Budesonide; Glycopyrrolate; Formoterol Metered Dose Inhaler (MDI)

What is this medication?

BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL (byoo DES oh nide; glye koe PYE roe late; for MOH te rol) treats chronic obstructive pulmonary disease (COPD). It works by opening the airways of the lungs, making it easier to breathe. It is a combination of an inhaled steroid, an anticholinergic, and a bronchodilator. It is often called a controller inhaler. Do not use it to treat a sudden COPD flare-up.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BREZTRI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bladder problems or trouble passing urine
• Bone problems
• Diabetes
• Eye disease, vision problems
• Heart disease
• High blood pressure
• History of irregular heartbeat
• Immune system problems
• Infection
• Kidney disease
• Pheochromocytoma
• Prostate disease
• Seizures
• Thyroid disease
• An unusual or allergic reaction to budesonide, formoterol, glycopyrrolate, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is inhaled through the mouth. Take it as directed on the prescription label at the same time every day. Shake well before each use. Rinse your mouth with water after use. Make sure not to swallow the water. Do not take your medication more often than directed. Keep taking it unless your care team tells you to stop. Make sure that you are using your inhaler correctly.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Do not take the medication with any of the following:

• Cisapride
• Dofetilide
• Dronedarone
• MAOIs like Marplan, Nardil, and Parnate
• Other medications that contain long-acting beta-2 agonists (LABAs) like arformoterol, formoterol, indacaterol, olodaterol, salmeterol, vilanterol
• Pimozide
• Procarbazine
• Thioridazine

This medication may also interact with the following:

• Antihistamines for allergy, cough, and cold
• Atropine
• Certain antibiotics like clarithromycin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain heart medications like atenolol, metoprolol
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, anxiety, or mental health conditions
• Certain medications for fungal infections like ketoconazole, itraconazole
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• Grapefruit juice
• Mifepristone
• Other inhaled medications that contain anticholinergics such as aclidinium, ipratropium, tiotropium, umeclidinium
• Other medications that prolong the QT interval (an abnormal heart rhythm)
• Some vaccines
• Steroid medications like prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

NEVER use this medication for an acute asthma or COPD attack. You should use your short-acting rescue inhalers for this purpose. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away.

This medication may increase your risk of getting an infection. Tell your care team if you are around anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

Do not get this medication in your eyes. It can cause irritation, pain, or blurred vision.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Muscle pain or cramps
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thrush—white patches in the mouth
• Trouble passing urine
• Wheezing or trouble breathing that is worse after use

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in taste
• Constipation
• Cough
• Dry mouth
• Headache
• Hoarseness
• Runny or stuffy nose
• Sore throat
• Tremors or shaking
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a dry place at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat. Do not freeze. Do not use or store near heat or flame, as the canister may burst. Throw away the inhaler 3 months after you open the foil pouch (for the 120-inhalation canister), or 3 weeks after you open the foil pouch (for the 28-inhalation canister), or when the dose indicator reaches zero "0", whichever comes first.

To get rid of medication that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.