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 your 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 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 dted 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, tak 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 SYMBICORT unless your health care professional tetts
you to stop because your symptoms might 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
with COPD.
SYMBICORT contains two medicines:
■ Budesonide (the same medicine found in PULMICORT FLEXHALER *'
[budesonide inhalation powderD, an inhaled corticosteroid medicine,
a ICS. ICS medbnes help to decrease inflammation in the lungs.
Inflammation in the lungs can lead to asthma symptoms
■ Formoterol (the same medicine found in Foradil ® Aerdizer ®) is a
long-acting beta^-agonist medicine, or LABA LABA medicines are used
in patients with 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 while.
Do not use SYMBICORT to treat sudden severe symptoms of asthma a
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
knos'/n 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 medicines you are
taking, including all your prescription and nonprescription medicines,
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.
HOW DO I USE SYMBICORT?
Do not use SYMBICORT unless your health care professional has
carefully demonstrated hew to do so. If you have any questions
concerning the use of SYMBICORT, ask your health care professorial.
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 professional will prescribe the strength
that is best fa you. SYMBICORT 160/4.5 meg is the approved dosage
faCOPO.
■ 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 a stop any of the medicines you use to control a
treat your breathing problems. Your health care professional w il
adjust your medbnes as needed
■ Do not spray SYMBICORT in your eyes. If you accidentally get
SYM8IC0RT in your eyes, rinse your eyes with water. If redness a
irritation persists, call you health care professional
■ Always have a fast-acting inhaler with you. Use rt if you have
breathing problems between doses of SYMBICORT
Seek emergency medical care if
■ your breathing problems worsen quickly and your fast-acting
inhater 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, a
tongue; a breathing problems
Contact your health care professional if
■ you need to use your fast-acting inhaler mae often than usual
■ your fast-acting inhater does not work as well fa you at relieving symptoms
■ you need to use four a m ae inhalations of your fast-acting inhaler fa
2 a mae days in a row
■ you use up your entire fast-acting inhater canister within 8 weeks
■ your peak-flow meter results decrease. Your health care professional
will tell you the numbers that are right fa you
■ your asthma symptoms do not improve after using SYMBICORT
regularty fa 1 week
■ you have COPD and notice any symptoms such as increase in mucus
a change in mucus cater, fever, chills, increased cough, a increased
breathing problems because these symptoms may mean you have
pneumonia a 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) fa any reason, such as
■ Serevent3 Diskus3 (saimeterol xinafoate inhalation powder)
■ Advair Diskus3 a Advair3 HFA (fluticasone propionate and saimeterol)
■ Fomx)terol-containing products such as Foradil3 Aerolizer3, Brovana®,
aPerforomist3
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
■ Osteopaosis. People at risk fa increased bone loss may have a greater
risk with SYMBICORT
■ Slowed growth in children. As a result growth should be carefully monitaed
■ Immune system effects and a higher chance fa infections
■ Cardiovascular and central nervous system effects of LABAs, such as
chest pain, increased blood aessure, fast a irregular heartbeat, trema,
a nervousness
WHAT ARE OTHER POSSIBLE SIDE EFFECTS
WITH SYMBICORT?
Adults and children age 12 years and older with asthma
■ Headache
■Saethroat
■ Oral thrush
■ Upper respiratory tract infection
Patients with COPD
■ Oral thrush
Long-acting beta?-agonists may increase the risk of asthma-related death.
Tell your hearth care professional about any side effect that bothers you a
that does not go away. These are not all the side effects with SYMBICORT
Ask your health care professional fa mae information.
NOTE: This summary provides important information about SYMBICORT.
For more information, please ask your doctor a health care professional
about the full Prescribing Information and discuss it with him a her.
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.
©2009 AstraZeneca LP. All rights reserved.
Manufactured for: AstraZeneca LP. Wilmington, DE 19850
By: AstraZeneca AB. Dunkerque. France
Product of France
Rev 9/09
288055
Visit
www.MySymbicort.com.
Or, call
1-866-SYMBICORT
Symbicort
(budesonide/lormoterol fumarate dihydrate)
Inhalation Aerosol
Æ
AstraZeneca
Z
