For US Residents

For US Residents

    Approved Use & Safety Info

    Approved Use

    Important Safety Information

    Approved Use

    • ARNUITY is a prescription medicine used to prevent and control symptoms of asthma for better breathing in adults and children aged 5 years and older.
    • ARNUITY is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
    • It is not known if ARNUITY is safe and effective in children younger than 5 years of age.

    Important Safety Information

    • Do not use ARNUITY to treat sudden symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
    • Do not use ARNUITY if you have a severe allergy to milk proteins or are allergic to any of the ingredients in ARNUITY. Ask your healthcare provider if you are not sure.
    • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
    • Do not use ARNUITY more often than prescribed.
    • 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.
    • ARNUITY can cause serious side effects, including:
      • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ARNUITY 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 (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 ARNUITY). When your body is under stress, such as from fever, trauma (such as a car accident), infection, surgery, or worse asthma 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 ARNUITY. If this happens, stop using ARNUITY 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
      • bone thinning or weakness (osteoporosis).
      • slow growth in children and adolescents. A child’s or adolescent’s growth should be checked often.
      • eye problems, including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using ARNUITY.
    • Common side effects of ARNUITY include:
      • runny nose and sore throat
      • headache
      • breathing problems (bronchitis)
      • flu
    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. You may also report negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.
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