FUCIDIN H CREAM
Active substances: FUSIDIC ACID MICRONISED NON-STERILE / HYDROCORTISONE ACETATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fucidin H Cream
®
fusidic acid and hydrocortisone acetate
Please 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or
pharmacist.
1. WHAT FUCIDIN® H CREAM IS AND WHAT IT
IS USED FOR
Fucidin® H Cream contains 2 different types of
medicine. One medicine is called fusidic acid. It is a
type of antibiotic. The other medicine is called
hydrocortisone acetate. It is a type of corticosteroid
(steroid).These 2 medicines work at the same time in
different ways.
Fucidin® H Cream works by:
• The antibiotic killing germs (bacteria) that cause
infections.
• The corticosteroid reducing any swelling, redness or
itchiness of your skin.
Fucidin® H Cream is used to treat:
• Conditions where the skin is inflamed (eczema or
dermatitis) and also infected by germs (bacteria).
2. BEFORE YOU USE FUCIDIN® H CREAM
Do not use Fucidin® H Cream
• If you are allergic (hypersensitive) to fusidic acid or
hydrocortisone acetate.
• If you are allergic (hypersensitive) to any of the other
ingredients in your medicine. You can find a list of
these ingredients in section 6 of this leaflet.
• To treat a skin condition called acne rosacea.
This is redness and inflammation over your nose and
cheeks. Ask your doctor if you are unsure.
• To treat a skin condition called perioral dermatitis.
This is a red spotty rash around your mouth or chin.
• To treat skin conditions caused by tuberculosis or
syphilis.
• To treat skin conditions caused only by bacteria, such
as boils or spots.
• To treat a skin condition caused by a virus, such as
cold sores or chickenpox.
• To treat a skin condition caused by a fungus, such as
athlete’s foot.
Take special care with Fucidin® H Cream
• Take special care if you are going to use this
medicine near your eyes or the eyes of a child. If the
cream gets into the eye, this may lead to glaucoma.
• 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.
• You must not use the medicine for a long time on your
face.
• Unless your doctor has told you to, you must not use
Fucidin® H Cream on open wounds or sensitive areas
such as the nostrils, ears, lips or genitals.
• Unless your doctor has told you to, you must not use
Fucidin® H Cream on thin skin, skin ulcers, broken
veins or acne.
• Adrenal suppression may occur. Signs are tiredness,
depression and anxiety. This can be reversed by
stopping Fucidin® H Cream.
• Treatment should be stopped after 7 days if your skin
has not improved after using Fucidin® H cream.
Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken any other medicines. This
includes any medicines which you have bought without
a prescription.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before
using Fucidin® H Cream:
• If you are pregnant, or think you are pregnant. You
must not use your medicine for a long time or in
large amounts. You must ask your doctor for advice.
• If you are breast-feeding.
Tell your doctor if you become pregnant while using
this medicine.
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.
Important information about some of the ingredients of
Fucidin® H Cream
Fucidin® H 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® H CREAM
Always use Fucidin® H Cream exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
How to put on Fucidin® H 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.
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.
Always wash your hands before using Fucidin® H
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® H 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® H Cream to use
Your doctor will tell you how much Fucidin® H Cream to
use.
The usual treatment time is up to 2 weeks. Ask your
doctor before using this medicine for any longer.
You should notice your skin improve after just a few
days of using the cream. If there is no improvement
after 7 days you should stop using the cream and go
back to your doctor.
017564-XX
In this leaflet:
1. What Fucidin® H Cream is and what it is used for
2. Before you use Fucidin® H Cream
3. How to use Fucidin® H Cream
4. Possible side effects
5. How to store Fucidin® H Cream
6. Further information
Other possible side effects:
Any of the problems listed below are more likely if the
medicine is used for a long time, in large amounts or on
skin folds (such as armpits or under breasts).
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.
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.
Adults and children:
Your doctor should tell you the dose that is right for you
or the child. If your doctor has told you the amount of
cream to use then keep to this advice. If not, the
following guide will help you to use the correct amount.
You can use your first (index) finger to measure how
much Fucidin® H Cream to use. Squeeze the cream
along your finger from the tip to the first joint as shown
in the diagram. This is called a fingertip unit.
The usual number of finger tip
units you need to cover different
parts of the body is shown in the
diagrams. If you need to use a
little more or a little less do not
worry. If you are using the cream
on a child still use an adult finger
to measure out the fingertip unit.
For an adult:
Face and neck:
21⁄2 fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including the foot):
6 fingertip units.
One foot:
2 fingertip units.
Skin problems
Uncommon side effects (probably affect less than 1 in
100 people)
• Itchy rash and skin inflammation in the area where the
medicine is used
• Worsening of your eczema.
• Skin rash
Common side effects (probably affect less than 1 in
10 people)
• Application site reaction (including itching, burning
and irritation)
Some side effects are known to be caused by
hydrocortisone (steroid), one of the ingredients in
Fucidin® H Cream. You should tell your doctor if any of
the side effects occur:
• Adrenal glands may stop working properly. Signs are
tiredness, depression and anxiety.
• Glaucoma
• Thinning of the skin
• Red spotty rash around the mouth or chin
• Stretch marks
• Small veins near the surface of the skin become visible
• Skin redness
• Lightening of your skin colour
• Changes in the growth of your body hair
• Excessive sweating
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 FUCIDIN® H CREAM
• Keep out of the reach and the sight of children.
• Do not use Fucidin® H Cream after the expiry date on
the carton. The expiry date is the 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 space provided on the carton.
For a child under 11 years:
Arm
Face
Leg
and neck and hand and foot
Child’s
age
3-6
months
1-2
years
3-5
years
6-10
years
Front
Back incl.
buttocks
Number of fingertip units needed
1
1
11⁄2
1
11⁄2
11⁄2
11⁄2
2
2
3
1
1 ⁄2
2
3
3
31⁄2
2
21⁄2
41⁄2
31⁄2
5
If you forget to use Fucidin® H 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 about using this
medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucidin® H Cream can cause side
effects, although not everybody gets them.
Important side effects to look out for:
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.
Medicines should not be thrown away in waste water or
in household waste. Please ask your pharmacist how
to throw away any medicine you do not need any more.
If you do this you will help protect the environment.
6. FURTHER INFORMATION
What Fucidin® H Cream contains
• There are 2 active ingredients, fusidic acid and
hydrocortisone acetate. Fucidin® H Cream
contains 2% fusidic acid and 1% hydrocortisone.
• The other ingredients are butylhydroxyanisole (E320),
cetyl alcohol, glycerol, liquid paraffin, potassium
sorbate, polysorbate 60, all-rac-α-tocopherol, water
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® H Cream looks like and
contents of the pack
Fucidin® H Cream is a white cream.
Fucidin® H Cream comes in tubes of 30 g and 60 g.
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 February 2014.
®Registered Trade Mark
LEO
017564-XX
Usually, you should use this medicine twice each day.
Use it in the morning and evening. To remind you to use
the medicine it may help to use it when you do another
regular action, such as brushing your teeth.
Fucidin H Cream
®
fusidic acid and hydrocortisone acetate
Please 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or
pharmacist.
1. WHAT FUCIDIN® H CREAM IS AND WHAT IT
IS USED FOR
Fucidin® H Cream contains 2 different types of
medicine. One medicine is called fusidic acid. It is a
type of antibiotic. The other medicine is called
hydrocortisone acetate. It is a type of corticosteroid
(steroid).These 2 medicines work at the same time in
different ways.
Fucidin® H Cream works by:
• The antibiotic killing germs (bacteria) that cause
infections.
• The corticosteroid reducing any swelling, redness or
itchiness of your skin.
Fucidin® H Cream is used to treat:
• Conditions where the skin is inflamed (eczema or
dermatitis) and also infected by germs (bacteria).
2. BEFORE YOU USE FUCIDIN® H CREAM
Do not use Fucidin® H Cream
• If you are allergic (hypersensitive) to fusidic acid or
hydrocortisone acetate.
• If you are allergic (hypersensitive) to any of the other
ingredients in your medicine. You can find a list of
these ingredients in section 6 of this leaflet.
• To treat a skin condition called acne rosacea.
This is redness and inflammation over your nose and
cheeks. Ask your doctor if you are unsure.
• To treat a skin condition called perioral dermatitis.
This is a red spotty rash around your mouth or chin.
• To treat skin conditions caused by tuberculosis or
syphilis.
• To treat skin conditions caused only by bacteria, such
as boils or spots.
• To treat a skin condition caused by a virus, such as
cold sores or chickenpox.
• To treat a skin condition caused by a fungus, such as
athlete’s foot.
Take special care with Fucidin® H Cream
• Take special care if you are going to use this
medicine near your eyes or the eyes of a child. If the
cream gets into the eye, this may lead to glaucoma.
• 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.
• You must not use the medicine for a long time on your
face.
• Unless your doctor has told you to, you must not use
Fucidin® H Cream on open wounds or sensitive areas
such as the nostrils, ears, lips or genitals.
• Unless your doctor has told you to, you must not use
Fucidin® H Cream on thin skin, skin ulcers, broken
veins or acne.
• Adrenal suppression may occur. Signs are tiredness,
depression and anxiety. This can be reversed by
stopping Fucidin® H Cream.
• Treatment should be stopped after 7 days if your skin
has not improved after using Fucidin® H cream.
Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken any other medicines. This
includes any medicines which you have bought without
a prescription.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before
using Fucidin® H Cream:
• If you are pregnant, or think you are pregnant. You
must not use your medicine for a long time or in
large amounts. You must ask your doctor for advice.
• If you are breast-feeding.
Tell your doctor if you become pregnant while using
this medicine.
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.
Important information about some of the ingredients of
Fucidin® H Cream
Fucidin® H 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® H CREAM
Always use Fucidin® H Cream exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
How to put on Fucidin® H 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.
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.
Always wash your hands before using Fucidin® H
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® H 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® H Cream to use
Your doctor will tell you how much Fucidin® H Cream to
use.
The usual treatment time is up to 2 weeks. Ask your
doctor before using this medicine for any longer.
You should notice your skin improve after just a few
days of using the cream. If there is no improvement
after 7 days you should stop using the cream and go
back to your doctor.
017564-XX
In this leaflet:
1. What Fucidin® H Cream is and what it is used for
2. Before you use Fucidin® H Cream
3. How to use Fucidin® H Cream
4. Possible side effects
5. How to store Fucidin® H Cream
6. Further information
Other possible side effects:
Any of the problems listed below are more likely if the
medicine is used for a long time, in large amounts or on
skin folds (such as armpits or under breasts).
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.
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.
Adults and children:
Your doctor should tell you the dose that is right for you
or the child. If your doctor has told you the amount of
cream to use then keep to this advice. If not, the
following guide will help you to use the correct amount.
You can use your first (index) finger to measure how
much Fucidin® H Cream to use. Squeeze the cream
along your finger from the tip to the first joint as shown
in the diagram. This is called a fingertip unit.
The usual number of finger tip
units you need to cover different
parts of the body is shown in the
diagrams. If you need to use a
little more or a little less do not
worry. If you are using the cream
on a child still use an adult finger
to measure out the fingertip unit.
For an adult:
Face and neck:
21⁄2 fingertip units.
Back: 7 fingertip units.
Front: 7 fingertip units.
One arm (not including the hand):
3 fingertip units.
Both sides of one hand:
1 fingertip unit.
One leg (not including the foot):
6 fingertip units.
One foot:
2 fingertip units.
Skin problems
Uncommon side effects (probably affect less than 1 in
100 people)
• Itchy rash and skin inflammation in the area where the
medicine is used
• Worsening of your eczema.
• Skin rash
Common side effects (probably affect less than 1 in
10 people)
• Application site reaction (including itching, burning
and irritation)
Some side effects are known to be caused by
hydrocortisone (steroid), one of the ingredients in
Fucidin® H Cream. You should tell your doctor if any of
the side effects occur:
• Adrenal glands may stop working properly. Signs are
tiredness, depression and anxiety.
• Glaucoma
• Thinning of the skin
• Red spotty rash around the mouth or chin
• Stretch marks
• Small veins near the surface of the skin become visible
• Skin redness
• Lightening of your skin colour
• Changes in the growth of your body hair
• Excessive sweating
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 FUCIDIN® H CREAM
• Keep out of the reach and the sight of children.
• Do not use Fucidin® H Cream after the expiry date on
the carton. The expiry date is the 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 space provided on the carton.
For a child under 11 years:
Arm
Face
Leg
and neck and hand and foot
Child’s
age
3-6
months
1-2
years
3-5
years
6-10
years
Front
Back incl.
buttocks
Number of fingertip units needed
1
1
11⁄2
1
11⁄2
11⁄2
11⁄2
2
2
3
1
1 ⁄2
2
3
3
31⁄2
2
21⁄2
41⁄2
31⁄2
5
If you forget to use Fucidin® H 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 about using this
medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucidin® H Cream can cause side
effects, although not everybody gets them.
Important side effects to look out for:
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.
Medicines should not be thrown away in waste water or
in household waste. Please ask your pharmacist how
to throw away any medicine you do not need any more.
If you do this you will help protect the environment.
6. FURTHER INFORMATION
What Fucidin® H Cream contains
• There are 2 active ingredients, fusidic acid and
hydrocortisone acetate. Fucidin® H Cream
contains 2% fusidic acid and 1% hydrocortisone.
• The other ingredients are butylhydroxyanisole (E320),
cetyl alcohol, glycerol, liquid paraffin, potassium
sorbate, polysorbate 60, all-rac-α-tocopherol, water
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® H Cream looks like and
contents of the pack
Fucidin® H Cream is a white cream.
Fucidin® H Cream comes in tubes of 30 g and 60 g.
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 February 2014.
®Registered Trade Mark
LEO
017564-XX
Usually, you should use this medicine twice each day.
Use it in the morning and evening. To remind you to use
the medicine it may help to use it when you do another
regular action, such as brushing your teeth.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.