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 HFA

Features of FLOVENT HFA

The medicine in FLOVENT HFA is in an aerosol form. FLOVENT HFA is NOT meant for fast-acting relief. It is meant to be taken twice a day as prescribed by your healthcare professional.

FLOVENT HFA has a counter to show how many sprays of medicine you have left. The counter starts at 124. The number will count down by 1 each time you spray the inhaler. The counter will stop counting at 000. When the counter reads 000, throw the inhaler away. You should not keep using the inhaler because you will not receive the right amount of medicine.

WHO SHOULD NOT USE FLOVENT HFA?

Do not use FLOVENT HFA:

  • to relieve sudden breathing problems
  • if you are allergic to fluticasone propionate or any of the ingredients in FLOVENT HFA.

How Long Does FLOVENT HFA Take to Start Working?

After you start using FLOVENT HFA, it may take 1 to 2 weeks or longer of daily use until you notice an improvement in your asthma symptoms. You must use FLOVENT HFA 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 HFA Exactly as Your Healthcare Provider Tells You to Use It

It is important that you inhale each dose as your healthcare provider has prescribed. The prescription label provided by your pharmacist will usually tell you what dose to take and how often. If it doesn't or if you aren't sure, ask your healthcare provider or pharmacist. DO NOT inhale more doses or use your FLOVENT HFA more often than your healthcare provider has prescribed.

What should I tell my healthcare provider before using FLOVENT HFA?

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 HFA or any other medicines. See "What are the ingredients in FLOVENT HFA?" below for a complete list of ingredients.
  • 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 HFA may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in FLOVENT HFA 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 HFA 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 HFA?

  • Store FLOVENT HFA at room temperature between 68°F and 77°F (20°C and 25°C) with the mouthpiece down.
  • The contents of your FLOVENT HFA inhaler are under pressure. Do not puncture. Do not use or store near heat or open flame. Temperatures above 120°F may cause the canister to burst.
  • Do not throw into fire or an incinerator.
  • Safely throw away FLOVENT HFA in the trash when the counter reads 000.
  • Keep FLOVENT HFA and all medicines out of the reach of children.

Approved Use for FLOVENT HFA

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

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

Important Safety Information for FLOVENT

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

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