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Subject Date Date
INS 175 x 280 mm 02/04/19
Colour Sign. Sign.
Black RBE

Preparation Place of production

Strength
Packsize Fucidin® cream Ireland
Comments:

16
Page 1 of 2 Pharmacode 16 Font size: Heading: 9 point, section: 8 point, linespacing: 3,351 mm Mock-up for reg. purpose

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Package leaflet: Information for the user

Fucidin 20 mg/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, 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

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IIE007-01
16
effects not listed in this leaflet. See section 4.

What is in this leaflet Driving and using machines

1. What Fucidin® cream is and what it is used for Usually your medicine will have very little effect on
2. What you need to know before you use your ability to drive or use machines. Check with
Fucidin® cream your doctor if you feel any side effect that may stop
3. How to use Fucidin® cream you from driving or using machines.
4. Possible side effects
Fucidin cream contains

042582-XX
5. How to store Fucidin® cream

OMA

PSR
6. Contents of the pack and other information • Butylhydroxyanisole (E320). This may give you
an itchy rash and inflammation on your skin
1. What Fucidin® cream is and what it is used where your medicine is used. This may also cause

Used for:
for irritation to the eyes and mucous membranes

Isathalmic®, Verutex®, Verutex® B

Fucibet®, Fucithalmic®, Isathal®,
Fucidin®, Fucidin® H, Fucicort®,
Taclonex®, Psorcutan®, Token®,
Dovonex®, Daivobet®, Dovobet®
Calcipotriene. Conoptal®, Daivonex®,
Fucidin cream contains fusidic acid. It is a type of (such as lips or genital area).
antibiotic. • Cetyl alcohol. This may give you an itchy rash
and inflammation on your skin where your
Fucidin cream works by killing germs (bacteria) that medicine is used.
cause infections. • Potassium sorbate. This may give you an itchy
rash and inflammation on your skin where your
Fucidin cream is used to treat conditions where the medicine is used.
skin is infected by germs (bacteria), such as:
• Impetigo (a weeping, crusty and swollen patch Please ask your doctor if you are worried about any
of skin) of the ingredients in this medicine.
• Infected dermatitis (inflammation of the skin)
3. How to use Fucidin® cream
280 mm

and spots
• Infected cuts and grazes. Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
2. What you need to know before you use
Fucidin® cream How to put on Fucidin cream
Do not use Fucidin cream This medicine is only for using on your skin or
• If you are allergic to fusidic acid or any of the other the skin of a child. Do not swallow it. Do not put it

Comments:
PackRat approved
1 column and 2 columns
ingredients of this medicine (listed in section 6). inside your body.
Warnings and precautions Remove the cap. Check the seal is not broken
Talk to your doctor, pharmacist or nurse before before you first use the cream. Then push the spike
using Fucidin cream. in the cap through the seal on the tube.
• Take special care if you are going to use this
medicine near your eyes or the eyes of a child. Always wash your hands before using Fucidin
• If you use the cream over a long time or in large cream. Rub the medicine gently on the skin. If you
amounts it may make the chance of getting any use it on your face be careful to avoid your eyes.
side effects higher. Also your skin may get more
sensitive to this medicine. Unless you are using the cream to treat your
hands, always wash your hands after using
Do not smoke or go near naked flames - risk of Fucidin cream.
severe burns. Fabric (clothing, bedding, dressings
etc) that has been in contact with this product burns If you accidentally get any medicine in your eye,
more easily and is a serious fire hazard. Washing wash it out with cold water straight away. Then
clothing and bedding may reduce product build-up bathe your eye with eyewash if possible. Your eye
but not totally remove it. may sting. If you start to have any problems with
your sight or your eye is sore, contact your doctor
Revision info:

Other medicines and Fucidin cream immediately.

changed reference from INS005 to IIE005-01
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber

Tell your doctor, pharmacist or nurse if you are

taking, have recently taken or might take any other How much Fucidin cream to use
medicines. Your doctor will tell you how much Fucidin cream
to use.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think Usually, you should use this medicine three or four
you may be pregnant or are planning to have a times each day.
baby, ask your doctor or pharmacist for advice
before using this medicine. Tell your doctor if you If you have been told to cover the skin with any
become pregnant while using this medicine. dressings or bandages you may not need to use
• You must not use your medicine for a long time or the medicine so often. A nappy on a baby may act
in large amounts. as a dressing. Follow the advice of your doctor.

3. RBE
04/11/19
SOP_000647, SOP_000962, SOP_000647, SOP_000962
SOP_003993 and and SOP_008676
SOP_008676
 Scale Get-up Material No Sent by e-mail
▲
100% GB 042582-XX
Subject Date Date
INS 175 x 280 mm 02/04/19
Colour Sign. Sign.
Black RBE

Preparation Place of production

Strength
Packsize Fucidin® cream Ireland
Comments:
Page 2 of 2 Mock-up for reg. purpose

175 mm
IIE007-01 - 175 x 280 mm

175 x 280mm

Insert
100%
If you use more Fucidin cream than you should 6. Contents of the pack and other information
If you accidentally apply too much cream or a small What Fucidin cream contains
quantity of the cream is accidentally swallowed, it • The active substance is fusidic acid. 1 gram of
is unlikely to cause any harm. If a larger quantity Fucidin cream contains 20 mg of fusidic acid.
of the cream is accidentally swallowed or you are • The other ingredients are butylhydroxyanisole
worried contact your doctor, pharmacist or A & E (E320), cetyl alcohol, glycerol, liquid paraffin,
department for advice. polysorbate 60, potassium sorbate, purified water,
all-rac-α-tocopherol, hydrochloric acid and white
If you forget to use Fucidin cream soft paraffin.
If you forget to use this medicine, use it as soon as
you remember. Then next use this medicine at the You can find important information about some of
usual time. the ingredients in your medicine near the end of

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section 2 of this leaflet.

16
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse. What Fucidin cream looks like and contents of
the pack
4. Possible side effects Fucidin cream is a white to off-white cream.
Like all medicines, this medicine can cause side Fucidin cream comes in tubes of
effects, although not everybody gets them. 3.5 g, 5 g, 10 g, 15 g, 25 g and 30 g.
Not all pack sizes may be marketed.
Important side effects to look out for:
Marketing Authorisation Holder and

042582-XX

OMA

PSR
Rare (may affect up to 1 in 1,000 people) Manufacturer
You must get urgent medical help if you have any Marketing Authorisation Holder:
of the following symptoms. LEO Laboratories Limited,

Used for:
You may be having an allergic reaction: Hurley,

Isathalmic®, Verutex®, Verutex® B

Fucibet®, Fucithalmic®, Isathal®,
Fucidin®, Fucidin® H, Fucicort®,
Taclonex®, Psorcutan®, Token®,
Dovonex®, Daivobet®, Dovobet®
Calcipotriene. Conoptal®, Daivonex®,
• You have difficulty breathing Berkshire SL6 6RJ,
• Your face or throat swell UK.
• Your skin develops a severe rash.
Manufacturer:
Other possible side effects: LEO Laboratories Limited,
Uncommon side effects (may affect up to 1 in Dublin 12,
100 people) Ireland.
• Irritation at site of application (including pain,
burning, irritation, stinging and skin redness) This leaflet was last revised in November 2019.
• Itching
• Rash
• Eczema.
For information in large print,
280 mm

Braille or audio/CD,
Rare side effects (may affect up to 1 in 1,000 people)
• Conjunctivitis telephone +44 (0)1844 347333.
• Hives ®Registered
• Skin swelling Trade Mark
• Blistering of the skin.

Comments:
PackRat approved
1 column and 2 columns
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 or search
for MHRA Yellow Card in the Google Play or Apple
App Store. By reporting side effects you can help
provide more information on the safety of this
medicine.

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

Revision info:

or household waste. Ask your pharmacist how to

changed reference from INS005 to IIE005-01
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber

throw away medicines you no longer use. These

measures will help protect the environment. LEO