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 Aug is right for you or take the place of careful
cfscussions with your health care professional. Only vour health
care professional has the training to weigh the risks and benefits
of a prescription (bug.
WHAT IS THE MOST IMPORTANT INFORMATION
I SHOULD KNOW ABOUT SYMBICORT?
In patients with asthma, long-acting betej-agonist (LABA)
medicines, such as fbtmoleml (one of the medicines in
SYMBICORT), may increase the chance of death from asthma
problems. In a large asthma study, more patents who used another LABA
medicine died from
asthma problems, compared w
ith patents who did not
use that LABA medicine. Talk w
ith your health care professional about this
risk and the benefits of treatng your asthma w
ith SYMBICORT.
SYMBICORT does not relieve sudden symptoms, so you should
always have a fast-acting inhaler (short-acting beta^agonist
medicine) with you. t 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 twice a day, every
day, over long periods of time to control asthma and chronic obstructive
pulmonary disease (COPD).
Asthma
SYMBICORT
80
/
4.5
meg or
160
/
4.5
meg 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 older.
Chronic Obstructive Pulmonary Disease
COPD Is a chronic lung disease that includes chronic bronchitis,
emphysema, or both. SYMBICORT
160
/
4.5
meg 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 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 aie used
in patients w
ith COPD and asthma. LABA medicines help the muscles
in the airways of your lungs slay 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 while.
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 milk and If It can harm
your baby. You and your health
care professional should decide If you w
ill be taking SYMBICORT
while 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?
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 twice
(2
puffs each time) every day as
prescribed by your health care professional.
SYMBICORT comes in two strengths for asthma:
80
/
4.5
meg and
160
/
4.5
meg. Your health care professioanl w
ill prescribe the strength
that is best for you. SYMBICORT
160
/
4.5
meg is the approved dosage
tor COPD.
■ Make sure that you rinse your mouth w
ith water after each
dose (two puffs) of SYMBICORT without swallowing 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 tour 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 within 8 weeks
■ your peak-flow meter results decrease. Your health care professional
w
ill tell you the numbers that are right tor 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 color, 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 beto,-agonist (LABA) tor any reason, such as
■ Sereverrt® Diskus® (salmeterol xinafoate inhalation powdei)
■ Advair Diskus® or Advair® HFA (fluticasone propionate and salmeterol)
■ Formoterol-containing products such as Foradil® Aerolizer®, Brovana®,
orPerforomist®
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 tor increased bone loss may have a greater
risk w
ith SYMBICORT
■ Stowed growth in children. As a result, growth should be carefully monitored
■ Immune system effects and a higher chance for infections
■ Cardiovascular and central nervous system effects of LABAs, such as
chest pain, increased blood pressure, tost or irregular heartbeat, tremor,
or nervousness
WHAT ARE OTHER POSSIBLE SIDE EFFECTS
WRH SYMBICORT?
Adults and children age
12
years and older with asthma
■ Headache
■ Sorethroat
■ Oralthrush
■ Upper respiratory tract infection
Patients with COPD
■ Oralthrush
Long-acting beta^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 with him or her.
SYMBICORT
is a reg
istered
trademark
of the
AstraZeneca
group
of
compan
ies, Other 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
9
/09
288055
rSymbicortV
Visit w ww.M ySym bicort.com .
(budesonide/formoterol fumarate dihyrtate) O fe
Or, call 1-866-SYMBICORT
Inhalation Aerosol
^
A
AstraZeneca
2
