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PULVINAL SALBUTAMOL 200MCG/METERED DOSE INHALATION POWDER

Active substance(s): BECLOMETASONE DIPROPIONATE / SALBUTAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pulvinal® Salbutamol 200 micrograms
per metered dose inhalation powder
salbutamol

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

In this leaflet:
1. What Pulvinal Salbutamol is and what it is used for
2. Before you use Pulvinal Salbutamol
3. How to use Pulvinal Salbutamol
4. Possible side effects
5. How to store Pulvinal Salbutamol
6. Further information
1. What Pulvinal Salbutamol is and what it is used for
Pulvinal Salbutamol inhalation powder is used to help relieve the symptoms of
mild, moderate and severe asthma, other chest illnesses and to avoid asthma
symptoms brought on by exercise or other ‘triggers’. Common ‘triggers’ include
pollen, cigarette smoke, house dust, cats and dogs.
The active ingredient, salbutamol, is one of a group of medicines called
bronchodilators or ‘relievers’. Salbutamol relaxes the muscles in the walls of the
small air passages in the lungs. This helps to open up the airways and so helps to
relieve chest tightness, wheezing and cough so that you can breathe more easily.

2. Before you use Pulvinal Salbutamol
Do not use Pulvinal Salbutamol:
• if you are allergic to salbutamol or any of the other ingredients contained in
your inhaler
• to treat premature labour or a threatened miscarriage.
Take special care with Pulvinal Salbutamol and always tell your doctor if:
• you suffer from an over active thyroid gland
• your asthma seems to be getting worse. Perhaps you are more wheezy or
short of breath than usual, your inhaler seems to be less effective, you
require more puffs from your inhaler than usual, or you do not seem to be
getting better. Your doctor will re-assess your asthma and may change your
treatment or give you an extra medicine.
• you suffer from any disease of the heart or if your symptoms appear to be
getting worse
• you experience chest pains
Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines obtained without a
prescription.
Remember to take these medicines and your inhalers with you if you have to go
into hospital.
In particular, tell your doctor if you are taking:
• beta-blockers (such as propanolol) or water tablets (diuretics), used to treat
high blood pressure or a heart condition
• theophylline, aminophylline or steroids, used to treat asthma.
• antidepressants, particularly monoamine oxidase inhibitors
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or could become pregnant, talk to your
doctor before using your inhaler.
Important information about some of the ingredients of Pulvinal Salbutamol
Pulvinal Salbutamol contains lactose monohydrate. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before
using this medicinal product.

3. How to use Pulvinal Salbutamol
Always use your inhaler exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure. Instructions for using your
inhaler are given after the dosage section. Do not stop using your inhaler unless
told to do so by your doctor.
Pulvinal Salbutamol must be used for the relief of your asthma symptoms only.
You may have other medicines which you take regularly to prevent the symptoms
of your asthma.
While you are using Pulvinal Salbutamol your doctor will want to check your
asthma regularly by carrying out simple breathing tests and may need to carry out
blood tests from time to time (see also Section 4 - Possible side effects).
Dosage
Adults, adolescents aged 12 years and over, and children 4 to 11 years of age
Take one puff (200 micrograms), for the relief of asthma symptoms such as
wheezing or shortness of breath.
To avoid the symptoms of asthma brought on by exercise or other ‘triggers’, such
as pollen, cigarette smoke, house dust, cats and dogs, take one puff (200
micrograms) 10-15 minutes before exercise or exposure to a ‘trigger’.
After taking a puff, you must wait for four hours before taking another puff.
Do not take more than 4 puffs (800 micrograms) in any 24 hour period.
If you use more Pulvinal Salbutamol than you should
If you accidentally take more puffs than you should, you may notice that your heart
is beating faster than usual and that you feel shaky. These effects usually
disappear after a few hours, but you must tell your doctor as soon as possible.
Please read the back of this leaflet

87336.08/01

Instructions for use
Instructions
It is importantfor
thatuse
you know how to use your inhaler properly. Your doctor, nurse
It
important that
you know
how to
to use
use your
your inhaler
inhaler correctly
properly. and
Your
doctor,
orispharmacist
will show
you how
will
checknurse
or
pharmacist
will are
show
you your
how inhaler
to use your
inhalerYou
correctly
and will
check
regularly
that you
using
correctly.
must follow
their
regularly
thatcarefully,
you are so
using
correctly.
instructions
thatyour
you inhaler
know how,
whenYou
andmust
how follow
many their
puffs to inhale
instructions
carefully,
so that
you know
how,
when
and howshould
manybe
puffs
to inhale
and how often
you must
use your
inhaler.
The
instructions
on the
and
how oftenlabel
you and
mustare
use
yourininhaler.
The instructions
should
ontothe
pharmacist’s
given
this leaflet.
If you are not
sure be
what
do or
pharmacist’s
label
and are
given
thisdoctor,
leaflet.nurse
If you
not sure for
what
to do or
have problems
inhaling
then
ask in
your
orare
pharmacist
advice.
have problems inhaling then ask your doctor, nurse or pharmacist for advice.
Do not remove the cap protecting the inhaler until the moment of use.
Do not remove the cap protecting the inhaler until the moment of use.
A. Opening
A.
Openingthe protective cap. Check that the mouthpiece is clean
1. Unscrew
1.
Unscrew
protectivewipe
cap. the
Check
that the mouthpiece
is clean
before
use. the
If necessary,
mouthpiece
with a fibre-free
before
use.
necessary,
wipe
the mouthpiece
tissue or
softIf cloth.
Hold the
inhaler
upright andwith
tap ait fibre-free
gently
tissue
Holdtothe
inhaler
uprightinand
it gently
againstorasoft
hardcloth.
surface
level
the powder
thetap
container.
against a hard surface to level the powder in the container.

11

22
3

3
5

5

B. Loading the dose
B.
Loading
the dose
2. Hold
the inhaler
upright, press the blue button on the
2.
Hold the inhaler
upright,
press
thethe
blue
button
onrotate
the the
mouthpiece
with one
hand and
with
other
hand
mouthpiece
with one hand
and with
otheruntil
handa rotate
the
inhaler anti-clockwise
through
180 the
degrees
red mark
inhaler
anti-clockwise
180 degreesThis
untilisathe
redloading
mark
shows through
the hole through
in the mouthpiece.
shows
through the hole in the mouthpiece. This is the loading
position.
position.
3. Keep holding the inhaler upright, and rotate the inhaler
3.
Keep holding
the 180
inhaler
upright,
and
rotate the
inhaler
clockwise
through
degrees
until
it makes
a click
and a green
clockwise
untilmouthpiece.
it makes a click
a green
mark showsthrough
through180
thedegrees
hole in the
Thisand
is the
mark
shows through
the hole in the mouthpiece. This is the
dose-delivery
position.
dose-delivery position.
C. Administration
C.
Administration
4. Breathe
out deeply (not through the inhaler) as far as is
4.
Breathe out deeply (not through the inhaler) as far as is
comfortable.
comfortable.
5. Put the inhaler between your lips, keep holding the inhaler
5.
Put the
between
youryour
lips,mouth
keep holding
the and
inhaler
upright
andinhaler
breathe
in through
as quickly
deeply
upright
and breathe
in through
your
mouth
as quickly and deeply
as possible.
Hold your
breath for
a few
seconds.
as possible. Hold your breath for a few seconds.
D. Closing
D.
Closing the inhaler from your mouth. Replace the protective
6. Remove
6.
Remove the inhaler from your mouth. Replace the protective
cap.
cap.

General Advice
General
Advice
- Always
keep the inhaler upright during the loading of the dose and
- Always
keep the
inhaler upright during the loading of the dose and
administration
steps.
administration steps.
- How will you know when your inhaler is empty? When you can see a red
- ring
Howatwill
know
when
your inhaler
is empty?
can see
a red
theyou
bottom
of the
container
your inhaler
needsWhen
to be you
replaced.
If you
ring
at thetobottom
of the
container
inhaler
be replaced.
If you
continue
use your
inhaler
when your
you can
see needs
the redtoring
you may not
get the
continue
to use
when you for
canyou.
see the red ring you may not get the
correct dose
thatyour
hasinhaler
been prescribed
correct dose that has been prescribed for you.
- When you have finished using Pulvinal, check that the hole in the mouthpiece
- is
When
youover
have
finished
using Pulvinal,
check
the hole in the mouthpiece
placed
the
green mark.
Then close
the that
inhaler.
is placed over the green mark. Then close the inhaler.
- If you can feel a slightly sweet tasting powder in your mouth after inhaling, you
- have
If youreceived
can feel the
a slightly
sweet
in your
after
inhaling,
dose and
thetasting
activepowder
substance
has mouth
reached
your
lungs. you
have received the dose and the active substance has reached your lungs.
- The inhaler base contains a desiccant capsule to keep the powder inside your
- inhaler
The inhaler
base contains
a desiccant
capsule
to keep
powder
your
dry. Always
replace
the inhaler
cap after
you the
have
used inside
the inhaler.
inhaler
dry. Always
replace
the inhaler
afterperiods
you have
used
the inhaler.
If, however,
you leave
the inhaler
cap off cap
for short
(e.g.
24 hours)
at
If,
however,
you leave
off the
for short
periods (e.g. 24 hours) at
room
temperature,
it isthe
stillinhaler
alright cap
to use
inhaler.
room temperature, it is still alright to use the inhaler.
- If you accidentally blow into the inhaler, simply hold the inhaler upside down
- and
If you
accidentally
blow
into the
simply
holdout
theof
inhaler
upsidechamber.
down
tap
it onto a hard
surface
to inhaler,
empty the
powder
the dosage
and
tap
it onto
hardhave
surface
to emptyloaded
the powder
out
of the
dosage
If you
think
youamay
accidentally
two or
more
doses
into chamber.
the
If
you thinkhold
youthe
may
have upside
accidentally
or amore
into
chamber,
inhaler
downloaded
and taptwo
it on
harddoses
surface
to the
empty
chamber,
hold
the powder
out.the inhaler upside down and tap it on a hard surface to empty
powder
- the
During
use, out.
regularly wipe the mouthpiece with a fibre-free tissue or soft cloth.
- During use, regularly wipe the mouthpiece with a fibre-free tissue or soft cloth.

4. Possible side effects
4. Possible side effects

Like all medicines, Pulvinal Salbutamol can cause side effects, although not
Like
all medicines,
Pulvinal Salbutamol can cause side effects, although not
everybody
gets them.
everybody gets them.
Very rare allergic reactions, including nettle rash or hives, wheezing, fall in blood
Very
rare allergic
including
rash
hives,
wheezing,
fall in blood
pressure,
collapsereactions,
or painless
swellingnettle
of the
skinoron
the face,
neck, hands,
feet
pressure,
collapse
painlessIfswelling
of the skin
onofthe
face,contact
neck, hands,
feet or
and lips have
beenor
reported.
you experience
any
these,
your doctor
and
lips have
been reported.
If you experience any of these, contact your doctor or
casualty
department
immediately.
casualty
department
immediately.
If your breathing or wheezing gets worse straight after using your inhaler,
If
your
breathing
wheezing and
getscontact
worse your
straight
after
using yourYour
inhaler,
stop
using
PulvinalorSalbutamol
doctor
straightaway.
doctor
stop
using your
Pulvinal
Salbutamol
contact
your
doctor straightaway.
Your doctor
will review
asthma
and mayand
change
your
treatment
and may prescribe
a
will
review
your asthma
and may
change your treatment and may prescribe a
different
inhaler
to treat your
asthma.
different
inhaler
treatof
your
asthma. in the blood (hypokalaemia) can be caused
Abnormally
low to
levels
potassium
Abnormally
lowoflevels
of potassium
in the
(hypokalaemia)
canlow
be levels
causedof
by regular use
‘reliever’
inhalers, such
as blood
Pulvinal
Salbutamol. The
by
regular use
of ‘reliever’
inhalers,
as Pulvinal
Salbutamol.
The during
low levels
potassium,
which
can cause
you to such
feel weak
and thirsty,
can worsen
an of
potassium,
which
can Therefore,
cause you while
to feelyou
weak
thirsty,
can worsen
during
an
acute asthma
attack.
areand
using
Pulvinal
Salbutamol
your
acute
attack.
Therefore,
while
you
aretime
using
doctorasthma
may need
to carry
out blood
tests
from
to Pulvinal
time. Salbutamol your
doctor
needortocough
carry sometimes
out blood tests
from
timeare
to time.
Throat may
irritation
occurs
if you
sensitive to inhaling a dry
Throat
cough
sometimes
occurs ifmay
youhelp
are prevent
sensitivethis.
to inhaling a dry
powder.irritation
Rinsingoryour
mouth
after inhalation
powder. Rinsing your mouth after inhalation may help prevent this.
The following side effects have also been reported. Tell your doctor as soon as
The
following
side effects
have
also been
reported.
Tellnot
your
doctor
as soon as
possible
if you suffer
from any
of these
side effects
but do
stop
treatment
possible
if you
suffer
unless told
to do
so: from any of these side effects but do not stop treatment
unless
told(affects
to do so:
Common
less than 1 in 10 people)
Common
(affects less than 1 in 10 people)
• feeling shaky
• feeling
shaky
headache
•Uncommon
headache (affects less than 1 in 100 people)
Uncommon
(affects
less than 1 in 100 people)
• feeling your
heartbeat
• feeling
yourless
heartbeat
Rare
(affects
than 1 in 1,000 people)
Rare
(affects less
than 1 in 1,000 people)
• hyperactivity
in children
• hyperactivity
in children
increased blood
flow to your extremities
• muscle
increased
blood flow to your extremities
cramps
•Very
muscle
rare cramps
(affects less than 1 in 10,000 people)
Very
rare (affects
lessorthan
1 in 10,000
• irregular
heartbeat
an extra
beat ofpeople)
the heart
• irregular
heartbeat
or or
anwithout
extra beat
of the heart
rapid heartbeats
with
flushing
•Unknown
rapid heartbeats with or without flushing
Unknown
• feeling nervous
• feeling
nervous
restriction
of bloodflow to the heart
• restriction
dizziness of bloodflow to the heart
•If any
dizziness
of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tellany
your
pharmacist.
If
of doctor
the sideoreffects
get serious, or if you notice any side effects not listed in this leaflet, please
Reporting
of side
effects
tell
your doctor
or pharmacist.

If you get any
sideeffects
effects talk to your doctor, pharmacist, or nurse. This includes any
Reporting
of side
possible
not listed
in your
this leaflet.
can also or
report
side
effects
directly
If
you getside
any effects
side effects
talk to
doctor,You
pharmacist,
nurse.
This
includes
anyvia
the YellowCard
Scheme
www.mhra.gov.uk/yellowcard.
reporting
side effects
you
possible
side effects
not at
listed
in this leaflet. You can also By
report
side effects
directly
via
canYellowCard
help provideScheme
more information
on the safety of this medicine.
the
at www.mhra.gov.uk/yellowcard.
By reporting side effects you
can
help provide
morePulvinal
informationSalbutamol
on the safety of this medicine.
5. How
to store

• Keep
of the
reach andSalbutamol
sight of children.
5. How
toout
store
Pulvinal
••


Do notout
useofPulvinal
Salbutamol
after
the expiry date which is stated on the carton and
Keep
the reach
and sight
of children.
label.
The
expiry
date
refers
to
the
last
day
of that
month.
Do not use Pulvinal Salbutamol after the
expiry
date
which is stated on the carton and
• label.
Do notThe
store
above
30ºC.
Keep
thelast
container
closed.
expiry
date
refers
to the
day of tightly
that month.
Always
replace
the cap
after
use.
•• Do
not store
above
30ºC.
Keep
the container tightly closed.
Medicines
should
beafter
disposed
•• Always
replace
thenot
cap
use. of via wastewater or household waste. Ask your
pharmacistshould
how tonot
dispose
of medicines
no longer required.
Thesewaste.
measures
help
• Medicines
be disposed
of via wastewater
or household
Askwill
your
to protect the
environment
pharmacist
how
to dispose. of medicines no longer required. These measures will help
Further
information
to protect
the environment.

6.
6.
Further
information
What
Pulvinal Salbutamol
contains

The active substance of your inhaler is salbutamol. Each puff contains 200 micrograms of salbutamol.
What Pulvinal Salbutamol contains
The other ingredient is lactose monohydrate.
The active substance of your inhaler is salbutamol. Each puff contains 200 micrograms of salbutamol.
Whatother
Pulvinal
Salbutamol
looks
like and contents of the pack
The
ingredient
is lactose
monohydrate.
Pulvinal Salbutamol is an inhalation powder contained in a multi-dose container with plastic mouthpiece
What Pulvinal Salbutamol looks like and contents of the pack
and protective cap. Each pack contains one inhaler which provides 100 puffs.
Pulvinal Salbutamol is an inhalation powder contained in a multi-dose container with plastic mouthpiece
Marketing
Authorisation
Holder
and Manufacturer
and
protective
cap. Each pack
contains
one inhaler which provides 100 puffs.
The Marketing Authorisation Holder of Pulvinal Salbutamol is Chiesi Ltd, Cheadle Royal Business Park,
Marketing Authorisation Holder and Manufacturer
Highfield, Cheadle, SK8 3GY, UK.
The Marketing Authorisation Holder of Pulvinal Salbutamol is Chiesi Limited, 333 Styal Road, Manchester,
The manufacturer of Pulvinal Salbutamol is Chiesi Farmaceutici S.p.A., 26/A Via Palermo, 43100 Parma, Italy.
M22 5LG, United Kingdom.
Is this
leaflet of
hard
to Salbutamol
see or read?
The
manufacturer
Pulvinal
is Chiesi Farmaceutici S.p.A., 26/A Via Palermo, 43122 Parma, Italy.

Phone
0161 488
5555
for help.
Is
this leaflet
hard
to see
or read?
This leaflet
was last revised in 02/2015
®
Phone
488
5555
for help.
Pulvinal® 0161
is a trade
mark
of Chiesi
Farmaceutici S.p.A.

This
leafletis was
lastmark
revised
in 07/2015
Pulvinal
a trade
of the
same patented Chiesi DPI.
Pulvinal®
is a trade mark of Chiesi Farmaceutici S.p.A.
®
Pulvinal is a trade mark of the same patented Chiesi DPI.

CP0017/4
CP0017/5
87336.08/01

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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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