Arcapta is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Arcapta Neohaler is used to control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Arcapta Neohaler will not treat a bronchospasm attack that has already begun and is not for use in treating asthma.

Arcapta Neohaler is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Arcapta is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Indacaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Use only the prescribed dose of this medicine, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.

Before you use this medicine, tell your doctor if you have heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, seizures, diabetes, a thyroid disorder, or lactose intolerance.

Do not take an Arcapta capsule by mouth. It is for use only in the Neohaler device. Call your doctor right away if your symptoms do not improve, or if they get worse while using indacaterol. Tell your doctor if any of your medications do not seem to work as well in preventing attacks. Do not stop using Arcapta without your doctor's advice. Your asthma symptoms may get worse after you stop using the medication.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Use Arcapta Neohaler capsules exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Using too much indacaterol can cause life-threatening side effects.

Arcapta is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not take an Arcapta Neohaler capsule by mouth. It is for use only in the Neohaler device.

This medicine comes with a special inhaler device and blister packs containing capsules of powder. You will load one capsule into the inhaler device each time you use the medicine. Pushing the buttons on the side of the Neohaler device will pierce the capsule and release the powder medicine into the inhaler chamber.

You may have a mild cough for about 15 seconds after using the inhaler.

Store at room temperature away from moisture, heat, and light. Keep each capsule in the blister pack until you ready to load your inhaler device.

Do not try to wash or take apart the Neohaler device. You may use a tissue to wipe the mouthpiece after each use. Throw away the device when your capsules run out. Always use the inhaler device that comes with each new prescription.

You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

75 mcg inhaled once daily.

You should not use Arcapta Neohaler if you are allergic to indacaterol. This medicine is for use only in people with COPD and should not be used to treat asthma.

To make sure Arcapta is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• diabetes;

• a seizure;

• a thyroid disorder; or

• galactose intolerance, or severe problems with lactose (milk sugar).

Tell your doctor if you are pregnant or breastfeeding.

Arcapta Neohaler is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medicine more than 1 time in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of indacaterol can be fatal.

Overdose symptoms may include muscle cramps, tremors, chest pain, fast heartbeats, weak pulse, fainting, or slow breathing (breathing may stop).

Do not use a second inhaled bronchodilator that contains Arcapta Neohaler or a similar medicine (such as arformoterol, formoterol, olodaterol, salmeterol, or vilanterol).

Get emergency medical help if you have signs of an allergic reaction to Arcapta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• wheezing, choking, or other breathing problems after using the Neohaler;

• worsening breathing problems;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common Arcapta side effects may include:

• runny nose;

• cough, sore throat;

• nausea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you also use a short-acting bronchodilator, do not use it daily while you are using Arcapta. Use the short-acting bronchodilator only for a sudden bronchospasm attack.

Other drugs may affect interact with indacaterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.