This product is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. It contains 2 medications: indacaterol and mometasone. Indacaterol belongs to the class of drugs known as long-acting beta agonists. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways.

When used alone, long-acting beta agonists (such as indacaterol) 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. 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.

This medication should not be used for severe/sudden breathing problems. Other medications, such as a quick-relief inhaler, should be used instead of indacaterol/mometasone for sudden breathing problems. This medication is not a substitute for corticosteroids (such as beclomethasone, fluticasone, prednisone).

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to control symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn and follow the directions for proper use and care of the inhaler device and this medication. If you have any questions, ask your healthcare provider or pharmacist.

Indacaterol/mometasone comes in a capsule. Do not swallow the capsules. Inhale the contents of the capsule by mouth using the inhaler device as directed by your doctor, usually one capsule once daily. This medication must always be used with its own special inhaler device. Always discard your old inhaler device and use the new inhaler device that you get each time you refill your indacaterol/mometasone prescription. Do not use a "spacer" device with the inhaler.

Leave the capsule sealed in the blister card until just before use. Wash and completely dry hands before touching the capsules. Inhale the capsule contents as directed to make sure you inhale all of the drug. Be sure to inhale quickly and deeply through the mouthpiece when using this drug. You should hear the inhaler make a whirring noise as you inhale the medication. Hold your breath for up to 5 seconds. Do not exhale or blow into the inhaler. Open the inhaler to see if any powder is left in the capsule. If there is, close the inhaler and inhale again. Inhale all of the powder from each capsule.

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.

If you are using other inhalers at the same time, wait at least one minute between the use of each medication.

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

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using indacaterol/mometasone. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.

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

Learn which of your inhalers you should use every day 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.

Headache, hoarseness, dry/irritated throat, or coughing may occur. If any of these effects last or get worse, tell your doctor or pharmacist 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Rarely, this medication may cause sudden breathing problems/wheezing 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:

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

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

• chest pain
• seizures

A very serious allergic reaction to this drug 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 product, tell your doctor or pharmacist if you are allergic to indacaterol or mometasone; or if you have any other allergies. This product may contain inactive ingredients, 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:

• current/past infections (such as tuberculosis, herpes)
• eye problems (such as cataracts, glaucoma)
• high blood pressure
• heart problems (such as irregular heartbeat, chest pain)
• diabetes
• bone loss (osteoporosis)
• overactive thyroid (hyperthyroidism)
• seizures

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.

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.

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 slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

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

It is unknown if indacaterol or mometasone pass into breast milk. Consult your doctor before breastfeeding.

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.

A product that may interact with this drug is:

• desmopressin

Do not use other LABA drugs (such as formoterol, salmeterol) while using this medication.

This medication will not work and may be harmful if swallowed. 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: fast/irregular heartbeat, severe nervousness, severe muscle cramps.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, lung function, eye exams, bone density tests) may be done while you are using this medication. Keep all medical and lab appointments.

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

Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.

Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

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 help promote healthy bones include doing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. 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).