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  • BEVESPI AEROSPHERE is a prescription medication used long-term to treat adults with COPD READ MORE...(chronic obstructive pulmonary disease), including chronic bronchitis, emphysema, or both. SHOW LESS
  • BEVESPI AEROSPHERE is not a rescue inhaler and is not for use to treat sudden COPD symptoms. READ MORE...It is not for use in asthma. SHOW LESS

SAFETY AND SIDE EFFECTS

Please read this safety information carefully and ask your health care provider if you have any questions.

Below you’ll find information about safety, risks, and side effects related to BEVESPI AEROSPHERE. Remember, this does not replace reviewing the Medication Guide or talking to your health care provider or pharmacist about any safety concerns.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT BEVESPI AEROSPHERE?

BEVESPI AEROSPHERE is only approved for use in chronic obstructive pulmonary disease (COPD). BEVESPI AEROSPHERE is NOT approved for use in asthma.

BEVESPI AEROSPHERE can cause serious side effects, including:

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as formoterol fumarate (one of the medicines in BEVESPI AEROSPHERE), have an increased risk of death from asthma problems
  • It is not known if LABA medicines, such as formoterol fumarate (one of the medicines in BEVESPI AEROSPHERE), increase the risk of death in people with COPD
  • Call your health care provider if breathing problems worsen over time while using BEVESPI AEROSPHERE. You may need different treatment
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler, but it does not relieve your breathing problems

WHO SHOULD NOT USE BEVESPI AEROSPHERE?

Do not use BEVESPI AEROSPHERE if you:

  • are allergic to glycopyrrolate, formoterol fumarate, or to any of the ingredients in BEVESPI AEROSPHERE. See “What are the ingredients in BEVESPI AEROSPHERE?” below and in the Medication Guide for a complete list of ingredients
  • have asthma. See “What is the most important information I should know about BEVESPI AEROSPHERE?” above

WHAT SHOULD I TELL MY HEALTH CARE PROVIDER BEFORE USING BEVESPI AEROSPHERE?

Before using BEVESPI AEROSPHERE, tell your health care provider about all of your medical conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have seizures
  • have thyroid problems
  • have diabetes
  • have liver problems
  • have eye problems such as glaucoma. BEVESPI AEROSPHERE may make your glaucoma worse
  • have prostate or bladder problems, or problems passing urine. BEVESPI AEROSPHERE may make these problems worse
  • are allergic to any other medicines or food products
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if BEVESPI AEROSPHERE may harm your unborn baby
  • are breastfeeding. It is not known if the medicines in BEVESPI AEROSPHERE pass into your breast milk and if they can harm your baby

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BEVESPI AEROSPHERE and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your health care provider if you take:

  • anticholinergics (including tiotropium, ipratropium, aclidinium, and umeclidinium)
  • other LABAs (including salmeterol, arformoterol, vilanterol, olodaterol, and indacaterol)
  • atropine

Know the medicines you take. Keep a list of them to show your health care provider and pharmacist each time you get a new medicine.

HOW SHOULD I USE BEVESPI AEROSPHERE?

Read the step-by-step instructions for using BEVESPI AEROSPHERE at the end of the Medication Guide.

  • Do not use BEVESPI AEROSPHERE unless your health care provider has taught you how to use the inhaler and you understand how to use it correctly
  • Use BEVESPI AEROSPHERE exactly as your health care provider tells you to use it. Do not use BEVESPI AEROSPHERE more often than prescribed
  • Use 2 inhalations of BEVESPI AEROSPHERE, 2 times each day (in the morning and in the evening)
  • If you miss a dose of BEVESPI AEROSPHERE, take your next dose at the same time you normally do. Do not take more than your prescribed dose of BEVESPI AEROSPHERE
  • Do not spray BEVESPI AEROSPHERE in your eyes. If BEVESPI AEROSPHERE gets in your eyes, rinse them well with water. If redness continues, call your health care provider
  • Do not stop using BEVESPI AEROSPHERE unless told to do so by your health care provider because your symptoms might come back. Your health care provider will change your medicines as needed
  • Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your health care provider or pharmacist if any of your other medicines are LABA or anticholinergic containing medicines
  • BEVESPI AEROSPHERE 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 health care provider to have one prescribed for you
  • Call your health care 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

WHAT ARE THE POSSIBLE SIDE EFFECTS WITH BEVESPI AEROSPHERE?

BEVESPI AEROSPHERE can cause serious side effects, including:

  • See “What is the most important information I should know about BEVESPI AEROSPHERE?” above
  • Sudden breathing problems immediately after inhaling your medicine
  • Serious allergic reactions. Call your health care provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • swelling of the face, mouth, and tongue
    • hives
    • breathing problems
  • Effects on your heart:
    • increased blood pressure
    • chest pain
    • a fast or irregular heartbeat
  • Effects on your nervous system:
    • tremor
    • nervousness
  • New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
    • eye pain or discomfort
    • seeing halos or bright colors around lights
    • nausea or vomiting
    • red eyes
    • blurred vision

If you have these symptoms, call your health care provider right away before taking another dose.

  • Urinary retention. People who take BEVESPI AEROSPHERE may develop new or worse urinary retention. Symptoms of urinary retention may include:
    • difficulty urinating
    • urinating frequently
    • painful urination
    • urination in a weak stream or drips

If you have these symptoms of urinary retention, stop taking BEVESPI AEROSPHERE and call your health care provider right away before taking another dose.

  • Changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm

Common side effects of BEVESPI AEROSPHERE include:

  • urinary tract infection
  • cough

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

These are not all the side effects of BEVESPI AEROSPHERE. Ask your health care 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-1088.1-800-FDA-1088. You may also report side effects to AstraZeneca at 1-800-236-9933.1-800-236-9933.

WHAT ARE THE INGREDIENTS IN BEVESPI AEROSPHERE?

Active ingredients: micronized glycopyrrolate and micronized formoterol fumarate

Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)

IMPORTANT SAFETY INFORMATION ABOUT BEVESPI AEROSPHERE INCLUDING BOXED WARNING

People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as formoterol fumarate (one of the medicines in BEVESPI AEROSPHERE), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD. BEVESPI AEROSPHERE is only approved for use in COPD. BEVESPI AEROSPHERE is not approved for use in asthma.

  • Call your healthcare provider if breathing problems worsen over time while using BEVESPI AEROSPHERE
  • Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler, but it does not relieve your breathing problems
  • Do not use BEVESPI AEROSPHERE to treat sudden symptoms of COPD. Always have a rescue inhaler with you to treat sudden symptoms
  • BEVESPI AEROSPHERE is not for the treatment of asthma. It is not known if BEVESPI AEROSPHERE is safe and effective in people with asthma
  • Do not use BEVESPI AEROSPHERE if you are allergic to glycopyrrolate, formoterol fumarate, or to any of the ingredients in BEVESPI AEROSPHERE
  • Do not use BEVESPI AEROSPHERE more often than prescribed
  • Do not take BEVESPI AEROSPHERE with other medicines that contain a LABA or an anticholinergic for any reason. Tell your healthcare provider about all the medicines you take
  • Tell your healthcare provider about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, liver problems, glaucoma, prostate or bladder problems, or problems passing urine

BEVESPI AEROSPHERE can cause serious side effects, including:

  • Sudden breathing problems immediately after inhaling your medicine
  • 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
  • Fast or irregular heartbeat, increased blood pressure, chest pain
  • Tremor or nervousness
  • New or worsened eye problems, including acute narrow-angle glaucoma. Symptoms may include: eye pain or discomfort, nausea or vomiting, blurred vision, seeing halos or bright colors around lights, and red eyes. If you have these symptoms, call your healthcare provider right away before taking another dose
  • New or worsened urinary retention. Symptoms may include difficulty urinating, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking BEVESPI AEROSPHERE and call your healthcare provider right away
  • High blood sugar or low blood potassium

Common side effects of BEVESPI AEROSPHERE include urinary tract infection and cough. Tell your healthcare provider about any side effect that bothers you or that does not go away.

APPROVED USES

BEVESPI AEROSPHERE is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD). COPD includes chronic bronchitis, emphysema, or both. BEVESPI AEROSPHERE is used long term as 2 inhalations, 2 times each day in the morning and in the evening, to improve symptoms of COPD for better breathing. Do not use BEVESPI AEROSPHERE to treat sudden symptoms of COPD; it won't replace a rescue inhaler. BEVESPI AEROSPHERE is not for the treatment of asthma.

Please read full Prescribing Information , including Boxed WARNING, and Medication Guide and Instructions for Use for BEVESPI AEROSPHERE.

IMPORTANT SAFETY INFORMATION ABOUT BEVESPI AEROSPHERE INCLUDING BOXED WARNING

People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as formoterol fumarate (one of the medicines in BEVESPI AEROSPHERE), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.1-800-FDA-1088.

USA flagThis site is intended for US Consumers only.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about BEVESPI AEROSPHERE or COPD, talk to your doctor or pharmacist. Only you and your doctor can decide if BEVESPI AEROSPHERE is right for you.