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FUCIDIN 20MG/G OINTMENT

Active substance(s): SODIUM FUSIDATE MICRONISED NON-STERILE / SODIUM FUSIDATE MICRONISED NON-STERILE / SODIUM FUSIDATE MICRONISED NON-STERILE

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

Subject

Item No.

GB

Rev. No.

Colour

Sent by e-mail

XX

030067

INS 145 x 280 mm

Date

Date

Date

14/07/15
Sign.

Sign.

Sign.

LOF

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



Scale

281

ARTWORK

Supplier / Place of production

Fucidin® ointment

Ireland

Comments:

Page 1 of 2

Pharmacode 281

Font size: Heading: 10 point, section: 9 point, linespacing: 3,4 mm Mock-up for reg purpose

145 mm

Package leaflet: Information for the user

Fucidin 20 mg/g ointment
®

sodium fusidate
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.

1. What Fucidin® ointment is and
what it is used for
Fucidin ointment contains sodium
fusidate. It is a type of antibiotic.

280 mm

Fucidin ointment works by killing germs
(bacteria) that cause infections.
Fucidin ointment is used to treat
conditions where the skin is infected by
germs (bacteria), such as:
• Impetigo (a weeping, crusty and
swollen patch of skin).
• Infected dermatitis (inflammation of the
skin) and spots.
• Infected cuts and grazes.

2. What you need to know before
you use Fucidin® ointment
Do not use Fucidin ointment
• If you are allergic to fusidic acid or
sodium fusidate or any of the other
ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Fucidin ointment.
• Take special care if you are going to use
this medicine near your eyes or the
eyes of a child.
• If you use the ointment over a long
time or in large amounts it may make
the chance of getting any side effects
higher. Also your skin may get more
sensitive to this medicine.
Other medicines and Fucidin® ointment
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
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. Tell your doctor if
you become pregnant while using this
medicine.
• You must not use your medicine for a
long time or in large amounts.
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Driving and using machines
Usually your medicine will have very
little 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.
Fucidin ointment contains
• Lanolin (wool fat). This may give you
an itchy rash and inflammation on your
skin where your medicine is used.
• Cetyl alcohol. This may give you an
itchy rash and inflammation on your
skin where your medicine is used.
• Butylhydroxytoluene (E321). This may
cause local skin reactions (e.g. contact
dermatitis), or irritation to the eyes and
mucous membranes (such as lips or
genital area).
Please ask your doctor if you are worried
about any of the ingredients in this
medicine.

3. How to use Fucidin® ointment
Always use this medicine exactly as
described in this leaflet or as your doctor
or pharmacist has told you. Check with
your doctor or pharmacist if you are not
sure.
How to put on Fucidin ointment
This medicine is only for using 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 ointment.
Then push the spike in the cap through
the seal on the tube.
Always wash your hands before using
Fucidin ointment. 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 ointment to
treat your hands, always wash your
hands after using Fucidin ointment.
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 Fucidin ointment to use
Your doctor will tell you how much
Fucidin ointment to use.
Usually, you should use this medicine
three or four times each day.

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

Scale

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

Subject

Item No.

GB

Rev. No.

Date

Date

Colour

Sign.

Sign.

LOF

Black

Supplier / Place of production

Fucidin® ointment

Ireland

Page 2 of 2

145 mm

If you use more Fucidin ointment than
you should
If you accidentally apply too much
ointment or a small quantity of the
ointment is accidentally swallowed, it is
unlikely to cause any harm. If a larger
quantity of the ointment is accidentally
swallowed or you are worried, contact
your doctor, pharmacist or A&E
department for advice.
If you forget to use Fucidin ointment
If you forget to use this medicine, use it
as soon as you remember. Then next use
this medicine at the usual time.
If you have any further questions on the
use of this medicine, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not everybody
gets them.

5. How to store Fucidin® ointment
• 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 label
after EXP. The expiry date refers to the
last day of that month.
• The tube should be discarded 3 months
after first opening. Write the date you
first opened the tube in the space
provided on the carton.
• This medicine does not require any
special storage conditions.
Do not throw away medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6. Contents of the pack and further
information
What Fucidin ointment contains
• The active substance is sodium
fusidate. 1 gram of Fucidin ointment
contains 20 mg of sodium fusidate.
• The other ingredients are cetyl alcohol,
lanolin (wool fat), liquid paraffin,
all-rac-α-tocopherol, butylhydroxytoluene
(E321) and white soft paraffin.

Important side effects to look out for:
Rare (may affect up to 1 in 1,000 people)
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.
Other possible side effects:
Uncommon side effects (may affect up
to 1 in 100 people)
• Irritation at site of application (including
pain, burning, irritation, stinging and
skin redness)
• Itching
• Rash
• Eczema.
Rare side effects (may affect up to 1 in
1,000 people)
• Conjunctivitis
• Hives
• Skin swelling
• Blistering of the skin.
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.

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You can find important information about
some of the ingredients in your medicine
near the end of section 2 of this leaflet.
What Fucidin ointment looks like and
contents of the pack
Fucidin ointment is a translucent yellow
to white ointment.
Fucidin ointment comes in tubes of 3 g,
5 g, 10 g, 15 g, 25 g and 30 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
November 2015.
®Registered Trade Mark

LEO

030067-XX

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.

Date

14/07/15

Comments:

280 mm

Sent by e-mail

XX

030067

INS 145 x 280 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

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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