Skip to Content

CLOBETASOL PROPIONATE 0.05% W/W OINTMENT

Active substance(s): CLOBETASOL PROPIONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Dermovate ® Ointment

Ref: 1490/290115/1/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.

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 eczema, psoriasis lichen
planus, discoid lupus, dermatitis and other skin
conditions and dermatitis 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 to clobetasol propionate or any
of the other ingredients of this medicine (listed in
Section 6)
• on a child under 1 year old
• to treat any of the following skin problems, it could
make them worse:
- acne
- severe flushing of skin on and around your nose
(rosacea)
- spotty red rash around your mouth (perioral
dermatitis)
- itching around your back passage or private
parts
- infected skin (unless the infection is being
treated with an anti-infective medicine at the
same time)
- itchy skin which is not inflamed
Do not use if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before
using Dermovate.
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.

• you have psoriasis, your doctor will want to see
you more often.

• you are applying the ointment on broken skin or
within the skin folds.

• using for a chronic leg ulcer as you may be at

increased risk of local allergic reaction or infection.

• you are applying to a large surface area or within
the skin folds.

• you are applying near eyes or on eyelids, as

cataracts or glaucoma may result if the ointment
repeatedly enters the eye.
• you are applying to thin skin such as the face or
on children as their skin is thinner than adults and
as a result may absorb larger amounts. Use on
children should be limited to 5 days and reviewed
weekly. Use on the face should be limited to 5
days.
• dressing or bandages should not be used on
children or on the face where the ointment is
applied.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using this
medicine.
Other medicines and 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.
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 1 or 2
times a day. This may be reduced as your skin
begins to get better, or stopped when it is better.
• This ointment is for use on your skin only.
• Do not use on large areas of the body for a long
time (such as every day for many weeks or
months).If you need treatment for a long time, your
doctor may decide you need to use a milder cream
or ointment.
• The germs that cause infections like warm and
moist conditions under dressings so always clean
the skin before a fresh dressing is put on.
• If you are applying the ointment on someone else
make sure you wash your hands after use or wear
disposable plastic gloves.
• If your skin problem does not improve in 2 to 4
weeks, talk to your doctor.
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

Uncommon (may affect up to 1 in 100 people)
• Stretch marks may develop.
• Veins under the surface of your skin may become
more noticeable.
Rare (may affect up to 1 in 1,000 people)
An increased risk of infection
An allergic skin reaction where the ointment is
applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your skin and it may also
damage or wrinkle more easily
• An increase or reduction in hair growth or hair
loss and changes in skin colour.
• Thinning of your skin that may also damage more
easily.
• Weight gain, rounding of the face.
• Delayed weight gain or slowing of growth in
children
• Bones can become thin, weak and break easily
• Cloudy lens in the eye (cataract) or increased
pressure in the eye (glaucoma)
• Increased blood sugar levels or sugar in the urine
• High blood pressure




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 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. 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.
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.

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: 29/01/15

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

Ref: 1490/290115/1/B

Ref: 1490/290115/2/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.

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 eczema, psoriasis
lichen planus, discoid lupus, dermatitis and other
skin conditions and dermatitis 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 to clobetasol propionate or any
of the other ingredients of this medicine (listed in
Section 6)
• on a child under 1 year old
• to treat any of the following skin problems, it could
make them worse:
- acne
- severe flushing of skin on and around your nose
(rosacea)
- spotty red rash around your mouth (perioral
dermatitis)
- itching around your back passage or private
parts
- infected skin (unless the infection is being
treated with an anti-infective medicine at the
same time)
- itchy skin which is not inflamed
Do not use if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before
using Clobetasol propionate.
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.



you have psoriasis, your doctor will want to see
you more often.
• you are applying the ointment on broken skin or
within the skin folds.
• using for a chronic leg ulcer as you may be at
increased risk of local allergic reaction or infection.
• you are applying to a large surface area or within
the skin folds.
• you are applying near eyes or on eyelids, as
cataracts or glaucoma may result if the ointment
repeatedly enters the eye.
• you are applying to thin skin such as the face or
on children as their skin is thinner than adults and
as a result may absorb larger amounts. Use on
children should be limited to 5 days and reviewed
weekly. Use on the face should be limited to 5
days.
• dressing or bandages should not be used on
children or on the face where the ointment is
applied.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using this
medicine.
Other medicines and Clobetasol propionate
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicine,
especially if you are taking ritonavir and itraconazole
medications.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Clobetasol propionate Ointment 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 1 or 2 times a day. This may be
reduced as your skin
begins to get better, or stopped when it is better.
• This ointment is for use on your skin only.
• Do not use on large areas of the body for a long
time (such as every day for many weeks or
months).If you need treatment for a long time, your
doctor may decide you need to use a milder cream
or ointment.
• The germs that cause infections like warm and
moist conditions under dressings so always clean
the skin before a fresh dressing is put on.
• If you are applying the ointment on someone else
make sure you wash your hands after use or wear
disposable plastic gloves.
• If your skin problem does not improve in 2 to 4
weeks, talk to your doctor.
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

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

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.
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.

Rare (may affect up to 1 in 1,000 people)
• An increased risk of infection
• An allergic skin reaction where the ointment is
applied
• Rash, itchy bumpy skin or redness of the skin
• Thinning and dryness of your skin and it may also
damage or wrinkle more easily
• An increase or reduction in hair growth or hair
loss and changes in skin colour.
• Thinning of your skin that may also damage more
easily.
• Weight gain, rounding of the face.
• Delayed weight gain or slowing of growth in
children
• Bones can become thin, weak and break easily
• Cloudy lens in the eye (cataract) or increased
pressure in the eye (glaucoma)
• Increased blood sugar levels or sugar in the urine
• High blood pressure
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: 29/01/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1490/290115/2/B

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.

Hide