CLOBETASOL PROPIONATE 0.05% W/W SCALP APPLICATION

Active substance: CLOBETASOL PROPIONATE

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Dermovate® Scalp Application / Clobetasol Propionate 0.05%w/w Scalp Application
(clobetasol propionate)
Your medicine is known by one of the above names, but will be referred to as
Dermovate throughout this:
Patient Information Leaflet
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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Dermovate is and what it is used for
2) Before you use Dermovate
3) How to use Dermovate
4) Possible side effects
5) How to store Dermovate
6) Further information

1) What Dermovate is and what it is used for
Dermovate Scalp Application (called ‘Dermovate’ in this leaflet) 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 scalp
problems. These include eczema and psoriasis that have not responded to
milder steroid creams, ointments, lotions or scalp applications.

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)
 if you have a skin infection on your scalp
 on a child under 1 year.
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 liquid under an airtight dressing. These dressings
make it easier for the active ingredient to pass through the skin. It is
possible to accidentally end up using too much.
 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.
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.

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.
Using this medicine
 You usually put Dermovate on your scalp in the morning and at night.
This may be reduced as your scalp problem begins to get better, or
stopped when it is better.
 For use on your skin of your scalp only.
 Do not use it more often than prescribed or use it 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 treatment.
 The germs that cause infections like warm and moist conditions under
dressings so always clean the skin before a fresh dressing is put on.
 Be very careful not to get the liquid in your eyes. Do not touch your eyes
until you have washed your hands.
 If you wash or shampoo your hair it should be dried before applying the
liquid.
 If you are applying the scalp application on someone else make sure you
wash your hands after use or wear disposable plastic gloves.
 The liquid is flammable, you should keep it away from fire.
 Do not dry your hair with a hairdryer or be near a fire.
Guidance on how to apply the liquid
1. Wash your hands.
2. Unscrew the bottle cap and place the nozzle directly on the scalp that
needs treating.
3. Gently squeeze the bottle to cover the area with a thin and even layer of
liquid.
4. You can rub this liquid in, but you don’t have to.
5. Your scalp will feel cool until the liquid has dried.
6. Wash your hands again.
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 scalp application, 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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines, Dermovate can cause side effects, although not everybody
gets them.
Stop using Dermovate and tell your doctor as soon as possible if:
 you find that your scalp problem gets worse or becomes swollen during
treatment. You may be allergic to the scalp application, have an infection
or need other treatment.

Who makes and repackages your medicine?
Your medicine is manufactured by Glaxo Wellcome Farmaceutica, Lda, R. Dr.
Antonio Loureiro Borges, 3 Arquiparque Miraflores 1495-131, Alges Portugal.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 18-07-2012

Other side effects you may notice when using Dermovate include:
 A feeling of burning, irritation or itching where the scalp application 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.

Dermovate® is a registered trademark of the GlaxoSmithKline group of
companies.

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:
 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.

National Eczema Society, Hill House, Highgate Hill, London N19 5NA

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.

5) How to store Dermovate






Keep all medicines out of the sight and reach of children.
Do not use Dermovate after the expiry date on the bottle label or carton
(Exp). The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep away from naked flames, fires or artificial heat as the liquid is
flammable.
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) Further information
What Dermovate contains:
 The active ingredient is clobetasol propionate 0.05%w/w.
 Dermovate scalp application also contains the following inactive
ingredients: carbomer, isopropyl alcohol, sodium hydroxide and purified
water.
What Dermovate looks like and contents of the pack
Dermovate scalp application is a clear colourless, slightly viscous liquid with a
strong odour of isopropanol in a white plastic squeeze bottle with a plastic
nozzle and a plastic cap with a tamper evident ring.
Dermovate scalp application is packed in 100ml bottles.
PL 10383/1617

POM

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:

The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF
You may also be able to find out more from books in public libraries.

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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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