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CLOBETASOL PROPRIONATE 0.05%W/W CREAM

Active substance(s): CLOBETASOL PROPIONATE

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Package Leaflet: Information for the user

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 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 but will be referred to as
Dermovate throughout this leaflet.

Other medicines and Dermovate
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicine, especially if you are taking ritonavir and
itraconazole medications.

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

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.

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
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.

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.

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.
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.

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 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

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

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


2
2

2
3
3
2




In children, also look out for the following symptoms:
 delayed weight gain
 slow growth
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.

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
 Keep out of the sight and reach of children.
 Do not store above 25oC. Store in the original package.
 Do not use this medicine after the expiry date which is stated on the
label and carton after (EXP). The expiry date refers to the last day of
that month.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Dermovate contains
Each 1g of cream contains 0.5mg of clobetasol propionate (0.05% w/w).
Also contains: glyceryl monostearate 40-55, arlacel 165, beeswax
substitute 6621, cetostearyl alcohol, propylene glycol, chlorocresol,
sodium citrate, citric acid monohydrate and purified water.
What Dermovate looks like and the contents of the pack
Dermovate is a white to off-white homogenous cream.
Dermovate comes in cartons containing 1 or 4 tubes of cream.
Each tube contains 25g of cream.
Manufactured by
GlaxoSmithKline Pharmaceuticals SA, ul. Grunwaldzka 189,
60-322 Poznan, Poland.

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.

Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.

Other side effects you may notice when using Dermovate include:

Leaflet dated 12th December 2016
Leaflet coded xxxxxxxxxxxx

Repackaged by MPT Pharma Ltd.
PL: 33532/0764
POM

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

Dermovate® 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.

To request a copy of this leaflet in Braille, large print
or audio please call 01922 745645 and ask for the
Regulatory Department.

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.
 Your medicine is called Clobetasol Propionate 0.05% w/w Cream but
will be referred to as Clobetasol Propionate throughout this leaflet.

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.

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

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.

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
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.

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.

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.

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

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.

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

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

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


2
2

2
3
3
2




In children, also look out for the following symptoms:
 delayed weight gain
 slow growth
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

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
 Keep out of the sight and reach of children.
 Do not store above 25oC. Store in the original package.
 Do not use this medicine after the expiry date which is stated on the
label and carton after (EXP). The expiry date refers to the last day of
that month.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Clobetasol Propionate contains
Each 1g of cream contains 0.5mg of clobetasol propionate (0.05% w/w).
Also contains: glyceryl monostearate 40-55, arlacel 165, beeswax
substitute 6621, cetostearyl alcohol, propylene glycol, chlorocresol,
sodium citrate, citric acid monohydrate and purified water.
What Clobetasol Propionate looks like and the contents of the pack
Clobetasol Propionate is a white to off-white homogenous cream.
Clobetasol Propionate comes in cartons containing 1 or 4 tubes of
cream. Each tube contains 25g of cream.
Manufactured by
GlaxoSmithKline Pharmaceuticals SA, ul. Grunwaldzka 189,
60-322 Poznan, Poland.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0764
POM
Leaflet dated 12th December 2016
Leaflet coded xxxxxxxxxxxx
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.

To request a copy of this leaflet in Braille, large print
or audio please call 01922 745645 and ask for the
Regulatory Department.

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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