IMPORTANT
INFORMATION
ABOUT
SYMBICORT
Please read this sum m ary 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 your health
care professional has the training to weigh the risks and benefits
of a prescription drug.
W H A T I S T H E M O S T I M P O R T A N T I N F O R M A T I O N
I S H O U L D K N O W A B O U T S Y M B I C O R T ?
In patients with 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 with patients who did not
use that LABA medicine. Talk with your health care professional about this
risk and the benefits of treating your asthma with 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 with 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 SYM
8
IC
0
RT unless your health care professional tells you
to stop because your symptoms might get worse.
W H A T I S S Y M B I C O R T ?
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 tong-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
with COPD.
SYMBICORT contains two medicines
■ Budesonide (the same medicine found in PULMICORT FL£XHALER'V
(budesonide inhalation powderD, 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 Foradil3 Aerolizer ?)isa
tong-acting beta^-agonist medicine, or LABA. LABA medaies are used
in patients with COPD and asthma. LABA medicines help the muscles
in the aiways 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
W H O S H O U L D N O T T A K E S Y M B I C O R T ?
You should not take SYMBICORT if your health care professional decides
that your asthma or COPD is weH 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.
W H A T S H O U L D I T E L L M Y H E A L T H C A R E
P R O F E S S I O N A L B E F O R E U S I N G S Y M B I C O R T ?
Tell your health care professional about all of your health conditions,
incfcxSng 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 will be taking SYMBICORT while
breast-feeding
Tell your health care professional about ALL the medtoines you are
taking, including all your prescription and nonprescription mecSdnes,
vitamins, and herbal supplements.
SYMBICORT and certain other medicines may interact with each other
and can cause serious side effects. Be sure to keep track of ALL the
medication you take. You might 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.
H O W D O I U S E S Y M B I C O R T 8 0 / 4 . 5 m e g ?
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. SYMBICORT
160
/
4.5
meg is the approved dosage for COPD. Your health care
professional w* prescribe the strength that is best for you.
■ make sure that you rinse your mouth with 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 will
adjust your medicines as needed
■ do not spray SYMBICORT in your eyes. If you accidentally get
SYMBICORT in your eyes, rinse your eyes with water. If redness or
irritation persists, call your health care professional
■ always have a fast-acting inhaler with 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 within 8 weeks
■ your peak-flow meter results decrease. Your health care professional will
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 color, fever, chfc, increased cough, or increased
breathing problems because these symptoms may mean you have
pneumonia or another lung infection
W H A T M E D I C A T I O N S S H O U L D I N O T T A K E
W H E N U S I N G S Y M B I C O R T ?
While you are using SYMBICORT, do not use other medicines that contain a
tong-acting beta2-agonist (LABA) for any reason, such as
■ Serevent3 Diskus3 (salmeterd xinafoate inhalation powder)
■ AA-air Diskus3 or Advair3 №A (fluticasone propionate and salmeteroT)
■ Formoterol-containing products such as Forad® Aerolizer 3, Brovana3,
orPerforomist3
W H A T A R E O T H E R I M P O R T A N T S A F E T Y
C O N S I D E R A T I O N S W I T H S Y M B I C O R T ?
■ 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 toss may have a greater
risk with SYMBICORT
■ Slaved 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, fast or irregular heartbeat, tremor,
or nervousness
W H A T A R E O T H E R P O S S I B L E S I D E E F F E C T S
W I T H S Y M B I C O R T ?
Adults and children age
12
years and older with asthma
■ Headache
■ Sorethroat
■ Oral thrush
■ Upper respiratory tract infection
Patients with 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 with 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 registered trademark of the AstraZeneca group of companies
Other brands menboned are trademarks of the* respective owners and are not
trademarks of the AstraZeneca group ot companies. The makers of these brands
are not affiliated w
ith and do not endorse AstraZeneca or its products.
©
2009
AstraZeneca LP. All rights reserved.
Manufactured for: AstraZeneca LP. W
ilm
ington. DE
19850
By: AstraZeneca AB. Dunkerque. France
Product of France
Rev
5/09
278384
V i s i t w w w . M y S y m b i c o r t . c o m
.
O r , c a l l 1 - 8 6 6 - S Y M B I C O R T
S y m b i c o r t
(budesonide/formoterol fumarate dihydrate)
/ L
A s t r a Z e n e c a
Jc
