IMPORTANT
INFORMATION
ABOUT
SYMBICORT
Please read this summary carefully and
then ask your doctor about SYMBICORT.
No advertisement can provide all the information
needed to determine if a drug is right for you or take
the place of careful discussions with your health care
professional. Only vour health care professional has
the training to weigh the risks and benefits of a
prescription drug.
WHAT IS THE MOST IMPORTANT
INFORMATION I SHOULD KNOW
ABOUT SYMBICORT?
•
In patients w
ith asthma, long-acting beta2-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) with 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],
PULMICORT 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 beta2-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 taking, 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 sure 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 miss 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 tor
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
■ Sereverrf®
Diskus®
(salmeterol xinafoate inhalation powder)
■ Advair Diskus®
or Advair®
HFA
(fluticasone propionate
and salmeterol)
■ Foradil®
Aerolizer®
(formoterol 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. People 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 monitored
•
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 irritation
■ Headache
■ 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 with him
or her.
SYMB
ICORTand
PULM
ICORTTURBUHALSRare
reg
istered
tadanate 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
, DE19850
By
: AstraZeneca
AB
, Dunkerque
, France
Product of France
311520-00 7/07 257298
Visit www.MySymbicort.com.
Or, call
1
-
888
-SYMBICORT
tSymbicort
A .
AstraZeneca
