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XEMACORT 20 MG/G + 1 MG/G CREAM

Active substance(s): BETAMETHASONE VALERATE / FUSIDIC ACID / BETAMETHASONE VALERATE / FUSIDIC ACID / 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).

Description Xemacort_1 mg_g + 20 mg_g_30 g_60 g
Component Type Leaflet
Affiliate Item Code 1222525
Superceded Affiliate Item Code 924767
TrackWise PR No. 1222525
MA No. PL04569/1625
Packing Site/Printer

Encube Ethicals Pvt Ltd
(Ponda - IN)

Supplier Code TBC

• 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.

Date: 24 Jun 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 478896
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom

1

Time: 16:34
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
136 x 300 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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

7
7

Site of application
Face and neck
Back of the trunk
Front of the trunk
One arm (not including
the hand)
One hand (both sides)
One leg (not including
the foot)One foot

3
1

Reporting of side effects

6
2

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
2

3
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

Description Xemacort_1 mg_g + 20 mg_g_30 g_60 g
Component Type Leaflet
Affiliate Item Code 1222525
Superceded Affiliate Item Code 924767
TrackWise PR No. 1222525
MA No. PL04569/1625
Packing Site/Printer

Encube Ethicals Pvt Ltd
(Ponda - IN)

Supplier Code TBC

• dry skin
• application site pain
• application site irritation
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

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

Date: 24 Jun 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 478896
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom

1222525

Code: GO/DRUGS/362

1

Time: 16:34
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
136 x 300 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand Transcript

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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