CLOBETASOL PROPIONATE/NEOMYCIN SULPHATE/NYSTATIN 0.5MG/5MG/100 000 IU/G CREAM
Active substance(s): CLOBETASOL PROPIONATE / NEOMYCIN SULPHATE / NYSTATIN
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.
clobetasol propionate, neomycin sulphate, nystatin
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 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.
Clobetasol propionate belongs to a group of
medicines called steroids. It helps to reduce
swelling and irritation of the skin.
Neomycin 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:
if you are allergic (hypersensitive) to
clobetasol propionate, neomycin sulphate,
nystatin or to any of the other ingredients (see
if you have a peanut or soya allergy
on a child under 2 years old
to treat any of the following skin problems, it
could make them worse:
- severe flushing of skin on and around
your nose (rosacea)
- spotty red rash around your mouth
- 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
- outer ear infections when the ear drum is
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:
have previously had an allergic reaction
with another steroid
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
have psoriasis. Your doctor will want to see
you more often
are applying the cream on broken skin or
within the skin folds
are using the cream for a chronic leg ulcer as
you may be at increased risk of local allergic
reaction or infection
are applying to a large surface area or
within the skin folds
you are applying near eyes or on eyelids, as
cataracts or glaucoma may result if the cream
repeatedly enters the eye
are applying to thin skin such as the face
or on children as their skin is thinner than
adults and as a result may absorb larger
amounts. Use on children should be limited to
5 days and reviewed weekly. Use on the face
should be limited to only a few days. Dressing
or bandages should not be used on children
or on the face where the cream is applied
have 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.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, especially if you are taking ritonavir
and itraconazole medications. Please also tell
your doctor or pharmacist if you are taking
medicines obtained without a prescription, or
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
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
arachis (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
You usually apply Dermovate-NN 1 or 2 times
a day. This may be reduced as your skin
begins to get better.
If your skin problem does not improve after
7 days talk to your doctor.
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) - unless your doctor tells you to.
The germs that cause infections like warm and
moist conditions under dressings so always
clean the skin before a fresh dressing is put
If you are applying the cream on someone
else, make sure you wash your hands after
use or wear disposable plastic gloves.
Do not mix with any other creams or
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
For a child
Do not use it on children under 2 years of age.
The smaller the child the less you will need to
A child of 4 years needs about a third of the
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.
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.
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. The maximum weekly dose should
not exceed 50 g/week.
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
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
Do not use a double dose to make up for a
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:
two fingertips of cream will cover both
hands or one foot
Continued over page
STOP using Dermovate-NN 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 cream or have a skin
infection which needs other treatment.
you have psoriasis and get raised bumps
with pus under the skin. This can happen
during or after the treatment and is known as
Other side effects you may notice when
using Dermovate-NN include:
Common (may affect up to 1 in 10 people)
Veins under the surface of your skin may
become more noticeable
Thinning of your skin
Uncommon (may affect up to 1 in 100 people)
Stretch marks may develop
Very rare (may affect up to 1 in 10,000 people)
An increased risk of infection
An allergic skin reaction where the cream is
A feeling of burning, pain, irritation or itching
where the cream is applied
Rash, itchy bumpy skin or redness of the skin
Thinning and dryness of your skin and it may
also damage or wrinkle more easily
An increase or reduction in hair growth or
hair loss and changes in skin colour
Weight gain, rounding of the face
Delayed weight gain or slowing of growth in
Bones can become thin, weak and break
Cloudy lens in the eye (cataract) or increased
pressure in the eye (glaucoma)
Increased blood sugar levels or sugar in the
High blood pressure.
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
Keep out of the reach and sight of children.
Do 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
Do not store above 25°C.
Do 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
The 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
The other ingredients are:
propyl gallate, titanium dioxide,
polyoxyethylene cetyl ether, arachis oil
(peanut oil), white beeswax or beeswax
substitute, microcrystalline wax and light
(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
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.
Purna Pharmaceuticals NV, Rijksweg 17, 2870
This leaflet was last revised in
'Dermovate' is a registered trademark of the GlaxoSmithKline
group of companies and is used under licence.
'Chemidex' is a registered trademark.
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.