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FUSIDIC ACID 20 MG/G CREAM

Active substance(s): 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.
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 gets serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Fusidic Acid Cream is and what it
is used for
2. 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. Further 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), follicultitis (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. 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.
Take special care with 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.
Using other medicines
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.
Pregnancy and breast-feeding
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:
There is not enough evidence to say that it
is safe to use Fusidic Acid Cream while
breast-feeding. However, using Fusidic Acid
Cream topically and breast-feeding is
unlikely to harm your baby.
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. You should 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.
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.
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.

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

110814-XXXX-PIL-02
N/A

Fusidic Acid Cream PIL - Page 1
320 x 148mm
11 August 2014
14115/02 PIL P1.ai
1 Colour - Black

M2

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
Uncommon
Skin and subcutaneous tissue disorders
Itching
Rash
Skin sensitivity reactions (contact
dermatitis)
Irritation at site of application
(including pain, stinging, burning and
redness of the skin)
Rare
Immune system disorders
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.
Eye disorders
Inflammation of the eye (conjunctivitis)
Not known
Hives

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.
Eczema
Sudden swelling around the eyes
(periorbital oedema)
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
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 20mg/g
Keep out of the reach and sight 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 25ÂșC.
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. Further 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.
MA 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 August 2014
WIP URN: 110814-XXXX-PIL-02

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

110814-XXXX-PIL-02
N/A

Fusidic Acid Cream PIL - Page 2
320 x 148mm
11 August 2014
14115/02 PIL P2.ai
1 Colour - Black

M2

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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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