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ATIMOS MODULITE

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE DIHYDRATE

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TECHNICAL WORKING

DRAFT

1 (Mac - IDcc) DRAFT 2 (Mac - IDcc)

13/07/2015

03/08/2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atimos® Modulite® 12 micrograms/actuation pressurised inhalation solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
Formoterol fumarate dihydrate

Atimos®® Modulite®® 12 micrograms/actuation pressurised inhalation solution
Atimos
Modulite 12 micrograms/actuation pressurised inhalation solution
Read all of this leaflet carefully before you start using this medicine.
-

Keep this leaflet. You may need to read Formoterol
it again.
fumarate dihydrate
If you have any further questions, ask your
doctor, orfumarate
pharmacist.
Formoterol
dihydrate
This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their
Read all
of this leaflet
carefully
before you start using this medicine.
symptoms
are the same
as yours.
Read
all of this
leafletYou
carefully
before
start using this medicine.
this
may
need
to
readyou
itor
again.
-- IfKeep
any of
theleaflet.
side effects
become
serious,
if you notice any side effects not listed in this leaflet, please tell
- your
Keep
this
leaflet.
You may
need toask
readyour
it again.
If youdoctor
have
any
further
questions,
doctor, or pharmacist.
or
pharmacist.
- IfThis
youmedicine
have anyhas
further
questions,
ask
pharmacist.
been
prescribed
foryour
you.doctor,
Do notorpass
it on to others. It may harm them even if their
- This
medicine
symptoms
arehas
thebeen
sameprescribed
as yours. for you. Do not pass it on to others. It may harm them even if their
samebecome
as yours.
In this
leaflet:
- Ifsymptoms
any of theare
sidethe
effects
serious, or if you notice any side effects not listed in this leaflet, please tell
- Ifyour
any
of the or
side
effects become
you
noticefor
any side effects not listed in this leaflet, please tell
1. What
Atimos
Modulite
is andserious,
whatoritifis
used
doctor
pharmacist.
your doctor
or pharmacist.
2. Before
you use
Atimos Modulite

3. How to use Atimos Modulite
In this
leaflet:
4.
Possible
side effects
In
leaflet:
1. this
What
Modulite
is and what it is used for
5.
How
toAtimos
store Atimos
Modulite
1.
What
Atimos
Modulite
and what it is used for
2. Further
Before
you
use
AtimosisModulite
6.
information
2.
Atimos
Modulite
3. Before
How to you
use use
Atimos
Modulite
3.
to use
Atimos
Modulite
4. How
Possible
side
effects
4.
Possible
sideModulite
effects Modulite
1.
is and what it is used for
5. What
How Atimos
to store
Atimos
5.
to store
Atimos Modulite
6. How
Further
information
6. Further
information
Atimos
Modulite
is an inhalation medicine delivering its active ingredient directly into your lungs where it is

needed. It is used to treat the symptoms of wheezing and breathlessness in patients with moderate to severe
1. WhatItsAtimos
Moduliteformoterol
is and what
it is used
forto a group of medicines called bronchodilators: they
asthma.
active ingredient,
fumarate,
belongs
1.
What
Atimos
Modulite
is
and
what
it
is
used
for
make breathing easier by relaxing muscle spasms in the air passages of the lungs. Regular use of Atimos
Modulite
togetheriswith
steroids (either
by inhaler
or byitsmouth),
will help todirectly
preventinto
breathing
problems
Atimos Modulite
an inhalation
medicine
delivering
active ingredient
your lungs
whereover
it is the
long
term.
Atimos
Modulite
is to
antreat
inhalation
medicineofdelivering
active
ingredient directly
into your
where
it is
needed.
It is used
the symptoms
wheezingitsand
breathlessness
in patients
with lungs
moderate
to severe
needed.
used ingredient,
to treat the formoterol
symptoms fumarate,
of wheezing
and breathlessness
in patientscalled
with moderate
to severe
asthma. It
Itsisactive
belongs
to a group of medicines
bronchodilators:
they
asthma.
Its active
ingredient,
formoterol
fumarate,
belongs
a group ofofmedicines
bronchodilators:
they
make breathing
easier
bybe
relaxing
muscle
spasms
in the airtosuch
passages
thewheezing
lungs. called
Regular
use of Atimos
Atimos
Modulite
can
also
used
for
the
relief
of
symptoms
as
cough,
and
shortness
of
breath
in
make
breathing
easier
by relaxing
muscle
spasms
the
air passages
lungs.breathing
Regular use
of Atimos
Modulite
together
with
steroids
(either
by inhaler
orinby
mouth),
will helpoftothe
prevent
problems
over the
patients
with
chronic
obstructive
pulmonary
disease
(COPD)
who
regular bronchodilator
Modulite
together
with
steroids (either
by inhaler
or by
mouth),
willrequire
help tolong-term
prevent breathing
problems over the
long
term.
therapy.
long term.
Atimos
Modulite
can also
be used
for the relief of symptoms such as cough, wheezing and shortness of breath in
2.
Before
you use
Atimos
Modulite

Atimos
can also
be usedpulmonary
for the relief
of symptoms
cough,
wheezing
and shortness
of breath in
patientsModulite
with chronic
obstructive
disease
(COPD)such
who as
require
long-term
regular
bronchodilator
patients
therapy. with chronic obstructive pulmonary disease (COPD) who require long-term regular bronchodilator
Do
not use Atimos Modulite:
therapy.
• if you are allergic to formoterol or to any of the ingredients of Atimos Modulite.
2. to
Before
you
use Atimos
Modulite
•2.
treat ayou
sudden
of Modulite
breathlessness. It will not help. Use a reliever for this purpose and
Before
use attack
Atimos
carry it with you at all times.
Do not use Atimos Modulite:
Do
use
Modulite:
• ifnot
you
areAtimos
allergic
to formoterol
or to any of the
ingredients
of Atimos
Modulite.
Take
special
care with
Atimos Modulite
always
tell your
doctorModulite.
if you:
• iftoyou
area allergic
toattack
formoterol
or to anyand
of the
ingredients
of Atimos
treat
sudden
of breathlessness.
It
will not
help.
Use aa reliever
for
this purpose and
•• to
suffer
from
severe
heart
disease,
especially
a
recent
heart
attack,
disease
of the
vessels
treat
a sudden
attack
of breathlessness. It will not help. Use a reliever for
this coronary
purpose and
carry
it
with
you
at
all
times.
of
the
heart
or
severe
weakness
of
the
heart
muscle
(congestive
heart
failure)
carry it with you at all times.
• suffer from disorders of heart rhythm such as increased heart rate, heart valve defect or certain
electrocardiogram
abnormalities
or any other
heart disease
Take
special care with
Atimos Modulite
and always
tell your doctor if you:
the arteries,
ordoctor
abnormal
widening
the vessel
wall
•Take
narrowing
of
the
blood
vessels,
especially
special
with
Atimos
Modulite
and always
tell
your
if you:
• have
suffer
fromcare
severe
heart
disease,
especially
a recent
heart
attack,
a disease
of the of
coronary
vessels
•• suffer
blood
pressure
suffer
from
severe
heart
disease, of
especially
recent heart
attack,heart
a disease
of the coronary vessels
the heartamuscle
(congestive
failure)
of the from
hearthigh
or severe
weakness
•• have
sugar
levelsofweakness
inheart
the blood
of
thehigh
heart
or severe
of(diabetes
the
heart
muscle
(congestive
heart
failure)
suffer
from
disorders
rhythm
such
asmellitus)
increased
heart rate,
heart
valve defect or certain
•• have
low
blood
potassium
levels
suffer
from
disorders
of heart
rhythm
such
as heart
increased
heart rate, heart valve defect or certain
electrocardiogram
abnormalities
or any
other
disease
•• have
overactive
thyroid
gland
electrocardiogram
or any
other heart
have an
narrowing
of abnormalities
the
blood
vessels,
especially
thedisease
arteries, or abnormal widening of the vessel wall
•• are
suffering
from
epinephrine
and nor-epinephrine
of widening
the adrenal
arteries, ortumours
abnormal
of medulla
the vessel wall
have
narrowing
of
the blood
vessels,
especially the producing
suffer
from high
blood
pressure
•• are
going
haveblood
any surgery
or receive
halogenated
suffer
fromtosugar
high
pressure
have
high
levels
in the blood
(diabetes
mellitus)anaesthetics
• have high
sugarpotassium
levels in the
blood (diabetes mellitus)
low blood
levels
• have low
blood potassium
an overactive
thyroid levels
gland
Taking
other
medicines:
• have
an overactive
thyroid gland
are
suffering
from
epinephrine
and
nor-epinephrine
producing
tumours
of the adrenal medulla
Tell
yoursuffering
doctor or
pharmacist
if you
arenor-epinephrine
taking or have recently
taken
any other
including medicines
• are
from
epinephrine
and
producing
tumours
of themedicines
adrenal medulla
going
to have
any
surgery or
receive halogenated
anaesthetics
obtained
without
prescription.
• are going to have any surgery or receive halogenated anaesthetics

Takingmedicines
other medicines:
Some
may interfere with the action of Atimos Modulite, these include medicines:
Taking
other
medicines:
Tellfor
your
doctor
or pharmacist
if you are(for
taking
or have
recently taken any other
medicines including medicines
procainamide)
•Tell
treating
abnormal
heart ifrhythms
example
quinidine,
your doctor
orprescription.
pharmacist
you are taking
or have
recentlydisopyramide,
taken any other
medicines including medicines
obtained
without
•obtained
for treating
heart
disease
(for
example
digitalis)
without prescription.
• for treating nasal congestion (for example ephedrine)
•Some
called
beta adrenergic
blockers
to treatofheart
conditions
glaucoma
(anmedicines:
increase of the
medicines
may interfere
withused
the action
Atimos
Modulite,orthese
include
in the
eye),
as
tablets
eye
drops
Some
may
interfere
withorthe
action
of Atimos
Modulite,
these include
medicines:
disopyramide,
procainamide)
• pressure
for medicines
treating
abnormal
heart
rhythms
(for
example
quinidine,
•• containing
(used
to treat
for treatingerythromycin
abnormal
heart
rhythms
(forinfections)
example quinidine, disopyramide, procainamide)
heart disease
(for
example
digitalis)
•• for
of depression:
monoamine
oxidase inhibitors (for example phenelzine
for treating
treating symptoms
heart
(for (for
example
digitalis)
nasal disease
congestion
example
ephedrine)
isocarboxazid)
or tricyclic
antidepressants
(for example
amitryptiline
and
imipramine)
• and
for
treating
congestion
(for
example
ephedrine)
called
beta nasal
adrenergic
blockers
used
to treat
heart
conditions
or glaucoma
(an
increase of the
•• to
treatbeta
severe
disorders
(for
example
chlorpromazine
trifluperazine)
called
blockers
used
todrops
treat heart
conditions and
or glaucoma
(an increase of the
pressure
in adrenergic
themental
eye), as
tablets or
eye
•• used
to treat
allergic
anti-histamines, for example terfenadine, astemizole, mizolastine)
pressure
in erythromycin
the
eye), reactions
as tablets
or treat
eyeasdrops
containing
(used(such
to
infections)
•• used
to treat
bronchial of
asthma
(for
example
theophylline,
steroids)
containing
erythromycin
(used
to treat
infections)
for treating
symptoms
depression:
monoamine
oxidaseaminophylline
inhibitors (for or
example
phenelzine
•• used
to increase
urine
production
(such
as diuretics)
for
symptoms
of
depression:
monoamine
inhibitors
(for example
phenelzine
andtreating
isocarboxazid)
or tricyclic
antidepressants
(foroxidase
example
amitryptiline
and imipramine)
•• for
treating
Parkinsonism
(for example
levodopa)
and
isocarboxazid)
or tricyclic
antidepressants
(for example amitryptiline
and imipramine)
to treat
severe
mental
disorders
(for example
chlorpromazine
and trifluperazine)
•• containing
oxytocin,
which
causes
uterus
contraction.
to
treat
mental
disorders
(for
example
chlorpromazine
and trifluperazine)
used
tosevere
treat
allergic
reactions
(such
as anti-histamines,
for example
terfenadine, astemizole, mizolastine)
•• to
treat
underactive
thyroid
(for
example
thyroxine)
used
toan
treat
allergic
reactions
(such
as anti-histamines,
for
example terfenadine,
astemizole, mizolastine)
bronchial
asthmagland
(for example
theophylline,
aminophylline
or steroids)
• used to treat
bronchial
(for(such
example
theophylline, aminophylline or steroids)
increase
urine asthma
production
as diuretics)
The
addition
of Parkinsonism
anticholinergics
as tiotropium
or ipratropium bromide) to the treatment with Atimos Modulite
• used
to increase
urine production
(such
as diuretics)
for
treating
(for(such
example
levodopa)
can
help
to open
your airways
even
more.
• for
treating
Parkinsonism
example
levodopa)
containing
oxytocin,
which(for
causes
uterus
contraction.
• containing
which
causes
uterus
contraction.
to treat an oxytocin,
underactive
thyroid
gland
(for example
thyroxine)
• to treat an underactive thyroid gland (for example thyroxine)
Other special warnings:
The
addition
of anticholinergics
(such
as tiotropium
or
ipratropium
bromide)
to the
treatment
with Atimos
Modulite
•The
You
have also
been prescribed
corticosteroids
foror
your
breathingbromide)
problems.
is treatment
very important
to
addition
of anticholinergics
(such
as tiotropium
ipratropium
to It
the
with Atimos
Modulite
cankeep
help
to open
your
airways Do
even
more.
using
these
regularly.
not
stop
using
them
or
change
the
dose
when
you
start
using
Atimos
Modulite.
can help to open your airways even more.
Other special
warnings:
Pregnancy
andwarnings:
breast feeding:
Other
special
Youare
have
also been
prescribed corticosteroids
for your
breathing
problems.
It is very
important
to
If•• you
pregnant
or breast-feeding,
or could become
pregnant,
talkproblems.
to your doctor
before
using Atimos
Modulite.
You
have
also
been
prescribed
your
It isyou
very
important
to
keep
using
these
regularly.
Do corticosteroids
not stop usingfor
them
orbreathing
change the
dose when
start
using Atimos
Modulite.
keep using these regularly. Do not stop using them or change the dose when you start using Atimos Modulite.
The use of Atimos Modulite during pregnancy is only indicated if absolutely necessary.
Pregnancy and breast feeding:
Pregnancy
and breast
feeding:
If you are pregnant
or breast-feeding,
or could become pregnant, talk to your doctor before using Atimos Modulite.
you are
are breast-feeding,
pregnant or breast-feeding,
or could
become
pregnant,
talk to your doctor before using Atimos Modulite.
talk to your doctor
before
using
Atimos Modulite.
IfIf you
The use of Atimos Modulite during pregnancy is only indicated if absolutely necessary.
The useand
of Atimos
during pregnancy is only indicated if absolutely necessary.
Driving
usingModulite
machines:
Atimos Modulite is unlikely to have any effect on the ability to drive and operate machinery.
If you are breast-feeding, talk to your doctor before using Atimos Modulite.
If you are breast-feeding, talk to your doctor before using Atimos Modulite.
Important information about some of the ingredients of Atimos Modulite:
DrivingModulite
and using
machines:
Atimos
contains
a small amount of alcohol: each puff of your inhaler contains about 9 mg of ethanol.
Driving
and using
machines:
Atimos Modulite
is unlikely
to have any effect on the ability to drive and operate machinery.
Atimos Modulite is unlikely to have any effect on the ability to drive and operate machinery.

3.
How to information
use Atimosabout
Modulite
some of the ingredients of Atimos Modulite:
Important

about
some
of the
Atimos
Modulite:
Important
information
of your
inhaler contains about 9 mg of ethanol.
Atimos Modulite
contains
a small
amount
of ingredients
alcohol: eachofpuff
Atimos Modulite contains a small amount of alcohol: each puff of your inhaler contains about 9 mg of ethanol.
Dosage:

3. How to use Atimos Modulite

For
Asthma:
3. How
to use Atimos Modulite
The dose of Atimos Modulite you must inhale will depend on the type of asthma you have and how severe it is.
Your
dose
Dosage: will be decided by your doctor and it is important that you only take the prescribed dose, regularly.
Dosage:
For usual
Asthma:
The
dose for adults, including the elderly and adolescents 12 years and older is 1 puff in the morning and 1
For
Asthma:
Thein
dose
of
AtimosThis
Modulite
you
must
inhale
will adepend
on
the type
of
asthma youofhave
andModulite
how severe
it is.
puff
the
evening.
means
you
need
to take
total ofon
2 the
puffs
(24of
micrograms)
Atimos
per itday.
The
Atimos
Modulite
inhale
type
you
have
anddose,
how severe
is.
Yourdose
doseofwill
be decided
by you
yourmust
doctor
and will
it is depend
important
that you
onlyasthma
take the
prescribed
regularly.
Your dose will be decided by your doctor and it is important that you only take the prescribed dose, regularly.
If you suffer from more severe asthma your doctor may prescribe 4 puffs per day (48 micrograms), 2 puffs in the
The usual
dose
for adults,
including the elderly and adolescents 12 years and older is 1 puff in the morning and 1
morning
and
2 puffs
in the evening.
The
for adults,
including
elderly
and
adolescents
12(24
years
and older is
puff inModulite
the morning
and 1
puff usual
in the dose
evening.
This means
you the
need
to take
a total
of 2 puffs
micrograms)
of 1Atimos
per day.
puff in the evening. This means you need to take a total of 2 puffs (24 micrograms) of Atimos Modulite per day.
4 puffs (48 micrograms) of Atimos Modulite is the maximum daily dose and it is important that you do not take
If you than
sufferthe
from
more
severe
asthma
your
doctor
may
prescribe
4 puffs per day (48 micrograms), 2 puffs in the
more
total
dailysevere
dose that
youryour
doctor
has may
told you
to take.
Ifmorning
you suffer
more
asthma
doctor
prescribe
4 puffs per day (48 micrograms), 2 puffs in the
andfrom
2 puffs
in the evening.
morning and 2 puffs in the evening.
This product is not suitable for asthmatic children under 12 years old.
4 puffs (48 micrograms) of Atimos Modulite is the maximum daily dose and it is important that you do not take
4more
puffsthan
(48 micrograms)
Atimos
is the
maximum
the total dailyofdose
thatModulite
your doctor
has
told you todaily
take.dose and it is important that you do not take
more
than theObstructive
total daily dose
that yourDisease
doctor has
told you to take.
For
Chronic
Pulmonary
(COPD):
The usual dose for adults, including the elderly and adolescents 18 years and older is 1 puff in the morning and 1
This product
is not suitable
for
asthmatic
children
under
12 years
old.
puff
the evening.
meansfor
you
need to take
a totalunder
of 2 puffs
(24 micrograms)
of Atimos Modulite per day.
Thisinproduct
is notThis
suitable
asthmatic
children
12 years
old.
For
Obstructive
Pulmonary
(COPD):
Disease
IfFor
youChronic
suffer from
more severe
COPD your
doctor(COPD):
may prescribe 4 puffs per day (48 micrograms), 2 puffs in the
Obstructive
Pulmonary
elderly and
adolescents 18 years and older is 1 puff in the morning and 1
The Chronic
usual
dose
for adults,
including theDisease
morning
and
2
puffs
in
the
evening.
elderly
and
adolescents
18(24
years
and older is
puff inModulite
the morning
and 1
The
for adults,
including
puff usual
in the dose
evening.
This means
you the
need
to take
a total
of 2 puffs
micrograms)
of 1Atimos
per day.
puff in the evening. This means you need to take a total of 2 puffs (24 micrograms) of Atimos Modulite per day.
4 puffs (48 micrograms) of Atimos is the maximum daily dose and it is important that you do not take more
If youthe
suffer
from
more
severe
COPD
your
doctor
may prescribe
4 puffs per day (48 micrograms), 2 puffs in the
take.
than
totalfrom
dailymore
dosesevere
that your
doctor
has
told you
Ifmorning
you suffer
COPD
your
doctor
maytoprescribe
4 puffs per day (48 micrograms), 2 puffs in the
and 2 puffs
in the evening.
morning and 2 puffs in the evening.
Do not take more than 2 puffs at any one time.
4 puffs (48 micrograms) of Atimos is the maximum daily dose and it is important that you do not take more
4than
puffs
micrograms)
Atimos
is the maximum
dose and it is important that you do not take more
to take.
the(48
total
daily dose of
that
your doctor
has told youdaily
to take.
than product
the total daily
that your
doctor patients
has told you
This
is notdose
suitable
for COPD
under
18 years old.
Do not take more than 2 puffs at any one time.
Do not
not take
more than
2 puffs to
at any
time. attack of breathlessness. You should use a “reliever” inhaler
Do
use Atimos
Modulite
treatone
a sudden
prescribed by your doctor for this purpose, carry this medicine with you at all times.
This product is not suitable for COPD patients under 18 years old.
This product is not suitable for COPD patients under 18 years old.
If you use more Atimos Modulite than you should:
Do not
use
Atimos
Modulite
to
treat a sudden
attack
of breathlessness.
You should
use a “reliever”
inhaler
You
mayuse
notice
that your
heart to
is treat
beating
faster than
usual
that you feel shaky.
You may
have a inhaler
Do
not
Atimos
Modulite
a sudden
attack
ofand
breathlessness.
should
usealso
a “reliever”
prescribed
by
yourfeeling
doctor
for this
purpose,
carry this
medicine
with
yousleepy.
at all You
times.
and
being
sick
(nausea
and
vomiting)
or
feel
Contact
your
doctor
as
soon
as
headache,
tremor,
prescribed by your doctor for this purpose, carry this medicine with you at all times.
possible for advice.
If you use more Atimos Modulite than you should:
If
you
usenotice
morethat
Atimos
Modulite
than you
should:
You
may
your
heart
is beating
faster
than usual and that you feel shaky. You may also have a
IfYou
you
forget
to that
use your
Atimos
Modulite:
may
notice
heart
is beating
faster than
usual
and that
yousleepy.
feel shaky.
You your
may doctor
also have
a
feeling
and being
sick take
(nausea
and
vomiting)
or feel
Contact
as soon
as
headache,
tremor,
Ifheadache,
you forgettremor,
to use feeling
your Atimos
Modulite,
it
asand
soon
as you remember.
If it Contact
is
almostyour
timedoctor
for your
and being sick (nausea
vomiting)
or feel sleepy.
as next
soondose,
as
possible
for
advice.
do
not take
dose you have missed, just take the next dose at the usual time. Do not double the dose.
possible
forthe
advice.
If you
forget
toreduce
use Atimos
Modulite:
Do
notforget
stop or
the dose
of Atimos Modulite or any other medicine for your breathing just because you
If you
touse
useyour
Atimos
Modulite:
you
forget
to
Atimos
Modulite,
takeIt itisas
soon
as you remember.
it is almostregularly.
time for your next dose,
without
talking
to
your
doctor first.
very
important
to use theseIfIf medicines
feel
better,
Ifdoyou
to use
your
Modulite,
take
it as
youatremember.
it isDo
almost
time for the
yourdose.
next dose,
notforget
take the
dose
youAtimos
have missed,
just
take
thesoon
next as
dose
the usual time.
not double
do not take the dose you have missed, just take the next dose at the usual time. Do not double the dose.
Do not increase your dose of Atimos Modulite without talking to your doctor first.
Do
not
stop
or
reduce
the
dose of Atimos
Modulite
or
any Atimos
other medicine
for your
breathing
just to
because
you
IfDo
you
feel
youor
are
gettingthe
breathless
or wheezy
whileor
using
Modulite,
should
continue
use Atimos
stop
reduce
dose
Atimos
Modulite
any other
medicine
foryou
your
breathing
just because
you
without
talking
todoctor
your of
doctor
first.
Itpossible,
is very
important
to
useadditional
these
medicines
regularly.
feelnot
better,
Modulite
but
go
to
see
your
as
soon
as
you
may
need
treatment.
Once
your
asthma
is
feel better, without talking to your doctor first. It is very important to use these medicines regularly.
well controlled, your doctor may consider it appropriate to gradually reduce the dose of Atimos Modulite.
Do not increase your dose of Atimos Modulite without talking to your doctor first.
Do
notfeel
increase
dose
of Atimosor
Modulite
talking
to your
doctor first.
If you
you areyour
getting
breathless
wheezywithout
while using
Atimos
Modulite,
you should continue to use Atimos
IfModulite
you feelbut
yougoare
breathless
wheezy
while using
Modulite,
you treatment.
should continue
useasthma
Atimosis
to getting
see your
doctor asorsoon
as possible,
youAtimos
may need
additional
Once to
your
Modulite
but go your
to see
your may
doctor
as soonit as
possible, to
you
may need
additional
treatment.
Once
your asthma is
well controlled,
doctor
consider
appropriate
gradually
reduce
the dose
of Atimos
Modulite.
well controlled, your doctor may consider it appropriate to gradually reduce the dose of Atimos Modulite.

Please read back of this leaflet
87H03.08/01

Please read back of this leaflet
Please read back of this leaflet
PAG. 1/2

TECHNICAL WORKING

DRAFT

1 (Mac - IDcc) DRAFT 2 (Mac - IDcc)

13/07/2015

03/08/2015

Instructions for use:
It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you how
Instructions
for use:
to
use your inhaler
correctly. You must follow their instructions carefully so that you know how, when and how
It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you how
many
puffs
to
inhale.
The correct
instructions
are given
in this carefully
leaflet. If so
youthat
areyou
not know
sure what
do orand
have
to use your inhaler correctly.
You must
follow their
instructions
how,towhen
how
problems
in to
inhaling
yourinstructions
doctor, nurse
pharmacist
for advice.
many
puffs
inhale.then
The ask
correct
areorgiven
in this leaflet.
If you are not sure what to do or have
problems in inhaling then ask your doctor, nurse or pharmacist for advice.
Testing your inhaler. If your inhaler is new or if it has not been used for 3 days or more, one puff should be
released into the air before using it, to make sure that it works.
Testing your inhaler. If your inhaler is new or if it has not been used for 3 days or more, one puff should be
released into the air before using it, to make sure that it works.
You should stand or sit in the upright position when using your inhaler.
You
should stand
or sit in thecover
upright
position
when and
using
your
inhaler. the thumb and forefinger as
1. Remove
the mouthpiece
from
the inhaler
hold
it between
shown.
1. Remove the mouthpiece cover from the inhaler and hold it between the thumb and forefinger as
2. Breathe out as far as is comfortable.
shown.
3. Hold the inhaler upright as shown with your thumb on the base below the mouthpiece; place the
2. Breathe out as far as is comfortable.
mouthpiece in your mouth between your teeth and close your lips tightly around it.
3. Hold the inhaler upright as shown with your thumb on the base below the mouthpiece; place the
4. Breathe in deeply through your mouth and at the same time press down on the top of the inhaler to
mouthpiece in your mouth between your teeth and close your lips tightly around it.
release a puff.
4. Breathe in deeply through your mouth and at the same time press down on the top of the inhaler to
5. Hold your breath as long as is comfortable, then take the inhaler from your mouth.
release a puff.
6. If you are to take another puff, keep the inhaler upright and wait about half a minute before
5. Hold your breath as long as is comfortable, then take the inhaler from your mouth.
repeating steps 2 to 5.
6. If you are to take another puff, keep the inhaler upright and wait about half a minute before
7. After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly and snap
repeating steps 2 to 5.
into position.
7. After use always replace the mouthpiece cover to keep out dust and fluff. Replace firmly and snap
into position.

1
11

1-2

2
2
2

3B

3A

3
3
3
7
7
7

4
4
4

4A

5-6
5-6
5-6

4C

4B

IImportant: Do not rush steps 2, 3, 4 and 5.
IItmportant:
Dothat
notyou
rush
steps
2, 3, 4 and
is important
start
to breathe
in as5.slowly as possible just before operating the inhaler.

It is important that you start to breathe in as slowly as possible just before operating the inhaler.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Atimos Modulite will not
get into your lungs as it should. Take another puff, carefully following the instructions from Step 2
If
you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Atimos Modulite will not
onwards.
get into your lungs as it should. Take another puff, carefully following the instructions from Step 2
onwards.
If you have weak hands it may be 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 have weak hands it may be easier to hold the inhaler with both hands. Put the two forefingers on top of the
below
theany
mouthpiece.
the bottom
inhaler
both nurse
thumbs
Tell yourand
doctor,
or on
pharmacist
if you
have
difficulties.
Tell your doctor, nurse or pharmacist if you have any difficulties.
Cleaning:
It is important to clean your inhaler regularly, at least once or twice a week to ensure that it works properly.
•Cleaning:
Pull the metal canister out of the plastic case of the inhaler and remove the mouthpiece cover.
important
to clean
your
inhaler
regularly, atcover
leastinonce
or water.
twice a week to ensure that it works properly.
•It isRinse
the plastic
case
and
the mouthpiece
warm
Pullnot
theput
metal
out of the
•• Do
the canister
metal canister
intoplastic
water. case of the inhaler and remove the mouthpiece cover.
Rinse the
plastic
case and
mouthpiece
cover
in warm water.
•• Leave
to dry
thoroughly
in athe
warm
place. Avoid
excessive
heat.
Do not put
metal canister
into water.
•• Replace
thethe
canister
and mouthpiece
cover.
• Leave to dry thoroughly in a warm place. Avoid excessive heat.
• Replace the canister and mouthpiece cover.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
4. Possible side effects

Like all medicines Atimos Modulite can cause side effects although not everybody gets them. Possible side effects
are listed below according to their frequency. If you are not sure what the side effects below are, ask your doctor
Like
all medicines
to
explain
them to Atimos
you. Modulite can cause side effects although not everybody gets them. Possible side effects
are listed below according to their frequency. If you are not sure what the side effects below are, ask your doctor
to explain them to you.
If your breathing or wheezing gets worse after using your inhaler stop using Atimos Modulite and tell
your doctor immediately. This is caused by narrowing of the airways in your lungs, but it only occurs rarely.
If your breathing or wheezing gets worse after using your inhaler stop using Atimos Modulite and tell
your doctor immediately. This is caused by narrowing of the airways in your lungs, but it only occurs rarely.
Common side effects which may affect up to 1 in 10 people are: unusually fast heart beat and palpitations,
cough, trembling (fine tremor), headache.
Common side effects which may affect up to 1 in 10 people are: unusually fast heart beat and palpitations,
cough, trembling (fine tremor), headache.
Uncommon side effects which may affect fewer than 1 in 100 people are: muscle cramps, pain in muscles,
nausea, agitation, restlessness, sleep disorders, dizziness, abnormal or impaired sense of taste, throat irritation,
Uncommon
side
effects
which
may affect
fewer
thanwith
1 in increase
100 people
are:
muscle
cramps,
in muscles,
of potassium in
abnormal
rapid
heart
beat,
disorders
of heart
rhythm
heart
rate,
abnormal
lowpain
levels
nausea, agitation, restlessness, sleep disorders, dizziness, abnormal or impaired sense of taste, throat irritation,
the
blood,
increase
in
blood
sugar
levels,
increase
in
the
blood
level
of
insulin,
free
fatty
acids,
glycerol
and
in
abnormal rapid heart beat, disorders of heart rhythm with increase heart rate, abnormal low levels of potassium
ketones,
sweating.
the
blood,excessive
increase in
blood sugar levels, increase in the blood level of insulin, free fatty acids, glycerol and
ketones, excessive sweating.
Rare side effects which may affect fewer than 1 in 1,000 people are: missed heartbeats caused by too early
contraction of the ventricles of the heart, feeling chest tightness, increase or decrease in blood pressure,
Rare side immediately
effects whichafter
mayusing
affectthe
fewer
than severe
1 in 1,000
people
missedinflammation
heartbeats caused
by too early
wheezing
inhaler,
fall in
bloodare:
pressure,
of the kidneys,
allergic
contraction
of as
theitching,
ventricles
of bronchospasm,
the heart, feelingurticaria,
chest tightness,
or mucous
decreasemembrane
in blood pressure,
reaction
such
rash,
swelling increase
of skin and
persisting for
wheezing
immediately after using the inhaler, severe fall in blood pressure, inflammation of the kidneys, allergic
several
days.
reaction such as itching, rash, bronchospasm, urticaria, swelling of skin and mucous membrane persisting for
several days.
Very rare side effects which may affect fewer than 1 in 10,000 people are: worsening of asthma, difficulty
breathing, swelling of the hands and/or feet, irregular heartbeat, reduced number of blood platelets,
Very rare side effects which may affect fewer than 1 in 10,000 people are: worsening of asthma, difficulty
hyperexcitability,
abnormal
behaviour,
breathing,
swelling
of the hands
and/orhallucinations.
feet, irregular heartbeat, reduced number of blood platelets,
hyperexcitability, abnormal behaviour, hallucinations.
Some side effects, such as tremor, nausea, abnormal or impaired sense of taste, throat irritation, excessive
sweating,
restlessness,
headache,
dizziness
and muscle
cramps, sense
may ease
during
the course
of excessive
one to two
of taste,
throat
irritation,
Some
effects, such
asyour
tremor,
nausea,
abnormal
or impaired
weeks side
of continued
use of
asthma
medication.
sweating, restlessness, headache, dizziness and muscle cramps, may ease during the course of one to two
weeks of continued use of your asthma medication.
Reporting of side effects
Reporting of side effects
If you experience any of the side effects and it causes you distress, is severe or lasts several days, or if you feel
unwell or notice anything unusual or a side effect which is not mentioned in this leaflet, you should contact your
If you experience
anyimmediately.
of the side effects and it causes you distress, is severe or lasts several days, or if you feel
doctor
or pharmacist
unwell or notice anything unusual or a side effect which is not mentioned in this leaflet, you should contact your
doctor
oralso
pharmacist
immediately.
You can
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.
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
Atimos
Modulite

5. How to store Atimos Modulite














Keep out of the reach and sight of children.
Keep out of the reach and sight of children.
Do not use beyond three months from the date you get the inhaler from your pharmacist and never use 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 use beyond three months from the date you get the inhaler from your pharmacist and never use 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 30°C.
Do not store the inhaler above 30°C.
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.
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.
Warning: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do
not pierce the canister.
Warning: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do
not pierce the canister.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
6. Further information

What Atimos Modulite contains:
The active substance of Atimos Modulite is formoterol fumarate dihydrate. Each metered actuation provides 12
What Atimos
micrograms
ofModulite
formoterolcontains:
fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms.
The other
activeingredients
substance of
Atimos
Moduliteacid,
is formoterol
fumarate
dihydrate.
Each metered actuation provides 12
The
are:
hydrochloric
ethanol and
norflurane
(HFA 134a).
micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms.
The other ingredients are: hydrochloric acid, ethanol and norflurane (HFA 134a).
What Atimos Modulite looks like and contents of the pack:
Atimos Modulite is a pressurised inhalation solution contained in an aluminium canister with plastic actuator and
What Atimos
protective
cap.Modulite looks like and contents of the pack:
Atimos
Modulite
is a1pressurised
inhalation solution contained in an aluminium canister with plastic actuator and
Each
pack
contains
inhaler which
provides 50, 100 or 120 puffs.
protective cap.
Each pack contains 1 inhaler which provides 50, 100 or 120 puffs.
Marketing Authorisation Holder:
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.
Marketing Authorisation Holder:
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.
Manufacturer:
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy
Manufacturer:
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy
This medicinal product has been authorised in the member states of the EEA under the following names:
the EEA under
the following names:
This
medicinal
product has beenBelgium
authorised in the
member states of
Austria
FORADIL
ATIMOS
Portugal
ATIMOS
Austria

FORADIL

Belgium

ATIMOS

Portugal

ATIMOS

Austria
France
France

FORADIL
ATIMOS
ATIMOS

Belgium
Holland
Holland

ATIMOS
ATIMOS

Portugal
Slovenia
Slovenia

ATIMOS
ATIMOS

France
Germany

ATIMOS
ATIFOR CHIESI

Holland
UK

ATIMOS
Poland
ATIMOS MODULITE Slovenia

ATIMOS
ATIMOS

Germany
Greece

ATIFOR CHIESI
FORADIL

UK
Poland
Czech
Republic ATIMOS MODULITE Estonia

Greece
Spain

FORADIL
Czech Republic
BRONCORAL
NEO Slovak
Republic ATIMOS

Estonia
Latvia

ATIMOS
ATIMOS

Spain

BRONCORAL NEO Slovak
Republic ATIMOS
Hungary
Hungary
ATIMOS

Latvia
Lithuania
Lithuania

ATIMOS
ATIMOS

ATIMOS

Lithuania

ATIMOS

Hungary

ATIMOS

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
Is
this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in 09/2015
This leaflet was last revised in 09/2015
This leaflet was last revised in 09/2015
CP0015/7
CP0015/7

87H03.08/01

PAG. 2/2

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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