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BETNOVATE SCALP APPLICATION

Active substance(s): BETAMETHASONE / BETAMETHASONE VALERATE

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Package Leaflet: Information for the User

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Betnovate® Scalp Application
betamethasone valerate

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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.

• you are applying to thin skin 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 where the scalp application is applied.
• Use on children should be limited to 5 days.

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

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.

1 What Betnovate is
and what it is used for
Betnovate Scalp Application (called ‘Betnovate’
in this leaflet) contains a medicine called
betamethasone valerate. It belongs to a group
of medicines called steroids that help to reduce
swelling and irritation.
Betnovate is used to help reduce the redness
and itchiness of certain scalp problems, such as
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)
• if you have a skin infection on your scalp
• on a child under 1 year.
Do not use Betnovate 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 you
use this medicine if:
• you have previously had an allergic reaction
with another steroid
• you are applying the liquid under an airtight
dressing. 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
• you are applying the liquid to broken skin or
within the skin folds
• you are applying to a large surface area

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.

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Betnovate
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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 put Betnovate on your scalp in the
morning and at night. This may be reduced as
your scalp problem begins to get better.
• Do not use Betnovate more often than
prescribed.
• Do not use it for a long time (such as every
day for many weeks or months) - unless your
doctor tells you to.
• Be very careful not to get the liquid in your
eyes. Do not touch your eyes until you have
washed your hands.
• If you wash or shampoo your hair it should
be dried before applying the liquid.
• If you are applying Betnovate on someone
else make sure you wash your hands after
use or wear disposable plastic gloves.
• Do not dry your hair with a hairdryer.
• This product is flammable. Keep the
liquid away from open fires and flames
and all sources of ignition including
smoking during application and
immediately after use.
Guidance on how to apply the liquid
1 Wash your hands.
2 Unscrew the bottle cap and place the nozzle
on the scalp that needs treating.
3 Gently squeeze the bottle to cover the area
with a thin and even layer of liquid.
4 You can rub this liquid in, but you don’t
have to.
5 Your scalp will feel cool until the liquid has
dried.
6 Wash your hands again.
7 It is important not to exceed the prescribed
amount.

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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 Betnovate, apply it as
soon as you remember. If it is close to the time
you are next meant to apply it you can 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.

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 liquid is applied.
Very rare
(may affect up to 1 in 10,000 people)
• an increased risk of infection
• an allergic skin reaction where the liquid 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 out of the sight and reach of children.
• Do not use this medicine after the expiry
date which is stated on the bottle label or
carton after (Exp). The expiry date refers to
the last day of that month.
• Do not store above 25°C.
• Keep the container tightly closed when not
in use. Contents are flammable. Keep
Betnovate Scalp Application away from all
sources of fire, flame and heat.
• Do not leave Betnovate Scalp Application in
direct sunlight.
• 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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United Kingdom-GBR
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6 Contents of the pack and other
information
What Betnovate contains
• The active ingredient is betamethasone
valerate. Each 10 ml contains 0.01 ml of
betamethasone (0.1 % w/w) as valerate.
• The other ingredients are carbomer, isopropyl
alcohol, sodium hydroxide and purified water.
What Betnovate looks like and contents of
the pack
Within each carton is a specially designed
plastic bottle with a nozzle and cap that
contains 100 ml of a sticky liquid.

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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
More Information
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 Scalp Application
Reference number 10949/0045
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in: June 2014
Betnovate is a registered trade mark of the GSK
group of companies
© 2014 GSK group of companies. All rights
reserved.

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Additional Information Panel
Replacement: 12000000102880

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.5pt
Leading: 11pt
Horizontal Scale: 100%
Smallest text size: 9.5pt
Microtext: N

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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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