This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: indacaterol and glycopyrrolate. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Glycopyrrolate belongs to a class of drugs known as anticholinergics. Both drugs are also known as bronchodilators.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed.

Indacaterol/glycopyrrolate is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as indacaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Read the Patient Information Leaflet 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.

Do not swallow these capsules. Use only the special inhaler that comes with the medication to inhale the powder in the capsules. Inhale this medication by mouth as directed by your doctor, usually once or twice daily, depending on the brand that you use.

Leave the capsule sealed in the blister packet until just before use. Dry your hands before touching the capsules. Do not push the capsule through the foil. Follow the instructions for loading the capsule into the inhaler and for piercing it. Inhale rapidly and deeply through the mouthpiece. You should hear the inhaler make a whirring noise as you inhale the medication. You will also have a sweet taste from the medicine. Hold your breath for at least 5 to 10 seconds. 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. Do not blow into the mouthpiece at any time.

Avoid getting this medication into your eyes. It may cause eye pain/irritation, temporary blurred vision, and other vision changes.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not increase your dose or use this drug more often than prescribed, or stop using it without first asking your doctor.

Do not wash the inhaler with water. You may wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth.

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. 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, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, 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.

Tell your doctor if your condition does not get better or if it gets worse.

Coughing may occur. Headache and dizziness may also occur, but are less common. 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.

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

• shaking (tremor)
• fast/irregular heartbeat
• difficult/painful urination
• muscle cramps/weakness
• increased thirst/urination

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, severe wheezing/trouble breathing immediately after you use it. If this happens, use your quick-relief inhaler and get medical help right away.

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

• chest pain
• eye pain/swelling/redness
• vision changes (such as seeing rainbows around lights at night, blurred vision)

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 indacaterol/glycopyrrolate, tell your doctor or pharmacist if you are allergic to either drug, or if you have any other allergies. This product may contain inactive ingredients (such as 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:

• heart problems (such as chest pain, irregular heartbeat)
• high blood pressure
• seizures
• overactive thyroid
• diabetes
• personal or family history of glaucoma (angle-closure type)
• difficulty urinating (such as due to an enlarged prostate, urinary tract blockage)
• kidney disease

This drug may uncommonly cause dizziness or blurred vision. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

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

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

It is unknown if this medication passes 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.

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: shaking (tremor), chest pain, fast/irregular heartbeat.

Do not share this medication with others.

Lab and/or medical tests (such as lung function, blood pressure, pulse/heart rate) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid smoking and other things that can worsen breathing problems. Because the flu virus can also worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

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 in a dry place at room temperature away from heat, light, and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Throw away the inhaler after 30 days of use. 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).