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IMPORTANT SAFETY INFORMATION
FOR ADVAIR 250/50 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR
ADVAIR DISKUS 250/50

  • ADVAIR DISKUS contains salmeterol, the same medicine found in SEREVENT DISKUS (salmeterol xinafoate inhalation powder). Long-acting beta2-adrenergic agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. ADVAIR DISKUS contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

IMPORTANT SAFETY INFORMATION
FOR BREO 100/25 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR
BREO 100/25 FOR COPD

  • BREO contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • Do not use BREO to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

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
BREO 100/25 and INCRUSE

IMPORTANT SAFETY
INFORMATION
FOR
BREO 100/25 FOR 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. MORE >

IMPORTANT SAFETY
INFORMATION
FOR
BREO 100/25 FOR COPD

  • BREO contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma 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.
  • Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms.
  • 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 (hypotension).
    • 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, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using BREO.
    • high levels of blood sugar (hyperglycemia) which may cause increased thirst, frequent urination, or unexplained tiredness.
    • changes in laboratory blood levels, including low levels of potassium (hypokalemia).
  • 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
    • back pain
    • pneumonia
    • bronchitis
    • inflammation of the sinuses
    • cough
    • mouth and throat pain
    • joint pain
    • high blood pressure
    • flu
    • fever

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

  • ADVAIR DISKUS contains salmeterol, the same medicine found in SEREVENT DISKUS (salmeterol xinafoate inhalation powder). Long-acting beta2-adrenergic agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. ADVAIR DISKUS contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems. 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

  • ADVAIR DISKUS contains salmeterol, the same medicine found in SEREVENT DISKUS (salmeterol xinafoate inhalation powder). Long-acting beta2-adrenergic agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. ADVAIR DISKUS contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • Do not use ADVAIR DISKUS to treat sudden breathing problems 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.
  • Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms, or if your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • 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 ICS (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 (hypotension).
    • 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, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using ADVAIR DISKUS.
    • changes in laboratory blood levels (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, and 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 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 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 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 Leaflet, 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.