DERMOVATE 0.05% OINTMENT

Active substance: CLOBETASOL 17-PROPIONATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package Leaflet: Information for the User

Dermovate® 0.05% Ointment
(clobetasol propionate)
The name of your medicine is Dermovate 0.05% ointment but
will be referred to as Dermovate through out the remainder of
this 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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell 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.

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 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.

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 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 creams or ointments.

2 Before you use Dermovate

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

Guidance on how to apply the ointment
1 Wash your hands.
2 Gently rub the correct amount of ointment 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.

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 years 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 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 .

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
You should find that:
• two fingertips of ointment will cover both hands or one foot
• three fingertips of ointment will cover one arm
• six fingertips of ointment will cover one leg
• fourteen fingertips of ointment 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.

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.

For a child
• Do not use it on children under 1 years 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 ointment.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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

If you have psoriasis

• Keep out of the reach and sight of children.

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.

• Do not use Dermovate after the expiry date on the tube or
carton (Exp). The expiry date refers to the last day of that
month.

If you apply Dermovate to your face
You should only apply the ointment 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 ointment 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 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. 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 skin problem gets worse or becomes
swollen during treatment. You may be allergic to the
ointment, 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 ointment 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.

• Do not store above 30°C.
• 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 ointment contains: the active ingredient - clobetasol
propionate 0·05% w/w
in a base containing propylene glycol, arlacel 83 and white
soft paraffin.

Warning:
This product contains propylene glycol, which may cause skin
irritation.

What Dermovate looks like and contents of the pack
The ointment is a smooth white translucent ointment packaged
in a collapsible tube with a white screw cap. The ointment is
available in 25g tubes.
Manufacturer: Glaxo Operations U.K. Ltd, England
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU
PL NO: 18799/1452 Dermovate 0.05% Ointment

POM

Leaflet Date: 16.09.2014
Dermovate is a registered trademark of 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. 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.

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
(web1)