RISKS & SIDE EFFECTS

Please review this safety information

Below you can learn about risks and side effects of INCRUSE. This, however, is not all the safety information for INCRUSE and does not replace talking to your healthcare professional about your medical condition or treatment. Please see the full Prescribing Information and Patient Information for INCRUSE for more information, and talk to your healthcare provider.

Who should not use INCRUSE?

Do not use INCRUSE if you:

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

What should I tell my healthcare provider before using INCRUSE?

Tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have eye problems such as glaucoma. INCRUSE may make your glaucoma worse.
  • have prostate or bladder problems, or problems passing urine. INCRUSE may make these problems worse.
  • are allergic to any of the ingredients in INCRUSE, any other medicines, or food products. See "What are the ingredients in INCRUSE?" below for a complete list of ingredients. Ask your healthcare provider if you are not sure.
  • are pregnant or plan to become pregnant. It is not known if INCRUSE may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in INCRUSE passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INCRUSE and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take anticholinergics (including tiotropium, ipratropium, aclidinium) or atropine.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects with INCRUSE?

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 doctor 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 the 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 doctor 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 doctor 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
  • fast or irregular heartbeat

These are not all the possible side effects of INCRUSE.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store INCRUSE?

  • Store INCRUSE at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store INCRUSE in the unopened tray, and only open when ready for use.
  • Safely throw away INCRUSE in the trash 6 weeks after you open the tray or when the counter reads "0", whichever comes first. Write the date you open the tray on the label on the inhaler.
  • Keep INCRUSE and all medicines out of the reach of children.

What are the ingredients in INCRUSE?

Active ingredients: umeclidinium
Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

APPROVED USE

Once-daily INCRUSE is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. INCRUSE is not used to relieve sudden breathing problems and won't replace a rescue inhaler.

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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.
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.