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FUSIDIC ACID 20 MG/G CREAM

Active substance(s): FUSIDIC ACID / FUSIDIC ACID / FUSIDIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fusidic Acid 20mg/g Cream
Fusidic Acid

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 symptoms
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.
Your medicine is called Fusidic Acid
20mg/g Cream, which will be referred to
as Fusidic Acid Cream throughout this
leaflet.
In this leaflet:
1. What Fusidic Acid Cream is and what it
is used for
2. What you need to know before you use
Fusidic Acid Cream
3. How to use Fusidic Acid Cream
4. Possible side effects
5. How to store Fusidic Acid Cream
6. Contents of the pack and other
information

1. What Fusidic Acid Cream is and
what it is used for
The active ingredient of Fusidic Acid Cream is
fusidic acid. This is an antibiotic (this means
that it kills bacteria that cause infections).
Fusidic Acid Cream 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),
erythrasma (infection with brown, scaly skin
patches, especially in the folds of the body).

2. What you need to know before
you use Fusidic Acid Cream
Do not use Fusidic Acid Cream if you are
allergic (hypersensitive) to fusidic acid or any
of the other ingredients of Fusidic Acid
Cream.
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 Cream
if you use Fusidic Acid Cream 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 Cream
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
There is no known effect of Fusidic Acid
Cream with other medicines.

Fertility, pregnancy and breast-feeding

Fertility:
There is not enough evidence to say that
Fusidic Acid Cream affects fertility. However,
using Fusidic Acid Cream is unlikely to affect
fertility in women of child bearing potential.
Pregnancy:

There is not enough evidence to say that it is
safe to use Fusidic Acid Cream during
pregnancy.
You need to discuss your specific
circumstances with your doctor to weigh up
the overall risks and benefits of using this
medicine. You and your doctor can make a
decision about whether you are going to use
this medicine during pregnancy.
You should only use this medicine during
pregnancy if your doctor thinks that you
need it.
Breast-feeding:
Using Fusidic Acid Cream topically and
breast-feeding is unlikely to harm your baby.
Fusidic Acid Cream may be used during
breast-feeding but you should avoid applying
it on your breast.
You should only breast-feed your baby while
using this medicine on the advice of your
doctor.
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.
Important information about some of the
ingredients of Fusidic Acid Cream
Fusidic Acid Cream 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 Cream
Always use Fusidic Acid Cream 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 Cream you should use.
Use in 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 usually can
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 Cream is too
strong or too weak, ask your doctor or
pharmacist for advice.
How to apply Fusidic Acid Cream
Fusidic Acid Cream 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.
(continued overleaf)

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.
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 Cream than
you should
If you apply too much or accidentally swallow
Fusidic Acid Cream, it is unlikely to cause any
harm. However, if you notice any effect or are
worried, contact your doctor or pharmacist.
You should contact the doctor if Fusidic Acid
Cream is accidentally swallowed by an infant.
If you forget to use Fusidic Acid Cream
If you forget to use the cream, apply the usual
amount of Fusidic Acid Cream as soon as
you remember. Do not apply a double dose
to make up for a forgotten dose.
If you stop using Fusidic Acid Cream
Always use Fusidic Acid Cream for duration
directed by your doctor. Speak to your doctor
if unsure.
If you stop using Fusidic Acid Cream
prematurely, it is possible that the skin
infection returns or does not cure.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Fusidic Acid Cream can
cause side effects, although not everybody
gets them.
The most frequently reported side effects are
various skin reactions and in particular
application site reactions.
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
Not known:
Frequency cannot be
estimated from the
available data
If you have any of the following rare side
effects while taking your medicine tell your
doctor immediately or go to hospital
straight away:
Severe allergic reaction which may
include a red and lumpy skin rash,
difficulty breathing, swelling of face,
mouth, lips or eyelids, unexplained high
temperature (fever and feeling faint). If the
swelling affects your throat and makes
breathing and swallowing difficult, go
to hospital straight away.
Uncommon
Itching
Rash
Eczema
Skin sensitivity reactions (contact
dermatitis)

Irritation at site of application
(including pain, stinging, burning and
redness of the skin)
Rare
Blister
Swelling of the skin
Hives
Conjunctivitus
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 Fusidic Acid Cream
Keep out of the sight and reach of children.
Do not use Fusidic Acid Cream 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 25ºC.
Discard the tube after 4 weeks of first opening
the tube even if there is still some
cream left in it.
Do not use if any signs of deterioration are
seen.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.

6. Contents of the pack and other
information
What Fusidic Acid Cream contains
The active substance is fusidic acid.
Each gram of cream contains 20mg
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 Cream looks like and
contents of the pack
Fusidic Acid Cream is a white to off-white
cream, and is available in an aluminium tube
with a HDPE screw cap.
Pack sizes: 15g and 30g
Not all pack sizes may be marketed.
PL holder
Manx Pharma Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA, UK
Procured from within the EU.
PL 15833/0064
POM
Manufacturer
Basic Pharma Manufacturing bv,
Burgemeester Lemmensstraat 352, 6163 JT
Geleen, The Netherlands
To request a copy of this leaflet in large print,
audio or Braille please call 01926 482511
This leaflet was last revised in July 2016

WIP URN: 180716-GFU01-PIL-04

Expand Transcript

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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