When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to indacaterol, or during an acute COPD flare-up. Do not use this medicine if you have asthma. Some people with asthma have had more severe asthma attacks when they used this medicine.

How to Use This Medicine:
Powder Under Pressure, Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You will use this medicine with a special inhaler device called the Neohaler™. The medicine capsule should not be swallowed. It is placed only into the Neohaler™ inhaler that comes with the package. This device opens the capsule and loads the powder medicine from the capsule into the air chamber. You then inhale the powder through the mouthpiece. Your caregiver will show you how to use your inhaler.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine. Do not use the inhaler for this medicine with any other medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana™), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist™), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).
• Make sure your doctor knows if you are also using erythromycin (Ery-Tab®), ketoconazole (Nizoral®), ritonavir (Norvir®), theophylline (Theo-Dur®), verapamil (Calan®, Isoptin®, Verelan®), certain blood pressure medicines (such as atenolol, metoprolol, propranolol, Inderal®, Tenormin®, or Toprol®), a diuretic or "water pill" (such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®), or a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®). Tell your doctor if you have used an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 2 weeks.
• Tell your doctor if you are also using arsenic trioxide (Trisenox®), cisapride (Propulsid®), dofetilide (Tikosyn®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), certain antibiotics (such as erythromycin, levofloxacin, moxifloxacin, sparfloxacin, Avelox®, Levaquin®, or Zagam®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart or blood vessel disease, heart rhythm problems (such as QT prolongation), high blood pressure, diabetes, seizures, an overactive thyroid, or low potassium in the blood.
• Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the other medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
• This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.
• This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you have coughing, difficulty with breathing, shortness of breath, or wheezing after using this medicine.
• Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: decreased urine; dry mouth; increased thirst; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; seizures; shortness of breath; uneven heartbeat; or unusual tiredness or weakness.
• This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
• The powder in the capsule contains lactose (milk sugar) and a small amount of milk proteins. Make sure your doctor knows if you have severe milk protein allergy before you start using this medicine.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or shortness of breath.
• Cough, fever, chills, sore throat, runny or stuffy nose, and body aches.
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting.
• Fast, pounding, or uneven heartbeat.
• Increased asthma attacks or other breathing problems.
• Increased hunger or thirst.
• Seizures or tremors.
• Swelling in your hands, ankles, or feet.
• Troubled breathing.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Headache or dizziness.
• Muscle or bone pain.
• Rash or itching skin.
• Upset stomach.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088