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Important Safety Information About SYMBICORT
160/4.5 for COPD

Call your health care provider 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.

SYMBICORT does not replace rescue inhalers for sudden 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.

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 COPD

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.

Please read Prescribing Information, including Boxed WARNING, with Medication Guide and discuss with your doctor. (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 COPD. If you have any questions about your condition, or if you would like more information about SYMBICORT 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.

SYMBICORT is a registered trademark of the AstraZeneca group of companies.

©2011 AstraZeneca. All rights reserved. 1415702 12/11

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