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CLOBETASOL PROPIONATE 0.05% CREAM

Active substance(s): CLOBETASOL 17-PROPIONATE / CLOBETASOL PROPIONATE / CLOBETASOL 17-PROPIONATE / CLOBETASOL PROPIONATE / CLOBETASOL 17-PROPIONATE

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Transcript
Ref:1060/050617/1/F

®

Dermovate Cream
(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.
Your medicine is called Dermovate Cream,
however throughout this leaflet it will be referred
to as Dermovate.

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

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:
• frequently relapsing eczema
• psoriasis (thickened patches of inflamed, red
skin, often covered by silvery scales), excluding
widespread plaque psoriasis
• lichen planus, (a skin disease that causes itchy,
reddish-purple, flat-topped bumps on the wrists,
forearms or lower legs)
• discoid lupus erythematosus (a disease of the
skin most often affecting the face, ears and
scalp causing scarring and increased sensitivity
of the affected skin to sunlight)
• 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
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 of age
• 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 anus or genitals (penis or
vagina)
- infected skin (unless the infection is being
treated with an anti-infective medicine at the
same time)
- itchy skin which is not inflamed
- widespread plaque psoriasis, except single
lesions.
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.
• make sure that the skin is cleansed before a
fresh dressing is applied to prevent infections.
• you are applying the cream on broken or
damaged skin or within skin folds.
• you are applying to a large surface area.
• you have psoriasis, your doctor will want to see
you more often.
• you are using for a chronic leg ulcer as you may
be at increased risk of local allergic reaction or
infection.
• 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, as
Dermovate may cause skin thinning. Use on the
face should be limited to 5 days. Dressings or
bandages should not be used on the face where
the cream is applied.

Package Leaflet: Information for the User
If an infection develops during the use of this
medicine, talk to your doctor or pharmacist.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
this medicine.
Children
• Do not use this medicine in children under 1
year of age.
• Avoid continuous treatment for a long period of
time in infants and children over 1 year of age,
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.
• Dressings or bandages should not be used on
children where the cream is applied.
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 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.
If you do use Dermovate when breast-feeding do
not use it on your breast area to ensure that the
baby does not accidentally get Dermovate in their
mouth.
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

• You usually apply a thin layer of Dermovate

once or twice a day. This may be reduced as
your skin begins to get better, or stopped
when better. Your doctor may prescribe a
weaker steroid for you to use instead.
• If you are also using an emollient (moisturiser),
allow time for Dermovate to be absorbed into
your skin before applying the emollient.
• This cream is for use on your skin only.
• Do not use for more than 4 weeks without
talking to your doctor. If you need treatment for
a long time, your doctor may decide you need to
use a milder cream or ointment.
• If your skin problem worsens or does not
improve within 2 to 4 weeks, talk to your doctor.
• The germs that cause infections like the 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.
• If you are applying the cream on someone else
make sure you wash your hands after use or
wear disposable plastic gloves.
Guidance on how to apply the cream
1 Wash your hands.
2 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

Ref:1060/050617/1/B

Do not worry if you find you need a little more or
less than this. It is only a rough guide.
For a child aged 1 – 10

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 over the age of
1 year should not normally last more than 5 days
unless your doctor has told you to use it for
longer. Your doctor may want to see the child
every week, whilst using the cream.
• Dressings or bandages should not be used on
children where the cream is applied.
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.
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.
Dressings or bandages should not be used on the
face where the cream is applied. Do not let the
cream get into your eyes. If it does, wash it out
with plenty of water.
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 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.
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.

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 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
Expiry Date
Do not use this medicine after the expiry date shown
on the carton label or tube. Only keep this medicine if
your doctor tells you to. If your cream becomes
discoloured or shows any other signs of deterioration,
consult your pharmacist (chemist) who will tell you
what to do. You should return any left over cream to
your pharmacist.
How to Store
Do not store above 30°C
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN
• 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 protect the environment.




Important
Remember this medicine is for you. It can only be
prescribed by a doctor. Never give your medicine to
other people, it may harm them, even if their
symptoms are the same. This leaflet does not tell you
everything about your medicine. If you have any
question or are not sure about anything, ask your
doctor or pharmacist (chemist) He/she will have
additional information about this medicine and will be
able to advise you.

6. Contents of the pack and other
information

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)
• 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

What Dermovate contains
Dermovate Cream contains 0.05% w/w of
clobetasol propionate as the active ingredient.
Your cream also contains the following inactive
ingredients: cetostearyl alcohol, glyceryl
monostearate, Arlacel 165, beeswax substitute 6621,
propylene glycol, chlorocresol, sodium
citrate, citric acid monohydrate, purified water.
What Dermovate looks like and contents of the
pack
Dermovate Cream is a white, smooth, shiny cream
packaged in a metal collapsible tube with a plastic
screw cap and tamper evident seal.
Dermovate Cream is available in tubes of 30g.
Who manufactured your medicine?
Dermovate Cream is manufactured by
INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.
Ctra. Cazona-adarzo, s/n, 39011, Spain and is
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL Number: 15184/1060

Leaflet revision date: 05/06/17
Dermovate Cream is a registered trademark of The
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 be able to find out more
information from books in public libraries.

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

Ref:1060/050617/2/F

®

Clovate Cream
(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.
Your medicine is called Clovate Cream,
however throughout this leaflet it will be referred
to as Clovate.

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

1 What Clovate is and what it is
used for
Clovate contains a medicine called clobetasol propionate. It belongs to a group of medicines called
steroids. It helps to reduce swelling and
irritation.
Clovate is used to help reduce the redness and
itchiness of certain skin problems. These skin
problems include:
• frequently relapsing eczema
• psoriasis (thickened patches of inflamed, red
skin, often covered by silvery scales), excluding
widespread plaque psoriasis
• lichen planus, (a skin disease that causes itchy,
reddish-purple, flat-topped bumps on the wrists,
forearms or lower legs)
• discoid lupus erythematosus (a disease of the
skin most often affecting the face, ears and
scalp causing scarring and increased sensitivity
of the affected skin to sunlight)
• dermatitis and other skin conditions that have
not responded to milder steroid creams or
ointments.

2 What you need to know before you
use Clovate
Do not use Clovate:
• 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 of age
• 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 anus or genitals (penis or
vagina)
- infected skin (unless the infection is being
treated with an anti-infective medicine at the
same time)
- itchy skin which is not inflamed
- widespread plaque psoriasis, except single
lesions.
Do not use if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist
before using Clovate.
Warning and precautions
Talk to your doctor or pharmacist before using
Clovate 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.
• make sure that the skin is cleansed before a
fresh dressing is applied to prevent infections.
• you are applying the cream on broken or
damaged skin or within skin folds.
• you are applying to a large surface area.
• you have psoriasis, your doctor will want to see
you more often.
• you are using for a chronic leg ulcer as you may
be at increased risk of local allergic reaction or
infection.
• 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, as
Clovate may cause skin thinning. Use on the
face should be limited to 5 days. Dressings or
bandages should not be used on the face where
the cream is applied.

Package Leaflet: Information for the User
If an infection develops during the use of this
medicine, talk to your doctor or pharmacist.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
this medicine.
Children
• Do not use this medicine in children under 1
year of age.
• Avoid continuous treatment for a long period of
time in infants and children over 1 year of age,
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.
• Dressings or bandages should not be used on
children where the cream is applied.
Other medicines and Clovate
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.
If you do use Clovate when breast-feeding do not
use it on your breast area to ensure that the baby
does not accidentally get Clovate in their mouth.
Clovate 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 Clovate
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

• You usually apply a thin layer of Clovate

once or twice a day. This may be reduced as
your skin begins to get better, or stopped
when better. Your doctor may prescribe a
weaker steroid for you to use instead.
• If you are also using an emollient (moisturiser),
allow time for Clovate to be absorbed into
your skin before applying the emollient.
• This cream is for use on your skin only.
• Do not use for more than 4 weeks without
talking to your doctor. If you need treatment for
a long time, your doctor may decide you need to
use a milder cream or ointment.
• If your skin problem worsens or does not
improve within 2 to 4 weeks, talk to your doctor.
• The germs that cause infections like the 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.
• If you are applying the cream on someone else
make sure you wash your hands after use or
wear disposable plastic gloves.
Guidance on how to apply the cream
1 Wash your hands.
2 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
Clovate 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

Ref:1060/050617/2/B

Do not worry if you find you need a little more or
less than this. It is only a rough guide.
For a child aged 1 – 10

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 over the age of
1 year should not normally last more than 5 days
unless your doctor has told you to use it for
longer. Your doctor may want to see the child
every week, whilst using the cream.
• Dressings or bandages should not be used on
children where the cream is applied.
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.
If you apply Clovate 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.
Dressings or bandages should not be used on the
face where the cream is applied. Do not let the
cream get into your eyes. If it does, wash it out
with plenty of water.
If you use more Clovate 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 Clovate
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.
Do not apply extra Clovate to make up for a
missed dose.
If you stop using Clovate
If you use Clovate 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 Clovate 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
Clovate 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)
• 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 Clovate 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 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 Clovate
Expiry Date
Do not use this medicine after the expiry date shown
on the carton label or tube. Only keep this medicine if
your doctor tells you to. If your cream becomes
discoloured or shows any other signs of deterioration,
consult your pharmacist (chemist) who will tell you
what to do. You should return any left over cream to
your pharmacist.
How to Store
Do not store above 30°C
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN
• 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 protect the environment.




Important
Remember this medicine is for you. It can only be
prescribed by a doctor. Never give your medicine to
other people, it may harm them, even if their
symptoms are the same. This leaflet does not tell you
everything about your medicine. If you have any
question or are not sure about anything, ask your
doctor or pharmacist (chemist) He/she will have
additional information about this medicine and will be
able to advise you.

6. Contents of the pack and other
information
What Clovate contains
Clovate Cream contains 0.05% w/w of
clobetasol propionate as the active ingredient.
Your cream also contains the following inactive
ingredients: cetostearyl alcohol, glyceryl
monostearate, Arlacel 165, beeswax substitute 6621,
propylene glycol, chlorocresol, sodium
citrate, citric acid monohydrate, purified water.
What Clovate looks like and contents of the pack
Clovate Cream is a white, smooth, shiny cream packaged in a metal collapsible tube with a plastic screw
cap and tamper evident seal.
Clovate Cream is available in tubes of 30g.
Who manufactured your medicine?
Clovate Cream is manufactured by
INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.
Ctra. Cazona-adarzo, s/n, 39011, Spain and is
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL Number: 15184/1060

Leaflet revision date: 05/06/17
Clovate Cream is a registered trademark of The
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 be able to find out more
information from books in public libraries.

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

Ref:1060/050617/3/F

Clobetasol Propionate 0.05% Cream
Package Leaflet: Information for the User
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.
Your medicine is called Clobetasol propionate
Cream, however throughout this leaflet it will be
referred to as Clobetasol propionate .

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

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:
• frequently relapsing eczema
• psoriasis (thickened patches of inflamed, red
skin, often covered by silvery scales), excluding
widespread plaque psoriasis
• lichen planus, (a skin disease that causes itchy,
reddish-purple, flat-topped bumps on the wrists,
forearms or lower legs)
• discoid lupus erythematosus (a disease of the
skin most often affecting the face, ears and
scalp causing scarring and increased sensitivity
of the affected skin to sunlight)
• 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
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 of age
• 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 anus or genitals (penis or
vagina)
- infected skin (unless the infection is being
treated with an anti-infective medicine at the
same time)
- itchy skin which is not inflamed
- widespread plaque psoriasis, except single
lesions.
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 .
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.
• make sure that the skin is cleansed before a
fresh dressing is applied to prevent infections.
• you are applying the cream on broken or
damaged skin or within skin folds.
• you are applying to a large surface area.
• you have psoriasis, your doctor will want to see
you more often.
• you are using for a chronic leg ulcer as you may
be at increased risk of local allergic reaction or
infection.
• 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, as
Clobetasol propionate may cause skin thinning.
Use on the face should be limited to 5 days.
Dressings or bandages should not be used on
the face where the cream is applied.

If an infection develops during the use of this
medicine, talk to your doctor or pharmacist.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
this medicine.
Children
• Do not use this medicine in children under 1
year of age.
• Avoid continuous treatment for a long period of
time in infants and children over 1 year of age,
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.
• Dressings or bandages should not be used on
children where the cream is applied.
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.
If you do use Clobetasol propionate when
breast-feeding do not use it on your breast area to
ensure that the baby does not accidentally get
Clobetasol propionate in their mouth.
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

• You usually apply a thin layer of Clobetasol

propionate
once or twice a day. This may be reduced as
your skin begins to get better, or stopped
when better. Your doctor may prescribe a
weaker steroid for you to use instead.
• If you are also using an emollient (moisturiser),
allow time for Clobetasol propionate to be
absorbed into your skin before applying the
emollient.
• This cream is for use on your skin only.
• Do not use for more than 4 weeks without
talking to your doctor. If you need treatment for
a long time, your doctor may decide you need to
use a milder cream or ointment.
• If your skin problem worsens or does not
improve within 2 to 4 weeks, talk to your doctor.
• The germs that cause infections like the 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.
• If you are applying the cream on someone else
make sure you wash your hands after use or
wear disposable plastic gloves.
Guidance on how to apply the cream
1 Wash your hands.
2 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.
For an adult

Ref:1060/050617/3/B

Do not worry if you find you need a little more or
less than this. It is only a rough guide.
For a child aged 1 – 10

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 over the age of
1 year should not normally last more than 5 days
unless your doctor has told you to use it for
longer. Your doctor may want to see the child
every week, whilst using the cream.
• Dressings or bandages should not be used on
children where the cream is applied.
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.
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.
Dressings or bandages should not be used on the
face where the cream is applied. 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 use Clobetasol propionate
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.
Do not apply extra Clobetasol propionate to make
up for a missed dose.
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.
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 propionate 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 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
Expiry Date
Do not use this medicine after the expiry date shown
on the carton label or tube. Only keep this medicine if
your doctor tells you to. If your cream becomes
discoloured or shows any other signs of deterioration,
consult your pharmacist (chemist) who will tell you
what to do. You should return any left over cream to
your pharmacist.
How to Store
Do not store above 30°C
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN
• 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 protect the environment.




Important
Remember this medicine is for you. It can only be
prescribed by a doctor. Never give your medicine to
other people, it may harm them, even if their
symptoms are the same. This leaflet does not tell you
everything about your medicine. If you have any
question or are not sure about anything, ask your
doctor or pharmacist (chemist) He/she will have
additional information about this medicine and will be
able to advise you.

6. Contents of the pack and other
information
What Clobetasol propionate contains
Clobetasol propionate Cream contains 0.05% w/w of
clobetasol propionate as the active ingredient.
Your cream also contains the following inactive
ingredients: cetostearyl alcohol, glyceryl
monostearate, Arlacel 165, beeswax substitute 6621,
propylene glycol, chlorocresol, sodium
citrate, citric acid monohydrate, purified water.
What Clobetasol propionate looks like and
contents of the pack
Clobetasol propionate Cream is a white, smooth,
shiny cream packaged in a metal collapsible tube with
a plastic screw cap and tamper evident seal.
Clobetasol propionate Cream is available in tubes of
30g.
Who manufactured your medicine?
Clobetasol propionate Cream is manufactured by
INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.
Ctra. Cazona-adarzo, s/n, 39011, Spain and is
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL Number: 15184/1060

Leaflet revision date: 05/06/17
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.

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you

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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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