Indacaterol inhalation powder

What is this medication?

INDACATEROL (IN da CA ter ol) is a long-acting bronchodilator. It treats COPD. It is always used with another medicine for COPD. Do not use this drug to treat an acute COPD attack or bronchospasm.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ARCAPTA NEOHALER

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes (high blood sugar)
• heart disease
• high blood pressure
• irregular heartbeat or rhythm
• liver disease
• low levels of potassium in the blood
• pheochromocytoma
• seizures
• thyroid disease
• an unusual or allergic reaction to indacaterol, milk, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

The capsules are only for inhalation through an inhaler device. Do NOT swallow the capsules. Do NOT use a spacer device. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask your doctor or health care provider if you have any questions. Small pieces of the capsule may get in your mouth or throat when you breathe in your medicine. This is normal and should not hurt you.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• other medicines that contain a long-acting beta2-agonist (LABA), such as formoterol or salmeterol

This medicine may also interact with the following medications:

• caffeine
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for blood pressure, heart disease, irregular heart beat
• cisapride
• diuretics
• furazolidone
• medicines for colds
• procarbazine
• ritonavir
• some antibiotics like clarithromycin, erythromycin, levofloxacin, and linezolid
• steroid medicines like prednisone or cortisone
• stimulant medicines for attention disorders, weight loss, or to stay awake
• theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

NEVER use this medicine for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your health care provider right away.

This medicine can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medicine right away and call your health care provider.

This medicine may increase your risk of dying from asthma-related problems. Talk to your health care provider if you have questions.

Do not treat yourself for coughs, colds or allergies without asking your health care provider for advice. Some nonprescription medicines can affect this one.

You and your health care provider should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones.

If you are going to need surgery or other procedure, tell your health care provider that you are using this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• fever
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• increase in blood pressure
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• headache
• nasal congestion (runny or stuffy nose)
• nausea
• sore throat
• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.