FLOVENT® DISKUS® 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT® HFA 44 mcg (fluticasone propionate 44 mcg) Inhalation Aerosol

Important Safety Information for FLOVENT

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

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Getting Started With FLOVENT DISKUS

Features of FLOVENT DISKUS

FLOVENT DISKUS is rounded in shape. It also has a counter, so you can see how many doses you have left. The counter number will count down each time you use FLOVENT DISKUS. After you have used 55 doses (23 doses from the sample and institutional packs), the numbers 5 to 0 will show in red to warn you that there are only a few doses left.

The DISKUS delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Whether or not you can taste or feel your dose of medicine, do not take an extra dose. If you are not sure you are getting your dose of FLOVENT DISKUS, contact your healthcare provider or pharmacist.

WHO SHOULD NOT TAKE FLOVENT DISKUS?

Do not use FLOVENT DISKUS if you have a severe allergy to milk proteins or if you are allergic to fluticasone propionate or any of the ingredients in FLOVENT DISKUS. Ask your healthcare provider if you are not sure.

How Long Does It Take for FLOVENT DISKUS to Start Working?

After you start using FLOVENT DISKUS, it may take 1 to 2 weeks or longer of twice-daily use until you notice an improvement in your asthma symptoms. You must use FLOVENT DISKUS regularly. If you don't notice an improvement in your asthma symptoms or if your condition worsens, be sure to talk to your healthcare provider as soon as possible. FLOVENT does not relieve sudden breathing problems from asthma. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

Use FLOVENT DISKUS Exactly as Your Healthcare Provider Tells You to Use It

Do not change the dose yourself. Your healthcare provider will tell you how many times to inhale your FLOVENT DISKUS and when to use your FLOVENT DISKUS. Do not inhale more doses or use your FLOVENT DISKUS more often than your healthcare provider has prescribed. Do not stop using FLOVENT DISKUS, even if you are feeling better, unless your healthcare provider tells you to.

WHAT TO TELL YOUR HEALTHCARE PROVIDER BEFORE USING FLOVENT DISKUS

Tell your healthcare provider about all of your health conditions, including if you:

  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in FLOVENT DISKUS, any other medicines, or food products.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if FLOVENT DISKUS may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in FLOVENT DISKUS passes into your milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FLOVENT DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Store FLOVENT DISKUS?

Store FLOVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Store FLOVENT DISKUS in a dry place away from heat and sunlight.

  • Store FLOVENT DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away FLOVENT DISKUS 50 mcg in the trash 6 weeks after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Safely throw away FLOVENT DISKUS 100 mcg and FLOVENT DISKUS 250 mcg in the trash 2 months after you open the foil pouch or when the counter reads 0, whichever comes first.

Keep FLOVENT DISKUS and all medicines out of the reach of children.

Approved Use for FLOVENT Diskus

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

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

Important Safety Information for FLOVENT

  • FLOVENT DISKUS does not relieve sudden breathing problems from 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 or if you are allergic to fluticasone propionate or any of the ingredients in FLOVENT DISKUS. 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 DISKUS more often than prescribed.
  • Do not stop using FLOVENT DISKUS, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of FLOVENT DISKUS, just take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT DISKUS can cause serious side effects, including:
    • fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT DISKUS 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 DISKUS). During this transition period, 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 DISKUS.
    • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT DISKUS. Always have a rescue inhaler with you to treat sudden wheezing.
  • Common side effects of FLOVENT DISKUS include:
    • upper respiratory tract infection
    • throat, nose and/or sinus irritation
    • nausea and vomiting
    • cough and/or persistent cough
    • fever
    • headache
    • upset stomach

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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