FLOVENTĀ® HFA 44 mcg (fluticasone propionate 44 mcg) Inhalation Aerosol

Important Safety Information for FLOVENT

FLOVENT does not relieve sudden symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
See full Important Safety Information below

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Approved Uses for FLOVENT

FLOVENT is a prescription inhaled corticosteroid medicine for the long-term treatment of asthma in people aged 4 years and older.

FLOVENT is not used to relieve sudden breathing problems. FLOVENT won't replace a rescue inhaler.

Important Safety Information for FLOVENT

  • FLOVENT does not relieve sudden symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use FLOVENT DISKUS if you have a severe allergy to milk proteins. Do not use FLOVENT DISKUS or FLOVENT HFA if you are allergic to fluticasone propionate or any of the ingredients in the products. 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 FLOVENT more often than prescribed.
  • Do not stop using FLOVENT, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of FLOVENT, just take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT can cause serious side effects, including:
    • fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT 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, 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 inhaled corticosteroid (such as FLOVENT). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, 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
    • 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, throat, and tongue
      • breathing problems
    • bone thinning or weakness (osteoporosis)
    • slowed growth in children. A child's growth should be checked often.
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using FLOVENT.
    • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT. Always have a rescue inhaler with you to treat sudden wheezing.
  • Common side effects of FLOVENT DISKUS include:
    • upper respiratory tract infection
    • throat irritation
    • nausea and vomiting
    • fever
    • headache
  • Common side effects of FLOVENT HFA include:
    • a cold or upper respiratory tract infection
    • throat irritation
    • headache
    • fever
    • diarrhea
    • ear infection

Asthma Control Test is a trademark of QualityMetric Incorporated.

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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