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
determ
ine if a drug is right for you or take the place of careful
discussions w
ith your health care professional. Onlyyour 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) 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 taken
tw
ice
a day, every
day, over long
periods of time
to
control asthma and
chronic obstructive
pulmonary disease (COPD).
Asthma
SYMBICORT 80/4.5 mcg or 160/4.5 mcg is used
long-term
, two
times
each day to
control symptoms of asthma and prevent symptoms such as
wheezing
in
patients age 12 years and o
lder.
Chronic Obstructive Pulmonary Disease
COPD
is a chronic lung
disease that includes chronic bronchitis,
emphysema, or both. SYMBICORT 160/4.5 mcg is used
every day, two
times each day, to
help
improve
lung
function
for better breathing
in
adults
w
ith
COPD
.
SYMBICORT contains two
medicines
■ Budesonide (the
same medicine found
in
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
■ Formotero
l (the
same medicine found
in
Foradil®
Aerolizer®) is a
long-acting
beta2
-agonist medicine, or LABA
. LABA
medicines are used
in
patients w
ith
COPD
and asthma. LABA
medicines help
the
muscles
in
the
airways of your 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. This makes it hard
to
breathe,
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 or COPD
is well controlled
using
another medicine, or you
only use a fast-acting inhaler once in
a wh
ile.
Do
not use SYMBICORT to
treat sudden
severe symptoms of asthma or
COPD
or if you
are allergic to
any of the
ingredients in
SYMBICORT.
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 osteoporosis
■ have an immune system
problem
■ are allergic to
any medications
■ are exposed to
chicken pox or measles
■ 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. You
and your health
care
professional should
decide if you
w
ill be taking
SYMBICORT wh
ile
breast-feeding
Tell your health
care professional about ALL the
medicines you
are
taking, including
all your prescription
and nonprescription
medicines,
vitam
ins, and herbal supplements.
SYMBICORT and certain
other medicines may interact w
ith
each other
and
can cause serious side effects. 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
be
sure there
are no
potential drug
interactions.
HOW
DO I USE SYMBICORT
80
/
4.5
mcg?
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 (2
puffs each time) every day as
prescribed
by your health
care professional.
SYMBICORT comes in
two
strengths for asthma. SYMBICORT
160/4.5 mcg is the
approved
dosage for COPD. Your health
care
professional w
ill prescribe the
strength
that is best for you.
■ make sure that you
rinse
your mouth
w
ith
water after each
dose (two
puffs) of SYMBICORT w
ithout swallow
ing
and spit
the
water out
■ 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
■ do
not spray SYMBICORT in
your eyes. If you
accidentally get
SYMBICORT in
your eyes, rinse
your eyes w
ith
water. If redness or
irritation
persists, call your health
care professional
■ 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, or
tongue; or 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
ith
in
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
■ you
have COPD
and
notice
any symptoms such as increase in
mucus
or change in
mucus co
lor, fever, chills, increased
cough, or increased
breathing
problems because these symptoms may mean
you
have
pneumonia or another lung
infection
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
propionate
and salmeterol)
■ Formoterol-containing
products such as Foradil®
Aerolizer®
, Brovana®
,
or Perforom
ist®
WHAT ARE OTHER IMPORTANT SAFETY
CONSIDERATIONS WITH SYMBICORT?
■ Increased
risk of pneumonia if you
have COPD
■ Eye
problems, such as glaucoma and cataracts. Regular eye exams
should
be
considered
while
using
SYMBICORT
■ Osteoporosis. People at risk for increased
bone loss may have a greater
risk w
ith
SYMBICORT
■ Slowed
grow
th
in
ch
ildren. As a resu
lt, grow
th
should
be carefully
mon
itored
■ Immune system
effects and
a higher chance for infections
■ Cardiovascular and central nervous system
effects of LABAs, such as
chest pain, increased
blood
pressure, fast or irregular heartbeat, tremor,
or nervousness
WHAT ARE OTHER POSSIBLE SIDE EFFECTS
WITH SYMBICORT?
Adults and children age 12 years and older w
ith asthma
■ Headache
■ Sore throat
■ Oral thrush
■ Upper respiratory
tract infection
Patients w
ith COPD
■ Oral thrush
Long-acting
beta2
-agonists may increase the risk of asthma-related death.
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
ICORT
is a
reg
istered
trademark
of the
AstraZeneca
group
of compan
ies.
O
ther brands mentioned
are
trademarks of the
ir respective
owners and
are
not
trademarks of the
AstraZeneca
group
of compan
ies. The
makers of these
brands
are
not affiliated
w
ith
and
do
not endorse
AstraZeneca
or its products.
©
2009
AstraZeneca
LP
. A
l rights reserved
.
Manufactured
for: AstraZeneca
LP
, W
ilm
ington
, DE
19850
By: AstraZeneca
AB
, Dunkerque
, France
Product of France
Rev
5
/09
278384
Visit www.MySymbicort.com.
Or, call
1
-
866
-SYMBICORT
^Symbicort'
(budesonide/formoterol fumarate dihydrate)
Inhalation Aerosol
Æ
AstraZeneca
J z
