BETNOVATE C CREAM

Active substance: CLIOQUINOL

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Betnovate-C Cream
betamethasone valerate, clioquinol
202618

96/L/m/3

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

i Keep this leaflet. You may need to read it again.
i If you have any further questions, ask your doctor or pharmacist.
i 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.
i If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Betnovate-C is and what it is used for
2. Before you use Betnovate-C
3. How to use Betnovate-C
4. Possible side effects
5. How to store Betnovate-C
6. Further information

1. What Betnovate-C is
and what it is used for
Betnovate-C contains two different medicines
called betamethasone valerate and clioquinol.
i Betamethasone valerate belongs to a group
of medicines called steroids. It helps to
reduce swelling and irritation.
i Clioquinol is a type of anti-infective medicine.
It fights bacterial and fungal infections of the
skin.
Betnovate-C is used to help reduce the redness
and itchiness of certain skin problems. These
skin problems include eczema, psoriasis,
dermatitis or insect bites, where an infection
may be a problem.

2. Before you use Betnovate-C
Do not use Betnovate-C:
i if you are allergic (hypersensitive) to
betamethasone valerate, clioquinol or any of
the other ingredients of Betnovate-C (listed in
Section 6)
i if you are allergic (hypersensitive) to iodine
i on a child under 1 year
i 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)
- viral infections, such as cold sores,
herpes or chicken pox
- blisters or sores on your face and hands
(impetigo), or other bacterial infections
- fungal infections, such as ringworm,
athletes foot, or thrush
- itching around your back passage (anus)
or private parts (genitals) - unless your
doctor has told you to do so.
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-C.
Take special care with Betnovate-C
Check with your doctor or pharmacist before
using your medicine if:
i 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.
i you have psoriasis, your doctor will want to
see you more often.

Pregnancy and breast-feeding
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-C
Always use Betnovate-C exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Guidance on how to apply the cream
1 Wash your hands.
2 Gently rub the correct amount of cream into
the skin until it has all disappeared.
You can measure how much Betnovate to
use with your fingertip. This picture shows
one fingertip unit.

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
You should find that:
i two fingertips of cream will cover both hands
or one foot
i three fingertips of cream will cover one arm
i six fingertips of cream will cover one leg
i fourteen fingertips of cream will cover the
front and back of the body.
Do not worry if you find you need a little more or
a little less than this. It is only a rough guide.

For a child
i Do not use it on children under 1 year of age.
i The smaller the child the less you will need to
use.
i A child of 4 years needs about a third of the
adult amount.
i 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.
Please turn over the page

Using this medicine
i You usually apply Betnovate-C 2 or 3 times a
day. This may be reduced as your skin begins
to get better.
i This cream is for use on your skin only.
i Do not use more than the amount prescribed
for you.
i 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.
i 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.
i If you are applying the cream on someone
else make sure you wash your hands after
use or wear disposable plastic gloves.
i If your skin problem does not improve
after 7 days talk to your doctor.
i Do not mix with any other creams or
ointments.
If you apply the Betnovate-C to your face
You should only apply the cream 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 cream get into your
eyes.

Staining of your hair, skin and clothes can
occur. You can protect clothes by covering the
treated area with a cotton bandage or piece of
clean cloth.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Betnovate-C
i Keep out of the reach and sight of children.
i Do not use Betnovate-C after the expiry date
on the tube end or carton (Exp). The expiry
date refers to the last day of that month.
i Do not store above 30°C.
i 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
protect the environment.

6. Further information

If you use more Betnovate-C 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 the hospital
as soon as possible.

What Betnovate-C Cream contains
i The active ingredients are betamethasone
valerate and clioquinol. Each 1 g contains
1 mg of betamethasone (0.1% w/w) as
valerate and 30 mg of clioquinol (3% w/w).
i The other ingredients are:
chlorocresol, cetomacrogol 1000,
cetostearyl alcohol, white soft paraffin,
liquid paraffin, sodium acid phosphate,
phosphoric acid, sodium hydroxide and
purified water.

If you forget to use Betnovate-C
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.

What Betnovate-C Cream looks like and
contents of the pack
Within each carton is a tube with a plastic screw
cap, which contains 15 g or 30 g of cream.
Not all pack sizes may be marketed.

If you stop using Betnovate-C
If you use Betnovate-C regularly make sure you
talk to your doctor before you stop using it.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House,
Egham Business Village, Crabtree Road,
Egham, Surrey TW20 8RB.

4. Possible side effects

Manufacturer
Purna Pharmaceuticals NV, Rijksweg 17,
2870 Puurs, Belgium.

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

This leaflet was last revised in
March 2010

STOP using Betnovate-C and tell your
doctor as soon as possible if:
i you find your condition gets worse or
becomes swollen during treatment. You may
be allergic to the cream or need other
treatment.

Betnovate-C is a registered trademark of the
GlaxoSmithKline group of companies and is
used under licence.
Chemidex and Chemidex logo are registered
trademarks of Chemidex Pharma Ltd.

Other side effects you may notice when
using Betnovate-C include:
i a feeling of burning, irritation or itching where
the cream is applied
i if you have psoriasis you may get raised
bumps with pus under the skin. This can
happen during or after the treatment and is
known as pustular psoriasis.
Side effects if you use Betnovate-C for a long
time, or you use a lot each time you apply it, or
you apply it under an airtight dressing or a
nappy:
i stretch marks may develop
i veins under the surface of your skin may
become more noticeable
i increased hair growth and changes in skin
colour
i thinning of your skin and it damages more
easily
i weight gain, rounding of the face and high
blood pressure. These are more likely to
happen in infants and children.

96/L/m/3

202618

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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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