DERMOVATE OINTMENT

Active substance: CLOBETASOL PROPIONATE

View full screen / Print PDF » Download PDF ⇩

Transcript
10000000050322

Package Leaflet: Information for the User

Dermovate® Ointment
clobetasol propionate
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.
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
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.
• 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 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 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.

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.

• 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.

5 How to store Dermovate

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.
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 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.
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.

• Keep out of the reach and sight of children.
• 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.
• 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 active ingredient is clobetasol
propionate. Each 1 g 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
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
Product licence held by GlaxoSmithKline UK,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufactured by Glaxo Wellcome Operations,
Barnard Castle, 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. 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.
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.
Leaflet date: November 2007
Dermovate is a registered
trademark of the GlaxoSmithKline
group of companies
© 2007 GlaxoSmithKline group of
companies

10000000050322

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
(web2)