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PULMICORT TURBOHALER 200 MICROGRAMS

Active substance(s): BUDESONIDE

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Pulmicort® Turbohaler® 200 micrograms
(budesonide)
This medicine is available as the above name but will be referred to as
Pulmicort Turbohaler throughout the following leaflet. Please note that the
leaflet also contains information about other strengths (Pulmicort Turbohaler
100 micrograms and 400 micrograms).
Package Leaflet: Information for the User
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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 get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Pulmicort Turbohaler is and what it is used for
2. Before you use Pulmicort Turbohaler
3. How to use Pulmicort Turbohaler
4. Possible side effects
5. How to store Pulmicort Turbohaler
6. Further information

1. WHAT PULMICORT TURBOHALER IS AND WHAT IT IS USED FOR
Pulmicort Turbohaler is an inhaler. It contains a medicine called budesonide.
This belongs to a group of medicines called ‘corticosteroids’. It works by
reducing and preventing swelling and inflammation in your lungs.
Your doctor has prescribed this medicine to treat asthma. Your doctor will
prescribe two asthma inhalers: Pulmicort Turbohaler and a separate ‘reliever
inhaler’.
• Use Pulmicort Turbohaler every day, as your doctor has told you to. This
helps to prevent asthma symptoms from happening.
• Use your ‘reliever inhaler’ when you get asthma symptoms, to make it
easier to breathe again.

2. BEFORE YOU USE PULMICORT TURBOHALER
Do not use Pulmicort Turbohaler if:
• You are allergic (hypersensitive) to budesonide (the only ingredient in this
medicine).
Take special care with Pulmicort Turbohaler
Before you use Pulmicort Turbohaler, tell your doctor or pharmacist if:
• You have a lung infection.
• You have a cold or chest infection or any problems with your breathing.
• You have or have ever had tuberculosis (TB).
• You have liver problems.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines that you buy without a
prescription and herbal medicines. This is because Pulmicort Turbohaler can
affect the way some medicines work and some medicines can have an effect
on Pulmicort Turbohaler.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
• Steroid medicines.
• Medicines to treat fungal infections (such as itraconazole and
ketoconazole).
• HIV protease inhibitors (such as ritonavir and nelfinavir).
Pregnancy and breast-feeding
• If you are pregnant, or planning to get pregnant, talk to your doctor before
using Pulmicort Turbohaler - do not use Pulmicort Turbohaler unless your
doctor tells you to.
• If you get pregnant while using Pulmicort Turbohaler, do not stop using
Pulmicort Turbohaler but talk to your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Pulmicort
Turbohaler.
Driving and using machines
Pulmicort Turbohaler is not likely to affect you being able to drive or use any
tools or machines.

Information you may have to carry while you are using Pulmicort
Turbohaler
If you are using a high dose of Pulmicort Turbohaler your doctor may ask you
to carry a steroid warning card. This explains to others about your
medication.

3. HOW TO USE PULMICORT TURBOHALER


Always use Pulmicort Turbohaler exactly as your doctor, nurse or
pharmacist has told you. Ask one of them for advice if you are not sure.
• If Pulmicort Turbohaler is to be used by your child, make sure they use it
correctly as your doctor has told you.
• It is important to use Pulmicort Turbohaler every day, even if you have no
asthma symptoms at the time.
• Your breathing may improve within 2 days. However it can take up to 4
weeks for the medicine to have its full effect.
Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using Pulmicort
Turbohaler, you should continue to use Pulmicort Turbohaler but go to see
your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
Your breathing is getting worse or you often wake up at night with asthma.
Your chest starts to feel tight in the morning or your chest tightness lasts
longer than usual.
These signs could mean that your condition is not being properly controlled
and you may need different or additional treatment immediately.




Use your Pulmicort Turbohaler every day. This helps to prevent asthma
symptoms from happening. Your doctor will advise you of the correct dose to
treat your asthma. Your doctor will reduce your medication to the lowest dose
needed to control your asthma.
If your doctor has told you to use your Turbohaler twice a day:
Adults and children (13 years and above)
• The usual dose is 1 or 2 inhalations, twice a day (in the morning and in the
evening).
• Your doctor may increase this to a maximum of 1600 micrograms a day.
• If your asthma is getting worse and you are using your ‘reliever inhaler’
more often or you have more symptoms:
double your dose of Pulmicort Turbohaler immediately and talk to your
doctor as soon as possible
double your dose by taking twice as many inhalations each time.
Children (5 - 12 years of age)
• The usual dose is 1 or 2 inhalations, twice a day (in the morning and in the
evening).
• The doctor may increase this to a maximum of 800 micrograms a day.
If your doctor has told you to use your Turbohaler once a day:
Only use your Turbohaler once a day if your doctor has told you to.
Use your Turbohaler at the same time each evening.




Adults and children (13 years and above)
The usual dose is 1 or 2 inhalations, in the evening.
If your asthma is getting worse and you are using your ‘reliever inhaler’
more often or you have more symptoms:
double your dose immediately and talk to your doctor as soon as
possible
double your dose by taking the same number of inhalations your doctor
has told you twice a day (once in the morning and once in the evening).




Children (5-12 years of age)
• The usual dose is 1 or 2 inhalations, in the evening.
• The maximum dose is 400 micrograms a day.
Use your separate ‘reliever inhaler’ to treat asthma symptoms when
they happen.
Always keep your ‘reliever inhaler’ with you to use when you need it. Do not
use Pulmicort Turbohaler to treat asthma symptoms – use your ‘reliever
inhaler’.
How to prepare a new Turbohaler for use
Before using Pulmicort Turbohaler for the first time you
need to prepare the Turbohaler for use.
Unscrew the white cover and lift it off.
Hold your Turbohaler upright with brown base at the
bottom. Do not hold the mouthpiece when you turn the
grip. Turn the brown base as far as it will go in one
direction. Then turn it back as far as it will go in the
other direction. It does not matter which way you turn
first. You should hear a click sound.
The Turbohaler is now ready for use, and you should
not repeat the above procedure again. To take a
dose, please follow the instructions below.

How
w to take
e an inhalation
Everry time you
y need
d to take
e an inha
alation, follow the
e instruc
ctions be
elow.



Sud
dden wh
heezing after inhaling yyour med
dicine. Iff this ha
appens, also use
you
ur ‘relievver’ inha
aler stra
aight away. This
s happens very rarely, affecting
less than 1 in 10,00
00 peop
ple.

nscrew the
t white
e cover and
a lift itt off.
1. Un
2. Ho
old your Turbohaler up
pright with
w the brown
b
ba
ase at th
he bottom
m.
3. Do
o not ho
old the mouthpie
m
ece whe
en you lo
oad yourr Turboh
haler. To
o load yo
our
Tu
urbohale
er with a dose, turn
t
the
e brown base a
as far as
s it will go in o
one
direction.. Then turn
t
it as far as
s it will go
g in th
he other directio
on. It do
oes
ot matterr which way
w you
u turn it first. You should
d hear a click so
ound. Yo
our
no
Tu
urbohale
er is now
w loaded and ready
r
to
o use. O
Only load
d your Turboha
T
aler
wh
hen you need to
o use it.
4. Ho
old yourr Turboh
haler aw
way from your mouth.
m
Breathe out
o gen
ntly (as far
as
s is comffortable)). Do nott breathe out through yyour Turb
bohaler.
e mouth
hpiece gently between
n your teeth.
5. Place the
Close you
in as de
ur lips. Breathe
B
eeply an
nd as ha
ard as
ou can through your mo
outh. Do
o not chew or b
bite on
yo
the
e mouth
hpiece.

6. Re
emove your
y
Tu
urbohale
er from your mouth.
m
T
Then breathe out
o genttly.
Th
he amou
unt of me
edicine that
t
is in
nhaled is
s very sm
mall. This means you m
may
no
ot be ablle to taste it afte
er inhala
ation. If you
y have
e followe
ed the in
nstruction
ns,
yo
ou can still be co
onfident that you
u have in
nhaled the dose
e and the
e mediciine
is now in your
y
lung
gs.
y are to take a secon
nd inhala
ation, rep
peat step
ps 2 to
7. If you
6.
8. Re
eplace the
t
cover by sc
crewing it back on tightlly after
us
se.
9. Riinse you
ur moutth out with
w wate
er after inhaling
g your prescrib
p
bed dose
e.
n try to
o remov
ve or twist the mouthpie
m
ece. It iss fixed to
t your Turboha
T
aler
Do not
and must not
n be taken
t
offf. Do not
n use your T
Turbohaller if it has be
een
m
ce has come
c
apart from your Tu
urbohale
er.
damaged or if the mouthpiec
Clea
aning yo
our Turb
bohaler
Wipe
e the ou
utside off the mo
outhpiece once a week with a dry tissu
ue. Do n
not
use water
w
orr liquids.
en to sta
art using
g a new
w Turboh
haler
Whe
Whe
en you first see a red mark
m
in the indicator window,
there
e are ab
bout 20 doses le
eft. You will then need to see
yourr doctor for anotther prescription
n. When
n the red
d mark
has reached
d the bottom
b
o the in
of
ndicator window
w, you
sing you
ur new Turbohale
er.
mustt start us

ble side effects::
Otherr possib
Comm
mon (afffects les
ss than 1 in 10 people))
• Thrrush (a ffungal in
nfection) in the m
mouth. This
T
is less likelyy if you rinse you
ur
mo
outh out w
with watter after using yo
our Turb
bohaler.
• Mild sore th
hroat, co
oughing and a hoarse vo
oice.
Rare (affects
(
less than 1 in 1,000 pe
eople)
• Sle
eeping problems
s, depres
ssion or feeling worried,, restlesss, nervo
ous, overrexc
cited or iirritable. These effects
e
a
are more
e likely to
o occur iin childre
en.
• Bru
uising of the skin
n.
• Los
ss of voice.
• Hoarse voice (in ch
hildren).
ed corticosteroid
ds can afffect the
e normall production of ssteroid hormone
h
es
Inhale
in you
ur body, particullarly if you
y
use high doses for a long ttime. Th
he effectts
include:
• cha
anges in
n bone mineral
m
d
density
(tthinning of the bones).
• cattaract (cllouding of the le
ens in the
e eye).
• gla
aucoma ((increased press
sure in the eye)..
• a slowing
s
o
of the ratte of gro
owth of cchildren and
a ado
olescentss (rare).
• an effect on
n the ad
drenal gla
and (a ssmall gla
and next to the kidney) (rrare).
e effects are muc
ch less likely
l
to happen with inh
haled corrticosteroids than
These
with corticoste
eroid tab
blets.
cts get serious
s
o
or if you notice any
a side effects not listed
If any of the side effec
t your doctor o
or pharm
macist.
in this leaflet, please tell
Reporrting of side efffects
If you get any side effects,
e
talk to your do
octor, ph
harmacisst or nurse. Thiis
includes any p
possible side efffects nott listed in
n this lea
aflet. You can allso report
effectss
dire
ectly
via
the
Y
Yellow
Schem
me
at:
side
Card
mhra.go
ov.uk/yellowcard. By rep
porting side effec
cts you can help
p provide
www.m
more informattion on the safetty of thiss medicin
ne.

5. HO
OW TO S
STORE PULMIC
CORT T
TURBOHALER
R
he sight and
a reac
ch of chiildren.
Keep out of th
ot store this medicine above 30°C
C.
Do no
Keep the cove
er screw
wed tighttly onto yyour Turbohalerr when yyou are not
n using
or
n as 'EX
XP' on the Turrbohaler label o
it. Do not use after the date shown
n.
carton
Medic
cines sho
ould not be dispo
osed of via wasttewater or house
ehold wa
aste. Assk
d.
your pharmac
p
cist how
w to disp
pose of medicin
nes that are no longer required
This will
w help tto protec
ct the en
nvironme
ent.
n,
If the Turboha
aler does
s not wo
ork properly or shows
s
an
ny signss of dete
erioration
ult your p
pharmac
cist who will
w tell yyou what to do.
consu

6. FURTHER
R INFOR
RMATIO
ON
e:
Note
• The brow
wn base will still twist and
a
‘clic
ck’ even when your
y
Turrbohalerr is
empty.
• The soun
nd that you
y hearr as you
u shake your Turbohalerr is prod
duced byy a
gent and not the
e medicin
ne. Therrefore th
he sound
d does not
n tell yyou
drying ag
ow much
h medicine is lefft in your Turboh
haler.
ho
• If you loa
ad your Turboha
T
e than on
nce by m
mistake before taking
t
yo
our
ler more
ose, you
u will still only receive on
ne dose..
do
If yo
ou use more
m
Pu
ulmicort Turboh
haler tha
an you s
should
It is importan
nt that you
y take your do
ose as stated
s
on
n the pharmacist’s label or
a
b your doctor. You should nott increasse or de
by
ecrease your do
ose
as advised
witho
out seek
king medical ad
dvice. If you use
e more P
Pulmicort Turbo
ohaler th
han
you should, contact your doc
ctor or pharmac
p
ist for ad
dvice.
If yo
ou forge
et to use
e Pulmic
cort Turrbohalerr
If you forget to take a dose,, skip the
e missed dose a
and take
e the next dose as
al.
usua
If yo
ou stop using Pulmicor
P
rt Turbo
ohaler
Do not
n stop using th
his medicine even when
n your a
asthma gets
g
better, unle
ess
yourr doctor tells
t
you
u to.

4. PO
OSSIBL
LE SIDE
E EFFEC
CTS
P
rt Turboh
haler can cause
e side efffects, altthough n
not
Like all medicines, Pulmicor
g
them
m.
everrybody gets
If either of
o the followin
f
ng happens to you, stop using Pulmico
ort
Turb
bohaler and talk
k to you
ur docto
or immediately:
• Swelling
S
of your face, particularly aro
ound yo
our mou
uth (with
h possib
ble
sw
welling of the lips, to
ongue, eyes and earss), rash, itching
g, conta
act
de
ermatitis
s (a skin
n proble
em), hives and broncho
ospasm (tighten
ning of tthe
m
muscles
i the airways which
in
w
cau
uses wh
heezing). This may
m mea
an that yyou
are havin
ng an allergic reaction. This
T
hap
ppens ra
arely, afffecting le
ess than
n1
n 1,000 people.
p
in

cort Turb
bohaler is a breath-actu
uated, metered
m
dose
d
pow
wder inh
haler with
Pulmic
ur
a darrk brown turnin
ng grip and a white plastic body a
and cov
ver. You
Turbohaler co
ontains 100
1 actu
uations, each co
ontaining
g 200 m
microgram
ms of the
ent bude
esonide.
active ingredie
el,
cort Turbohaler is manu
ufactured
d by AsttraZenec
ca GmbH, 22876 Wede
Pulmic
Germa
any. Pro
ocured from within
w
the
e EU by
b the Product
P
Licence
e holder:
B.
Casev
view (PL
L) Ltd., 20 Allia
ance Co
ourt, Allliance Road,
R
Lo
ondon W3
W 0RB
Repac
ckaged b
by: OPD
D Labora
atories L
Ltd., Unitt 6 Colonial Wayy, Watfo
ord, Hertts
WD24
4 4PR.

3826/157
72
PL 13

POM

Pullmicort®
® Turbo
ohaler® 2
200 mic
crograms
Leafle
et revisio
on date (ref) 08
8/08/2014
e,
cort and
d Turboh
haler are
e tradem
marks of the AstrraZeneca
a AB, Sö
ödertälje
Pulmic
Swede
en.
all
quest a copy of this le
eaflet in Braille, large print or a
audio ple
ease ca
To req
01923
3 332 79
96.

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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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