DERMOVATE-NN CREAM

Active substance: NYSTATIN

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Dermovate-NN
Cream

For a child
iDo not use it on children under 2 years of
age.
iThe smaller the child the less you will need
to use.
iA child of 4 years needs about a third of the
adult amount.
iA 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.

clobetasol propionate, neomycin sulphate, nystatin
202625

100/L/m/3

Read all of this leaflet carefully before you start using this medicine.
iKeep this leaflet. You may need to read it again.
iIf you have any further questions, ask your doctor or pharmacist.
iThis 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.
iIf 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 this medicine is and what it is used for
2. Before you use
3. How to use
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is and what
it is used for
Dermovate-NN cream contains clobetasol
propionate, neomycin sulphate and nystatin.
iClobetasol propionate belongs to a group of
medicines called steroids. It helps to reduce
swelling and irritation of the skin.
iNeomycin sulphate and nystatin are
anti-infective medicines. They fight bacterial
and fungal infections of the skin.
Dermovate-NN is used to help reduce the
redness and itchiness of certain skin problems.
These skin problems include eczema or
psoriasis, where an infection may be a problem.

2. Before you use
Do not use Dermovate-NN:
iif you are allergic (hypersensitive) to
clobetasol propionate, neomycin sulphate,
nystatin or to any of the other ingredients
(see Section 6)
iif you have a peanut or soya allergy
ion a child under 2 years old
ito 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
- outer ear infections when the ear drum is
perforated.
If any of the above apply to you, or if you are not
sure, speak to your doctor or pharmacist.
Take special care with Dermovate-NN
Check with your doctor or pharmacist before
using your medicine if you:
iare 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
ihave psoriasis. Your doctor will want to see
you more often
ihave kidney problems. Your doctor may
decide to change the amount or number of
times you apply the cream.
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.
Driving and using machines
Dermovate-NN is unlikely to affect your ability to
operate machinery or to drive.
Important information about some of the
ingredients of Dermovate-NN Cream
iarachis (peanut) oil
If you are allergic to peanut or soya, do not
use this medicine.

3. How to use
Always use Dermovate-NN exactly as your
doctor has told you and always read the label.
Your doctor will decide on the appropriate dose
to suit your condition. Ask your doctor or
pharmacist if you are not sure.
Using this medicine
iYou usually apply Dermovate-NN 1 or 2
times a day. This may be reduced as your
skin begins to get better.
iIf your skin problem does not improve
after 7 days talk to your doctor.
iThis cream is for use on your skin only.
iDo not use on large areas of the body for a
long time (such as every day for many
weeks or months) - unless your doctor tells
you to.
iThe germs that cause infections like warm
and moist conditions under dressings so
always clean the skin before a fresh
dressing is put on.
iIf you are applying the cream on someone
else make sure you wash your hands after
use or wear disposable plastic gloves.
iDo not mix with any other creams or
ointments.
Guidance on how to apply the cream
1 Wash your hands.
2 Gently rub the correct amount of cream into
the skin until it has all disappeared. You can
measure how much Dermovate-NN to use
with your fingertip. This picture shows one
fingertip unit.

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.
If you apply Dermovate-NN to your face
You should only apply the cream to your face if
your doctor tells you to and for not more than 5
days. Do not cover the treated area with a
dressing, 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.
How long
You should stop using the cream as soon as the
skin problem is better.
Sometimes only a few days treatment is needed.
If there is no improvement after 7 days, see your
doctor again. If the doctor recommends that you
continue to use the cream, you should never use
it for more than 4 weeks without seeing your
doctor again.
If your doctor has prescribed the cream for
psoriasis you should let your doctor review your
progress at regular intervals, as such treatment
needs careful supervision.
If you use more 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.
1. Tell your doctor, pharmacist or nearest
hospital casualty department immediately.
2. Take the cream tube with you so that people
can see what you have used or taken.
3. Do this even if you feel well.
If you forget to use
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.
Do not use a double dose to make up for a
missed dose.
If you stop using
If you use Dermovate-NN 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-NN can cause
side effects, although not everybody gets them.
Do not be alarmed by this list of possible side
effects. You may not experience any of them.

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:
itwo fingertips of cream will cover both
hands or one foot
ithree fingertips of cream will cover one arm
isix fingertips of cream will cover one leg
ifourteen 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.

STOP using Dermovate-NN and tell your
doctor as soon as possible if:
iyou find that your skin problem gets worse
or becomes swollen during treatment. You
may be allergic to the cream or have a skin
infection which needs other treatment.
Other side effects you may notice when
using Dermovate-NN include:
ia feeling of burning, irritation or itching
where the cream is applied. These may be
similar to the skin condition being treated
iif 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.
100/L/m/3

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription, and herbal preparations.
If Dermovate-NN is absorbed into the body in large
amounts, the effects of medicines used to relax
muscles during surgery can last longer or even
be increased. If you are having surgery you
should tell the doctor that you have used
Dermovate-NN.
Continued over page

202625

Side effects if you use Dermovate-NN 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:
istretch marks may develop
iveins under the surface of your skin may
become more noticeable
iincreased hair growth and changes in skin
colour
ithinning of your skin that may also damage
more easily
iweight gain, rounding of the face and high
blood pressure. These are more likely to
happen in infants and children.
If you absorb or swallow Dermovate-NN in large
quantities, it can affect your hearing, nerves and
kidneys. This is unlikely when you use the
cream normally.
If any of the side effects get troublesome, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store
iKeep out of the reach and sight of children.
iDo not use after the expiry date which is
stated on the tube and on the carton. The
expiry date refers to the last day of that month.
iDo not store above 25°C.
iDo not throw it away with your household
waste or in water. Return all the unwanted
medicine to your pharmacist. This will help to
protect the environment.

6. Further information
What Dermovate-NN Cream contains
iThe active ingredients are:
clobetasol propionate (0.5 mg in 1 g of
cream),
neomycin sulphate (5 mg in 1 g of cream),
nystatin (100,000 units in 1 g of cream).
iThe other ingredients are:
propyl gallate, titanium dioxide,
polyoxyethylene cetyl ether, arachis oil
(peanut oil), white beeswax or beeswax
substitute, microcrystalline wax, and light
liquid paraffin.
(See end of Section 2 for further information
on arachis oil).
What Dermovate-NN Cream looks like and
contents of the pack
Dermovate-NN Cream is a smooth yellow-brown
cream.
It is available in aluminium tubes of 25 g or 30 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House,
Egham Business Village, Crabtree Road,
Egham, Surrey TW20 8RB.
Manufacturers
Purna Pharmaceuticals NV, Rijksweg 17, 2870
Puurs, Belgium.
This leaflet was last revised in
February 2010
'Dermovate' is a registered trademark of the
GlaxoSmithKline group of companies and is
used under licence.
'Chemidex' is a registered trademark.

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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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