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BETNOVATE RD CREAM

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

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Betnovate RD Cream

Package Leaflet: Information for the User

3

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 RD is and what it is used for
2 What you need to know before you use Betnovate RD
3 How to use Betnovate RD
4 Possible side effects
5 How to store Betnovate RD
6 Contents of the pack and other information

1 What Betnovate RD is and what it is
used for
Betnovate RD contains a medicine called betamethasone
valerate. It belongs to a group of medicines called steroids
that reduce swelling and irritation.
Betnovate RD is used to help reduce the redness and
itchiness of certain skin problems, such as eczema,
psoriasis and dermatitis.
RD stands for ‘Ready Diluted’, it contains less active
ingredient than Betnovate. It is used:
• for milder skin problems, or
• to keep your skin problem under control after Betnovate
has improved it.

3 How to use Betnovate RD

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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 RD 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.

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Do not use Betnovate RD:
• if you are allergic (hypersensitive) to betamethasone
valerate or any of the other ingredients of Betnovate RD
(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 RD.
Warnings and precautions
Check with your doctor or pharmacist before using your
Betnovate RD 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 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 cream 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.
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 RD Cream contains chlorocresol and
cetostearyl alcohol
Betnovate RD Cream contains chlorocresol which may
cause allergic reactions and cetostearyl alcohol which may
cause local skin reactions (e.g. contact dermatitis).

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
Face Arm Leg
Back
Child’s age and and
and Front including
neck hand foot
buttocks
1-2 years
1½ 1½
2
2
3
3-5 years

2
3
3

6-10 years
2



5
• 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.
If you apply Betnovate RD to your face
You should only apply the cream to your face if your
doctor tells you to. It should not be 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 RD 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 RD
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 RD
If you use Betnovate RD 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.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop using Betnovate RD 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 RD,
have an infection or need other treatment.

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Pharma code Ref. No. 280

2 What you need to know before you use
Betnovate RD

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Pharma code Ref. No. 280

Pharma code Ref. No. 280

• 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 RD 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
• 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.

3
10000000147217
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

Betnovate RD
N/A
JMF333

N/A
N/A
1
K

0

0

5 How to store Betnovate RD
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the tube end 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.

6 Contents of the pack and other
information
What Betnovate RD cream contains
• The active ingredient is betamethasone valerate. Each
1 g contains 0.25 mg of betamethasone (0.025% w/w)
as valerate.
• The other ingredients are cetostearyl alcohol,
cetomacrogol 1000, white soft paraffin, liquid paraffin,
chlorocresol, disodium hydrogen phosphate, citric acid
monohydrate and purified water.
What Betnovate RD looks like and contents of the
pack
Within each carton is a tube with a plastic screw cap,
which contains 100 g of cream.
Marketing Authorisation Holder and Manufacturer
Product Licence held by Glaxo Wellcome UK Ltd, 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.
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:

0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name:
Betnovate RD Cream
Reference number 10949/0021
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.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.5pt
Leading: 11.0pt
Horizontal Scale: 100%
Smallest text size: 9.5pt
Microtext: No

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Expand Transcript

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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