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BETNOVATE OINTMENT

Active substance(s): BETAMETHASONE VALERATE / BETAMETHASONE VALERATE / BETAMETHASONE VALERATE

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12000000109876

12000000109876

Package Leaflet: Information for the User

Betnovate Ointment

GSK-ContractMfg-Eur-DeuGermany-Aspen-Bad Oldesloe

betamethasone valerate

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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.

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)
- 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 ointment 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 ointment on broken skin or
within the skin folds.
• you are applying near eyes or on eyelids, as cataracts
or glaucoma may result if the ointment repeatedly
enters the eye.
• you have an infection of the skin as this will need to
be treated
• 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 ointment is applied.
• Use on children or on the face should be limited to 5 days.
Contact your doctor if you experience blurred vision or
other visual disturbances.
If this product comes into contact with dressings, clothing and
bedding the fabric can be easily ignited with a naked flame.
You should keep away from fire when using this product.
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before using this medicine.

United Kingdom-GBR

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
N/A
BE07_148X297

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 ointment 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 ointment 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 ointment
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 ointment but still
use an adult finger to measure out the fingertip unit. This
picture shows one fingertip unit.

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3 Unless you are meant to apply the ointment to your
hands as a part of the treatment, wash them again
after using the ointment.
For an adult

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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

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

Face
and
neck

Arm
and
hand

Leg
Back
and Front including
foot
buttocks

1-2 years





2

2

3

3-5 years



2

3

3



6-10 years

2







5

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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 ointment is applied.
Very rare (may affect up to 1 in 10,000 people)
• an increased risk of infection
• an allergic skin reaction where the ointment 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
• blood vessels 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)
• a decrease in the level of the hormone cortisol in your
blood
• increased blood sugar levels or sugar in the urine
• high blood pressure
Not Known (frequency cannot be estimated from the
available data)
• blurred vision
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.

• 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.

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GSK-ContractMfg-Eur-DeuGermany-Aspen-Bad Oldesloe

6 Contents of the pack and other
information
What Betnovate ointment 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 liquid paraffin and white
soft paraffin.
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 ointment.
Marketing Authorisation Holder and Manufacturer
Product Licence held by Glaxo Wellcome UK Ltd, Stockley
Park West, Uxbridge, Middlesex UB11 1BT
Manufactured by Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
If you have any questions or are not sure about anything,
ask your doctor or pharmacist who will advise you.
You may be able to find out more information 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:

United Kingdom-GBR
Betnovate
N/A
BE07_148X297

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0800 198 5000 (UK Only)

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Please be ready to give the following information:
Product name:
Betnovate Ointment
Reference number
10949/0020
This is a service provided by the Royal National Institute
of Blind People.
This leaflet was last revised in August 2017.
Trade marks are owned by or licensed to the GSK group
of companies.
© 2017 GSK group of companies or its licensor.

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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 ointment
under an airtight dressing. It will only be at night to help
the ointment to start working. After a short period of
time you will then apply the ointment as normal.
If you apply Betnovate to your face
You should only apply the ointment 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 ointment 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 ointment, 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.

5 How to store Betnovate
• Keep 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 30°C.
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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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