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BETNOVATE SCALP APPLICATION 0.1% W/W CUTANEOUS SOLUTION

Active substance(s): BETAMETHASONE VALERATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Betnovate scalp application
0.1% w/w Cutaneous Solution
(betamethasone valerate)
Your medicine is available using the name Betnovate scalp
application 0.1% w/w Cutaneous Solution but will be referred to
as Betnovate throughout this leaflet.

Read all of this leaflet carefully before you
start using this medicine.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

Take special care with Betnovate

Check with 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.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Like all medicines, Betnovate can cause side effects, although not
everybody gets them.

Talk to your doctor or pharmacist before using this medicine if you
are pregnant, might become pregnant or are breast-feeding.

3. How to use Betnovate
Always use Betnovate exactly as your doctor has told you. You
should 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.
The liquid is flammable, you should keep it away from
fire.
Do not dry your hair with a hairdryer or be near a fire.

Betnovate is used to reduce the redness and itchiness of certain
scalp problems, such as psoriasis and dermatitis.

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.

If you use Betnovate regularly make sure you talk to your doctor
before you stop using it.

Pregnancy and breast-feeding

Betnovate contains a medicine called betamethasone valerate. It
belongs to a group of medicines called steroids that help to reduce
swelling and irritation.

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.

If you stop using Betnovate

4. Possible side effects

1. What Betnovate is and what it is used for

Do not 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 are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using this medicine.

What Betnovate is and what it is used for
Before you use Betnovate
How to use Betnovate
Possible side effects
How to store Betnovate
Further information

2. Before you use Betnovate

If you forget to use Betnovate

Guidance on how to apply the liquid
1.
2.
3.
4.
5.
6.

Wash your hands.
Unscrew the bottle cap and place the nozzle on the scalp that
needs treating.
Gently squeeze the bottle to cover the area with a thin and
even layer of liquid.
You can rub this liquid in, but you don't have to.
Your scalp will feel cool until the liquid has dried.
Wash your hands again.

If you use more Betnovate than you should

If, by mistake on a few occasions you use more than you should,
do not worry. If you apply a lot or if a lot is accidentally
swallowed, it could make you ill. Talk to your doctor or go to
hospital as soon as possible.

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Stop using Betnovate and tell your doctor as soon
as possible if:

you find that your skin condition gets worse or becomes
swollen during treatment.
You may be allergic to Betnovate, have an infection or need
other treatment.
you have psoriasis and you 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

(affects less than 1 in 10 people)
a feeling of burning, irritation or itching where the liquid is
applied.
Side effects if you use Betnovate for a long time, you use a lot
each time you apply it, or you apply it under an airtight dressing:

Very rare

(affects less than 1 in 10,000 people)
stretch marks may develop
veins under the surface of your skin may become more
noticeable
increased hair growth and changes in skin colour
thinning of your skin and it may also damage more easily
weight gain, rounding of the face and high blood pressure.
These are more likely to happen in infants and children.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. How to store Betnovate
Keep out of the sight and reach of children.
Do not use Betnovate after the expiry date on the bottle
label or carton (Exp). The expiry date refers to the last day
of that month.
Do not store above 25°C. Store in the original package.
Caution: Inflammable. Do not use or dry the hair near a fire
or naked flame.
If your doctor decides to stop your treatment, take any
leftover medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any
other signs of deterioration, take it back to your pharmacist
who will advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Other formats

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name
Betnovate® scalp application
0.1% w/w Cutaneous Solution
Reference number
21828/0531
Leaflet revision date: 11.02.13
Betnovate® is a registered trademark of the GlaxoSmithKline
group of companies.

6. Further information
What Betnovate contains

Betnovate contains the active ingredient betamethasone
0.1% w/w (as betamethasone valerate).
The other ingredients are: carbomer, isopropyl alcohol,
sodium hydroxide and purified water.

What Betnovate looks like and contents of the pack
Betnovate is a colourless solution available in 100 ml plastic
bottles with a nozzle and a tamper proof screw cap.

Manufacturer

Manufactured by: Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0531

POM

More information

If you have any questions or are not sure about anything, ask
your doctor or pharmacist who will advise you.
Other sources of information are:
National Eczema Society,
Hill House, Highgate Hill,
London, N19 5NA.
The Psoriasis Association,
2 Queensbridge,
Northampton, NN4 7BF.
You may also be able to find out more from books in public
libraries.

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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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