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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Risks and Side Effects

Below you can learn about the risks and side effects of FLOVENT. This, however, is not all the safety information, and does not replace talking to your healthcare professional about your medical condition or treatment. Please see the complete Prescribing Information and Patient Information Leaflet for FLOVENT DISKUS and FLOVENT HFA for more information, or ask your healthcare provider or pharmacist.



RISKS & SIDE EFFECTS FOR FLOVENT DISKUS

Do not use FLOVENT DISKUS if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone propionate or any of the ingredients in FLOVENT DISKUS. See "What are the ingredients in FLOVENT DISKUS?" below for a complete list of ingredients.

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. See "What are the ingredients in FLOVENT DISKUS?" 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 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.

Read the step-by-step instructions for using FLOVENT DISKUS at the end of the
Patient Information Leaflet.

  • Do not use FLOVENT DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use FLOVENT DISKUS with an adult's help, as instructed by the child's healthcare provider.
  • FLOVENT DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use FLOVENT DISKUS exactly as your healthcare provider tells you to use it. Do not use FLOVENT DISKUS more often than prescribed.
  • It may take 1 to 2 weeks or longer after you start FLOVENT DISKUS for your asthma symptoms to get better. You must use FLOVENT DISKUS regularly.
  • 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 skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT DISKUS does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

FLOVENT DISKUS can cause serious side effects, including:

  • fungal infection 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)
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (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, mouth, 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 irritation
  • nausea and vomiting
  • fever
  • headache

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with FLOVENT DISKUS. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • Store FLOVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep 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.

Active ingredient: fluticasone propionate
Inactive ingredient: lactose monohydrate (contains milk proteins)

RISKS & SIDE EFFECTS FOR 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. See "What are the ingredients in FLOVENT HFA?" below for a complete list of ingredients.

Tell your healthcare provider about all 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.
  • have been exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if FLOVENT HFA will harm your unborn baby.
  • are breastfeeding a baby. It is not known if FLOVENT HFA passes into your breast milk.

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.

Read the step-by-step instructions for using FLOVENT HFA at the end of the Patient Information Leaflet.

  • Do not use FLOVENT HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use FLOVENT HFA with an adult’s help, as instructed by the child’s healthcare provider.
  • FLOVENT HFA comes in 3 different strengths. Your healthcare provider has prescribed the strength that is best for you.
  • Use FLOVENT HFA exactly as your healthcare provider tells you to use it. Do not use FLOVENT HFA more often than prescribed.
  • It may take 1 to 2 weeks or longer after you start FLOVENT HFA for your asthma symptoms to get better. You must use FLOVENT HFA regularly.
  • Do not stop using FLOVENT HFA, even if you are feeling better, unless your healthcare provider tells you to.
  • Talk to your healthcare provider right away if you stop using FLOVENT HFA.
  • 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 does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

FLOVENT HFA can cause serious side effects, including:

  • fungal infection 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).
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (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, mouth, 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:

  • a cold or upper respiratory tract infection
  • throat irritation
  • headache
  • fever
  • diarrhea
  • ear infection

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with FLOVENT HFA. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • 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.

Active ingredient: fluticasone propionate
Inactive ingredient: propellant HFA-134a

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 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. 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 skip that dose. 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). 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.
    • 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

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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