Important Safety Information

• Do not use TRELEGY to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
• Do not use TRELEGY if you have a severe allergy to milk proteins or are allergic to any of the ingredients in TRELEGY. Ask your healthcare provider if you are not sure.
• Do not use TRELEGY more often than prescribed.
• Do not take TRELEGY with other medicines that contain a long-acting beta₂-adrenergic agonist (LABA) or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take.
• 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.
• TRELEGY can cause serious side effects, including:
  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY to help reduce your chance of getting thrush.
  • pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: change in amount or color of mucus; fever; chills; increased cough; increased breathing problems.
  • weakened immune system and increased chance of getting infections.
  • reduced adrenal function. This can happen when you stop taking oral corticosteroids and start taking inhaled corticosteroids.
  • sudden breathing problems immediately after inhaling TRELEGY. If this happens, stop taking TRELEGY 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: 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, blurred vision, worsening of narrow-angle glaucoma, or other changes in vision. You should have regular eye exams while using TRELEGY 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
    • seeing halos or bright colors around lights
    • nausea or vomiting
    • red eyes
    • blurred vision
      • If you have these symptoms, call your healthcare provider right away before taking another dose.
  • new or worse urinary retention. Symptoms may include: difficult, painful, or frequent urination; urination in a weak stream or drips. If you have these symptoms, stop taking TRELEGY and call your healthcare provider right away.
  • changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
• Common side effects of TRELEGY include: upper respiratory tract infection; pneumonia; bronchitis; thrush in your mouth and throat (rinse your mouth with water without swallowing after use to help prevent this); headache; back pain; joint pain; flu; inflammation of the sinuses; runny nose and sore throat; taste disturbance; constipation; painful and frequent urination (signs of a urinary tract infection); nausea, vomiting, and diarrhea; mouth and/or throat pain; cough; and hoarseness.