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BETAMETHASONE VALERATE 1MG/G AND CLIOQUINOL 30 MG/G CREAM

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

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Betamethasone valerate 1mg/g and Clioquinol 30 mg/g Cream
Your medicine is known by the above name, but will be referred to as
Betamethasone/Clioquinol Cream throughout this:
Patient Information 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 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 this medicine is and what it is used for
2) Before you use Betamethasone/Clioquinol Cream
3) How to use Betamethasone/Clioquinol Cream
4) Possible side effects
5) How to store Betamethasone/Clioquinol Cream
6) Further information

1) What this medicine is and what it is used for
Betamethasone/Clioquinol Cream contains two different medicines called
betamethasone valerate and clioquinol.
• Betamethasone valerate belongs to a group of medicines called
steroids. It helps to reduce swelling and irritation.
• Clioquinol is a type of anti-infective medicine. It fights bacterial and
fungal infections of the skin.
This medicine 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 Betamethasone/Clioquinol Cream
Do not use Betamethasone/Clioquinol Cream:
• if you are allergic (hypersensitive) to betamethasone valerate, clioquinol
or any of the other ingredients (listed in Section 6)
• if you are allergic (hypersensitive) to iodine
• 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)
− 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 this medicine.
Take special care with Betamethasone/Clioquinol Cream
Check with your doctor or pharmacist before using your medicine if:
• 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.

For a child
• Do not use it on children under 1 year of age.
• The smaller the child the less you will need to use.
• A child of 4 years needs about a third of the adult 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.
Using this medicine
• You usually apply the cream 2 or 3 times 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 after 7 days talk to your
doctor.
• Do not mix with any other creams or ointments.
If you apply Betamethasone/Clioquinol Cream 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.
If you use more Betamethasone/Clioquinol Cream 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.
If you forget to use Betamethasone/Clioquinol Cream
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

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.

If you stop using Betamethasone/Clioquinol Cream
If you use this medicine regularly make sure you talk to your doctor before
you stop using it.

3) How to use Betamethasone/Clioquinol Cream

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

Always use the cream exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

4) Possible side effects
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 cream to use with your fingertip. This
picture shows one fingertip unit.

Like all medicines, Betamethasone/Clioquinol Cream can cause side
effects, although not everybody gets them.
STOP using this medicine and tell your doctor as soon as possible if:
• you find your condition gets worse or becomes swollen during treatment.
You may be allergic to the cream or need other treatment.
Other side effects you may notice when using
Betamethasone/Clioquinol Cream include:
• a feeling of burning, irritation or itching where the cream is applied
• 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.

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:
• two fingertips of cream will cover both hands or one foot
• three fingertips of cream will cover one arm
• six fingertips of cream will cover one leg
• fourteen fingertips of cream will cover the front and back of the body.

Side effects if you use Betamethasone/Clioquinol Cream 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:
• 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 damages more easily
• weight gain, rounding of the face and high blood pressure. These are
more likely to happen in infants and children.

Do not worry if you find you need a little more or a little less than this. It is
only a rough guide.

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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Betamethasone/Clioquinol Cream
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton, tube end and label after EXP. The expiry date refers to the last
day of that month.
• Do not store above 30°C.
• Do not throw away any 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) Further information
What Betamethasone/Clioquinol Cream
• The active ingredients are betamethasone valerate and clioquinol.
Each 1g of cream contains 1mg (0.1 %w/w) betamethasone (as valerate)
and 30mg (3%w/w) clioquinol.
• The other ingredients are: chlorocresol, macrogol cetostearyl ether,
cetostearyl alcohol, white soft paraffin, liquid paraffin, sodium dihydrogen
phosphate dihydrate, phosphoric acid, sodium hydroxide and purified
water.
What Betamethasone/Clioquinol Cream looks like and contents of the
pack
Within each carton is a tube with a white plastic screw cap, which contains
30g of smooth pale yellow cream.
PL 10383/2209 Betamethasone valerate 1mg/g and Clioquinol 30 mg/g
Cream
POM
Who makes and repackages your medicine?
Your medicine is manufactured by Glaxo Operations UK Ltd, Barnard
Castle, UK. Procured from within the EU and repackaged by Product
Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 29.11.2016

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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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