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DERMOVATE OINTMENT

Active substance(s): CLOBETASOL PROPIONATE / CLOBETASOL PROPIONATE

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Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

Package Leaflet: Information for the user

Dermovate Ointment
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.
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:

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

-

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 experience blurred vision or other visual disturbances.
 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.

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

If this product comes into contact with dressings, clothing and bedding the fabric can
be easily ignited with a naked flame. You should keep away from fire when using this
product.
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 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 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.

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

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.
[Pictogram of 1 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
[Pictogram of an adult with fingertip units to be used as per text below with
arrows pointing to relevant body part]
Face and neck:
2 ½ fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including the foot):
6 fingertip units
One foot:
2 fingertip units.
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

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

Number of fingertip units needed
Child’s
age
1-2 years

3-5 years

6-10 years

Face
and
neck

Arm
and
hand

Leg
and
foot

Front

Back
including
buttocks





2

2

3



2

3

3



2







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 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.

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

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

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4

 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
Not Known (frequency cannot be estimated from the available data)
 blurred vision
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.





6.

How to store Dermovate
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube or
carton after (EXP). The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.

Contents of the pack and other information

What Dermovate contains
 The active ingredient is clobetasol propionate. Each 1 g contains 0.5 mg of
clobetasol propionate (0.05% w/w).

Reason for Update: Addition of Paraffin Warning, PRAC recommendation for blurred vision and FMD
QRD 10 update
Market: UK
Agency Approval Date: TBC
Text Date: 27/06/2017
Text Issue and Draft No.: Issue 4, Draft 4



The other ingredients are propylene glycol (see section 2), sorbitan sesquioleate
and white soft paraffin.

What Dermovate looks like and contents of the pack
Within each carton is a tube with a plastic screw cap, which contains either 30 or 100
g of ointment.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Manufacturer:
Glaxo Operations UK Limited, Harmire Road, Barnard Castle, Co. Durham, DL12
8DT
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.
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Dermovate Ointment
Reference number 10949/0028
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in June 2017.
Trade marks are owned by or licensed to the GSK group of companies
© 2017 GSK group of companies or its licensor

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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