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Prescribing Information

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Important Information
About SYMBICORT

*Subject to eligibility rules; restrictions apply.

Please read this summary carefully and then ask your doctor about SYMBICORT^®.

Important Safety Information About SYMBICORT

SYMBICORT contains formoterol, a long-acting beta₂-adrenergic agonist (LABA). LABA medicines such as formoterol increase the 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.

SYMBICORT does not replace rescue inhalers for sudden asthma symptoms.

Be sure to tell your health care provider about all your health conditions, including heart conditions or high blood pressure, and all medicines you may be taking. Some patients taking SYMBICORT may experience increased blood pressure, heart rate, or change in heart rhythm.

Do not use SYMBICORT more often than prescribed. While taking SYMBICORT, never use another medicine containing a LABA for any reason. Ask your health care provider or pharmacist if any of your other medicines are LABA medicines, as using too much LABA may cause chest pain, increase in blood pressure, fast and irregular heartbeat, headache, tremor, and nervousness.

Patients taking SYMBICORT should call their health care provider or get emergency medical care:

if you experience serious allergic reactions including rash, hives, swelling of the face, mouth and tongue, and breathing problems.
if you think you are exposed to infections such as chicken pox or measles, or if you have any signs of infection. You may have a higher chance of infection.
if you experience an increase in wheezing right after taking SYMBICORT, eye problems including glaucoma and cataracts, decreases in bone mineral density, swelling of blood vessels (signs include a feeling of pins and needles or numbness of arms or legs, flu like symptoms, rash, pain and swelling of the sinuses), decrease in blood potassium and increase in blood sugar levels.

If you are switching to SYMBICORT from an oral corticosteroid, follow your health care provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.

Additional Information Specific to Asthma

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.

Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Common side effects include nose and throat irritation, headache, upper respiratory tract infection, sore throat, sinusitis, stomach discomfort, flu, back pain, nasal congestion, vomiting, and thrush in the mouth and throat.

Additional Information Specific to COPD

Call your doctor if you notice any of the following symptoms: change in amount or color of sputum, fever, chills, increased cough, or increased breathing problems. People with COPD may have a higher chance of pneumonia.

Common side effects include inflammation of the nasal passages and throat, thrush in the mouth and throat, bronchitis, sinusitis, and upper respiratory tract infection.

Approved Uses for SYMBICORT

SYMBICORT 80/4.5 and 160/4.5 are medicines for the treatment of asthma for people 12 years and older whose doctor has determined that their asthma is not well controlled with a long term asthma control medicine such as an inhaled corticosteroid or whose asthma is severe enough to begin treatment with SYMBICORT. SYMBICORT is not a treatment for sudden asthma symptoms.

SYMBICORT 160/4.5 is for adults with COPD, including chronic bronchitis and emphysema. You should only take 2 inhalations of SYMBICORT twice a day. Higher doses will not provide additional benefits.

Talk to your doctor about prescription SYMBICORT.

Read Prescribing Information, including Boxed WARNING, with Medication Guide Adobe PDF (PDF — 551 KB)

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this Web site should not take the place of talking with your doctor or health care provider about how to manage and treat your asthma or COPD. If you have any questions about your condition, or if you would like more information about SYMBICORT, asthma, or COPD, talk to your doctor or pharmacist. Only you and your doctor can decide if SYMBICORT is right for you.

This product information is intended for US customers only.