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FUCIBET CREAM

Active substance(s): BETAMETHASONE VALERATE / FUSIDIC ACID MICRONISED NON-STERILE

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Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Rev. No.

Date

Colour

Sent by e-mail

YY

016003

INS 175 x 280 mm

Date

Date

Sign.

Sign.

01/09/14
Sign.

OMA

Black

Industriparken 55 – DK-2750 – Ballerup

Supplier / Place of production

Fucibet® Cream

Ireland

Comments:

Page 1 of 2

Pharmacode 303 - Font size: Heading: 10 point, section: 9 point, linespacing: 3,3 mm

Mock-up for reg. purpose

303

Preparation
Strength

Get-up

100%



ARTWORK

175 mm

Package leaflet: Information for the user

Fucibet cream
®

Fusidic acid and betamethasone valerate

Fucibet® contains 2 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 2 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).

280 mm

2. What you need to know before you use Fucibet®
Do not use Fucibet®
• If you are allergic (hypersensitive) to fusidic acid or
betamethasone valerate or 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 caused by a fungus, such as
athlete’s foot.
• To treat a skin condition caused by a virus, such as cold
sores or chickenpox.
• To treat skin conditions caused only by bacteria, such as
boils or spots.
• To treat skin conditions caused by tuberculosis (TB) or syphilis.
• To treat a skin condition called perioral dermatitis. This is a
red, spotty rash around your mouth or chin.
• To treat a skin condition called rosacea. This is redness and
inflammation over your nose and cheeks. Ask your doctor if
you are unsure.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fucibet®:
• Do not use the cream on yourself or a child for more than
2 weeks; this is to avoid bacteria becoming resistant to the
antibiotic and to avoid the steroid causing you side effects.
• 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 or
infections 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®
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®
on thin skin, skin ulcers, broken veins or acne.
• Adrenal suppression may occur. Signs are tiredness,
depression and anxiety. This can be reversed by stopping
Fucibet®.
Other medicines and Fucibet®
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes any
medicines which you have bought without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be

13.

EBD
03/08/15

3. How to use Fucibet®
Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
How to apply Fucibet®
This medicine is only for use 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 2 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.

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1. What Fucibet® is and what it is used for

pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
• If you are pregnant or think you might be pregnant; Fucibet®
should not be used during pregnancy, unless you are told to
do so by your doctor.
• If you are breast-feeding; Fucibet® may be used by women
who are breast-feeding, but the cream should not be applied
to the breasts to avoid accidental ingestion by the infant.
Tell your doctor if you become pregnant while using this
medicine.
Driving and using machines
This medicine should not have any 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.
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.

016003-YY

In this leaflet:
1. What Fucibet® is and what it is used for
2. What you need to know before you use Fucibet®
3. How to use Fucibet®
4. Possible side effects
5. How to store Fucibet®
6. Contents of the pack and other information

80 mm

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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
• In this leaflet Fucibet® Cream will be called Fucibet®.

Item-number:
See details below.

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Rev. No.

Date

Colour

Sent by e-mail

YY

016003

INS 175 x 280 mm

Date

Date

Sign.

Sign.

01/09/14
Sign.

OMA

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Supplier / Place of production

Fucibet® Cream

Ireland

Comments:

Page 2 of 2

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.

280 mm

For a child under 11 years:

Face
and neck

Child’s age

Arm
and hand

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

1

1

If you use more Fucibet® than you should
Tell your doctor straight away if have used more Fucibet®
than you should. You may need to stop using this medicine.
If you forget to use Fucibet®
If you forget to use the cream at the right time, use it as soon as
you remember. Then use this medicine again at the usual time.
Do not use a double dose to make up for a forgotten dose.
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:
Tell your doctor or nurse immediately if any of the following
happen. You may need to stop your treatment:
• You have difficulty breathing
• Your face or throat swell
• Your skin develops a severe rash.
The following less serious side effects have also been
reported. If any of them last a long time or cause problems,
you should tell your doctor or nurse as soon as possible:
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).
These problems are more likely in babies and children.

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For an adult:

They are also more likely if the skin is covered with a dressing,
bandage or nappy.
Uncommon (may affect up to 1 in 100 people)
• Itchy rash and skin inflammation in the area where the
medicine is used
• Worsening of your eczema
• Burning feeling
• Itching
• Dry skin
• Application site pain
• Application site irritation
Rare (may affect up to 1 in 1,000 people)
• Skin redness
• Hives
• Skin rash
• Application site swelling
• Application site blisters
Some side effects are known to be caused by betamethasone
valerate (steroid), one of the ingredients in Fucibet®. You should
tell your doctor if any of the side effects occur:
• Adrenal glands may stop working properly. Signs are
tiredness, depression and anxiety.
• Glaucoma
• Thinning of the skin
• Red, spotty rash around the mouth or chin
• Stretch marks
• Small veins near the surface of the skin become visible
• Changes in growth of your body hair
• Excessive sweating
• Lightening of your skin colour
• Redness and pimples around the mouth
• Redness of the skin, nose or mouth
• Formation of cataracts
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.

016003-YY

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 fingertip 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.

80 mm

175 mm

Item-number:
See details below.

5. How to store Fucibet®
• Keep this medicine out of the sight and reach of children.
• Do not use Fucibet® after the expiry date on the tube or carton.
The expiry date is the last day of that month.
• Do not store the medicine above 30°C.
• Do not use the tube for more than 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 throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
any medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Fucibet® contains
• The active substances are 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-αtocopherol, purified water and sodium hydroxide for pH
adjustment.
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 3 g, 5 g, 10 g, 15 g, 25 g, 30 g, 50 g
and 60 g.
Not all pack sizes may be marketed.
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 July 2015.
®Registered Trade Mark

LEO

Screen % - Child = 20%

Screen % - Schedule = 8%

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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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