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 provider. Only your health care provider has the training to weigh the risks and benefi ts of a prescription drug.


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 benefi ts 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 breathing problems.


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 infl ammation in the lungs. Infl ammation in the lungs can lead to asthma symptoms


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:


Asthma


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 with COPD.


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 have high blood pressure have seizures


have thyroid problems have diabetes have liver problems have osteoporosis


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 breast-feeding


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.


HOW DO I USE SYMBICORT?


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 fl ow 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


Serevent® Diskus® Advair Diskus®


-agonist (LABA) for any reason, such as: (salmeterol xinafoate inhalation powder)


or Advair®


Formoterol-containing products such as Foradil Aerolizer, Brovana® Perforomist®


WHAT ARE THE POSSIBLE SIDE EFFECTS


WITH SYMBICORT? 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 insuffi ciency–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, or nervousness


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 and throat


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 SYMBICORT. 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 affi liated 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 Rev 11/11 1504903


Product of France


HFA (fl uticasone propionate and salmeterol) , or


Visit www.MySymbicort.com Or, call 1-866-SYMBICORT


© PARADE Publications 2014. All rights reserved


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