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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
Fucidin® H cream Ireland

213
Packsize
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Page 1 of 2 Pharmacode 213 Font size: Heading: 9 pt, section: 8 pt, linespacing: 3 mm Mock-up for reg. purpose

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucidin H cream ®

Fusidic acid and hydrocortisone acetate

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

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What is in this leaflet: Other medicines and Fucidin H cream

213
1. What Fucidin® H cream is and what it is used for Tell your doctor or pharmacist if you are taking, or have
2. Before you use Fucidin® H cream recently taken or might take any other medicines.
3. How to use Fucidin® H cream
4. Possible side effects Pregnancy and breast-feeding
5. How to store Fucidin® H cream Please ask your doctor or pharmacist for advice before
6. Contents of the pack and other information using Fucidin H cream:
• If you are pregnant, or think you are pregnant. You
1. What Fucidin® H cream is and what it is used for must not use your medicine for a long time or in large
Fucidin H cream contains 2 different types of medicine. amounts. You must ask your doctor for advice.

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One medicine is called fusidic acid. It is a type of • If you are breast-feeding.
antibiotic. The other medicine is called hydrocortisone
acetate. It is a type of corticosteroid (steroid). Tell your doctor if you become pregnant while using this
These 2 medicines work at the same time in different ways. medicine.

Used for:
Fucidin H cream works by: Driving and using machines

Isathalmic®, Verutex®, Verutex® B

Fucibet®, Fucithalmic®, Isathal®,
Fucidin®, Fucidin® H, Fucicort®,
Taclonex®, Psorcutan®, Token®,
Dovonex®, Daivobet®, Dovobet®
Calcipotriene. Conoptal®, Daivonex®,
• The antibiotic killing germs (bacteria) that cause infections. Usually your medicine will have very little effect on your
• The corticosteroid reducing any swelling, redness or ability to drive or use machines. Check with your doctor if
itchiness of your skin. you feel any side effect that may stop you from driving or
using machines.
Fucidin H cream is used to treat:
• Conditions where the skin is inflamed (eczema or Important information about some of the ingredients of
dermatitis) and also infected by germs (bacteria). Fucidin H cream
Fucidin H cream contains:
2. What you need to know before you use • Butylhydroxyanisole (E320). This may give you an itchy
Fucidin® H cream rash and inflammation on your skin where your medicine
Do not use Fucidin H cream is used. This may also cause irritation to the eyes and
• If you are allergic (hypersensitive) to fusidic acid or mucous membranes (such as lips or genital area).
hydrocortisone acetate. • Cetyl alcohol. This may give you an itchy rash and
• If you are allergic (hypersensitive) to any of the other
280 mm

inflammation on your skin where your medicine is used.

ingredients in your medicine. You can find a list of these • Potassium sorbate. This may give you an itchy rash and
ingredients in section 6 of this leaflet. inflammation on your skin where your medicine is used.
• To treat a skin condition called acne rosacea. This is
redness and inflammation over your nose and cheeks. Please ask your doctor if you are worried about any of the
Ask your doctor if you are unsure. ingredients in this medicine.
• To treat a skin condition called perioral dermatitis. This
is a red spotty rash around your mouth or chin. 3. How to use Fucidin® H cream

Comments:
• To treat skin conditions caused by tuberculosis or syphilis. Always use Fucidin H cream exactly as your doctor has

PackRat approved
1 column and 2 columns
• To treat skin conditions caused only by bacteria, such as told you. Check with your doctor or pharmacist if you are
boils or spots. not sure.
• To treat a skin condition caused by a virus, such as cold
How to put on Fucidin H cream
sores or chickenpox.
This medicine is only for using on your skin or the skin of
• To treat a skin condition caused by a fungus, such as
a child. Do not swallow it. Do not put it inside your body.
athlete’s foot.
Warnings and precautions Remove the cap. Check the seal is not broken before
Talk to your doctor, pharmacist or nurse before using you first use the cream. Then push the spike in the cap
Fucidin H cream through the seal on the tube.
• Take special care if you are going to use this medicine Always wash your hands before using Fucidin H cream.
near your eyes or the eyes of a child. If the cream gets Rub the medicine gently on the skin. If you use it on your
into the eye, this may lead to glaucoma. face be careful to avoid your eyes.
• Contact your doctor if you experience blurred vision or
other visual disturbances. Unless you are using the cream to treat your hands,
• If you use the cream over a long time or in large amounts always wash your hands after using Fucidin H cream.
it may make the chance of getting any side effects higher.
Also your skin may get more sensitive to this medicine. If you accidentally get any medicine in your eye, wash it
• You must not use the medicine for a long time on your out with cold water straight away. Then bathe your eye
face. with eyewash if possible. Your eye may sting. If you start
• Unless your doctor has told you to, you must not use to have any problems with your sight or your eye is sore,
contact your doctor immediately.
Revision info:

Fucidin H cream on open wounds or sensitive areas

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IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
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such as the nostrils, ears, lips or genitals.

How much Fucidin H cream to use
• Unless your doctor has told you to, you must not use
Your doctor will tell you how much Fucidin H cream to use.
Fucidin H cream on thin skin, skin ulcers, broken veins
or acne. The usual treatment time is up to 2 weeks. Ask your
• Adrenal suppression may occur. Signs are tiredness, doctor before using this medicine for any longer.
depression and anxiety. This can be reversed by
stopping Fucidin H cream. You should notice your skin improve after just a few
• Treatment should be stopped after 7 days if your skin days of using the cream. If there is no improvement after
has not improved after using Fucidin H cream. 7 days you should stop using the cream and go back to
your doctor.
Do not smoke or go near naked flames - risk of severe
burns. Fabric (clothing, bedding, dressings etc) that has Usually, you should use this medicine twice each day.
been in contact with this product burns more easily and is Use it in the morning and evening. To remind you to use
a serious fire hazard. Washing clothing and bedding may the medicine it may help to use it when you do another
reduce product build-up but not totally remove it. regular action, such as brushing your teeth.

4. RBE
01/10/19
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 059516-XX
Subject Date Date
INS 175 x 280 mm 02/04/19
Colour Sign. Sign.
Black RBE

Preparation Place of production

Strength
Packsize Fucidin® H 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 have been told to cover the skin with any dressings Skin problems
or bandages you may not need to use the medicine so Common side effects (may affect up to 1 in 10 people)
often. A nappy on a baby may act as a dressing. Follow • Application site reaction (including itching, burning and
the advice of your doctor. irritation).
Adults and children: Uncommon side effects (may affect up to 1 in 100 people)
Your doctor should tell you the dose that is right for you or • Itchy rash and skin inflammation in the area where the
the child. If your doctor has told you the amount of cream medicine is used
to use then keep to this advice. If not, the following guide • Worsening of your eczema
will help you to use the correct amount. • Skin rash.
You can use your first (index) finger to measure how Frequency not known (cannot be estimated from the
much Fucidin H cream to use. Squeeze the cream along available data)
your finger from the tip to the first joint as shown in the • Blurred vision.
diagram. This is called a fingertip unit. Some side effects are known to be caused by

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The usual number of finger tip units hydrocortisone (steroid), one of the ingredients in

213
you need to cover different parts of Fucidin H cream. You should tell your doctor if any of the
the body is shown in the diagrams. If side effects occur:
you need to use a little more or a little • Adrenal glands may stop working properly. Signs are
less do not worry. If you are using tiredness, depression and anxiety
the cream on a child still use an adult • Glaucoma
finger to measure out the fingertip • Thinning of the skin
unit. • Red spotty rash around the mouth or chin
• Stretch marks
For an adult: • Small veins near the surface of the skin become visible

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Face and neck: • Skin redness
21⁄2 fingertip units. • Lightening of your skin colour
Back: 7 fingertip units. • Changes in the growth of your body hair
Front: 7 fingertip units. • Excessive sweating.

Used for:
Isathalmic®, Verutex®, Verutex® B
Fucibet®, Fucithalmic®, Isathal®,
Fucidin®, Fucidin® H, Fucicort®,
Taclonex®, Psorcutan®, Token®,
Dovonex®, Daivobet®, Dovobet®
Calcipotriene. Conoptal®, Daivonex®,
One arm (not including the hand): Reporting of side effects
3 fingertip units. If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
Both sides of one hand: in this leaflet. You can also report side effects directly via
1 fingertip unit. the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
One leg (not including the foot): or search for MHRA Yellow Card in the Google Play or
6 fingertip units. Apple App Store.
By reporting side effects you can help provide more
One foot: information on the safety of this medicine. Screen % - Child = 20%
2 fingertip units. 5. How to store Fucidin® H cream
• Keep out of the sight and the reach of children.
• Do not use Fucidin H cream after the expiry date which
For a child under 11 years: is stated on the carton after EXP. The expiry date is the
280 mm

last day of that month.

• Do not store above 30°C.
• The tube should be discarded 3 months after first
opening. Write the date you first opened the tube in the Screen % - Schedule = 15%
space provided on the carton.
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

Comments:
PackRat approved
1 column and 2 columns
help protect the environment.
Face Arm Leg Front
Back incl. 6. Contents of the pack and other information
and neck and hand and foot buttocks What Fucidin H cream contains
Child’s • There are 2 active ingredients, fusidic acid and
Number of fingertip units needed
age hydrocortisone acetate. Fucidin H cream contains 2%
3-6 fusidic acid and 1% hydrocortisone.
months 1 1 11⁄2 1 11⁄2 • The other ingredients are butylhydroxyanisole (E320),
1-2 cetyl alcohol, glycerol, liquid paraffin, potassium
years 11⁄2 11⁄2 2 2 3 sorbate, polysorbate 60, all-rac-a-tocopherol, water and
3-5 white soft paraffin.
years 11⁄2 2 3 3 31⁄2
You can find important information about some of the
6-10 ingredients in your medicine near the end of section 2 of
years 2 21⁄2 41⁄2 31⁄2 5
this leaflet.
If you forget to use Fucidin H cream What Fucidin H cream looks like and
If you forget to use this medicine, use it as soon as you contents of the pack
remember. Then next use this medicine at the usual time. Fucidin H cream is a white cream.
If you have any further questions on the use of this Fucidin H cream comes in tubes of 3 g, 5 g, 10 g, 15 g,
medicine, please ask your doctor or pharmacist. 25 g, 30 g and 60 g. Not all pack sizes may be marketed.
4. Possible side effects Marketing Authorisation Holder and Manufacturer
Like all medicines, Fucidin H cream can cause side effects, Marketing Authorisation Holder:
Revision info:

although not everybody gets them. LEO Laboratories Limited,

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

Hurley, Berkshire SL6 6RJ, UK

Important side effects to look out for: Manufacturer:
You must get urgent medical help if you have any of the LEO Laboratories Limited, Dublin 12, Ireland
following symptoms. You may be having an allergic reaction: This leaflet was last revised in November 2019.
• You have difficulty breathing
• Your face or throat swell For information in large print,
• Your skin develops a severe rash.
Other possible side effects:
Braille or audio/CD, telephone
Any of the problems listed below are more likely if the +44 (0)1844 347333.
medicine is used for a long time, in large amounts or ®Registered Trade Mark
on skin folds (such as armpits or under breasts). These
problems are more likely in babies and children. They
are also more likely if the skin is covered with a dressing,
bandage or nappy. LEO