BETNOVATE LOTION

Active substance: BETAMETHASONE VALERATE

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Package Leaflet: Information for the User

Betnovate® Lotion

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GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

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

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)
- 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 lotion 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 lotion on broken skin or
within the skin folds.
• you are applying near eyes or on eyelids, as
cataracts or glaucoma may result if the lotion
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 lotion 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 Lotion contains cetostearyl
alcohol
Betnovate Lotion contains cetostearyl
alcohol which may cause local skin reactions
(e.g. contact dermatitis).

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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 apply Betnovate once or
twice a day. This may be reduced as your
skin begins to get better.
• This lotion 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 lotion 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.
• This product is flammable. Keep the lotion
away from open fire and flames and all
sources of ignition including smoking during
application and immediately after use.
Guidance on how to apply the lotion
1 Wash your hands.
2 Gently rub a small amount of lotion into the
skin until it has all disappeared.
3 Unless you are meant to apply the lotion to
your hands as a part of the treatment, wash
them again after using the lotion.

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For a child
• Do not use it on children under 1 year of age.
• It is especially important in children not to
exceed the prescribed amount. The smaller
the child the less lotion you will need to use.
• 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 lotion under an airtight dressing. It
will only be at night to help the lotion to start
working. After a short period of time you will
then apply the lotion as normal.
If you apply Betnovate to your face
You should only apply the lotion 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 lotion 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 lotion, 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.

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 lotion is applied.
Very rare (may affect up to 1 in 10,000 people)
• an increased risk of infection
• an allergic skin reaction where the lotion 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 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 Lotion away from all sources of
fire, flame and heat.
• 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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6 Contents of the pack and
other information
What Betnovate Lotion 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 methyl
hydroxybenzoate, xanthan gum, cetostearyl
alcohol, liquid paraffin, isopropyl alcohol,
glycerol, macrogol cetostearyl ether, sodium
citrate, citric acid and purified water.
What Betnovate looks like and contents of
the pack
Within each carton is a plastic bottle with a
nozzle and cap that contains 100 ml of lotion.
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:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name:
Betnovate Lotion
Reference number
10949/0044
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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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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