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BETNOVATE CREAM

Active substance(s): BETAMETHASONE VALERATE

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Package leaflet: Information for the user

Betnovate Cream
®

betamethasone valerate













Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
• 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 only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1 What Betnovate is and what it is used for
2 What you need to know before you use Betnovate
3 How to use Betnovate
4 Possible side effects
5 How to store Betnovate
6 Contents of the pack and other information

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

Do not worry if you find you need a little more or less than
this. It is only a rough guide.
For a child aged 1 – 10
Number of fingertip units needed
Child’s age

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 that reduce
swelling and irritation.
Betnovate is used to help reduce the redness and itchiness of
certain skin problems, such as eczema, psoriasis and dermatitis.

2 What you need to know 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)

Face and Arm and Leg and
neck
hand
foot

Front

Back including
buttocks

1-2 years





2

2

3

3-5 years



2

3

3



6-10 years

2







5

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• Do not use it on children under 1 year of age
• It is especially important in children not to exceed the
prescribed 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.

GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Betnovate
N/A
JMF333

3 How to use Betnovate











Always use this medicine exactly as your doctor has told you.
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 Apply a thin layer to the affected area(s) and gently rub into
the skin until it has all disappeared. You can measure how
much Betnovate to use with your fingertip. For children you
will need to use less cream but still use an adult finger to
measure out the fingertip unit. This picture shows one
fingertip unit.

Offset

If you apply 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 you apply too much or if 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 as your condition may get
worse if stopped suddenly.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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4 Possible side effects






















Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop using Betnovate and tell your doctor immediately if:
• you find that your skin condition gets worse, you develop a
generalised rash or your skin becomes swollen during
treatment. You may be allergic to Betnovate, have an
infection or need other treatment.
• you have psoriasis and 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: may affect up to 1 in 10 people
• a feeling of burning, pain, irritation or itching where the
cream is applied.
Very rare: may affect up to 1 in 10,000 people
• an increased risk of infection
• an allergic skin reaction 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
• stretch marks may develop
• veins under the surface of your skin may become more
noticeable
• 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 children
• bones can become thin, weak and break easily
• cloudy lens in the eye (cataract) or increased pressure in eye
(glaucoma)
• increased blood sugar levels or sugar in the urine
• high blood pressure
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 Betnovate
• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date
which is stated on the tube or carton after
(EXP). The expiry date refers to the last day of
that month.
• Do not store above 25ºC.
• Do not throw away medicines via wastewater
or household waste. Ask your pharmacist how
to throw away medicines you no longer use.
These measures will help protect the
environment.

Pharma code Ref. No. 116

- spotty red rash around your mouth (perioral dermatitis)
- itching around your back passage or private parts
- 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.
Warnings and precautions
Talk to your doctor or pharmacist before using Betnovate 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.
• using for a chronic leg ulcer as you may be at increased risk
of local allergic reaction or infection.
• you are applying to a large surface area
• you are applying the cream on broken skin 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.
• you 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.
• Dressing or bandages should not be used on children or on
the face where the cream is applied.
• Use on children or on the face should be limited to 5 days.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using this medicine.
Other medicines and Betnovate
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicine, especially if you are
taking ritonavir and itraconazole medications.
Pregnancy and breast-feeding and fertility
If you are pregnant or are breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Betnovate Cream contains chloroscresol and cetostearyl
alcohol
Betnovate cream contains chlorocresol which may cause
allergic reactions and cetostearyl alcohol which may cause
local skin reactions (e.g. contact dermatitis).

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Pharma code Ref. No. 116

Pharma code Ref. No. 116

6 Contents of the pack and other 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 g or 100 g of cream.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer
Glaxo Wellcome Operations, Barnard Castle, Durham,
DL12 8DT
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.
This leaflet was last revised in:
March 2016.
Betnovate is a registered trade mark of the GSK group of
companies.
© 2016 GSK group of companies. All rights reserved.

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GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Betnovate
N/A
JMF333

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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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