ASTHMA SYMPTOMS

Signs and symptoms of asthma can include:

Shortness of Breath

Moments where you find yourself needing to catch your breath or feel out of breath.

COUGHING

Fits of coughing can occur at any time.

WHEEZING

Difficulty breathing in and out. Often you can hear a slight whistling or squeaky sound coming from your chest.

CHEST TIGHTNESS

The feeling that something heavy is sitting on your chest restricting your breathing.

Often symptoms are caused by triggers. It’s important that you know which triggers affect you the most so that you can do your best to avoid them.

Important Safety Information for BREO ELLIPTA

  • 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.

Important Safety Information for BREO ELLIPTA

  • 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.
  • BREO should not be used in children and adolescents. It is not known if BREO is safe and effective in children and adolescents younger than 18 years of age.
  • 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, or if your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • 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.
    • 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 ICS (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 chronic obstructive pulmonary disease 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 and cataracts. You should have regular eye exams while using BREO.
    • changes in laboratory blood values: high blood sugar (hyperglycemia) and low potassium (hypokalemia).
    • slowed growth in children.
  • Common side effects of BREO for asthma include: runny nose and sore throat; thrush in your mouth or throat–Rinse your mouth with water without swallowing after use to help prevent this; headache; flu; respiratory tract infection; bronchitis; inflammation of the sinuses; mouth and throat pain; hoarseness and voice changes; cough.

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.