ARCAPTA NEOHALER- indacaterol maleate capsule 
Novartis Pharmaceuticals Corporation


Medication Guide


(indacaterol inhalation powder)

Important: Do not swallow ARCAPTA capsules. ARCAPTA capsules are used only with the NEOHALER inhaler that comes with ARCAPTA NEOHALER. Never place a capsule in the mouthpiece of the NEOHALER inhaler.

Read the Medication Guide that comes with ARCAPTA NEOHALER before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your health care provider about your medical condition or treatment.

What is the most important information I should know about ARCAPTA NEOHALER?

ARCAPTA NEOHALER has been approved for COPD only. Therefore, ARCAPTA NEOHALER is NOT to be used in asthma.

ARCAPTA NEOHALER can cause serious side effects, including:


ARCAPTA NEOHALER is used long term, 1 time each day, in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

LABA medicines such as ARCAPTA NEOHALER help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness and shortness of breath. 

ARCAPTA NEOHALER is not for use to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.

It is not known if ARCAPTA NEOHALER is safe and effective in people with asthma.

ARCAPTA NEOHALER should not be used in children. It is not known if ARCAPTA NEOHALER is safe and effective in children. 

Who should not use ARCAPTA NEOHALER?

Do not use ARCAPTA NEOHALER if you:

What should I tell my healthcare provider before using ARCAPTA NEOHALER?

Tell your healthcare provider about all of your health conditions, including if you:

ARCAPTA NEOHALER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in patients who have a severe milk protein allergy.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ARCAPTA NEOHALER and certain other medicines may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use ARCAPTA NEOHALER?

What are the possible side effects with ARCAPTA NEOHALER?

ARCAPTA NEOHALER can cause serious side effects, including:

Common side effects of ARCAPTA NEOHALER include:

Tell your healthcare provider about any side effect that bothers you or that does not go away. 

These are not all the side effects with ARCAPTA NEOHALER. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

How should I store ARCAPTA NEOHALER?

General Information about ARCAPTA NEOHALER

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ARCAPTA NEOHALER for a condition for which it was not prescribed. Do not give ARCAPTA NEOHALER to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ARCAPTA NEOHALER. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ARCAPTA NEOHALER that was written for healthcare professionals. 

For more information, go to or call 1-888-669-6682.

Active ingredient: indacaterol

Inactive ingredients: lactose monohydrate (contains trace levels of milk protein)

Revised September 2012

Revised: 4/2013
Novartis Pharmaceuticals Corporation