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

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.
See full Important Safety Information below

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FAQs

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.

Ask your doctor if FLOVENT is right for you.



FLOVENT helps prevent asthma symptoms by reducing inflammation in the airways of the lungs. Your results may vary.

Asthma is a long-term, chronic disease of the airways of the lungs characterized by two main causes: airway constriction and inflammation. Together, they cause narrowing of the airways, which results in symptoms such as wheezing and shortness of breath. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT won't replace a rescue inhaler. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

FLOVENT is a long-term asthma control medicine for patients with asthma who are 4 years of age or older, and whose symptoms are not well controlled on a rescue inhaler.

Taken twice daily as directed, FLOVENT can help prevent symptoms before they start because it helps reduce airway inflammation, an underlying cause of asthma symptoms. Your results may vary. By preventing symptoms before they occur, you or your child may not need to use a rescue inhaler as often. FLOVENT does not treat sudden symptoms of an asthma attack, such as wheezing, cough, shortness of breath, and chest pain or tightness. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

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. After use, rinse your mouth with water without swallowing to help prevent thrush in your mouth and throat.
  • 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

If you have asthma, airway inflammation is always there whether you have symptoms or not. Take FLOVENT as prescribed by your doctor. Do not stop using FLOVENT even if you are feeling better, unless your doctor tells you to do so, because your symptoms might get worse. Your doctor will change your medicines as needed.

FLOVENT DISKUS is a product that you inhale to help prevent your asthma symptoms from occurring in the first place. Take FLOVENT twice a day, every day, approximately 12 hours apart, as prescribed by your healthcare provider. Learn how to use FLOVENT DISKUS.

FLOVENT HFA is a product that you inhale to help prevent your asthma symptoms from occurring in the first place. Take FLOVENT twice a day, every day, approximately 12 hours apart, as prescribed by your healthcare provider. Learn how to use FLOVENT HFA.

Clean the inhaler at least once a week after your evening dose. It is important to keep the canister and plastic actuator clean, so the medicine will not build up and block the spray.

  1. Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the canister out of the plastic actuator.
  2. Use a clean cotton swab dampened with water to clean the small circular opening where the medicine sprays out of the canister. Gently twist the swab in a circular motion to take off any medicine. Repeat with a new swab dampened with water to take off any medicine still at the opening.
  3. Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.
  4. Put the cap back on the mouthpiece after the actuator has dried.

No. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT does not replace a rescue inhaler. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

FLOVENT HFA is a metered-dose inhaler that comes in 3 strengths. Only the lowest strength is approved for use in children aged 4 to 11 years.

FLOVENT DISKUS is a dry powder inhaler that comes in 3 strengths. Only the 2 lowest strengths are approved for use in children aged 4 to 11 years.

FLOVENT is not approved for use in children younger than 4 years of age.

FLOVENT is available by prescription only.

Your healthcare provider will determine which strength is best for you or your child.

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

FLOVENT DISKUS is not reusable. Safely throw away medicine that is out of date or no longer needed.

Do not try to take FLOVENT DISKUS apart.

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

Store FLOVENT HFA at room temperature between 59°F and 86°F (15°C-30°C). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.

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

FLOVENT DISKUS contains lactose. Do not use FLOVENT DISKUS if you have severe allergy to milk proteins. Ask your healthcare provider if you are not sure.

FLOVENT HFA does NOT contain lactose.

Thrush is the overgrowth of candida, a fungus, in the mouth. It can occur when the normal balance of bacteria in your mouth is altered. Thrush is treatable, and there are things you can do to help prevent it. If you take FLOVENT, make sure to rinse your mouth with water after taking the medicine and spit the water out. Do not swallow it.

GlaxoSmithKline offers multiple programs to help patients afford their medicine. To learn more about these programs, please go to www.GSKforYou.com.

Inhaled corticosteroids like FLOVENT can cause serious side effects, including slow growth in children. The growth of children using FLOVENT should be checked regularly.

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 for FLOVENT

  • 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. After use, rinse your mouth with water without swallowing to help prevent thrush in your mouth and throat.
    • 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

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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