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 provider. Only your health
care provider has the training to weigh the risks and benefits of a
WHAT IS THE MOST IMPORTANT INFORMATION
I SHOULD KNOW ABOUT SYMBICORT?
People with asthma who take long-acting beta2-agonist
(LABA) medicines, such as formoterol (one of the medicines
in SYMBICORT), have an increased risk of death from asthma
problems. It is not known whether budesonide, the other medicine
in SYMBICORT, reduces the risk of death from asthma problems
seen with formoterol.
SYMBICORT should be used only if your health care provider
decides that your asthma is not well controlled with a long-term
asthma control medicine, such as an inhaled corticosteroid, or that
your asthma is severe enough to begin treatment with SYMBICORT.
Talk with your health care provider about this risk and the benefits of treating
your asthma with SYMBICORT.
If you are taking SYMBICORT, see your health care provider if your asthma
does not improve or gets worse. It is important that your health care provider
assess your asthma control on a regular basis. Your doctor will decide if it
is possible for you to stop taking SYMBICORT and start taking a long-term
asthma control medicine without loss of asthma control.
Get emergency medical care if:
breathing problems worsen quickly, and
you use your rescue inhaler medicine, but it does not relieve your
Children and adolescents who take LABA medicines may be at increased
risk of being hospitalized for asthma problems.
WHAT IS SYMBICORT?
SYMBICORT is an inhaled prescription medicine used for asthma and
chronic obstructive pulmonary disease (COPD). It contains two medicines:
Budesonide (the same medicine found in Pulmicort Flexhaler™,
an inhaled corticosteroid). Inhaled corticosteroids help to decrease
inflammation in the lungs. Inflammation in the lungs can lead to asthma
Formoterol (the same medicine found in Foradil® Aerolizer®). LABA
medicines are used in patients with COPD and asthma to 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
SYMBICORT is used for asthma and chronic obstructive pulmonary
disease as follows:
SYMBICORT is used to control symptoms of asthma and prevent symptoms
such as wheezing in adults and children ages 12 and older.
Chronic Obstructive Pulmonary Disease
COPD is a chronic lung disease that includes chronic bronchitis,
emphysema, or both. SYMBICORT 160/4.5 mcg is used long term, two
times each day, to help improve lung function for better breathing in adults
WHO SHOULD NOT USE SYMBICORT?
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
PROVIDER BEFORE USING SYMBICORT?
Tell your health care provider about all of your health conditions,
including if you:
have heart problems
HOW DO I USE SYMBICORT?
have high blood pressure
have thyroid problems
have liver problems
have an immune system problem
have eye problems such as increased pressure in the eye,
glaucoma, or cataracts
are allergic to any medicines
are exposed to chicken pox or measles
are pregnant or planning to become pregnant. It is not known
if SYMBICORT may harm your unborn baby
are breast-feeding. Budesonide, one of the active ingredients
in SYMBICORT, passes into breast milk. You and your health care
provider should decide if you will take SYMBICORT while
Tell your health care provider about all the medicines you take including
prescription and nonprescription medicines, vitamins, and herbal
supplements. SYMBICORT and certain other medicines may interact
with each other and can cause serious side effects. Know all the
medicines you take. Keep a list and show it to your health care provider
and pharmacist each time you get a new medicine.
Do not use SYMBICORT unless your health care provider has taught
you and you understand everything. Ask your health care provider or
pharmacist if you have any questions.
Use SYMBICORT exactly as prescribed. Do not use SYMBICORT
more often than prescribed. SYMBICORT comes in two strengths for
asthma: 80/4.5 mcg and 160/4.5 mcg. Your health care provider will
prescribe the strength that is best for you. SYMBICORT 160/4.5 mcg
is the approved dosage for COPD.
SYMBICORT should be taken every day as 2 puffs in the morning
and 2 puffs in the evening.
Rinse your mouth with water and spit the water out after each dose
( 2 puffs) of SYMBICORT. This will help lessen the chance of getting
a fungus infection (thrush) in the mouth and throat.
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 provider.
Do not change or stop any medicines used to control or treat your
breathing problems. Your health care provider will change your
medicines as needed
While you are using SYMBICORT 2 times each day, do not
use other medicines that contain a long-acting beta2-agonist
(LABA) for any reason. Ask your health care provider or
pharmacist if any of your other medicines are LABA medicines.
SYMBICORT does not relieve sudden symptoms. Always have a
rescue inhaler medicine with you to treat sudden symptoms. If you
do not have a rescue inhaler, call your health care provider to have
one prescribed for you.
Call your health care provider or get medical care right away if:
your breathing problems worsen with SYMBICORT
you need to use your rescue inhaler medicine more often than usual
your rescue inhaler does not work as well for you at relieving symptoms
you need to use 4 or more inhalations of your rescue inhaler medicine for
2 or more days in a row
you use one whole canister of your rescue inhaler medicine in 8 weeks’ time
your peak flow meter results decrease. Your health care provider will tell you
the numbers that are right for you
your 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® Diskus® (salmeterol xinafoate inhalation powder)
Advair Diskus® or Advair® HFA (fluticasone propionate and salmeterol)
Formoterol-containing products such as Foradil Aerolizer, Brovana®, or
WHAT ARE THE POSSIBLE SIDE EFFECTS
SYMBICORT can cause serious side effects.
Increased risk of pneumonia and other lower respiratory tract infections if
you have COPD. Call your health care provider if you notice any of these
symptoms: increase in mucus production, change in mucus color, fever,
chills, increased cough, increased breathing problems
Serious allergic reactions including rash; hives; swelling of the face,
mouth and tongue; and breathing problems. Call your health care
provider or get emergency care if you get any of these symptoms
Immune system effects and a higher chance for infections
Adrenal insufficiency–a condition in which the adrenal glands do not
make enough steroid hormones
Cardiovascular and central nervous system effects of LABAs, such as
chest pain, increased blood pressure, fast or irregular heartbeat, tremor,
Increased wheezing right after taking SYMBICORT
Eye problems, including glaucoma and cataracts. You should have regular
eye exams while using SYMBICORT
Osteoporosis. People at risk for increased bone loss may have a greater
risk with SYMBICORT
Slowed growth in children. As a result, growth should be carefully monitored
Swelling of your blood vessels. This can happen in people with asthma
Decreases in blood potassium levels and increases in blood sugar levels
WHAT ARE COMMON SIDE EFFECTS OF SYMBICORT?
Patients with Asthma
Sore throat, headache, upper respiratory tract infection, thrush in the mouth
Patients with COPD
Thrush in the mouth and throat
These are not all the side effects with SYMBICORT. Ask your health care
provider or pharmacist for more information.
NOTE: This summary provides important information about S YMBICORT.
For more information, please ask your doctor or health care provider.
SYMBICORT is a registered trademark of the AstraZeneca group of companies.
Other brands mentioned are trademarks of their respective owners and are not
trademarks of the AstraZeneca group of companies. The makers of these brands
are not affiliated with and do not endorse AstraZeneca or its products.
© 2010 AstraZeneca LP. All rights reserved.
Manufactured for: AstraZeneca LP, Wilmington, DE 19850
By: AstraZeneca AB, Dunkerque, France Product of France
Rev 11/11 1504903