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FUCIBET CREAM

Active substance: FUSIDIC ACID MICRONISED NON-STERILE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucibet Cream
®

fusidic acid and betamethasone valerate
Please read all of this leaflet carefully before you start taking 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or
pharmacist.
• In this leaflet Fucibet® Cream will be called Fucibet®.
In this leaflet:
1. What Fucibet® is and what it is used for
2. Before you use Fucibet®
3. How to use Fucibet®
4. Possible side effects
5. How to store Fucibet®
6. Further information

1. WHAT FUCIBET® IS AND WHAT IT IS USED FOR
Fucibet® contains two different types of medicine. One
medicine is called fusidic acid. It is a type of antibiotic. The
other medicine is called betamethasone valerate. It is a type of
corticosteroid (steroid). These two medicines work at the same
time in different ways.
Fucibet® works by:
• The antibiotic killing germs (bacteria) that cause infections.
• The corticosteroid reducing any swelling, redness or
itchiness of your skin.
Fucibet® is used to treat:
• Conditions where the skin is inflamed (eczema or dermatitis)
and also infected by germs (bacteria).

2. BEFORE YOU USE FUCIBET®
Do not use Fucibet®
• If you are allergic (hypersensitive) to fusidic acid or
betamethasone valerate.
• If you are allergic (hypersensitive) to any of the other
ingredients in your medicine. You can find a list of these
ingredients in section 6 of this leaflet.
• To treat a skin condition called acne rosacea.
This is redness and inflammation over your nose and
cheeks. Ask your doctor if you are unsure.
• To treat a skin condition called perioral dermatitis. This is a
red spotty rash around your mouth or chin.
• To treat skin conditions caused only by bacteria, such as
boils or spots.
• To treat a skin condition caused by a virus, such as cold
sores or chickenpox.
• To treat a skin condition caused by a fungus, such as
athlete’s foot.
Take special care with Fucibet®
• Take special care if you are going to use this medicine near
your eyes or the eyes of a child. If the cream gets into the
eye, this may lead to glaucoma.
• If you use the cream over a long time or in large amounts it
may make the chance of getting any side effects higher.
Also your skin may get more sensitive to this medicine.
• You must not use the medicine for a long time on your face.
• Unless your doctor has told you to, you must not use
Fucibet® Cream on open wounds or sensitive areas such as
the nostrils, ears, lips or genitals.
• Unless your doctor has told you to, you must not use
Fucibet® Cream on thin skin, skin ulcers, broken veins or
acne.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or
have recently taken any other medicines. This includes any
medicines which you have bought without a prescription.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before using
Fucibet®:

• If you are pregnant, or think you are pregnant. You must not
use your medicine for a long time or in large amounts. You
must ask your doctor for advice.
• If you are breast-feeding.
Tell your doctor if you become pregnant while using this
medicine.
Driving and using machines
Usually your medicine will have very little effect on your
ability to drive or use machines. Check with your doctor if you
feel any side effect that may stop you from driving or using
machines.
Important information about some of the ingredients of
Fucibet®
Fucibet® contains:
• Cetostearyl alcohol. This may give you an itchy rash and
inflammation on your skin where your medicine is used.
• Chlorocresol. This is a preservative. It may give you an
allergic reaction. Please read section 4 so you can spot any
signs that this may be happening to you.
Please ask your doctor if you are worried about any of the
ingredients in this medicine.

3. HOW TO USE FUCIBET®
Always use Fucibet® exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not
sure.
How to put on Fucibet®
This medicine is only for using on your skin or the skin of a
child. Do not swallow it. Do not put it inside your body.
Remove the cap. Check the seal is not broken before you first
use the cream. Then push the spike in the cap through the
seal on the tube.
Always wash your hands before using Fucibet®. Rub the
medicine gently on the skin. If you use it on your face be
careful to avoid your eyes.
Unless you are using the cream to treat your hands, always
wash your hands after using Fucibet®.
If you accidentally get any medicine in your eye, wash it out
with cold water straight away. Then bathe your eye with
eyewash if possible. Your eye may sting. If you start to have
any problems with your sight or your eye is sore, contact your
doctor immediately.
How much Fucibet® to use
Your doctor will tell you how much Fucibet® to use.
The usual treatment time is up to two weeks. Ask your doctor
before using this medicine for any longer.
You should notice your skin improve after just a few days of
using the cream. If there is no improvement after 7 days you
should stop using the cream and go back to your doctor.
Usually you should use this medicine twice each day. Use it in
the morning and evening. To remind you to use the medicine it
may help to use it when you do another regular action, such
as brushing your teeth.
If you have been told to cover the skin with any
dressings or bandages you may not need to use the medicine
so often. A nappy on a baby may act as a dressing. Follow
the advice of your doctor.

Adults and children:
Your doctor should tell you the dose that is right for you or the
child. If your doctor has told you the amount of cream to use
then keep to this advice. If not, the following guide will help
you to use the correct amount.
You can use your first (index) finger to measure how much
Fucibet® to use. Squeeze the cream along your finger from
the tip to the first joint as shown in the diagram. This is called
a fingertip unit.
The usual number of finger tip units you
need to cover different parts of the body
is shown in the diagrams. If you need to
use a little more or a little less do not
worry. If you are using the cream on a
child still use an adult finger to measure
out the fingertip unit.
For an adult:
Face and neck:
21⁄2 fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including the foot):
6 fingertip units.
One foot:
2 fingertip units.

Child’s age

Arm
and hand

Rare side effects (probably affect less than 1 in 1000 people)
• Hives
• Dry skin
Side effects where the number of people affected is not
known:
• Itchy rash and skin inflammation in the area where the
medicine is used.
• Rash
• Small veins near the surface of the skin become visible.
Some side effects are known to be caused by betamethasone
valerate (steroid), one of the ingredients in Fucibet® Cream.
You should tell your doctor if any of the side effects occur:
• Thinning of the skin
• Stretch marks
• Inflammation or swelling of the hair root (folliculitis)
• Changes in growth of your body hair
• Red spotty rash around the mouth or chin
• Lightening of your skin colour
• Glaucoma
• Adrenal glands may stop working properly. Signs are
tiredness, depression and anxiety.

5. HOW TO STORE FUCIBET®
• Keep out of the reach and the sight of children.
• Do not use Fucibet® after the expiry date on the carton.
The expiry date is the last day of that month.
• Do not keep the tube for 3 months after you first open
it. Make a note of the date you first opened the tube in the
space provided on the carton.
• Do not store the medicine above 30°C.
Leg
and foot

Front

Back
including
buttocks

Number of fingertip units needed

3-6 months

1

1

11⁄2

1

11⁄2

1-2 years

11⁄2

11⁄2

2

2

3

3-5 years

11⁄2

2

3

3

31⁄2

6-10 years

2

2 ⁄2

4 ⁄2

3 ⁄2

5

1

Skin problems
Uncommon side effects (probably affect less than 1 in 100
people)
• Skin irritation
• Burning feeling
• Itching
• Worsening of your eczema
• Stinging feeling
• Skin redness

If any of the side effects become serious or you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

For a child under 11 years:

Face
and neck

These problems are more likely in babies and children. They
are also more likely if the skin is covered with a dressing,
bandage or nappy.

1

1

If you forget to use Fucibet®
If you forget to use this medicine, use it as soon as you
remember. Then next use this medicine at the usual time.
If you have any further questions about using this medicine,
please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucibet® can cause side effects, although
not everybody gets them.
Important side effects to look out for:
You must get urgent medical help if you have any of the
following symptoms. You may be having an allergic reaction:
• You have difficulty breathing
• Your face or throat swell
• Your skin develops a severe rash.
Other possible side effects:
Any of the problems listed below are more likely if the
medicine is used for a long time, in large amounts or on skin
folds (such as armpits or under breasts).

Medicines should not be thrown away in waste water or in
household waste. Please ask your pharmacist how to throw
away any medicine you do not need any more. If you do this
you will help protect the environment.

6. FURTHER INFORMATION
What Fucibet® contains
• There are two active ingredients, fusidic acid and
betamethasone valerate.
Fucibet® contains 2% fusidic acid and 0.1% betamethasone.
• The other ingredients are macrogol cetostearyl ether,
cetostearyl alcohol, chlorocresol, liquid paraffin, sodium
dihydrogen phosphate, white soft paraffin,
all-rac-α-tocopherol and purified water.
You can find important information about some of the
ingredients in your medicine near the end of section 2 of
this leaflet.
What Fucibet® looks like and contents of the pack
Fucibet® is a white cream.
Fucibet® comes in tubes of 30g and 60g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited, Hurley, Berkshire SL6 6RJ, UK
Manufacturer:
LEO Laboratories Limited, Dublin 12, Ireland.
This leaflet was last revised in October 2013.
®Registered Trade Mark

LEO

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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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