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 (Jed 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.
tf 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 SYMBICORT unless \our health care professional tells
you to stop because your symptoms might get worse.
WHAT IS SYMBICORT?
SYM8IC0RT is an inhaled prescription medicine taken twice a day. every
day, over king periods of time to control asthma and chronic obstructive
pulmonary disease (COPO).
Asthma
SYM8IC0RT 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
v/heezing in patients age 12 years and oWer.
Chronic Obstructive Pulmonary Disease
COPD is a chronic lung dsease 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'W
[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 betzi-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 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 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 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 professional will prescribe the strength
that is best for you. SYMBICORT 160/4.5 meg is the approved dosage
for COPO.
■
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 v.H
adjust your medicines as needed
■
Do not spray SYMBICORT in your eyes, tf 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 probtems 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 afiergic 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 wefl 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 COPO and notice any symptoms such as increase in mucus
or change in mucus cotor, 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® Diskus® (sa'-meterol xinafoate inhalation powder)
■
Advair Diskus® or Advair® HFA (fluticasone propionate and salmeterol)
■
FooDoterot-containing products such as Foradil® Aerolizer 3, Brovana®,
or Perforomist®
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 toss may have a greater
risk with SYMBICORT
■
Slowed 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
WHAT ARE OTHER POSSIBLE SIDE EFFECTS
WITH SYMBICORT?
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 $YMB£0RT.
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.
SYM BICORT 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 m akers of these brands are not affiliated with and do not endorse
AstraZeneca or its products.
© 2 0 0 9 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/formoterol fumarate dihydrate)
Inhalation Aerosol
Æ
AstraZeneca
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