PULMICORT TURBOHALER 200 MICROGRAMS

Active substance: 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 to take an inhalation
w
e
Ever time y need to take an inha
ry
you
d
e
alation, follow the instruc
e
ctions be
elow.



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

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

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

r
ble
:
Other possib side effects:
Comm (aff
mon
fects les than 1 in 10 people)
ss
)
• Thr
rush (a f
fungal in
nfection) in the m
mouth. T
This is less likely if you rinse you
y
ur
mo
outh out w wat after using yo Turb
with
ter
our
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 depres
s,
ssion or feeling worried, restless nervo
,
s,
ous, over
rexc
cited or i
irritable. These e
effects a more likely to occur i childre
are
e
o
in
en.
• Bru
uising of the skin
n.
• Los of voice.
ss
• Hoarse voice (in ch
hildren).
ed
ds
ffect the normal production of s
e
l
steroid hormone
h
es
Inhale corticosteroid can af
in you body, particul
ur
larly if y
you use high doses for a long t
time. Th effect
he
ts
include:
• cha
anges in bone mineral d
n
m
density (t
thinning of the bones).
• cat
taract (cl
louding of the le in the eye).
ens
e
• gla
aucoma (
(increased press
sure in the eye).
.
• a slowing o the rat of gro
s
of
te
owth of c
children a ado
and olescents (rare).
s
• an effect on the ad
n
drenal gla (a s
and small gla next to the kidney) (r
and
rare).
e
ch
likely to happen with inh
haled cor
rticosteroids than
These effects are muc less l
with corticoste
eroid tab
blets.
cts
serious o if you notice any side effects not listed
or
a
If any of the side effec get s
t
or
macist.
in this leaflet, please tell your doctor o pharm
rting of side eff
fects
Repor
If you get any side effects, talk to your do
e
octor, ph
harmacis or nurse. Thi
st
is
includes any p
possible side eff
fects not listed in this lea
t
n
aflet. You can al report
lso
effects
s
dire
ectly
via
the
Yellow
Y
Schem
me
at:
side
Card
mhra.go
ov.uk/yellowcard. By rep
porting side effec you can help provide
cts
p
www.m
more informat
tion on the safet of this medicin
ty
s
ne.

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

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

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

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

3826/157
72
PL 13

POM

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