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CLENIL MODULITE 200 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): BECLOMETASONE DIPROPIONATE

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

PREVENTER
PREVENTER
Clenil®® Modulite
Modulite®® 50
50 micrograms
micrograms per
per actuation
actuation pressurised
pressurised inhalation
inhalation solution
solution
Clenil
®
®
® Modulite® 100 micrograms per actuation pressurised inhalation solution
Clenil
Clenil Modulite 100 micrograms per actuation pressurised inhalation solution
Clenil®® Modulite
Modulite®® 200
200 micrograms
micrograms per
per actuation
actuation pressurised
pressurised inhalation
inhalation solution
solution
Clenil
®
®
® Modulite® 250 micrograms per actuation pressurised inhalation solution
Clenil
Clenil Modulite 250 micrograms per actuation pressurised inhalation solution
beclometasone dipropionate
dipropionate
beclometasone
Read all
all of
of this
this leaflet
leaflet carefully
carefully before
before you
you start
start using
using this
this medicine.
medicine.
Read
-Keep
this
leaflet.
You
may
need
to
read
it
again.
Keep this leaflet. You may need to read it again.
If you
you have
have any
any further
further questions,
questions, ask
ask your
your doctor,
doctor, or
or pharmacist.
pharmacist.
-If
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
-This
their
symptoms
are
the
same
as
yours.
their symptoms are the same as yours.
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
-If
this
leaflet,
please
tell
your
doctor
or
pharmacist.
this leaflet, please tell your doctor or pharmacist.

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

1. What
What Clenil
Clenil Modulite
Modulite is
is and
and what
what it
it is
is used
used for
for
1.
Clenil 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,
Clenil
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
moderate
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 antiantimedicines
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,
inflammatory
and so
so ease
ease breathing
breathing problems.
problems.
and

2. Before
Before you
you use
use Clenil
Clenil Modulite
Modulite
2.
Do not
not use
use Clenil
Clenil Modulite:
Modulite:
Do
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
•• ifif you
treat asthma.
asthma.
treat
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
•• to
for this
this purpose
purpose and
and carry
carry itit with
with you
you at
at all
all times.
times.
for
Take special
special care
care with
with Clenil
Clenil Modulite
Modulite and
and always
always tell
tell your
your doctor
doctor if:
if:
Take
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.
•• you
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
•• your
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
than
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
Your
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
steroid
doctor may
may prescribe
prescribe a
a course
course of
of antibiotics.
antibiotics.
doctor
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
•• when
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
better,
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.
sneezing
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
If
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
of
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
hospital
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
a
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
and
should reduce
reduce these
these as
as you
you get
get better.
better.
should
If you
you are
are using
using Clenil
Clenil 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
If
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
trying
doctor tells
tells you
you that
that you
you don’t
don’t need
need to.
to.
doctor
Taking other
other medicines:
medicines:
Taking
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
Before
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
any
medicines and
and your
your inhalers
inhalers with
with you
you ifif you
you have
have to
to go
go into
into hospital.
hospital.
medicines
Pregnancy and
and breast-feeding:
breast-feeding:
Pregnancy
If you
you are
are pregnant
pregnant or
or breast-feeding,
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
inhaler.
inhaler.
Important information
information about
about some
some of
of the
the ingredients
ingredients of
of Clenil:
Clenil:
Important
Clenil 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.
Clenil

3. How
How to
to use
use Clenil
Clenil Modulite
Modulite
3.
Clenil 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
Clenil
need. Clenil
Clenil Modulite
Modulite 200
200 and
and Clenil
Clenil Modulite
Modulite 250
250 are
are not
not suitable
suitable for
for children.
children.
need.
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
Always
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.
pharmacist
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.
It
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
Do
your inhaler
inhaler abruptly.
abruptly.
your
While you
you are
are using
using Clenil
Clenil Modulite
Modulite your
your doctor
doctor will
will want
want to
to check
check your
your asthma
asthma regularly
regularly by
by carrying
carrying
While
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.
out
Dosage:
Dosage:
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.
The
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 Clenil
Clenil
It
Modulite that
that will
will control
control your
your symptoms.
symptoms.
Modulite
A device
device called
called a
a Volumatic
Volumatic spacer
spacer should
should always
always be
be used
used when:
when:
A
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
•• adults,
Clenil Modulite
Modulite of
of 1,000
1,000 micrograms
micrograms or
or more,
more,
Clenil
when Clenil
Clenil Modulite
Modulite is
is used
used in
in children
children and
and adolescents
adolescents 15
15 years
years of
of age
age and
and under
under whatever
whatever
•• when
dose has
has been
been prescribed.
prescribed.
dose
Clenil Modulite
Modulite 50
50 micrograms
micrograms
Clenil
The common
common starting
starting dose
dose is:
is:
The
Adults and
and the
the elderly:
elderly: 200
200 micrograms
micrograms (4
(4 puffs)
puffs) twice
twice a
a day
day
Adults
Children:
100 micrograms
micrograms (2
(2 puffs)
puffs) twice
twice a
a day
day
Children:
100
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:
Usually
Adults and
and the
the elderly:
elderly: 800
800 micrograms
micrograms (16
(16 puffs)
puffs)
Adults
Children:
400 micrograms
micrograms (8
(8 puffs)
puffs)
Children:
400
The total
total daily
daily dose
dose may
may be
be divided
divided into
into 2,
2, 3
3 or
or 4
4 doses
doses per
per day.
day.
The
Clenil Modulite
Modulite 100
100 micrograms
micrograms
Clenil
The common
common starting
starting dose
dose is:
is:
The
Adults and
and the
the elderly:
elderly: 200
200 micrograms
micrograms (2
(2 puffs)
puffs) twice
twice a
a day
day
Adults
Children:
100 micrograms
micrograms (one
(one puff)
puff) twice
twice a
a day
day
Children:
100
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:
Usually
Adults and
and the
the elderly:
elderly: 800
800 micrograms
micrograms (8
(8 puffs)
puffs)
Adults
Children:
400 micrograms
micrograms (4
(4 puffs)
puffs)
Children:
400
The total
total daily
daily dose
dose may
may be
be divided
divided into
into 2,
2, 3
3 or
or 4
4 doses
doses per
per day.
day.
The
Clenil Modulite
Modulite 200
200 micrograms
micrograms
Clenil
The common
common starting
starting dose
dose is:
is:
The
Adults and
and the
the elderly
elderly only:
only: 200
200 micrograms
micrograms (1
(1 puff)
puff) twice
twice a
a day
day
Adults
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:
Usually

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

The total
total daily
daily dose
dose may
may be
be divided
divided into
into 2,
2, 3
3 or
or 4
4 doses
doses per
per day.
day.
The
This product
product strength
strength is
is not
not suitable
suitable for
for children
children
This
Clenil Modulite
Modulite 250
250 micrograms
micrograms
Clenil
The common
common starting
starting dose
dose is:
is:
The
Adults and
and the
the elderly
elderly only:
only: 500
500 micrograms
micrograms (2
(2 puffs)
puffs) twice
twice a
a day
day
Adults
Usually the
the most
most you
you would
would take
take in
in a
a day
day is:
is:
Usually

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

The total
total daily
daily dose
dose may
may be
be divided
divided into
into 2,
2, 3
3 or
or 4
4 doses
doses per
per day.
day.
The
This product
product strength
strength is
is not
not suitable
suitable for
for children
children
This
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.
It
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
Do
your inhaler
inhaler abruptly.
abruptly.
your

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

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
Tell
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
and
in the
the body).
body).
in
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
It
should not
not increase
increase or
or decrease
decrease your
your dose
dose without
without seeking
seeking medical
medical advice.
advice.
should

If you
you forget
forget to
to use
use Clenil
Clenil Modulite:
Modulite:
If

If you
you forget
forget to
to take
take your
your Clenil
Clenil 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.
If
Do not
not take
take more
more puffs
puffs than
than you
you were
were told
told to
to take.
take.
Do
Please read
read back
back of
of this
this leaflet
leaflet
Please
87K89.14/01

Pag. 1/2

TECHNICAL INFORMATION / INFORMAZIONI TECNICHE

37 mm

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
correctly. You must follow their instructions 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

1-2

2

3
3A

3B

7

4
1.

5-6

4A
4B
4C
To remove the mouthpiece cover, hold between the thumb and forefinger, squeeze gently and
pull apart as shown. Check inside and outside to make sure that the mouthpiece is clean,
and that there are no foreign objects.
Testing Your Inhaler: If the inhaler is new or if it has not been used for three days or more,
one puff should be released into the air to make sure that it works.

2.
3.
4.
5.
6.
7.

Hold the inhaler upright as shown, with your thumb on the base, below the mouthpiece.
Breathe out as far as is comfortable.
Place the mouthpiece in your mouth between your teeth and close your lips around it but do
not bite it.
Just after starting to breathe in through your mouth press down on the top of the inhaler to
release a puff while still breathing in steadily and deeply
Hold your breath; take the inhaler from your mouth and your finger from the top of the inhaler.
Continue holding your breath for a few seconds or as long as is comfortable. Breathe out
slowly.
If you are to take another puff, keep the inhaler upright and wait about half a minute before
repeating steps 2 to 5.
After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly
and snap into position.

Important: Do not rush steps 2, 3, 4 and 5.
It is important that you start to breathe in as slowly as possible just before operating the inhaler. Practice
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, Clenil will not
get into your lungs as it should. Take another puff, carefully following the instructions from
Step 2 onwards.
People with weak hands or children may find it easier to hold the inhaler with both hands. Put the two
forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece.
If you find it difficult to operate the inhaler while starting to breathe in you may use the
Volumatic spacer device. Ask your doctor, pharmacist or a nurse about this device.
However, the Volumatic spacer device must always be used if:
• you are an adult, elderly or an adolescent 16 years of age and older and are taking total
daily doses of Clenil Modulite of 1,000 micrograms or more,
• Clenil Modulite is used in children and adolescents 15 years of age and younger, whatever
dose has been prescribed.
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,
nurse or pharmacist if you have any difficulties.
Cleaning:
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.
• Rinse the plastic case and the mouthpiece cover in warm water. If you use a mild liquid
detergent, rinse carefully with clean water before drying. Do not put the metal canister into
water.
• Leave to dry thoroughly in a warm place. Avoid excessive heat.
• Replace the canister and mouthpiece cover.
It is important that you also read the Package leaflet which is supplied with your Volumatic spacer device
and that you follow the instructions on how to use the Volumatic and on how to clean it, carefully.

4. Possible side effects
Like all medicines, Clenil Modulite can cause side effects, although not everybody gets them.
If you notice an immediate increase in wheezing, shortness of breath and cough straight
after using your inhaler, stop using Clenil 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
The
side side
effects
havebut
been
Tell your doctor
soon
asso.
possible
if you will
suffer
fromfollowing
any of these
effects
do reported.
not stop treatment
unless as
told
to do
Your doctor
from
of these
side
effects
do not stop
treatment
to do
so. possible
Your doctor
will
try toany
prevent
these
effects
by but
prescribing
Clenil
Moduliteunless
in thetold
lowest
dose
to control
try
to asthma.
prevent these effects by prescribing Clenil Modulite in the lowest dose possible to control
your
your asthma.



Allergic reactions including skin rashes, hives, itching or redness, or swelling of the face, eyes,
Allergic
lips andreactions
throat. 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
Thrush
in the Thrush
mouth and
Thiswith
is more
likely if medicines
the daily dose
taken
greaterto
than
micrograms.
can throat.
be treated
anti-fungal
whilst
you is
continue
use400
Clenil
micrograms.
Thrushyour
can teeth,
be treated
with anti-fungal
medicines
you continue
to use Clenil
Modulite. Brushing
or throughly
rinsing your
mouth whilst
with water
immediately
Modulite.
Brushing
your
teeth,
or
throughly
rinsing
your
mouth
with
water
immediately
after each dose may help prevent thrush.
after each dose may help prevent thrush.




Hoarse voice or a sore throat or tongue. Using a Volumatic spacer device or rinsing your
Hoarse
voicewater
or a immediately
sore throat orafter
tongue.
Volumatic
devicethis.
or rinsing your
mouth with
usingUsing
your a
inhaler
may spacer
help prevent
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
Changes
to the at
normal
production
the steriods
the body, particularly after treatment with
Clenil Modulite
high doses
over of
a long
period ofintime.
Clenil 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
Ifloss,
you tiredness,
become unwell
or (feeling
developsick),
symptoms
such
as loss
of appetite,
abdominal
pain,
nausea
vomiting
(being
sick),
feeling faint,
sweating
andweight
possible
loss,
tiredness,
nausea
(feeling
sick), your
vomiting
(being
feeling faint,
sweating
andhave
possible
convulsions
(fits),
you should
consult
doctor.
Thissick),
is particularly
important
if you
convulsions
(fits),
you should
consult
yourinfection,
doctor. This
is particularly
if you
have
been exposed
to stress
such as
surgery,
an acute
attack ofimportant
asthma, or
other
serious
been
exposed to stress such as surgery, infection, an acute attack of asthma, or other serious
illness.
illness.
Your doctor may carry out blood test from time to time to monitor the levels of steroids in
Your
your doctor
body. 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
Children
adolescents
mayoccurs
grow more
slowly after
and may
need to
have
their
height checked
regularlyand
by their
doctor. This
particularly
treatment
with
Clenil
Modulite
at high
regularly
by atheir
occurs particularly after treatment with Clenil Modulite at high
doses over
longdoctor.
periodThis
of time.
doses over a long period of time.




A decrease in bone mineral density (thinning and weakening of the bones) and eye problems
A decrease
in the
bone
mineral of
density
(thinning
and weakening
of thepressure
bones) and
eyeeye).
problems
which
include
formation
cataracts
and glaucoma
(increased
in the
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
Sleeping
problems,
depression
feeling worried, restless, nervous, over-excited or irritable. These
effects are
more likely
to occur or
in children.
effects are more likely to occur in children.




Headaches
Headaches




Nausea (feeling sick)
Nausea (feeling sick)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
Iftell
any
of the
sideoreffects
gets serious, or if you notice any side effects not listed in this leaflet, please
your
doctor
pharmacist.
tell your doctor or pharmacist.
Reporting of side effects
Reporting
of side
If you get any
sideeffects
effects talk to your doctor, pharmacist, or nurse. This includes any possible side
Ifeffects
you get
side
talk to
your
pharmacist,
or nurse.
Thisvia
includes
any possible
side at
notany
listed
in effects
this leaflet.
You
candoctor,
also report
side effects
directly
the YellowCard
Scheme
effects
not listed in this leaflet. By
Youreporting
can alsoside
report
side you
effects
via themore
YellowCard
Scheme
www.mhra.gov.uk/yellowcard.
effects
candirectly
help provide
information
on at
www.mhra.gov.uk/yellowcard.
the safety of this medicine. By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Clenil Modulite
5. How to store Clenil Modulite

Keep out of the sight and reach of children.
Keep
out ofafter
the sight
and date
reachwhich
of children.
Do notthis
usemedicine
Clenil Modulite
the expiry
is stated on the carton and label. The
Do
not date
use Clenil
expiry
date which is stated on the carton and label. The
expiry
refers Modulite
to the lastafter
daythe
of that
month.
o
expiry
to the above
last day30ofC.
that
month.from frost and direct sunlight.
Do notdate
storerefers
the inhaler
Protect
o
Do
notinhaler
store the
above
30the
C. metal
Protect
from frost
and
direct
sunlight.
If the
getsinhaler
very cold,
take
canister
out of
the
plastic
case and warm it in your
Ifhands
the inhaler
gets minutes
very cold,
take use.
the metal
out of the
case
and warm it in your
for a few
before
Nevercanister
use anything
elseplastic
to warm
it up.
hands
for ashould
few minutes
before use.
Never
use anything
else to warm
it up.
Medicines
not be disposed
of via
wastewater
or household
waste.
Ask your pharmacist
Medicines
shouldofnot
be disposed
of viarequired.
wastewater
or household
Asktoyour
pharmacist
how to dispose
medicines
no longer
These
measureswaste.
will help
protect
the
how
to dispose of medicines no longer required. These measures will help to protect the
environment.
environment.
Warning: The canister contains a pressurised liquid. Keep away from heat and direct sunlight, do not
Warning:
contains
a pressurised
awayorfrom
and directeven
sunlight,
not
expose to The
highcanister
temperatures
(above
50°C) andliquid.
do notKeep
puncture
burnheat
(incinerate),
whendo
empty.
expose to high temperatures (above 50°C) and do not puncture or burn (incinerate), even when empty.

••


••




6. Further information
6. Further information

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

Is this leaflet hard to see or read?
Is this leaflet hard to see or read?
Phone 0161 488 5555 for help.
Phone
for help.
The leaflet 0161
was last 488
revised5555
in 06/2015

The
leaflet iswas
last revised
in 07/2015
Volumatic
a registered
trademark
of the GlaxoSmithKline Group of Companies.
Volumatic is a registered trademark of the GlaxoSmithKline Group of Companies.
CP0016/9
CP0016/9

87K89.14/01

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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