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DERMOVATE 0.05% W/W CREAM

Active substance(s): CLOBETASOL PROPIONATE / CLOBETASOL PROPIONATE

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Package Leaflet: Information for the user

Dermovate® 0.05% w/w 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 side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Dermovate 0.05% w/w Cream but will
be referred to as Dermovate throughout this 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.

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 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

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 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.
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.

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
Number of fingertip units needed
Child’s
Face
Arm
Leg
Front
age
and
and
and
neck
hand
foot
1-2


2
2
years
3-5

2
3
3
years
6-10
2



years

Back
including
buttocks
3

5

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.

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
In children, also look out for the following symptoms:
 delayed weight gain
 slow growth
Very rare side effects that may show up in blood tests or when your
doctor gives you a medical examination:
 a decrease in the level of the hormone cortisol in your blood
 increased levels of sugar in your blood or urine
 high blood pressure
 cloudy lens in the eye (cataract)
 increased pressure in the eye (glaucoma)
 weakening of the bones through gradual loss of mineral
(osteoporosis); additional tests may be needed after your medical
examination to confirm if you have this condition
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report any side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.

5. How to store Dermovate







Keep out of the sight and reach of children.
Do not use the cream after the expiry date which is stated on the
carton and tube label after ‘Exp’. The expiry date refers to the last
day of that month.
Do not store above 25°C.
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.
If the cream becomes discoloured or shows any signs of
deterioration, seek the advice of your pharmacist.

6. Contents of the pack and other information
What Dermovate contains
The active ingredient in Dermovate is clobetasol propionate.
 Each 1g contains 0.5mg of clobetasol propionate (0.05% w/w).
 The other ingredients are chlorocresol, cetostearyl alcohol,
glyceryl monostearate, arlacel 165, beeswax substitute 6621,
propylene glycol, sodium citrate, citric acid monohydrate and
purified water.
What Dermovate looks like and contents of the pack
The cream is a smooth white opaque cream packaged in a
collapsible aluminium tube with a white screw cap, containing 30g.
Manufactured by: Industrial Farmaceutica Cantabria, S.A., Ctra.
Cazona-Adarzo, s/n, 39011, Santander, Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Dermovate® 0.05% w/w Cream; PL 18799/1794

POM

Leaflet date: 23.02.2017
Dermovate is a registered trademark of GlaxoSmithKline group of
companies
More Information
If you have any questions or are not sure about anything, ask your
doctor or pharmacist who will advise you.
You may also be able to find out more information books in public
libraries.

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

Package Leaflet: Information for the user

Clobetasol Propionate 0.05% w/w Cream
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Clobetasol Propionate 0.05% w/w
Cream but will be referred to as Clobetasol Propionate throughout
this leaflet.
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.

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 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

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 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.

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
Number of fingertip units needed
Child’s
Face
Arm
Leg
Front
age
and
and
and
neck
hand
foot
1-2


2
2
years
3-5

2
3
3
years
6-10
2



years

Back
including
buttocks
3

5

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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report any side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.

5. How to store Clobetasol Propionate







Keep out of the sight and reach of children.
Do not use the cream after the expiry date which is stated on the
carton and tube label after ‘Exp’. The expiry date refers to the last
day of that month.
Do not store above 25°C.
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.
If the cream becomes discoloured or shows any signs of
deterioration, seek the advice of your pharmacist.

6. Contents of the pack and other information
What Clobetasol Propionate contains
The active ingredient in Clobetasol Propionate is clobetasol
propionate.
 Each 1g contains 0.5mg of clobetasol propionate (0.05% w/w).
 The other ingredients are chlorocresol, cetostearyl alcohol,
glyceryl monostearate, arlacel 165, beeswax substitute 6621,
propylene glycol, sodium citrate, citric acid monohydrate and
purified water.
What Clobetasol Propionate looks like and contents of the pack
The cream is a smooth white opaque cream packaged in a
collapsible aluminium tube with a white screw cap, containing 30g.
Manufactured by: Industrial Farmaceutica Cantabria, S.A., Ctra.
Cazona-Adarzo, s/n, 39011, Santander, Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Clobetasol Propionate 0.05% w/w Cream; PL 18799/1794
Leaflet date: 23.02.2017

POM

More Information
If you have any questions or are not sure about anything, ask your
doctor or pharmacist who will advise you.
You may also be able to find out more information books in public
libraries.

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

Expand view ⇕

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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