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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 Leaflet 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. Ask your healthcare provider if you are not sure.
  • are allergic to umeclidinium or any of the ingredients in INCRUSE. See “What are the ingredients in
    INCRUSE?” below for a complete list of ingredients.

What should I tell my healthcare provider before using INCRUSE?

Tell your healthcare provider about all of your health 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.
  • have any other medical conditions.
  • are pregnant or planning 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 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)
  • 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. 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
  • 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 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 infection
  • stuffy or runny nose
  • cough
  • sore throat
  • joint pain
  • muscle pain
  • tooth pain
  • stomach pain
  • bruising or dark areas of skin
  • fast or irregular heartbeat

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with INCRUSE. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the 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 foil tray and only open when ready for use.
  • Safely throw away INCRUSE in the trash 6 weeks after you open the foil 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) for better breathing.

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IMPORTANT SAFETY INFORMATION
FOR ADVAIR 250/50 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR
ADVAIR DISKUS 250/50

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), 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 BREO 100/25 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR
BREO 100/25 FOR COPD

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in BREO), 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 INCRUSE

  • Do not use INCRUSE to treat sudden symptoms of COPD. 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 BREO 100/25 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR
BREO 100/25 FOR COPD

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in BREO), 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. MORE >

IMPORTANT SAFETY
INFORMATION
FOR INCRUSE

  • Do not use INCRUSE to treat sudden symptoms of COPD. 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. MORE >

IMPORTANT SAFETY
INFORMATION
FOR
BREO 100/25 FOR COPD

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in BREO), 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 BREO.
  • 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 BREO to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use BREO if you have a severe allergy to milk proteins or are allergic to any of the ingredients in BREO. Ask your healthcare provider if you are not sure.
  • Do not use BREO more often than prescribed.
  • Do not take BREO with other medicines that contain a LABA for any reason. Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • BREO can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREO to help reduce your chance of getting thrush.
    • pneumonia. People with COPD have a higher chance of getting pneumonia. BREO may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: increase in mucus (sputum) production; change in mucus color; fever; chills; increased cough; increased breathing problems.
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye may occur.
    • reduced adrenal function (adrenal insufficiency). This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as BREO). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms include: feeling tired; lack of energy; weakness; nausea and vomiting; low blood pressure.
    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking BREO 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.
    • bone thinning or weakness (osteoporosis).
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using BREO.
    • changes in laboratory blood values (sugar, potassium).
  • Common side effects of BREO 100/25 for COPD include:
    • runny nose and sore throat
    • upper respiratory tract infection
    • headache
    • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this

BREO ELLIPTA was
developed in collaboration with

IMPORTANT SAFETY INFORMATION FOR ADVAIR 250/50 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR ADVAIR 250/50 FOR COPD

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), 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. MORE >

IMPORTANT SAFETY
INFORMATION
FOR INCRUSE

  • Do not use INCRUSE to treat sudden symptoms of COPD. 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. MORE >

IMPORTANT SAFETY
INFORMATION
FOR ADVAIR DISKUS 250/50

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with LABA medicines, such as salmeterol.
  • It is not known if LABA medicines, such as salmeterol, increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler, but it does not relieve your breathing problems.
  • Do not use ADVAIR DISKUS to treat sudden symptoms from asthma or COPD. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use ADVAIR DISKUS if you have a severe allergy to milk proteins or are allergic to any of the ingredients in ADVAIR DISKUS. Ask your healthcare provider if you are not sure.
  • Do not use ADVAIR DISKUS more often than prescribed.
  • Do not take ADVAIR DISKUS with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • ADVAIR DISKUS can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.
    • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
      • increase in mucus (sputum) production
      • change in mucus color
      • fever
      • chills
      • increased cough
      • increased breathing problems
  • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
  • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as ADVAIR DISKUS). During this transition period, when your body is under stress, such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR DISKUS 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
    • chest pain
  • effects on nervous system
    • tremor
    • nervousness
  • bone thinning or weakness (osteoporosis)
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
  • changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • Common side effects of ADVAIR DISKUS 250/50 for COPD include:
    • thrush in your mouth or throat
    • throat irritation
    • hoarseness and voice changes
    • viral respiratory infections
    • headache
    • muscle and bone pain
  • Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.

IMPORTANT SAFETY
INFORMATION
FOR INCRUSE

  • Do not use INCRUSE to treat sudden symptoms of COPD. 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 health 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. 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.
    • 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 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 infection, stuffy or runny nose, cough, sore throat, joint pain, 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.