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XEMACORT 20 MG/G + 1 MG/G CREAM

Active substance(s): BETAMETHASONE VALERATE / FUSIDIC ACID

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Package leaflet: Information for the patient

Xemacort
20 mg/g + 1 mg/g cream
(fusidic acid and betamethasone)

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

What is in this leaflet:

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

1. What Xemacort is and what it is used for
Xemacort contains two different types of medicine.
One medicine is called fusidic acid. It is a type of
antibiotic.
The other medicine is called betamethasone. It is a
type of corticosteroid (steroid). These two medicines
work at the same time in different ways.
Xemacort works by:
• the antibiotic killing germs (bacteria) that cause
infections
• the corticosteroid reducing any swelling, redness
or itchiness of your skin.
Xemacort is used to treat:
• conditions where the skin is inflamed (eczema or
dermatitis) and also infected by germs (bacteria).
If there is no improvement after 7 days you should
stop using the cream and go back to your doctor.

2. What you need to know before you use
Xemacort
Do not use Xemacort:

• If you are allergic to fusidic acid or betamethasone
or any of the other ingredients in this medicine
(listed in section 6).
• To treat infected dermatitis in infants under one
year of age.
• To treat acne vulgaris.
• 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 only by bacteria,
such as boils or spots.
• To treat skin conditions caused by tuberculosis
(TB) or syphilis.
• 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 or more generalised infections
caused by a fungus, e,g. candidiasis.

Warnings and precautions

Talk to your doctor or pharmacist, before using
Xemacort:
• Do not use the cream on yourself or a child for
more than 2 weeks; this is to avoid bacteria
becoming resistant to the antibiotic and to avoid
the steroid causing you side effects.
• 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
increased pressure in the eye which may cause
loss of vision (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 Xemacort 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 Xemacort on thin skin, skin ulcers, broken
veins or acne.
• Your adrenal glands may stop working properly.
Signs are tiredness, depression and anxiety. This
can be reversed by stopping Xemacort.
• Contact your doctor if you experience blurred
vision or other visual disturbances.
Other medicines and Xemacort
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes any medicines which you have bought
without a prescription.

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
Xemacort:
• If you are pregnant, or think you are pregnant:
Xemacort should not be used during pregnancy,
unless you are told to do so by your doctor.
• If you are breast-feeding, Xemacort may be used
by women who are breast-feeding, but the cream
should not be applied to the breasts to avoid
accidental ingestion by the infant.
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.

Xemacort contains cetostearyl alcohol and
chlorocresol:

• Cetostearyl alcohol. May cause local skin reactions
(e.g. contact dermatitis).
• Chlorocresol. May cause allergic reactions.
Please ask your doctor if you are worried about any
of the ingredients in this medicine.

3. How to use Xemacort
Always use this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.

How to put on Xemacort

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 Xemacort.
Apply thinly to the affected areas. 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 Xemacort.
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 Xemacort to use

Your doctor will tell you how much Xemacort to use.
The usual treatment time is up to two 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.
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.

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.

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 Xemacort to use. Squeeze the cream along
your finger from the tip to the first joint. This is called
a fingertip unit.
The usual number of fingertip units you need
to cover different parts of the body is described
hereafter. 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:
Usual number of
fingertip units
of cream
Face and neck

Back of the trunk
7
Front of the trunk
7
One arm (not including the hand)
3
One hand (both sides)
1
One leg (not including the foot)6
One foot
2
Site of application

FOR A CHILD FROM 1 TO 10 YEARS:

Site of application
Face and neck
One arm and hand
One leg and foot
Front of the trunk
Back of the trunk
including the buttocks

Usual number of fingertip
units of cream
For a
For a
For a
child
child
child
aged
aged
aged
1-2
3-5
6-10
years
years years


2

2

2
3

2
3

3



5

If you use more Xemacort than you should

Tell your doctor straight away if you have used more
Xemacort than you should. You may need to stop
using this medicine.

If you forget to use Xemacort

If you forget to use this medicine, use it as soon as
you remember. Then next use this medicine at the
usual time. Do not use a double dose to make up for
the forgotten dose.
If you have any further questions about using this
medicine, please ask your doctor or pharmacist.

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

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, eyelids, lips, tongue or throat swell
• 
your skin develops a severe rash.

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).
• 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.
Uncommon (may affect up to 1 in 100 people):
• itchy rash and skin inflammation in the area where
the medicine is used
• burning feeling
• itching
• worsening of your eczema
• dry skin
• application site pain
• application site irritation

Code : GO/DRUGS/362

Rare (may affect up to 1 in 1,000 people):
• hives
• skin redness
• skin rash
• application site swelling
• application site blisters
Some side effects are known to be caused by
betamethasone (steroid), one of the ingredients in
Xemacort. You should tell your doctor if any of the
side effects occur:
• thinning of the skin
• stretch marks
• small veins near the surface of the skin become
visible
• changes in growth of your body hair
• excessive sweating
• red spotty rash around the mouth or chin
• lightening of your skin colour
• redness of the skin, nose or mouth
• loss of vision caused by damage to the optic nerve
in the eye, caused by increased pressure in the eye
(glaucoma) or by clouding of the lens in the eye
(cataract)
• adrenal glands may stop working properly. Signs
are feeling sick, stomach pain, headache, poor
weight gain, lacking energy, tiredness, depression
and anxiety.
Not known (frequency cannot be estimated from the
available data)
• Blurred vision

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 Xemacort
• 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 carton after EXP. The expiry
date is the last day of that month.
• Do not keep the tube for more than 6 months
after you first open it. Make a note of the date you
first opened the tube in the space provided on
the carton.
• Do not store the medicine above 30°C.
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 other
information
What Xemacort contains

• The active substances are, fusidic acid and
betamethasone.
• Xemacort contains 20 mg/g of fusidic acid and
1 mg/g of betamethasone.
• The other ingredients are macrogol cetostearyl
ether, cetostearyl alcohol, chlorocresol (see
section 2 ‘Xemacort contains cetostearyl alcohol
and chlorocresol’), liquid paraffin, sodium
dihydrogen phosphate dihydrate, white soft
paraffin, all-rac-α-tocopherol, purified water and
sodium hydroxide.

What Xemacort looks like and contents of
the pack

Xemacort is a white to off-white smooth cream in
an aluminium tube, with a white polypropylene
screw cap.
Xemacort comes in tubes of 5 g; 15 g; 30 g and 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL.
United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary.
This leaflet was last revised in 06/2017

1270574
MXC5/03

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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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