Bevespi Aerosphere is an inhalation aerosol containing a combination of formoterol and glycopyrrolate. Formoterol is a bronchodilator. Glycopyrrolate is an anticholinergic. These medications work by relaxing muscles in the airways to improve breathing.

Bevespi Aerosphere is used to prevent airflow obstruction or bronchospasm and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Bevespi Aerosphere is not for use in treating asthma.

Formoterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risk.

Bevespi Aerosphere is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Bevespi Aerosphere is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Before taking this medicine

You should not use Bevespi Aerosphere if you are allergic to formoterol or glycopyrrolate. This medicine is for use only in people with COPD and should not be used to treat asthma.

To make sure Bevespi Aerosphere is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• liver disease;

• glaucoma;

• diabetes;

• a thyroid disorder;

• urination problems; or

• any food or drug allergies.

Tell your doctor if you are pregnant or breastfeeding.

This medicine is not approved for use by anyone younger than 18 years old.

Use Bevespi Aerosphere exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

Use only the inhaler device provided with your medicine or you may not get the correct dose. Use the new inhaler each time you get your prescription refilled.

Shake the Bevespi Aerosphere well just before you inhale your dose.

This medicine is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

You should not stop using Bevespi Aerosphere suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Keep Bevespi away from an open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Throw the inhaler device away 3 months after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

2 inhalations orally twice a day, in the morning and in the evening
Maximum dose: 2 inhalations twice daily

Comments:
-Two inhalations of formoterol 4.8 mcg-glycopyrrolate 9 mcg equal one dose.

Uses: Long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

You should not use Bevespi Aerosphere if you are allergic to formoterol or glycopyrrolate. This medicine is for use only in people with COPD and should not be used to treat asthma.

To make sure Bevespi Aerosphere is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• liver disease;

• glaucoma;

• diabetes;

• a thyroid disorder;

• urination problems; or

• any food or drug allergies.

Tell your doctor if you are pregnant or breastfeeding.

This medicine is not approved for use by anyone younger than 18 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause vomiting, severe constipation, blurred vision, chest pain, heart problems, or fainting.

If this medicine gets in your eyes, rinse them with water and call your doctor if you have ongoing eye redness even after rinsing.

Do not use a second inhaled bronchodilator that contains formoterol or a similar medicine (such as arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

Get emergency medical help if you have signs of an allergic reaction to Bevespi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• wheezing, choking, or other breathing problems after using this medicine;

• painful or difficult urination;

• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common Bevespi side effects may include:

• cough; or

• urination problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• atropine;

• antifungal or antiviral medicine;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• other bronchodilator medication.

This list is not complete. Other drugs may interact with formoterol and glycopyrrolate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.