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FUCIDIN 20 MG/G CREAM

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

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

Subject

Item No.

GB

Rev. No.

Sent by e-mail

YY

014158
Date

INS 145 x 280 mm

Date

Date

Sign.

Sign.

06/07/15

Colour

Sign.

LOF

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



Scale

Supplier / Place of production

Fucidin® cream

Ireland

Comments:

Page 1 of 2

Font size: Heading: 9 point, section: 8 point, linespacing: 2,85 mm

Pharmacode 16

145 mm

Package leaflet: Information for the user

Fucidin 20 mg/g cream
®

fusidic acid

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

1. What Fucidin® cream is and what
it is used for
Fucidin cream contains fusidic acid. It is a
type of antibiotic.
Fucidin cream works by killing germs
(bacteria) that cause infections.

280 mm

Fucidin cream 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® cream

Fucidin cream contains
• Butylhydroxyanisole (E320). This may
give you an itchy rash and inflammation
on your skin where your medicine is
used. This may also cause irritation to the
eyes and mucous membranes (such as
lips or genital area).
• Cetyl 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.
Please ask your doctor if you are worried
about any of the ingredients in this
medicine.

3. How to use Fucidin® cream
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

Do not use Fucidin cream
• If you are allergic to fusidic acid or
any of the other ingredients of this
medicine. (listed in section 6).

How to put on Fucidin cream
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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Fucidin cream.
• Take special care if you are going to use
this medicine near your eyes or the eyes
of a child.
• If you use the cream 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.

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.

Other medicines and Fucidin cream
Tell your doctor, pharmacist or nurse 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.
00570468

13.

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.

EBD
23/11/15

v1.0

Always wash your hands before using
Fucidin cream. 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 Fucidin cream.
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 cream to use
Your doctor will tell you how much
Fucidin cream to use.
Usually, you should use this medicine
three or four times each day.

014158-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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

Mock-up for reg purpose

16

ARTWORK

Scale

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

Subject

Get-up

100%

Rev. No.

Sent by e-mail

YY

014158
Date

INS 145 x 280 mm

Date

Date

Sign.

Sign.

06/07/15

Colour

Sign.

LOF

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Item No.

GB



ARTWORK

Supplier / Place of production

Fucidin® cream

Ireland

Comments:

Page 2 of 2

145 mm

If you use more Fucidin cream than you
should
If you accidentally apply too much cream
or a small quantity of the cream is
accidentally swallowed, it is unlikely to
cause any harm. If a larger quantity of the
cream is accidentally swallowed or you
are worried contact your doctor,
pharmacist or A & E department for advice.
If you forget to use Fucidin cream
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.
Important side effects to look out for:

280 mm

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.

00570468

v1.0

5. How to store Fucidin® cream
• 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.
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 protect the
environment.

6. Contents of the pack and further
information
What Fucidin cream contains
• The active substance is fusidic acid.
1 gram of Fucidin cream contains 20 mg
of fusidic acid.
• The other ingredients are
butylhydroxyanisole (E320), cetyl alcohol,
glycerol, liquid paraffin, polysorbate 60,
potassium sorbate, purified water,
all-rac-α-tocopherol, hydrochloric acid
and white soft paraffin.
You can find important information about
some of the ingredients in your medicine
near the end of section 2 of this leaflet.
What Fucidin cream looks like and
contents of the pack
Fucidin cream is a white to off-white
cream.
Fucidin cream comes in tubes of
3.5 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

014158-YY

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.

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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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