BETAMETHASONE VALERATE/NEOMYCIN SULPHATE 1 MG/5 MG/G CREAM

Active substance: NEOMYCIN SULPHATE

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Betnovate-N Cream
betamethasone valerate, neomycin sulphate
202620

98/L/m/3

Read all of this leaflet carefully before you start using this medicine.

i Keep this leaflet. You may need to read it again.
i If you have any further questions, ask your doctor or pharmacist.
i 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.
i 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 Betnovate-N is and what it is used for
2. Before you use Betnovate-N
3. How to use Betnovate-N
4. Possible side effects
5. How to store Betnovate-N
6. Further information

1. What Betnovate-N is
and what it is used for
Betnovate-N contains two different medicines
called betamethasone valerate and neomycin
sulphate.
i Betamethasone valerate belongs to a group
of medicines called steroids. It helps to
reduce swelling and irritation.
i Neomycin sulphate is a type of anti-infective
medicine. It fights bacterial infections of the
skin.
Betnovate-N is used to help reduce the redness
and itchiness of certain skin problems. These
skin problems include eczema, psoriasis,
dermatitis or insect bites, where an infection
may be a problem.

2. Before you use Betnovate-N
Do not use Betnovate-N:
i if you are allergic (hypersensitive) to
betamethasone valerate, neomycin sulphate
or any of the other ingredients of Betnovate-N
(listed in Section 6)
i on a child under 2 years old
i 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
- outer ear infections.
Do not use if any of the above apply to you. If
you are not sure, talk to your doctor or
pharmacist before using Betnovate-N.
Take special care with Betnovate-N
Check with your doctor or pharmacist before
using your medicine if:
i you 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
much cream
i you have psoriasis, your doctor will want to
see you more often

For an adult
You should find that:
i two fingertips of cream will cover both hands
or one foot
i three fingertips of cream will cover one arm
i six fingertips of cream will cover one leg
i 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.

i you 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. This includes medicines obtained
without a prescription and herbal products.
If Betnovate-N 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
Betnovate-N.
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 Betnovate-N
Always use Betnovate-N exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Using this medicine
i You usually apply Betnovate-N 2 or 3 times a
day. This may be reduced as your skin begins
to get better.
i If your skin problem does not improve
after 7 days talk to your doctor.
i This cream is for use on your skin only.
i 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.
i The germs that cause infections like warm
and moist conditions under dressings so
always clean the skin before a fresh dressing
is put on.
i If you are applying the cream on someone
else make sure you wash your hands after
use or wear disposable plastic gloves.
i Do not mix with any other creams or
ointments.
Guidance on how to apply the cream
1 Wash your hands.

5. How to store Betnovate-N
For a child
i Do not use it on children under 2 years of age.
i The smaller the child the less you will need to
use.
i A child of 4 years needs about a third of the
adult amount.
i 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 Betnovate-N to your face
You should only apply the cream to your face if
your doctor tells you to. The cream should not
be used for too long 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.
If you use more Betnovate-N 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 Betnovate-N
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.
If you stop using Betnovate-N
If you use Betnovate-N 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

2 Gently rub the correct amount of cream into
the skin until it has all disappeared. You can
measure how much Betnovate-N to use with
your fingertip. This picture shows one
fingertip unit.

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.
Please turn over the page

Side effects if you use Betnovate-N 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:
i stretch marks may develop
i veins under the surface of your skin may
become more noticeable
i increased hair growth and changes in skin
colour
i thinning of your skin and it damages more
easily
i weight gain, rounding of the face and high
blood pressure. These are more likely to
happen in infants and children.
If you absorb or swallow Betnovate-N 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 serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Like all medicines, Betnovate-N can cause side
effects, although not everybody gets them.
STOP using Betnovate-N and tell your doctor
as soon as possible if:
i you find that your skin problem gets worse or
becomes swollen during treatment. You may
be allergic to the cream or need other
treatment.
Other side effects you may notice when
using Betnovate-N include:
i a feeling of burning, irritation or itching where
the cream is applied
i 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.

i Keep out of the reach and sight of children.
i Do not use Betnovate-N after the expiry date
on the tube or carton (Exp). The expiry date
refers to the last day of that month.
i Do not store above 25°C.
i 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 Betnovate-N Cream contains
i The active ingredients are betamethasone
valerate and neomycin sulphate. Each 1 g
contains 1 mg of betamethasone (0.1% w/w)
as valerate and 5 mg of neomycin sulphate
(0.5% w/w).
i The other ingredients are:
chlorocresol, cetomacrogol 1000,
cetostearyl alcohol, white soft paraffin,
liquid paraffin, sodium acid phosphate,
phosphoric acid, sodium hydroxide and
purified water.
What Betnovate-N Cream looks like and
contents of the pack
Within each carton is a tube with a plastic screw
cap, which contains 30 or 100 g of cream.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House,
Egham Business Village, Crabtree Road,
Egham, Surrey TW20 8RB.
Manufacturer
Purna Pharmaceuticals NV, Rijksweg 17,
2870 Puurs, Belgium.
This leaflet was last revised in
March 2010
Betnovate-N is a registered trademark of the
GlaxoSmithKline group of companies and is
used under licence.
Chemidex and Chemidex logo are registered
trademarks of Chemidex Pharma Ltd.

98/L/m/3

202620

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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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