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COPD MAKES IT HARD TO BREATHE AIR. ANORO HELPS YOU BREATHE AIR BETTER. (COPD is chronic obstructive pulmonary disease)


APPROVED USE


ANORO ELLIPTA is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. ANORO ELLIPTA is used long term as 1 inhalation, 1 time each day, to improve symptoms of COPD for better breathing. ANORO is not used to treat sudden symptoms of COPD and won’t replace a rescue inhaler. ANORO is not for the treatment of asthma.


IMPORTANT SAFETY INFORMATION


• ANORO ELLIPTA is only approved for use in COPD. ANORO is NOT approved for use in asthma.


• People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in ANORO), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.


• Call your healthcare provider if breathing problems worsen over time while using ANORO.


• Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems.


• Do not use ANORO to treat sudden symptoms of COPD. Always have a rescue inhaler with you to treat sudden symptoms.


• ANORO is not for the treatment of asthma. It is not known if ANORO is safe and effective in people with asthma.


• Do not use ANORO if you have a severe allergy to milk proteins or any of the ingredients in ANORO. Ask your healthcare provider if you are not sure.


• Do not use ANORO more often than prescribed.


ANORO ELLIPTA is the fi rst FDA-approved product that contains 2 long-acting bronchodilators in 1 inhaler. Once-daily ANORO helps you breathe better for a full 24 hours. Your results may vary.


In clinical trials, ANORO ELLIPTA helped people breathe air better than SPIRIVA® HandiHaler®.*†


* Results shown in 2 of 3 clinical trials. Individual results may vary. SPIRIVA contains 1 long-acting bronchodilator and is used to treat COPD and reduce COPD fl are-ups. ANORO is not approved to reduce COPD fl are-ups. Each product has its own risks and benefi ts.


(Important Safety Information, cont’d)


• Do not take ANORO with other medicines that contain a LABA or an anticholinergic for any reason. Tell your healthcare provider about all the medicines you take and about all of your health conditions. Especially tell your healthcare provider if you take anticholinergics, including tiotropium, ipratropium, aclidinium, or atropine.


• ANORO ELLIPTA can cause serious side effects, including: – sudden breathing problems immediately after inhaling your medicine


– serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash; hives; swelling of the face, mouth, and tongue; breathing problems.


– effects on your heart: increased blood pressure; fast and/or irregular heartbeat; chest pain


– effects on your nervous system: tremor; nervousness


– new or worsened eye problems, including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: eye pain or discomfort; nausea or vomiting; blurred vision; seeing halos or bright colors around lights; red eyes. If you have these symptoms, call your doctor right away before taking another dose.


– urinary retention. People who take ANORO may develop new or worse urinary retention. Symptoms of urinary retention may include: diffi culty urinating; painful urination; urinating frequently; urination in a weak stream or drips. If you have these symptoms of urinary retention, stop taking ANORO and call your doctor right away before taking another dose.


– changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)


• Common side effects of ANORO include: sore throat; sinus infection; lower respiratory infection; common cold symptoms; constipation; diarrhea; pain in your arms or legs; muscle spasms; neck pain; chest pain.


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.


Please see Brief Summary of Prescribing Information for ANORO ELLIPTA on the following pages.





SPIRIVA and HandiHaler are registered trademarks owned by Boehringer Ingelheim.


ANORO ELLIPTA was developed in collaboration with


Talk to your doctor about ANORO. Visit ANORO.com and sign up for savings.‡ ‡Subject to eligibility. Restrictions apply. See ANORO.com for eligibility rules.


© PARADE Publications 2014. All rights reserved


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