Skip to Content

XEMACORT 20 MG/G + 1 MG/G CREAM

Active substance(s): BETAMETHASONE VALERATE / FUSIDIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
TBC

Xemacort
20 mg/g + 1 mg/g CREAM

(fusidic acid and betamethasone valerate)
Please read all of this leaflet carefully before
you start taking this medicine.
• 
Keep this leaflet. You may need to read
it again.
• 
If you have any further questions, please 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 symptoms 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.

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
valerate. 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).

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

• 
If you are allergic (hypersensitive) to fusidic acid
or betamethasone valerate.
• 
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 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 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.

Warnings and precautions

• 
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.

TBC

PACKAGE LEAFLET: INFORMATION FOR
THE USER

• 
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.

Other medicines and Xemacort

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 Xemacort:
• 
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.

Xemacort contains cetostearyl alcohol
and chlorocresol:

• 
Cetostearyl alcohol. This may give you an itchy
rash and inflammation on your skin where your
medicine is used.
Chlorocresol. This is a preservative. It may give
• 
you an allergic reaction. Please read section
4 so you can spot any signs that this may be
happening to you.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.

3. How to use Xemacort

Always use Xemacort 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 the medicine 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 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:

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

Usual number of
fingertip units of cream

7
7
3
6
2

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

Face and Neck





2

One arm
and hand
One leg and foot
Front of
the trunk
Back of the trunk
including the
buttocks



2



2

3



2

3



3



5

If you forget to take Xemacort

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, Xemacort 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.

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.

Skin problems

Side effects where the number of people
affected is not known:

• 
itchy rash and skin inflammation in the area
where the medicine is used
• 
rash
• 
small veins near the surface of the skin become
visible.
Some side effects are known to be caused by
betamethasone valerate (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
• 
inflammation or swelling of the hair root
• 
(folliculitis)
changes in growth of your body hair
• 
red spotty rash around the mouth or chin
• 
lightening of your skin colour
• 
glaucoma
• 
• 
adrenal glands may stop working properly.
Signs are tiredness, depression and anxiety.

Reporting of side effects

1

FOR A CHILD FROM 1 TO 11 YEARS:

Site of
application

Rare side effects (probably affect less than 1 in
1000 people):
hives
• 
dry skin.
• 

Uncommon side effects (probably affect less
than 1 in 100 people):
• 
skin irritation
• 
burning feeling
• 
itching
• 
worsening of your eczema
• 
stinging feeling
• 
skin redness.

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. The expiry date is
the last day of that month.
• Do not keep the tube for 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:

• There are two active ingredients, fusidic acid
and betamethasone valerate.
• Xemacort contains 20 mg/g of fusidic acid and
1 mg/g of betamethasone.
• The other ingredients are macrogol cetostearyl
ether, cetostearyl alcohol, chlorocresol,
liquid paraffin, sodium dihydrogen
phosphate dihydrate, white soft paraffin,
all-rac-α-tocopherol, purified water and
sodium hydroxide.
You can find important information about some
of the ingredients in your medicine near the end
of section 2 of this leaflet.

What Xemacort looks like and contents of the
pack
Xemacort is a white to off-white 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

Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary.
This leaflet was last revised in 05/2016

Code: GO/DRUGS/362

697948

Expand view ⇕

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.

Hide