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Risks & Side Effects

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This is not all the safety information about ADVAIR. Please see the complete Prescribing Information and Medication Guide for ADVAIR DISKUS and complete Prescribing Information and Medication Guide for ADVAIR HFA for more information, and ask your healthcare provider or pharmacist.

What is the most important information I should know about ADVAIR?

ADVAIR can cause serious side effects, including:

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR, reduces the risk of death from asthma problems seen with salmeterol.
    • Call your healthcare provider if breathing problems worsen over time while using ADVAIR. You may need different treatment.
    • Get emergency medical care if:
      • breathing problems worsen quickly and
      • you use your rescue inhaler medicine, but it does not relieve your breathing problems.
  • ADVAIR should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as inhaled corticosteroids.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR. Your healthcare provider will decide if you can stop ADVAIR without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Do not use ADVAIR DISKUS:

  • to treat sudden, severe symptoms of asthma or COPD and
  • if you have a severe allergy to milk proteins. Ask your doctor if you are not sure.

Do not use ADVAIR HFA:

  • to treat sudden, severe symptoms of asthma
  • if you are allergic to any of the ingredients in ADVAIR HFA. Ask your doctor if you are not sure

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

  • have heart problems
  • have high blood pressure
  • have seizures
  • have thyroid problems
  • have diabetes
  • have liver problems
  • have osteoporosis
  • have an immune system problem
  • have eye problems such as increased pressure in the eye (glaucoma) or cataracts
  • are pregnant or planning to become pregnant. It is not known if ADVAIR may harm your unborn baby.
  • are breastfeeding. It is not known if ADVAIR passes into your milk and if it can harm your baby.
  • are allergic to any of the ingredients in ADVAIR, any other medicines, or food products. See Medication Guides for ADVAIR DISKUS and ADVAIR HFA for a complete list of the ingredients in ADVAIR.
  • are exposed to chickenpox or measles

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. ADVAIR and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take ritonavir. The anti-HIV medicines NORVIR® (ritonavir capsules) Soft Gelatin, NORVIR (ritonavir oral solution), and KALETRA® (lopinavir/ritonavir) Tablets contain ritonavir.

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

NORVIR and KALETRA are registered trademarks of Abbott Laboratories.

ADVAIR can cause serious side effects, including:

  • 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 the face, mouth, and tongue
    • breathing problems
  • sudden breathing problems immediately after inhaling your medicine
  • effects on heart
    • increased blood pressure
    • a fast and irregular heartbeat
    • chest pain
  • effects on nervous system
    • tremor
    • nervousness
  • reduced adrenal function (may result in loss of energy)
  • changes in blood (sugar, potassium, certain types of white blood cells)
  • weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
  • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR.
  • slowed growth in children. A child's growth should be checked often.
  • ADVAIR HFA can cause throat tightness.

Common side effects of ADVAIR DISKUS for asthma include:

  • upper respiratory tract infection
  • throat irritation
  • hoarseness and voice changes
  • thrush in the mouth and throat
  • bronchitis
  • cough
  • headache
  • nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

Common side effects of ADVAIR HFA for asthma include:

  • upper respiratory tract infection
  • throat irritation
  • hoarseness and voice changes
  • headache
  • dizziness
  • nausea and vomiting

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

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.

Do not use ADVAIR more often than prescribed.

While you are using ADVAIR, do not use other medicines that contain a LABA for any reason.

Do not stop using ADVAIR or other asthma medicines unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

Call your healthcare provider or get medical care right away if:

  • your breathing problems worsen with ADVAIR
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms
  • you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row
  • you use 1 whole canister of your rescue inhaler medicine in 8 weeks' time
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you
  • you have asthma and your symptoms do not improve after using ADVAIR regularly for 1 week

Call your doctor for medical advice about side effects.

Approved Uses for ADVAIR

ADVAIR DISKUS is for the treatment of asthma in patients 4 years and older. ADVAIR HFA is for the treatment of asthma in patients 12 years and older. ADVAIR is available by prescription only.

ADVAIR should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.

ADVAIR is not for, and should not be used to treat, sudden, severe symptoms of asthma. ADVAIR won’t replace a rescue inhaler.

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

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR, reduces the risk of death from asthma problems seen with salmeterol.
    • Call your healthcare provider if breathing problems worsen over time while using ADVAIR. You may need different treatment.
    • Get emergency medical care if:
      • breathing problems worsen quickly and
      • you use your rescue inhaler medicine, but it does not relieve your breathing problems.
  • ADVAIR should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR. Your healthcare provider will decide if you can stop ADVAIR without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents with asthma who take LABA medicines may have an increased risk of hospitalization for asthma problems.
  • Do not use ADVAIR to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
  • Do not use ADVAIR if you are allergic to any of the ingredients in ADVAIR. Do not use ADVAIR DISKUS if you have severe allergy to milk proteins. Ask your doctor if you are not sure.
  • Do not use ADVAIR more often than prescribed. Do not take ADVAIR with other medicines that contain a LABA for any reason. Tell your doctor about medicines you take and about all of your medical conditions.
  • ADVAIR can cause serious side effects, including:
    • 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 the face, mouth, and tongue
      • breathing problems
    • sudden breathing problems immediately after inhaling your medicine
    • effects on heart
      • increased blood pressure
      • a fast and irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • reduced adrenal function (may result in loss of energy)
    • changes in blood (sugar, potassium, certain types of white blood cells)
    • weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
    • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR.
    • slowed growth in children. A child's growth should be checked often.
    • ADVAIR HFA can cause throat tightness.
  • Common side effects of ADVAIR DISKUS for asthma include:
    • upper respiratory tract infection
    • throat irritation
    • hoarseness and voice changes
    • thrush in the mouth and throat
    • bronchitis
    • cough
    • headache
    • nausea and vomiting

    In children with asthma, infections in the ear, nose, and throat are common.

  • Common side effects of ADVAIR HFA for asthma include:
    • upper respiratory tract infection
    • throat irritation
    • hoarseness and voice changes
    • headache
    • dizziness
    • nausea and vomiting

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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See how to use ADVAIR DISKUS

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