This inhaler contains 2 medications: budesonide and formoterol. It is used regularly as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Before using this medication, it is important to learn how to use it properly. This medication must be used regularly to prevent breathing problems.

This product may be prescribed to treat sudden breathing problems caused by asthma (asthma attack), even though formoterol is usually used to cause a slower, longer-lasting effect. To treat an asthma attack, your doctor may instruct you to use this product or a different quick-relief medicine/inhaler (such as salbutamol, terbutaline). If you have COPD, this product should not be used for sudden breathing problems. Your doctor should instruct you to use a different quick-relief medicine/inhaler for sudden COPD breathing problems. You should always have a quick-relief inhaler with you.

When used alone, long-acting beta agonists (such as formoterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination inhaled corticosteroid and long-acting beta agonists, such as this product, do not increase the risk of serious asthma-related breathing problems. For asthma treatment, this product should be used when breathing problems are not well controlled with one asthma-control medication (such as inhaled corticosteroid) or if your symptoms need combination treatment.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Inhale this medication as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to receive the most benefit from it. This medication works best if used at evenly spaced times. To help you remember, use it at the same time(s) each day. Do not increase your dose, use this medication more often, or stop using it without talking with your doctor. Also, do not use other long-acting beta agonists while using this medication.

If your doctor has instructed you to use this product for quick relief from an asthma attack, and symptoms continue after the first inhalation, you may use another inhalation after a few minutes. Do not use more than 6 inhalations to treat a single asthma attack. Get medical help right away if symptoms last or get worse.

Do not shake the inhaler. To use the inhaler, hold the inhaler upright. Unscrew and lift off the cover. Load the inhaler with a dose by turning the grip as far as it will go in one direction and then turning it back as far as it will go in the other direction. Breathe out. Never breathe out through the mouthpiece. Place the mouthpiece gently between your teeth and close your lips. Do not chew or bite on the mouthpiece. Forcefully and deeply inhale this medication by mouth. You may or may not taste/feel the drug when you inhale. Remove the inhaler from your mouth before breathing out. If your doctor has prescribed more than 1 inhalation, repeat these steps. Always replace the cover properly after using the inhaler.

After the inhaler is loaded, if you accidentally drop, shake, or breathe out into the inhaler, you will lose your dose. If this happens, you should load a new dose and inhale it.

If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug last.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.

To clean your inhaler, wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or other liquids. Do not take the inhaler apart.

If you are regularly taking corticosteroids by mouth (such as prednisone), continue to follow your doctor's instructions on taking them. Do not stop taking them. Your doctor may want you to reduce your dose gradually.

If you have been using a quick-relief inhaler (such as salbutamol) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use it as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

It may take 1 week or longer before the full benefit of this drug takes effect. Tell your doctor if your condition does not get better or if it gets worse.

Headache, nausea, nervousness, trouble sleeping, cough, hoarseness or throat irritation may occur. If any of these effects last or get worse, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, this medication may cause sudden breathing problems/asthma right after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if you have any serious side effects, including:

• unusual weight gain
• increased thirst/urination
• mental/mood changes (such as agitation, depression)
• muscle cramps
• shaking (tremors)
• vision problems (such as blurred vision)
• signs of infection (such as sore throat that doesn't go away, fever)
• white patches on tongue/in mouth

Get medical help right away if you have any very serious side effects, including:

• chest pain
• fast/slow/irregular heartbeat
• severe dizziness
• fainting

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to arformoterol; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high blood pressure
• bone loss (osteoporosis)
• depression
• diabetes
• eye problems (such as cataracts, glaucoma)
• heart problems (such as angina, irregular heartbeat)
• any recent infection
• liver problems
• overactive thyroid (hyperthyroidism)
• seizures
• smoking
• swelling of an artery (aneurysm)
• a certain adrenal gland tumor (pheochromocytoma)

Budesonide/formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using budesonide/formoterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using budesonide/formoterol safely.

This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child's height can be checked.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Budesonide passes into breast milk. It is unknown if formoterol passes into breast milk. Consult your doctor before breastfeeding.

See also Uses section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aldesleukin
• desmopressin
• mifepristone

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: shaking (tremors), dizziness, fast/irregular heartbeat.

Do not share this medication with others.

Lab and/or medical tests (such as lung function, morning cortisol levels, bone density tests, eye exams) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Avoid allergens/irritants such as smoke, pollen, pet dander, dust, and molds that may worsen asthma and other breathing problems.

Ask your doctor or pharmacist whether you should have an annual flu shot.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).