BETNOVATE CREAM

Active substance: BETAMETHASONE VALERATE

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10000000096508

Package Leaflet: Information for the User

Betnovate® Cream
betamethasone valerate
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 Betnovate is and what it is used for
2 Before you use Betnovate
3 How to use Betnovate
4 Possible side effects
5 How to store Betnovate
6 Further information

1 What Betnovate is
and what it is used for
Betnovate contains a medicine called
betamethasone valerate. It belongs to a group
of medicines called steroids. It helps to reduce
swelling and irritation.
Betnovate is used to help reduce the redness
and itchiness of certain skin problems, such as
eczema, psoriasis and dermatitis.

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











2 Before you use Betnovate











Do not use Betnovate:
• if you are allergic (hypersensitive) to
betamethasone valerate or any of the other
ingredients of Betnovate (listed in Section 6)
• on a child under 1 year
• 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
- infected skin (unless the infection
is being treated with an
anti-infective medicine at the
same time)
- itchy skin which is not inflamed
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.
Take special care with Betnovate
Check with your doctor or pharmacist
before using your medicine if:
• you have previously had an
allergic reaction with another
steroid
• 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.
• you have psoriasis, your doctor will want to
see you more often.






Always use Betnovate 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 Betnovate once or twice a
day. This may be reduced as your skin
begins to get better.
• This cream is for use on your skin only.
• Do not use more than the amount
prescribed for you.
• 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,
moist conditions under bandages or
dressings so always clean the skin before a
fresh dressing is put on.
• If you are applying the cream 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 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 Betnovate 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.
For an adult
You should find that:
• two fingertips of cream will cover both
hands or one foot
• three fingertips of cream will cover one arm
• 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.

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• 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 Betnovate

For a child
• Do not use it on children under 1 year 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.
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 the Betnovate to your face
You should only apply the cream 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 cream get into
your eyes.
If you use more Betnovate 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 a lot is accidentally swallowed, it could
make you ill. Talk to your doctor or go to the
hospital as soon as possible.
If you forget to use Betnovate
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
If you use Betnovate 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, Betnovate can cause side
effects, although not everybody gets them.
Stop using Betnovate and tell your doctor
as soon as possible if:
• you find that your skin condition gets worse
or becomes swollen during treatment. You
may be allergic to the Betnovate, have an
infection or need other treatment.
• you have psoriasis you may get raised
bumps with pus under the skin. This can
happen very rarely during or after treatment
and is known as pustular psoriasis.
Other side effects you may notice when
using Betnovate include:
Common (affects less than 1 in 10 people)
• a feeling of burning, irritation or itching
where the cream is applied.
Side effects if you use Betnovate for a long
time, you use a lot each time you apply it, or
you apply it under an airtight dressing:
Very rare (affects less than 1 in 10,000 people)
• 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 and it may also
damage more easily

• Keep out of the reach and sight of children.
• Do not use Betnovate after the expiry date
on the tube end or carton (Exp). The expiry
date refers to the last day of that month.
• Do not store above 25°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
protect the environment.

6 Further information
What Betnovate cream contains
• The active ingredient is betamethasone
valerate. Each 1 g contains 1 mg of
betamethasone (0.1% w/w) as valerate.
• 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 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
cream.
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
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
Betnovate Cream
Reference number
10949/0014
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet date: February 2012
Betnovate is a registered trademark
of the GlaxoSmithKline group of
companies
© 2012 GlaxoSmithKline group of
companies

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10000000096508

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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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