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CLOBETASOL PROPIONATE 0.05% W/W OINTMENT

Active substance(s): CLOBETASOL PROPIONATE / CLOBETASOL PROPIONATE

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Dermovate ® Ointment

Ref: 1490/270417/1/F

(clobetasol propionate)
Patient Information Leaflet
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.
Your medicine is called Dermovate Ointment but will
be referred to as Dermovate throughout the leaflet.

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.
Warnings 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 ointment 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 ointment.
• make sure that the skin is cleansed before a fresh
dressing is applied to prevent infections.
• you are applying the ointment on broken or
damaged skin or within the 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 ointment
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 ointment 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 ointment 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 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 Ointment contains propylene glycol
Propylene glycol may cause skin irritation.

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 it is 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 ointment is for use on your skin only.
• Do not use or 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 ointment on someone else
make sure you wash your hands after use or wear
disposable plastic gloves.
Guidance on how to apply the ointment
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 ointment 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 ointment to
your hands as a part of the treatment, wash them
again after using the ointment.
For an adult

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 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
ointment.
• Dressings or bandages should not be used on
children where the ointment is applied.
If you have psoriasis
If you have thick patches of psoriasis on your
elbows or knees, your doctor may suggest applying
the ointment under an airtight dressing. It will only
be at night to help the ointment to start working.
After a short period of time you will then apply the
ointment as normal.
If you apply Dermovate to your face
You should only apply the ointment to your face if
your doctor tells you to. It should be limited to 5
days, as the skin on your face thins easily.
Dressings or bandages should not be used on the
face where the ointment is applied. Do not let the
ointment 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 ointment, 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 skin problem gets worse, you
develop a generalised rash or your skin becomes
swollen during treatment. You may be allergic to
the ointment, 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 ointment is applied.
Uncommon (may affect up to 1 in 100 people)
• skin thinning, stretch marks may develop.
• 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 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

Do not store above 30°C.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
Do not use Dermovate after the expiry date which
is stated on the tube, carton label or on the
carton after “EXP”. The expiry date refers to the
last day of that month.
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 gram of ointment contains 0.5 mg of
clobetasol propionate (0.05% w/w).
• The other ingredients are propylene glycol,
sorbitan sesquioleate and white soft paraffin.
What Dermovate looks like and contents of the
pack
Dermovate is an off-white ointment.
Each pack contains 25g or 4 x 25g of ointment.
Manufacturer and Licence Holder
Dermovate is manufactured by GlaxoSmithKline
Pharmaceuticals SA, ul. Grunwaldzka 189,
60-322 Poznan, Poland 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
Dermovate is a registered trademark of
GlaxoSmithKline Group of Companies.

POM

PL 15184/1490

Leaflet revision date: 27/04/17

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: 1490/270417/1/B

Ref: 1490/270417/2/F

Clobetasol Propionate 0.05% w/w Ointment
Patient Information Leaflet
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.
Your medicine is called Clobetasol propionate
Ointment but will be referred to as Clobetasol
propionate throughout the leaflet.

What is in this leaflet:
1 What Clobetasol propionate is and what it
is used for
What you need to know before you use
2
Clobetasol propionate
How to use Clobetasol propionate
3
Possible side effects
4
How to store Clobetasol propionate
5
Contents of the pack and other
6
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.
Warnings 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 ointment 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 ointment.
• make sure that the skin is cleansed before a fresh
dressing is applied to prevent infections.
• you are applying the ointment on broken or
damaged skin or within the 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 ointment
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 ointment 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 ointment 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 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
Dermovate in their mouth.
Clobetasol propionate contains propylene glycol
Propylene glycol may cause skin irritation.

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 it is 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 ointment is for use on your skin only.
• Do not use or 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 ointment on someone else
make sure you wash your hands after use or wear
disposable plastic gloves.
Guidance on how to apply the ointment
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 ointment 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 ointment to
your hands as a part of the treatment, wash them
again after using the ointment.
For an adult

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

.





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
ointment.

If you have psoriasis
If you have thick patches of psoriasis on your
elbows or knees, your doctor may suggest applying
the ointment under an airtight dressing. It will only
be at night to help the ointment to start working.
After a short period of time you will then apply the
ointment as normal.
If you apply Clobetasol propionate to your face
You should only apply the ointment to your face if
your doctor tells you to. It should be limited to 5
days, as the skin on your face thins easily. Do not
let the ointment 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 ointment, 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 ointment, 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 ointment is applied.
Uncommon (may affect up to 1 in 100 people)
• skin thinning, stretch marks may develop.
• 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




Do not store above 30°C.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
• Do not use Clobetasol propionate after the expiry
date which
is stated on the tube, carton label or on the
carton after “EXP”. The expiry date refers to the
last day of that month.
• 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 propionate contains
• Each gram of ointment contains 0.5 mg of
clobetasol propionate (0.05% w/w).
• The other ingredients are propylene glycol,
sorbitan sesquioleate and white soft paraffin.
What Clobetasol propionate looks like and
contents of the pack
Clobetasol propionate is an off-white ointment.
Each pack contains 25g or 4 x 25g of ointment.
Manufacturer and Licence Holder
Clobetasol Propionate is manufactured by
GlaxoSmithKline Pharmaceuticals SA, ul.
Grunwaldzka 189, 60-322 Poznan, Poland 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 15184/1490

Leaflet revision date: 27/04/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1490/270417/2/B

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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