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BECOLEX MODULITE 250 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): BECLOMETASONE DIPROPIONATE

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PACKAGE
PACKAGE LEAFLET:
LEAFLET: INFORMATION
INFORMATION FOR
FOR USER
USER

PREVENTER
®
®
Becolex
Becolex® Modulite
Modulite® 50
50 micrograms
micrograms per
per actuation
actuation pressurised
pressurised inhalation
inhalation solution
solution
®
®
Becolex
Becolex® Modulite
Modulite® 100
100 micrograms
micrograms per
per actuation
actuation pressurised
pressurised inhalation
inhalation solution
solution
®
®
Becolex
Becolex® Modulite
Modulite® 200
200 micrograms
micrograms per
per actuation
actuation pressurised
pressurised inhalation
inhalation solution
solution
®
®
Becolex
Becolex® Modulite
Modulite® 250
250 micrograms
micrograms per
per actuation
actuation pressurised
pressurised inhalation
inhalation solution
solution

beclometasone
beclometasone dipropionate
dipropionate
Read
Read all
all of
of this
this leaflet
leaflet carefully
carefully before
before you
you start
start using
using this
this medicine.
medicine.
-Keep
this
leaflet.
You
may
need
to
read
it
again.
Keep this leaflet. You may need to read it again.
-If
If you
you have
have any
any further
further questions,
questions, ask
ask your
your doctor,
doctor, or
or pharmacist.
pharmacist.
-This
This medicine
medicine has
has been
been prescribed
prescribed for
for you.
you. Do
Do not
not pass
pass itit on
on to
to others.
others. It
It may
may harm
harm them
them even
even ifif
their
symptoms
are
the
same
as
yours.
their symptoms are the same as yours.
-If
If any
any of
of the
the side
side effects
effects become
become serious,
serious, or
or ifif you
you notice
notice any
any side
side effects
effects not
not listed
listed in
in
this
leaflet,
please
tell
your
doctor
or
pharmacist.
this leaflet, please tell your doctor or pharmacist.

In
In this
this leaflet:
leaflet:
1.
1. What
What Becolex
Becolex Modulite
Modulite is
is and
and what
what it
it is
is used
used for
for
2.
2. Before
Before you
you use
use Becolex
Becolex Modulite
Modulite
3.
3. How
How to
to use
use Becolex
Becolex Modulite
Modulite
4.
4. Possible
Possible side
side effects
effects
5.
How
to
store
Becolex
5. How to store Becolex Modulite
Modulite
6.
6. Further
Further information
information

1.
1. What
What Becolex
Becolex Modulite
Modulite is
is and
and what
what it
it is
is used
used for
for
Becolex
Becolex Modulite
Modulite pressurised
pressurised inhalation
inhalation solution
solution is
is used
used to
to help
help prevent
prevent the
the symptoms
symptoms of
of mild,
mild,
moderate
moderate or
or severe
severe asthma.
asthma. The
The active
active ingredient,
ingredient, beclometasone
beclometasone dipropionate,
dipropionate, is
is one
one of
of a
a group
group of
of
medicines
medicines called
called corticosteroids
corticosteroids which
which are
are often
often referred
referred to
to simply
simply as
as steroids.
steroids. Steroids
Steroids have
have an
an antiantiinflammatory
inflammatory action
action reducing
reducing the
the swelling
swelling and
and irritation
irritation in
in the
the walls
walls of
of the
the small
small air
air passages
passages in
in the
the lungs,
lungs,
and
and so
so ease
ease breathing
breathing problems.
problems.

2.
2. Before
Before you
you use
use Becolex
Becolex Modulite
Modulite
Do
Do not
not use
use Becolex
Becolex Modulite:
Modulite:
•• ifif you
you are
are allergic
allergic to
to any
any of
of the
the ingredients
ingredients of
of this
this medicine
medicine or
or to
to any
any other
other medicines
medicines used
used to
to
treat
treat asthma.
asthma.
•• to
to treat
treat a
a sudden
sudden attack
attack of
of breathlessness.
breathlessness. It
It will
will not
not help.
help. Use
Use a
a quick-acting
quick-acting ‘reliever’
‘reliever’ inhaler
inhaler
for
for this
this purpose
purpose and
and carry
carry itit with
with you
you at
at all
all times.
times.
Take
Take special
special care
care with
with Becolex
Becolex Modulite
Modulite and
and always
always tell
tell your
your doctor
doctor if:
if:
•• you
you are
are being,
being, or
or have
have ever
ever been,
been, treated
treated for
for tuberculosis
tuberculosis (TB).
(TB).
•• you
you must
must avoid
avoid alcohol
alcohol for
for any
any reason.
reason.
•• your
your asthma
asthma seems
seems to
to be
be getting
getting worse.
worse. Perhaps
Perhaps you
you are
are more
more wheezy
wheezy and
and short
short of
of breath
breath
than
than usual,
usual, your
your ‘reliever’
‘reliever’ inhaler
inhaler seems
seems to
to be
be less
less effective,
effective, you
you require
require more
more puffs
puffs from
from
your
your ‘reliever’
‘reliever’ inhaler
inhaler than
than usual,
usual, or
or you
you do
do not
not seem
seem to
to be
be getting
getting better.
better.
Your
Your doctor
doctor may
may need
need to
to increase
increase the
the dose
dose of
of your
your steroid
steroid inhaler
inhaler or
or give
give you
you a
a course
course of
of
steroid
steroid tablets,
tablets, or
or change
change your
your treatment
treatment altogether.
altogether. If
If you
you have
have an
an infection
infection in
in your
your chest
chest your
your
doctor
doctor may
may prescribe
prescribe a
a course
course of
of antibiotics.
antibiotics.
•• when
when transferring
transferring from
from steroid
steroid tablets
tablets to
to an
an inhaler
inhaler you
you find
find that,
that, even
even ifif your
your chest
chest is
is getting
getting
better,
better, you
you feel
feel generally
generally unwell,
unwell, you
you develop
develop a
a rash,
rash, eczema
eczema or
or a
a runny
runny nose
nose and
and
sneezing
sneezing (rhinitis).
(rhinitis). Do
Do not
not stop
stop treatment
treatment with
with your
your inhaler
inhaler unless
unless your
your doctor
doctor tells
tells you
you to.
to.
If
If you
you have
have been
been treated
treated for
for a
a long
long time
time with
with high
high doses
doses of
of inhaled
inhaled steroid,
steroid, you
you may
may require
require a
a course
course
of
of steroid
steroid tablets
tablets or
or possibly
possibly a
a steroid
steroid injection
injection in
in times
times of
of stress.
stress. For
For example,
example, during
during admission
admission to
to
hospital
hospital after
after a
a serious
serious accident,
accident, before
before an
an operation,
operation, during
during an
an acute
acute attack
attack of
of asthma
asthma or
or ifif you
you have
have
a
a chest
chest infection
infection or
or other
other serious
serious illness.
illness. Your
Your doctor
doctor will
will decide
decide ifif you
you need
need any
any extra
extra steroid
steroid treatment
treatment
and
and will
will also
also advise
advise you
you as
as to
to how
how long
long you
you need
need to
to take
take the
the course
course of
of steroid
steroid tablets
tablets and
and how
how you
you
should
should reduce
reduce these
these as
as you
you get
get better.
better.

technical area for the leaflet broken line
at discretion of supplier

If
If you
you are
are using
using Becolex
Becolex Modulite
Modulite instead
instead of,
of, or
or as
as well
well as
as taking
taking steroid
steroid tablets,
tablets, or
or ifif your
your doctor
doctor is
is
trying
trying to
to reduce
reduce the
the dose
dose of
of your
your steroid
steroid tablets,
tablets, you
you should
should carry
carry a
a steroid
steroid warning
warning card
card until
until your
your
doctor
doctor tells
tells you
you that
that you
you don’t
don’t need
need to.
to.
Taking
Taking other
other medicines:
medicines:
Before
Before starting
starting treatment,
treatment, please
please tell
tell your
your doctor
doctor or
or pharmacist
pharmacist ifif you
you are
are taking
taking or
or have
have recently
recently taken
taken
any
any other
other medicines,
medicines, including
including medicines
medicines obtained
obtained without
without a
a prescription.
prescription. Remember
Remember to
to take
take these
these
medicines
medicines and
and your
your inhalers
inhalers with
with you
you ifif you
you have
have to
to go
go into
into hospital.
hospital.
Pregnancy
Pregnancy and
and breast-feeding:
breast-feeding:
If
breast-feeding, or
or could
could become
become pregnant,
pregnant, talk
talk to
to your
your doctor
doctor before
before using
using your
your
If you
you are
are pregnant
pregnant or
or breast-feeding,
inhaler.
inhaler.
Important
Important information
information about
about some
some of
of the
the ingredients
ingredients of
of Becolex:
Becolex:
Becolex
Becolex Modulite
Modulite contains
contains a
a small
small amount
amount of
of alcohol.
alcohol. Each
Each actuation
actuation (puff)
(puff) from
from your
your inhaler
inhaler contains
contains about
about 9
9 mg
mg of
of ethanol.
ethanol.

3.
3. How
How to
to use
use Becolex
Becolex Modulite
Modulite
Becolex
Becolex Modulite
Modulite is
is available
available in
in 4
4 different
different strengths.
strengths. Your
Your doctor
doctor will
will have
have decided
decided which
which strength
strength you
you
need.
need. Becolex
Becolex Modulite
Modulite 200
200 and
and Becolex
Becolex Modulite
Modulite 250
250 are
are not
not suitable
suitable for
for children.
children.
Always
Always use
use your
your inhaler
inhaler exactly
exactly as
as your
your doctor
doctor has
has told
told you.
you. You
You should
should check
check with
with your
your doctor
doctor or
or
pharmacist
pharmacist ifif you
you are
are not
not sure.
sure. Instructions
Instructions for
for using
using your
your inhaler
inhaler are
are given
given after
after the
the dosage
dosage section.
section.
It
It takes
takes a
a few
few days
days for
for your
your inhaler
inhaler to
to work.
work. It
It is
is very
very important
important that
that you
you use
use itit regularly.
regularly.
Do
Do not
not stop
stop treatment
treatment even
even ifif you
you feel
feel better
better unless
unless told
told to
to do
do so
so by
by your
your doctor.
doctor. Do
Do not
not stop
stop using
using
your
inhaler
abruptly.
your inhaler abruptly.
While
While you
you are
are using
using Becolex
Becolex Modulite
Modulite your
your doctor
doctor will
will want
want to
to check
check your
your asthma
asthma regularly
regularly by
by carrying
carrying
out
out simple
simple breathing
breathing tests
tests and
and may
may need
need to
to carry
carry out
out blood
blood tests
tests from
from time
time to
to time.
time.
Dosage:
Dosage:
The
The starting
starting dose
dose will
will depend
depend on
on how
how severe
severe your
your asthma
asthma is
is and
and will
will be
be decided
decided by
by your
your doctor.
doctor.
It
It may
may be
be higher
higher than
than the
the doses
doses given
given below.
below. Your
Your doctor
doctor will
will prescribe
prescribe the
the lowest
lowest dose
dose of
of Becolex
Becolex
Modulite
Modulite that
that will
will control
control your
your symptoms.
symptoms.
A
A device
device called
called a
a Volumatic
Volumatic spacer
spacer should
should always
always be
be used
used when:
when:
•• adults,
adults, the
the elderly
elderly and
and adolescents
adolescents 16
16 years
years of
of age
age and
and older
older are
are taking
taking total
total daily
daily doses
doses of
of
Becolex
Modulite
of
1,000
micrograms
or
more,
Becolex Modulite of 1,000 micrograms or more,
•• when
Becolex
Modulite
is
used
in
children
and
adolescents
15
years
of
age
and
under
whatever
when Becolex Modulite is used in children and adolescents 15 years of age and under whatever
dose
dose has
has been
been prescribed.
prescribed.
Becolex
Becolex Modulite
Modulite 50
50 micrograms
micrograms
The
The common
common starting
starting dose
dose is:
is:
Adults
Adults and
and the
the elderly:
elderly: 200
200 micrograms
micrograms (4
(4 puffs)
puffs) twice
twice a
a day
day
Children:
100
Children:
100 micrograms
micrograms (2
(2 puffs)
puffs) twice
twice a
a day
day
Usually
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:
Adults
Adults and
and the
the elderly:
elderly: 800
800 micrograms
micrograms (16
(16 puffs)
puffs)
Children:
400
micrograms
(8
Children:
400 micrograms (8 puffs)
puffs)
The
The total
total daily
daily dose
dose may
may be
be divided
divided into
into two,
two, three
three or
or four
four doses
doses per
per day.
day.
Becolex
Becolex Modulite
Modulite 100
100 micrograms
micrograms
The
The common
common starting
starting dose
dose is:
is:
Adults
Adults and
and the
the elderly:
elderly: 200
200 micrograms
micrograms (2
(2 puffs)
puffs) twice
twice a
a day
day
Children:
100
Children:
100 micrograms
micrograms (one
(one puff)
puff) twice
twice a
a day
day
Usually
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:
Adults
Adults and
and the
the elderly:
elderly: 800
800 micrograms
micrograms (8
(8 puffs)
puffs)
Children:
400
Children:
400 micrograms
micrograms (4
(4 puffs)
puffs)
The
The total
total daily
daily dose
dose may
may be
be divided
divided into
into two,
two, three
three or
or four
four doses
doses per
per day.
day.
Becolex
Becolex Modulite
Modulite 200
200 micrograms
micrograms
The
The common
common starting
starting dose
dose is:
is:
Adults
Adults and
and the
the elderly
elderly only:
only: 200
200 micrograms
micrograms (one
(one puff)
puff) twice
twice a
a day
day
Usually
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:

800
800 micrograms
micrograms (4
(4 puffs)
puffs)

The
The total
total daily
daily dose
dose may
may be
be divided
divided into
into two,
two, three
three or
or four
four doses
doses per
per day.
day.
This
This product
product strength
strength is
is not
not suitable
suitable for
for children
children
Becolex
Becolex Modulite
Modulite 250
250 micrograms
micrograms
The
The common
common starting
starting dose
dose is:
is:
Adults
Adults and
and the
the elderly
elderly only:
only: 500
500 micrograms
micrograms (2
(2 puffs)
puffs) twice
twice a
a day
day
Usually
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:

2,000
2,000 micrograms
micrograms (8
(8 puffs)
puffs)

The
The total
total daily
daily dose
dose may
may be
be divided
divided into
into two,
two, three
three or
or four
four doses
doses per
per day.
day.
This
This product
product strength
strength is
is not
not suitable
suitable for
for children
children
It
It takes
takes a
a few
few days
days for
for this
this medicine
medicine to
to work.
work. It
It is
is very
very important
important that
that you
you use
use itit regularly.
regularly.
Do
Do not
not stop
stop treatment
treatment even
even ifif you
you feel
feel better
better unless
unless told
told to
to do
do so
so by
by your
your doctor.
doctor. Do
Do not
not stop
stop using
using
your
inhaler
abruptly.
your inhaler abruptly.

If
If you
you use
use more
more Becolex
Becolex Modulite
Modulite than
than you
you should
should::

Tell
Tell your
your doctor
doctor as
as soon
soon as
as possible.
possible. Your
Your doctor
doctor may
may want
want to
to check
check the
the cortisol
cortisol levels
levels in
in your
your blood
blood
and
and therefore,
therefore, may
may need
need to
to take
take a
a blood
blood sample
sample (cortisol
(cortisol is
is a
a steroid
steroid hormone
hormone which
which occurs
occurs naturally
naturally
in
the
body).
in the body).
It
It is
is important
important that
that you
you take
take your
your dose
dose as
as stated
stated on
on the
the pharmacist’s
pharmacist’s label
label or
or as
as advised
advised by
by your
your doctor.
doctor. You
You
should
should not
not increase
increase or
or decrease
decrease your
your dose
dose without
without seeking
seeking medical
medical advice.
advice.

If
If you
you forget
forget to
to use
use Becolex
Becolex Modulite:
Modulite:

If
If you
you forget
forget to
to take
take your
your Becolex
Becolex Modulite,
Modulite, miss
miss out
out your
your forgotten
forgotten dose
dose and
and take
take the
the next
next dose
dose when
when itit is
is due.
due.
Do
Do not
not take
take more
more puffs
puffs than
than you
you were
were told
told to
to take.
take.
Please
Please read
read back
back of
of this
this leaflet
leaflet
81N65.04/01

PAG. 1/2

Instructions for use:
It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will
show you how to use your inhaler correctly and will check regularly that you are using your inhaler
Instructions
use:
correctly. Youfor
must
follow their instructions carefully, so that you know how, when and how many
Itpuffs
is important
to use
your
inhaler
properly.
Your doctor,
nursebeoron
pharmacist
will
to inhalethat
andyou
howknow
often how
you must
use
your
inhaler.
The instructions
should
the pharmacist’s
show
youare
howgiven
to use
yourleaflet.
inhalerIf correctly
andsure
will what
checktoregularly
thatproblems
you are using
your
inhaler
label and
in this
you are not
do or have
inhaling
then
ask
correctly.
Younurse
mustor
follow
their instructions
your doctor,
pharmacist
for advice.carefully, so that you know how, when and how many
puffs to inhale and how often you must use your inhaler. The instructions should be on the pharmacist’s
label and are given in this leaflet. If you are not sure what to do or have problems inhaling then ask
your doctor, nurse or pharmacist for advice.

1

2
1-2

3
3A

3B

7

1.
1.

4

5-6

To remove the mouthpiece cover, hold between the thumb and forefinger, squeeze gently and
C mouthpiece is clean,
A shown. Check inside and
4 Boutside to make sure that 4the
pull apart4as
and that there are no foreign objects.
To remove the mouthpiece cover, hold between the thumb and forefinger, squeeze gently and
pull
apartYour
as shown.
Check
and
outside
sure
thatused
the mouthpiece
is or
clean,
Testing
Inhaler:
If theinside
inhaler
is new
or iftoit make
has not
been
for three days
more,
and
foreign into
objects.
one that
puff there
shouldare
beno
released
the air to make sure that it works.

Inhaler:
theshown,
inhalerwith
is new
orthumb
if it hasonnot
used
for the
three
days or more,
2. Testing
Hold theYour
inhaler
uprightIf as
your
thebeen
base,
below
mouthpiece.
one
puff should
be as
released
into the air to make sure that it works.
Breathe
out as far
is comfortable.
3. Place the mouthpiece in your mouth between your teeth and close your lips around it but do
2. Hold
theit.inhaler upright as shown, with your thumb on the base, below the mouthpiece.
not bite
as far to
asbreathe
is comfortable.
4. Breathe
Just afterout
starting
in through your mouth press down on the top of the inhaler to
3. Place
thea mouthpiece
in breathing
your mouth
betweenand
yourdeeply.
teeth and close your lips around it but do
release
puff while still
in steadily
not
bite
it.
5. Hold your breath; take the inhaler from your mouth and your finger from the top of the inhaler.
4. Just
after starting
to breathe
through
your mouth
press
the top of the
inhaler
Continue
holding your
breathinfor
a few seconds
or as
longdown
as is on
comfortable.
Breathe
outto
release
slowly. a puff while still breathing in steadily and deeply.
5.
breath;
take thepuff,
inhaler
from
mouth
and and
yourwait
finger
fromhalf
theatop
of thebefore
inhaler.
6. Hold
If youyour
are to
take another
keep
theyour
inhaler
upright
about
minute
Continue
repeatingholding
steps 2your
to 5.breath for a few seconds or as long as is comfortable. Breathe out
7. slowly.
After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly
6. Ifand
yousnap
are tointo
take
another puff, keep the inhaler upright and wait about half a minute before
position.
repeating steps 2 to 5.
7. After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly
and snap
intorush
position.
Important:
Do not
steps 2, 3, 4 and 5.
It is important
start
to breathe
as 5.
slowly as possible just before operating the inhaler. Practice
Important:
Dothat
notyou
rush
steps
2, 3, 4 in
and
in front of a mirror for the first few times.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Becolex will not
Itget
is important
youasstart
to breathe
in another
as slowlypuff,
as possible
just
before operating
the inhaler.
Practice
into your that
lungs
it should.
Take
carefully
following
the instructions
from
in
front2 of
a mirror for the first few times.
Step
onwards.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Becolex will not
get into your lungs as it should. Take another puff, carefully following the instructions from
People
with weak hands or children may find it easier to hold the inhaler with both hands. Put the two
Step
2 onwards.
forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece.

technical area for the leaflet broken line
at discretion of supplier

People with weak hands or children may find it easier to hold the inhaler with both hands. Put the two
If you find on
it difficult
toinhaler
operate
theboth
inhaler
while
to below
breathe
you may use the
forefingers
top of the
and
thumbs
on starting
the bottom
theinmouthpiece.
Volumatic spacer device. Ask your doctor, pharmacist or a nurse about this device.
However, the Volumatic spacer device must always be used if:
If you
findare
it difficult
operate
the
inhaler while
starting
to and
breathe
youare
may
usetotal
the
• you
an adult,to
elderly
or an
adolescent
16 years
of age
olderinand
taking
Volumatic
spacer
your of
doctor,
nurse about this device.
daily doses
of device.
BecolexAsk
Modulite
1,000 pharmacist
micrograms or
or a
more,
However,
the Volumatic
device
must
always
be used15
if: years of age and younger, whatever
• Becolex
Modulite isspacer
used in
children
and
adolescents
• you
adult,
elderly or an adolescent 16 years of age and older and are taking total
doseare
hasanbeen
prescribed.
daily doses of Becolex Modulite of 1,000 micrograms or more,
• Becolex Modulite is used in children and adolescents 15 years of age and younger, whatever
dose
has been
Young
children
may prescribed.
find it difficult to use the inhaler properly and will require help. Using the inhaler with
the Volumatic spacer device with a face mask may help in children under 5 years. Tell your doctor,
nurse or pharmacist if you have any difficulties.
Young children may find it difficult to use the inhaler properly and will require help. Using the inhaler with
the Volumatic spacer device with a face mask may help in children under 5 years. Tell your doctor,
Cleaning:
nurse
or pharmacist if you have any difficulties.
It is important to clean your inhaler at least once a week, to stop it blocking up.
• Pull the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.
Cleaning:
• Rinse the plastic case and the mouthpiece cover in warm water. If you use a mild liquid
It is important
to clean
your inhaler
leastwater
once before
a week,drying.
to stopDo
it blocking
up.metal canister into
detergent,
rinse carefully
withatclean
not put the
• Pull
the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.
water.
•• Rinse
plastic
case and
the
mouthpiece
coverexcessive
in warm water.
Leavethe
to dry
thoroughly
in a
warm
place. Avoid
heat. If you use a mild liquid
rinse
carefully
clean water
before drying. Do not put the metal canister into
• detergent,
Replace the
canister
and with
mouthpiece
cover.
water.
• important
Leave tothat
dry you
thoroughly
in athe
warm
place.leaflet
Avoidwhich
excessive
heat. with your Volumatic spacer device
It is
also read
Package
is supplied
• that
Replace
the canister
and mouthpiece
cover.
and
you follow
the instructions
on how to
use the Volumatic and on how to clean it, carefully.
It is important that you also read the Package leaflet which is supplied with your Volumatic spacer device
4. Possible
side
and
that you follow
theeffects
instructions on how to use the Volumatic and on how to clean it, carefully.
Like all medicines, Becolex Modulite can cause side effects, although not everybody gets them.

4. Possible side effects

Like
allnotice
medicines,
Becolex Modulite
can
side effects,
although
not everybody
gets
them.
If you
an immediate
increase
in cause
wheezing,
shortness
of breath
and cough
straight
after using your inhaler, stop using Becolex Modulite and use a quick-acting ‘reliever’ inhaler
immediately. Contact your doctor straightaway. Your doctor will review your asthma and may
Ifchange
you notice
an immediate
increase
in wheezing,
of breath
and cough straight
your treatment
and may
prescribe
a different shortness
inhaler to treat
your asthma.
after using your inhaler, stop using Becolex Modulite and use a quick-acting ‘reliever’ inhaler
immediately. Contact your doctor straightaway. Your doctor will review your asthma and may
change your treatment and may prescribe a different inhaler to treat your asthma.
The following side effects have been reported. Tell your doctor as soon as possible if you suffer
from any of these side effects but do not stop treatment unless told to do so. Your doctor will
try to prevent these effects by prescribing Becolex Modulite in the lowest dose possible to control
your asthma.


Allergic reactions including skin rashes, hives, itching or redness, or swelling of the face, eyes,
lips and throat.



Thrush in the mouth and throat. This is more likely if the daily dose taken is greater than 400
micrograms. Thrush can be treated with anti-fungal medicines whilst you continue to use Becolex
Modulite. Brushing your teeth, or throughly rinsing your mouth with water immediately
after each dose may help prevent thrush.



Hoarse voice or a sore throat or tongue. Using a Volumatic spacer device or rinsing your
mouth with water immediately after using your inhaler may help prevent this.



Changes to the normal production of the steriods in the body, particularly after treatment with
Becolex Modulite at high doses over a long period of time.



If you become unwell or develop symptoms such as loss of appetite, abdominal pain, weight
loss, tiredness, nausea (feeling sick), vomiting (being sick), feeling faint, sweating and possible
convulsions (fits), you should consult your doctor. This is particularly important if you have
been exposed to stress such as surgery, infection, an acute attack of asthma, or other serious
illness.
Your doctor may carry out blood test from time to time to monitor the levels of steroids in
your body.



Children and adolescents may grow more slowly and may need to have their height checked
regularly by their doctor. This occurs particularly after treatment with Becolex Modulite at high
doses over a long period of time.



A decrease in bone mineral density (thinning and weakening of the bones) and eye problems
which include the formation of cataracts and glaucoma (increased pressure in the eye).



Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These
effects are more likely to occur in children.



Headaches



Nausea (feeling sick)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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 Becolex Modulite






Keep out of the sight and reach of children.
Do not use Becolex Modulite after the expiry date which is stated on the carton and label. The
expiry date refers to the last day of that month.
Do not store the inhaler above 30oC. Protect from frost and direct sunlight.
If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your
hands for a few minutes before use. Never use anything else to warm it up.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

Warning: The canister contains a pressurised liquid. Keep away from heat and direct sunlight, do not
expose to high temperatures (above 50°C) and do not puncture or burn (incinerate), even when empty.

6. Further information
What Becolex Modulite contains
The active substance of your inhaler is beclometasone dipropionate. Each puff contains 50, 100, 200
or 250 micrograms of beclometasone dipropionate.
The other ingredients are glycerol, ethanol and the CFC-free propellant norflurane (HFA-134a).
To help protect the environment, the inhaler contains the CFC-free propellant HFA-134a, which replaces completely the
chlorofluorocarbon (CFC) propellants and appears to have a less damaging effect on the ozone layer. The only differences you
might notice from your previous CFC-containing inhaler are the taste and the feel of the spray in your mouth.
What Becolex Modulite looks like and content of the pack
Becolex Modulite is a pressurised inhalation solution contained in an aluminum can with plastic actuator
and protective cap. Each canister contains 200 puffs.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder of Becolex Modulite is Chiesi Limited, 333 Styal Road, Manchester,
M22 5LG, United Kingdom.
The manufacturer of Becolex Modulite is Chiesi Farmaceutici S.p.A., 26/A Via Palermo,
43122 Parma, Italy.

Is this leaflet hard to see or read?
Phone 0161 488 5555 for help.

The leaflet was last revised in 07/2015
Volumatic is a registered trademark of the GlaxoSmithKline Group of Companies.
ZP0014/9

81N65.04/01

PAG. 2/2

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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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