IMPORTANT SAFETY INFORMATION

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 chronic obstructive pulmonary disease (COPD).
See full Important Safety Information below ▼

Other Approved Use APPROVED USES

BREO ELLIPTA 100/25 is a prescription medicine used to treat COPD, including chronic bronchitis, emphysema, or both. BREO ELLIPTA 100/25 is used long term as 1 inhalation 1 time each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days). BREO is not used to relieve sudden breathing problems and won't replace a rescue inhaler.

TALK TO YOUR DOCTOR TO SEE IF BREO CAN IMPROVE YOUR SYMPTOMS OF COPD FOR BETTER BREATHING.

Whether you're coordinating a food drive or planning a family outing, you believe in making things happen. And you don't want your breathing problems to get in the way. BREO ELLIPTA may be able to help you breathe better.

BREO is a combination of two medicines—an inhaled corticosteroid (ICS) medicine called fluticasone furoate, and a long-acting beta2-adrenergic agonist (LABA) medicine called vilanterol—creating the first and only once-daily ICS/LABA that helps improve lung function for a full 24 hours. Your results may vary.

IMPORTANT SAFETY INFORMATION

  • 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 ELLIPTA 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

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.

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