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    RISKS & SIDE EFFECTS

    This is not all the safety information about FLOVENT. For more information, please see the complete Prescribing Information and Patient Information for FLOVENT DISKUS and FLOVENT HFA, and ask your healthcare provider or pharmacist.

    Prescription FLOVENT is for patients with asthma 4 years of age and older. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT won’t replace a rescue inhaler.

    Who should not use FLOVENT?

    Do not use FLOVENT DISKUS:

    • to treat sudden symptoms of asthma. FLOVENT DISKUS is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler, such as albuterol, during a sudden asthma attack.
    • if you have severe allergy to milk proteins or fluticasone propionate. Ask your healthcare provider if you are not sure.

    Do not use FLOVENT HFA if you:

    • are allergic to any of the ingredients in FLOVENT HFA or other inhaled corticosteroids. See "What are the ingredients in FLOVENT HFA?" in the Patient Information leaflet.
    • have an acute asthma attack or status asthmaticus. FLOVENT HFA is not a bronchodilator and should not be used to give you fast relief from your breathing problems during an asthma attack. Always use a short-acting bronchodilator (rescue medicine), such as an albuterol inhaler, during a sudden asthma attack. You must take FLOVENT HFA at regular times as recommended by your healthcare provider, and not as an emergency medicine.
    What should I tell my healthcare provider before taking FLOVENT?

    Before you use FLOVENT, tell your healthcare provider if you:

    • have liver problems.
    • 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 will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
    • are breast-feeding or plan to breast-feed. It is not known if FLOVENT passes into your breast milk. You and your healthcare provider should decide if you should use FLOVENT while you breast-feed.

    Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. FLOVENT may affect the way other medicines work, and other medicines may affect how FLOVENT works. Especially, tell your healthcare provider if you take:

    • anti-viral medicines, including medicines that contain ritonavir (commonly used to treat HIV infection
      or AIDS).
    • any other corticosteroid medicines.
    • ketoconazole (NIZORAL®*), an antifungal medicine.

    This is not a complete list of medicines that can affect FLOVENT. Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.

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

    *NIZORAL is a registered trademark of Janssen Pharmaceutica.

    What should I avoid while taking FLOVENT® DISKUS® (fluticasone propionate inhalation powder) or
    FLOVENT® HFA (fluticasone propionate) Inhalation Aerosol?

    If you have not had or have not been vaccinated against chickenpox, measles, or active tuberculosis, you should stay away from people who are infected.

    What are the possible side effects of FLOVENT?

    FLOVENT can cause serious side effects, including:

    • fungal infection (thrush) in your mouth and throat. Tell your healthcare provider if you have any redness or white-colored coating in your mouth.
    • decreased ability to fight infections. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while you use FLOVENT.
    • decreased adrenal function (adrenal insufficiency). Symptoms of decreased adrenal function include tiredness, weakness, nausea and vomiting, and low blood pressure. Decreased adrenal function can lead to death.
    • allergic reaction (anaphylaxis). Call your healthcare provider and stop FLOVENT right away if you have any symptoms of an allergic reaction:
      • swelling of the face, throat, and tongue
      • hives
      • rash
      • breathing problems
    • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
    • slow growth in children. The growth of children using FLOVENT should be checked regularly.
    • eye problems including glaucoma and cataracts. Tell your healthcare provider about any vision changes while using FLOVENT. Your healthcare provider may tell you to have your eyes checked.
    • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT. Always have a rescue inhaler with you to treat sudden wheezing.

    Call your healthcare provider right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.

    The most common side effects of FLOVENT DISKUS include:

    • a cold or upper respiratory tract infection
    • throat irritation
    • nausea and vomiting
    • fever
    • headache

    The most 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 if you have any side effects that bother you or that do not go away. These are not all the possible side effects of FLOVENT. For more information, ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA
    at 1-800-FDA-1088 or 1-800-332-1088.

    Approved Uses for FLOVENT

    Prescription FLOVENT is for patients with asthma 4 years of age and older. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT won’t replace a rescue inhaler.

    Important Safety Information About FLOVENT® DISKUS® (fluticasone propionate inhalation powder) and FLOVENT® HFA (fluticasone propionate) Inhalation Aerosol

    • Do not use FLOVENT:
      • to treat sudden symptoms of asthma. FLOVENT is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler, such as albuterol, during a sudden asthma attack.
      • if you are allergic to any of the ingredients in FLOVENT or other inhaled corticosteroids. Do not use FLOVENT DISKUS if you have severe allergy to milk proteins or fluticasone propionate. Ask your doctor if you are not sure.
    • Tell your doctor about the medicines you take and about all of your medical conditions. Do not stop taking FLOVENT, even if you are feeling better, unless your doctor tells you to. If you miss a dose, just take your next scheduled dose when it is due. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
    • If you have not had or have not been vaccinated against chickenpox, measles, or active tuberculosis, you should stay away from people who are infected. You should avoid exposure to chickenpox, measles, and tuberculosis. If exposed, consult your healthcare provider without delay.
    • FLOVENT can cause serious side effects, including:
      • fungal infections (thrush) in your mouth and throat. Tell your doctor if you have any redness or white-colored coating in your mouth.
      • decreased ability to fight infections. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you use FLOVENT.
      • decreased adrenal function (adrenal insufficiency). Symptoms of decreased adrenal function include tiredness, weakness, nausea and vomiting, and low blood pressure. Decreased adrenal function can lead to death.
      • allergic reaction (anaphylaxis). Call your doctor and stop FLOVENT right away if you have any symptoms of an allergic reaction:
        • swelling of the face, throat, and tongue
        • hives
        • rash
        • breathing problems
      • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
      • slow growth in children. The growth of children using FLOVENT should be checked regularly.
      • eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using FLOVENT. Your doctor may tell you to have your eyes checked.
      • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT. Always have a rescue inhaler with you to treat sudden wheezing.
    • The most common side effects of FLOVENT DISKUS include:
      • a cold or upper respiratory tract infection
      • throat irritation
      • nausea and vomiting
      • fever
      • headache
    • The most common side effects of FLOVENT HFA include:
      • a cold or upper respiratory tract infection
      • throat irritation
      • headache
      • fever
      • diarrhea
      • ear infection

      • Complete Prescribing Information and Patient Information for FLOVENT DISKUS

      Complete Prescribing Information and Patient Information for FLOVENT HFA

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