IMPORTANT
INFORMATION
ABOUT
S Y M B IC O R T
Please read this summary carefully and
then ask your doctor about SYMBICORT.
No advertisement can provide all the information
needed to determ
ine if a drug is right lor you or take
the place of careful discussions w
ith your health care
professional. Only your health care professional has
the training to weigh the risks and benefits of a
prescription dmg.
WHAT IS THE MOST IMPORTANT
INFORMATION I SHOULD KNOW
ABOUT SYMBICORT?
■ In patients w
ith asthma, long-acting beta^agonist
(LABA) medicines, such as formoterol (one of the
medicines in SYMBICORT), may increase the chance
of death from
asthma problems. In
a large asthma
study, more patients who
used another LABA
medicine
died from
asthma problems, compared w
ith
patients who
did not use that LABA
medicine. Talk w
ith
your health care
professional about this risk and the benefits of treating
your asthma w
ith
SYMBICORT.
•
SYMBICORT does not relieve sudden symptoms, so you
should always have a fast-acting inhaler (short-acting
beta2-agonist medicine) w
ith you. If you do
not have
this type of inhaler, talk w
ith
your health care professional
to
have one prescribed for you.
•
Get emergency medical care if your breathing
problems worsen quickly and your fast-acting
inhaler does not relieve them
.
■ Do
not stop using SYMBICORT unless your health care
professional tells you to
stop
because your symptoms
m
ight get worse.
WHAT IS SYMBICORT?
SYMBICORT is an inhaled prescription medicine for
long-term
maintenance treatment, taken tw
ice a day, every
day, to
control asthma in patients
12
years and older. It
w
ill not replace your fast-acting inhaler for relief of sudden
asthma symptoms.
SYMBICORT contains two
medicines:
■ Budesonide (the
same medicine found in PULM
ICORT
TURBUHALER®[budesonide inhalation powder],
PULM
ICORT FLEXHALER™
[budesonide inhalation
powder]), an inhaled corticosteroid medicine, or ICS. ICS
medicines help to decrease inflammation in the lungs.
Inflammation in
the lungs can lead to
asthma symptoms.
■ Formoterol (the same medicine found in
Foradil®
Aerolizer®) is a long-acting befa.-agonist medicine, or
LABA. LABA
medicines help the muscles in the airways of
the lungs stay relaxed to
prevent asthma symptoms, such
as wheezing and shortness of breath. These symptoms
can happen when the muscles in
the airways tighten,
which, in
severe cases, can cause breathing to
stop
completely if not treated right away.
WHO SHOULD NOT TAKE SYMBICORT?
You should NOT take SYMBICORT if your health care
professional:
■ decides that your asthma is well controlled using another
asthma-controller medicine
■ you only use a fast-acting inhaler less than tw
ice a week
WHAT SHOULD I TELL MY HEALTH
CARE PROFESSIONAL BEFORE USING
SYMBICORT?
Tell your health care professional about all of your health
conditions, including if you
■ have heart problems
■ have high blood
pressure
■ have seizures
■ have thyroid problems
■ have diabetes
■ have liver problems
•
have been on
an oral steroid, like prednisone
■ have osteoporosis
■ have an immune system
problem
or have been exposed
to
chicken pox or measles
■ have tuberculosis or other infections
■ are pregnant or planning to
become pregnant because it
is not known if SYMBICORT may harm
your unborn baby
■ are breast-feeding because it is not known if SYMBICORT
passes into
your m
ilk and if it can harm
your baby
Tell your health care professional about ALL the medicines
you are faking, including all your prescription and nonpre-
scription medicines, vitam
ins, and herbal supplements.
SYMBICORT and certain other medicines may interact
w
ith
each other and can cause serious side effects. So
be sura to
keep track of ALL the medication you take. You
m
ight want to
make a list and show
it to
your health care
professional, including your pharmacist, each time you get
any new
medicine, just to
ensure there are no
potential drug
interactions.
HOW DO I USE SYMBICORT?
Do
not use SYMBICORT unless your health care professional
has carefully demonstrated how
to
do so. If you have any
questions concerning the use of SYMBICORT, ask your health
care professional.
SYMBICORT should be taken tw
ice every day as prescribed
by your health care professional.
SYMBICORT comes in two
strengths. Your health care
professional w
ill prescribe the strength that is best for you.
When you use SYMBICORT, make sure you
■ use SYMBICORT exactly as prescribed
■ take two
puffs of SYMBICORT in
the morning and two
puffs in
the evening every day. If you m
iss a dose of
SYMBICORT, you should take your next dose at the same
time you normally do
■ do
not take SYMBICORT more often
or use more puffs
than you have been prescribed
■ rinse your mouth
w
ith
water after each dose (two
puffs)
of SYMBICORT w
ithout swallow
ing
•
do
not change or stop
any of the medicines you use
to
control or treat your breathing problems. Your health
care professional w
ill adjust your medicines as needed
■ always have a fast-acting inhaler w
ith
you. Use it if you
have breathing problems between
doses of SYMBICORT
Seek emergency medical care if
■ your breathing problems worsen quickly and your fast-
acting inhaler does not relieve your breathing problems
■ you experience any symptoms of a serious allergic
reaction to SYMBICORT, such as a rash; hives; swelling
of the face, mouth, tongue; and breathing problems
Contact your health care professional if
■ you need to
use your fast-acting inhaler more often
than usual
■ your fast-acting inhaler does not work as well for you
at relieving symptoms
■ you need to
use four or more inhalations of your
fast-acting inhaler for 2 or more days in
a row
■ you use up
your entire fast-acting inhaler canister w
ithin
8
weeks
■ your peak-flow
meter results decrease. Your health care
professional w
ill tell you the numbers that are right for you
■ your asthma symptoms do
not improve after using
SYMBICORT regularly for
1
week
WHAT MEDICATIONS SHOULD I NOT
TAKE WHEN USING SYMBICORT?
While you are using SYMBICORT, do
NOT use other
medicines that contain a long-acting beta2-agonist (LABA)
for any reason, such as
■ Serevent®
D
iskus®
(salmeterol xinafoate inhalation powder)
■ Advair D
iskus®
or Advair®
HFA
(fluticasone prop
ionate
and salmeterol)
■ Foradil®
Aerolizer®
(formotero
l fumarate inhalation powder)
WHAT ARE OTHER IMPORTANT SAFETY
CONSIDERATIONS WITH SYMBICORT?
■ Cardiovascular and central nervous system
effects of
LABAs, such as chest pain, increased blood
pressure,
fast or irregular heartbeat, tremor, or nervousness
■ Immune system
effects and a higher chance for infections
■ Osteoporosis. Peop
le at risk for increased
bone
loss may have
a greater risk w
ith
SYMBICORT
■ Slowed growth
in children. As a result, growth
should be
carefully mon
itored
•
Eye problems, such as glaucoma and cataracts. Regular
eye exams should be considered while using SYMBICORT
WHAT ARE OTHER POSSIBLE SIDE
EFFECTS WITH SYMBICORT?
■ Nose and throat im
itation
■ Fieadache
■ Upper respiratory tract infection
■ Sore throat
■ Sinusitis
■ Stomach discomfort
■ Oral thrush
Tell your health care professional about any side effect
that bothers you or that does not go away. These are not all
the side effects w
ith SYMBICORT. Ask your health care
professional for more information.
NOTE: This summary provides important information
about SYMBICORT. For more information, please ask
your doctor or health care professional about the full
Prescribing Information and discuss it w
ith him
or her.
SYMB
ICORTand
PULM
ICORT
TURBUHALER
are
reg
istered
trademarks
and
PULM
ICORT
FLEXHALER
is a
trademark
of the
AstraZeneca
group
of compan
ies. ADVA
IR
D
ISKUS
,
ADVA
IR
HFA
, SEREVENT
D
ISKUS
are
reg
istered
trademarks
of G
laxoSm
ithK
line
. FORAD
IL
AEROLIZER
is a
reg
istered
trademark
of Novartis
Pharmaceutica
ls
Corporation
.
©
2007
AstraZeneca
LP
. A
l rights
reserved
.
Manufactured
for: AstraZeneca
LP
, W
ilm
ington
, DE
19850
By
: AstraZeneca
AB
, Dunkerque
, France
Product of France
311520-00
7
/07
257298
Visit w w w .M ySym bicort.com .
Or, call 1-888-SYMBICORT
cS y m b ic o r t
(budeson
ide/formotero
l fumarate
d
ihydrate)
Inhalation
Aeroso
l
^
, =
4
-,
AstraZeneca J:
