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DERMOVATE 0.05% CREAM

Active substance: CLOBETASOL PROPIONATE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

DERMOVATE® 0.05% w/w CREAM
(clobetasol propionate)
Patient Information Leaflet
This product is known as the above name but will be referred to as Dermovate throughout this leaflet

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 and dermatitis that have not responded to milder steroid
cream or ointments.

WARNING!

2. BEFORE YOU USE DERMOVATE
Do not use Dermovate:
• if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Dermovate
(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 - unless your doctor has told you to do so
- viral infections, such as cold sores, herpes or chicken pox
- fungal infections, such as ringworm, athletes foot or thrush
- skin blisters or sores that are caused by an infection.
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.
Take special care with Dermovate
Check with your doctor or pharmacist before using your medicine if:
• 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.
• you have psoriasis, your doctor will want to see you more often.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this
medicine.

DATE:

CUSTOMER
APPROVED:

4. Possible side effects
5. How to store Dermovate
6. Further information

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or
are breast-feeding.

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 better.
• This cream 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 cream 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.

25/07/14
DATE OF PROOF:

DATE:

Guidance on how to apply the cream
1 Wash your hands.

STORAGE & EXCIPIENTS

6464/0284

2 Gently rub the correct amount of cream into the skin until it has all
disappeared.
You can measure how much Dermovate to use with your fingertip.
This picture shows one fingertip unit.

CODE:

DT
ARTWORKER:
PRODUCT:

Dermovate cream

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

3. HOW TO USE DERMOVATE
Always use Dermovate exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

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
You should find that:
• two fingertips of cream will cover both hands or one foot
• three fingertips of cream will cover one arm
• six fingertips of cream will cover one leg
• fourteen fingertips of cream will cover the front and back
of the body.
Do not worry if you find you need a little more or a little less than this.
It is only a rough guide.
For a child
• Do not use it on children under 1 year of age.
• The smaller the child the less you will need to use.
• A child of 4 years needs about a third of the adult 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 cream.

2 UNITS

3 UNITS

6 UNITS

FRONT
AND
BACK
14 UNITS

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.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

In this leaflet:
1. What Dermovate is and what it is used for
2. Before you use Dermovate
3. How to use Dermovate

PROOF HISTORY:
v.1 - waymade - 25/07/14

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If you apply Dermovate to your face
You should only apply the cream to your face if your doctor tells you to. It should not be used for more than
5 days, as the skin on your face thins easily. 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, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is
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.

Stop using Dermovate and tell your doctor as soon as possible if:
• you find that your skin problem gets worse or become swollen during treatment.
You may be allergic to the cream, have an infection or need other treatment.
Other side effects you may notice when using Dermovate include:
• A feeling of burning, irritation or itching where the cream is applied.
• If you have psoriasis you may get raised bumps with pus under the skin. This can happen during or after
the treatment and is known as pustular psoriasis.
Side effects if you use Dermovate for a long time, or you use a lot each time you apply it, or you apply it
under an airtight dressing or a nappy:
• Stretch marks may develop.
• Veins under the surface of your skin may become more noticeable.
• Increased hair growth and changes in skin colour.
• Thinning of your skin that may also damage more easily.
• Weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and
children.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

WARNING!

6. FURTHER INFORMATION
Your medicine is called Dermovate 0.05% w/w cream. It contains the active ingredient, Clobetasol propionate
0.05% w/w in a white cream base.
Dermovate 0.05% w/w cream also contains the following:
propylene glycol, glyceryl monostearate, cetostearyl alcohol, Arlacel 165, beeswax substitute 6621,
chlorocresol, sodium citrate dihydrate, citric acid monohydrate and purified water

POM

PL No: 6464/0284

DT

25/07/14

ARTWORKER:

DATE OF PROOF:

More Information
If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you.
Other sources of information are:
National Eczema Society, Hill House, Highgate Hill, London N19 5NA
The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF
You may also be able to find out more from books in public libraries.

Dermovate cream

6464/0284

PRODUCT:

CODE:

Dermovate is a registered trademark of the Glaxo Group Ltd.

STORAGE & EXCIPIENTS

05-0269

Leaflet revision and issue date (Ref.) 22.07.2014

PRE-PRESS NO.:

DATE:

This product is manufactured by Industrial Farmacéutica Cantabria S.A., Ctra. Cazoña-Adarzo, s/n 39011
Santander, Spain and is procured from within the EU and repackaged by the Product Licence holder who is:
Waymade Plc. Miles Gray Road, Basildon Essex SS14 3FR

CUSTOMER: Waymade

Q.A.
APPROVED:

Dermovate 0.05% w/w cream is available as tubes of 30g.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

5. HOW TO STORE DERMOVATE
• Do not store above 30º C.
• Do not use after the expiry date printed on the tube or carton label. The expiry date refers to the last day of
that month.
• KEEP OUT OF SIGHT AND REACH OF CHILDREN
• If your doctor tells you to stop using the cream, please take it back to the pharmacist for safe disposal. Only
keep the cream if your doctor tells you to.
• If the cream becomes discoloured or shows any other signs of deterioration, you should ask your doctor or
pharmacist before using it.
• 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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dermovate can cause side effects, although not everybody gets them.

PROOF HISTORY:
v.1 - waymade - 25/07/14

Leaflet Flat Size = 148 x 400

If you stop using Dermovate
If you use Dermovate regularly make sure you talk to your doctor before you stop using it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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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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