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IMPORTANT SAFETY INFORMATION FOR ANORO ELLIPTA

  • ANORO 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.

IMPORTANT SAFETY INFORMATION FOR ANORO ELLIPTA

  • ANORO 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 breathing problems. 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.
  • 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 can cause serious side effects, including:
    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ANORO and call your healthcare provider right away.
    • 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 your face, mouth, and tongue
      • breathing problems
    • effects on heart
      • increased blood pressure
      • a fast or irregular heartbeat, awareness of heartbeat
      • chest pain
    • effects on 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 healthcare provider 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:
      • difficulty 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 healthcare provider 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.
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.