to the affected area(s) and gently
rub into the skin until it has all disappeared. You
can measure how much Clobetasol Propionate to use
with your fingertip. For children you will need to use less
cream but still use an adult finger to measure out the
fingertip unit. This picture shows one fingertip unit.

3

Unless you are meant to apply the cream to your
hands as a part of the treatment, wash them again
after using the cream.

Warning and precautions
Talk to your doctor or pharmacist before
using Clobetasol Propionate if:
• you have previously had an allergic
reaction with another steroid
• you are applying the cream under an
airtight dressing, including a child’s
nappy. These dressings make it easier
for the active ingredient to pass through
the skin. It is possible to accidentally
end up using too much cream.
• you have psoriasis, your doctor will
want to see you more often.
• you are applying the cream on broken
skin or within skin folds.
• using for a chronic leg ulcer as you may
be at increased risk of local allergic
reaction or infection.
• you are applying to a large surface area or within the
skin folds.
• you are applying near eyes or on eyelids, as cataracts
or glaucoma may result if the cream repeatedly
enters the eye.
• you are applying to thin skin such as the face or on
children as their skin is thinner than adults and as a
result may absorb larger amounts. Use on children
should be limited to 5 days and reviewed weekly. Use
on the face should be limited to 5 days.
• dressing or bandages should not be used on children
or on the face where the cream is applied.

For an adult
Face and neck:
2½ fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including
the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including
the foot):
6 fingertip units.
One foot:
2 fingertip units.

Do not worry if you find you need a little more or less
than this. It is only a rough guide.
Continued overleaf




For a child aged 1 – 10

Child’s
age
1–2 years
3-5 years
6-10 years




Number of fingertip units needed
Face
Arm
Leg
and
and
and
Front
neck
hand
foot


2
2

2
3
3
2




Back
including
buttocks
3

5

Do not use it 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 5 days - unless your doctor has told
you to use it for longer. The doctor may want to see
the child every week, whilst using the cream.

If you have psoriasis
If you have thick patches of psoriasis on your elbows or
knees, your doctor may suggest applying the cream under
an airtight dressing. It will only be at night to help the
cream to start working. After a short period of time you
will then apply the cream as normal.




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.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Clobetasol Propionate






If you apply Clobetasol Propionate to your face
You should only apply the cream to your face if your
doctor tells you to. It should be limited to only 5 days as
the skin on your face thins easily. Do not let the cream
get into your eyes. If it does, wash it out with plenty
of water.

If you use more Clobetasol Propionate 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 apply your cream, 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 Propionate
If you use Clobetasol Propionate 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 Propionate and tell your
doctor immediately if:




you find that your skin problem gets worse, you
develop a generalised rash or your skin becomes
swollen during treatment. You may be allergic to the
cream, 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 Propionate include:
Common (may affect up to 1 in 10 people)


A feeling of burning, pain, irritation or itching where
the cream is applied.

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the tube or carton after (Exp). The expiry
date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment
If you notice any sign of deterioration or discolouration
of the cream consult your pharmacist.

6. Contents of the pack and
other information
What Clobetasol Propionate contains




If you forget to use Clobetasol Propionate

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

The active ingredient is clobetasol propionate.
Each 1 g contains 0.5 mg of clobetasol propionate
(0.05% w/w).
The other ingredients are cetostearyl alcohol, glyceryl
monostearate, arlacel 165, beeswax substitute 6621,
propylene glycol, chlorocresol, sodium citrate, citric
acid monohydrate and purified water.

What Clobetasol Propionate looks like and contents
of the pack
Within each carton is a tube of white cream, which is sealed
and capped with a white plastic screw cap and pointer for
breaking the seal. Each tube contains 30g of cream.
Product Licence Holder
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd both at
St James’ House, 8 Overcliffe, Gravesend, Kent,
DA11 0HJ.
Manufacturer
Industrial Farmaceutica Cantabria S.A, Carretera de
Cazona-Adarzo, S/N, Santander ES-39011, Spain.
Clobetasol Propionate Cream
PL No: 18067/0306
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 be able to find out more information from books
in public libraries.
Other formats
To request a copy of this leaflet in Braille, large
print or audio please call 01622 690172.
th

Leaflet date: 5 January 2015.

Uncommon (may affect up to 1 in 100 people)



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 cream 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 children

500887/PL1d

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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