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FUSIDIC ACID 2% CREAM

Active substance(s): FUSIDIC ACID

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TEVA UK Ref:

231-30-30160-B LEA FUSIDIC ACID 2% CREAM TUK
FUSIDIC ACID 2% CREAM
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 or pharmacist.
• 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.
WHAT IS IN THIS LEAFLET:

1. What Fusidic Acid is and what it is
used for
2. What you need to know before you
use Fusidic Acid
3. How to use Fusidic Acid
4. Possible side effects
5. How to store Fusidic Acid
6. Contents of the pack and other
information

1

WHAT FUSIDIC ACID IS AND
WHAT IT IS USED FOR

The active ingredient of Fusidic Acid is
fusidic acid. This is an antibiotic (this
means that it kills bacteria that cause
infections).
Fusidic Acid should be used on the skin.
The cream is used for the local treatment
of skin infections caused by bacteria that
are sensitive to fusidic acid (especially
staphylococcus infections) such as
impetigo (a weeping, crusty and swollen
patch of skin), folliculitis (inflammation
of one or more hair follicles), sycosis
barbae (infection of the bearded skin),
paronychia (infection of the tissue
surrounding a fingernail or toenail) and
erythrasma (infection with brown, scaly
skin patches, especially in the folds of
the body). It is also used to treat infected
dermatitis (inflammation of the skin),
spots, cuts and grazes.

2

WHAT YOU NEED TO KNOW
BEFORE YOU USE FUSIDIC ACID

Do not use Fusidic Acid
• if you are allergic (hypersensitive) to
fusidic acid or any of the other
ingredients of this medicine (listed in
section 6).Therefore, always tell your
doctor which medicines or other
substances you are allergic to.
Warnings and precautions
Talk to your doctor or pharmacist before
using Fusidic Acid
• if you use Fusidic Acid on the face. The
cream should not be applied in or near
the eye because it can lead to a
prickling feeling in the eye
• if you use the cream for a long time or
in large amounts as it may make the
chance of getting any side effects
higher. Also your skin may get more
sensitive to the cream.
Please tell your doctor if one of the
above warnings applies to you or has
applied to you in the past.
Other medicines and Fusidic Acid
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

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2

27 January 2016

There is no known effect of Fusidic Acid
with other medicines.
Pregnancy and breast-feeding
Pregnancy:
You need to discuss your specific
circumstances with your doctor to weigh
up the overall risks and benefits of using
this medicine.
You should only use this medicine
during pregnancy if your doctor thinks
that you need it.
Breast-feeding:
Using Fusidic Acid topically and
breast-feeding is unlikely to harm your
baby. However, it is not recommended to
apply Fusidic Acid to the breast whilst
breast-feeding.
You should talk to your doctor if you
have any concerns using this medicine
whilst breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine!
Driving and using machines
This cream does not affect your ability to
drive or operate machinery.
Fusidic Acid contains
butylhydroxyanisole, cetyl alcohol and
potassium sorbate which may cause
local skin reactions (e.g. contact
dermatitis). Butylhydroxyanisole may
also cause irritation to the eyes and
mucous membranes.

3

HOW TO USE FUSIDIC ACID

Always use this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Dosage
Your doctor will tell you how much
Fusidic Acid you should use.
Adults and children
Usually a small amount of cream is
applied to the infected skin three or four
times each day. If your doctor advises
you to use a sterile bandage or dressing,
you can usually reduce the number of
applications.
A nappy on a baby may act as a
dressing. Follow the advice of your
doctor.
If you think that the effect of Fusidic Acid
is too strong or too weak, ask your
doctor or pharmacist for advice.
How to apply Fusidic Acid
Fusidic Acid should be applied to the
skin. Do not swallow it.
1. Always wash your hands before you
use the cream
2. Remove the cap
3. Check that the seal is not broken
before you use the cream for the first
time
4. Push the spike in the cap through the
seal of the tube
5. Rub the cream gently on the skin
6. If you use the cream on your face be
careful to avoid your eyes
7. Always wash your hands after using
the cream, unless you are using the
cream to treat your hands.
If you accidentally get any cream in your
eye, wash it out with cold water straight
away. Then rinse your eye with eye wash
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.

TEVA UK Ref:

231-30-30160-B LEA FUSIDIC ACID 2% CREAM TUK
Duration of treatment
The duration of the treatment will be
decided by your doctor. Treatment is
usually 1 to 2 weeks, although it may be
longer. This depends on the type of
infection and the result of the treatment.
Take special care if you use the cream for
a long time or in large amounts, because
then there is a higher chance of getting
side effects. Therefore, always follow the
advice of your doctor.
If you use more Fusidic Acid than you
should
If you apply too much or accidentally
swallow Fusidic Acid, it is unlikely to
cause any harm.
Generalised effects (e.g. jaundice) may
be caused if you apply too much of this
medicine, in particular on wide skin
surfaces. However, no cases of overdose
have been reported so far.
However, if you notice any effect or are
worried, contact your doctor or
pharmacist. You should contact the
doctor if Fusidic Acid is accidentally
swallowed by an infant.
If you forget to use Fusidic Acid
If you forget to use the cream, apply the
usual amount of Fusidic Acid as soon as
you remember. Do not apply a double
dose to make up for a forgotten dose.
If you stop using Fusidic Acid
Always use Fusidic Acid for duration
directed by your doctor. Speak to your
doctor if unsure. If you stop using Fusidic
Acid prematurely, it is possible that the
skin infection returns or does not cure.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
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.
The frequency of occurrence of side
effects is as follows:
Very common: Affects more than 1 in
10 users
Common:
Affects up to 1 in 10
users
Uncommon:
Affects up to 1 in 100
users
Rare:
Affects up to 1 in 1,000
users
Very rare:
Affects up to 1 in 10,000
users
The most frequently reported side effects
are various skin reactions and in
particular application site reactions.
Uncommon
• Itching (pruritis)
• Rash
• Skin sensitivity reactions (contact
dermatitis and eczema)
• Irritation at site of application
(including pain, stinging, burning and
redness of the skin).
Rare
• Inflammation of the eye (conjunctivitis)
• Hives
• Blistering of the skin

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27 January 2016

• Angioedema (sudden swelling in the
skin and mucous membranes (for
example throat and tongue), breathing
problems and/or itching and skin rash,
often the symptoms of an allergic
reaction) Immediately contact your
doctor or pharmacist if this occurs.
Reporting of side effects
If you get any side effects talk to your
doctor or pharmacist. 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 FUSIDIC ACID

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton or the
tube after “EXP”.The expiry date refers to
the last day of that month.
Do not store above 25°C.
Discard the tube after 4 weeks of first
opening the tube even if there is still
some cream left in it.
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 to protect the
environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Fusidic Acid contains
• The active substance is fusidic acid 2%.
Each gram of cream contains 20 mg
fusidic acid
• The other ingredients are
butylhydroxyanisole (E320), cetyl
alcohol, glycerol (E422), liquid paraffin,
potassium sorbate (E202), polysorbate
60 (E435), white soft paraffin,
hydrochloric acid for pH adjustment,
purified water. Some of these
ingredients can cause a skin reaction,
see section 2 of this leaflet.
What Fusidic Acid looks like and
contents of the pack
Fusidic Acid is a white to off-white
cream, and is available in an aluminium
tube with HDPE screw cap.
Pack sizes: 15 gram and 30 gram.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
BN22 9AG, UK

Manufacturer
Basic Pharma Manufacturing B.V.,
Burgemeester Lemmensstraat 352,
Geleen, 6163 JT, The Netherlands
This leaflet was last revised in 10/2014.
PL 00289/1849

30160-B
320 x 148
248989.02-GB

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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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