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IMPORTANT SAFETY INFORMATION FOR INCRUSE

  • Do not use INCRUSE to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use INCRUSE if you have a severe allergy to milk proteins or any of the ingredients in INCRUSE. Ask your healthcare provider if you are not sure.
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IMPORTANT SAFETY
INFORMATION FOR INCRUSE

  • Do not use INCRUSE to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use INCRUSE if you have a severe allergy to milk proteins or any of the ingredients in INCRUSE. Ask your healthcare provider if you are not sure.
  • Do not use INCRUSE more often than prescribed.
  • Do not take INCRUSE with other medicines that contain an anticholinergic for any reason. Tell your healthcare provider about all the medicines you take and about all of your medical conditions. Especially tell your healthcare provider if you take anticholinergics including tiotropium, ipratropium, aclidinium, or atropine.
  • 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.
  • INCRUSE 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 taking INCRUSE and call your healthcare provider right away.
    • serious allergic reactions (anaphylaxis). Stop taking INCRUSE and call your healthcare provider or go to the nearest emergency room right away if you get any of the following symptoms of a serious allergic reaction: rash; hives; severe itching; swelling of your face, lips, mouth, or tongue; breathing problems.
    • new or worsening eye problems including acute narrow-angle glaucoma. You should have regular eye exams while using INCRUSE ELLIPTA. 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 INCRUSE 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 INCRUSE, and call your healthcare provider right away before taking another dose.
  • Common side effects of INCRUSE include upper respiratory tract infection, stuffy or runny nose, cough, mouth and throat pain, joint pain, change in taste, muscle pain, tooth pain, stomach pain, bruising or dark areas of skin, and fast or irregular heartbeat.
Prescribing Information, including Patient Information, for INCRUSE ELLIPTA
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.