Skip to Content

FUCIBET LIPID CREAM

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

View full screen / Print PDF » Download PDF ⇩
Transcript
Scale

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

Subject

Item No.

GB

Rev. No.

023223

Colour

Sent by e-mail

YY
Date

INS 175 x 280 mm

Date

Date

01/09/14
Sign.

Sign.

Sign.

OMA

Black

Industriparken 55 – DK-2750 – Ballerup

Supplier / Place of production

Fucibet® Lipid cream

Ireland

Comments:

Page 1 of 2 Pharmacode 446

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

Mock-up for reg. purpose

175 mm

Package leaflet: Information for the user

Fucibet Lipid cream
®

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

• 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.

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

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 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 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 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 or pharmacist before using Fucibet®
• Do not use the cream on yourself or a child for more than
2 weeks; this is to avoid the 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 pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before using this medicine.

15.

EBD
03/08/15

Fucibet® contains
• Cetostearyl alcohol. This may give you an itchy rash and
inflammation on your skin where your medicine is used.
• Potassium sorbate. This may give you an itchy rash and
inflammation on your skin where your medicine is used.
• Methylparahydroxybenzoate (E218) and
propylparahydroxybenzoate (E216). These are preservatives.
They may give you an allergic reaction. This may happen at any
time after you have your medicine. Please read section 4 so you
can spot any signs 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 this medicine exactly as your doctor 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 over
6 years. 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. Follow
the advice of your doctor.
Adults and children over 6 years:
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.

023223-YY

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

000000-00

80 mm

Fusidic acid and betamethasone valerate

Item-num
See deta

446

Preparation
Strength

Get-up

100%



ARTWORK

Scale

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

Subject

Item No.

GB

Rev. No.

Date

Colour

Date

Date

01/09/14
Sign.

Black + 15% screen of black

Sent by e-mail

YY

023223

INS 175 x 280 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

Sign.

OMA
Supplier / Place of production

Fucibet® Lipid 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 over 6 years and under 11 years:

5. How to store Fucibet®
Arm
Face
Leg
and neck and hand and foot

Child’s
age
6-10
years

Front

Back incl.
buttocks

31⁄2

5

Number of fingertip units needed
2

21⁄2

41⁄2

If you use more Fucibet® than you should
Tell your doctor straight away if you have used more Fucibet®
than you should. You may need to stop taking 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 take 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 children. They are also more
likely if the skin is covered with a dressing or bandage.

• 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 25°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 you 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 steareth-21, cetostearyl alcohol,
white soft paraffin, liquid paraffin, hypromellose, citric acid
monohydrate, methylparahydroxybenzoate,
propylparahydroxybenzoate, potassium sorbate,
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 5 g, 15 g, 30 g or 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

000000-00

For an adult:

Skin problems
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.

023223-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.

Expand view ⇕

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.

Hide