IMPORTANT SAFETY INFORMATION AND INDICATION FOR ARCAPTA NEOHALER
IMPORTANT SAFETY INFORMATION
ARCAPTA NEOHALER has been approved for COPD only and is NOT indicated for the treatment of asthma. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as ARCAPTA NEOHALER, have an increased risk of death from asthma problems. It is not known if LABA medicines, such as indacaterol, increase the risk of death in people with COPD.
ARCAPTA NEOHALER does not relieve sudden symptoms of COPD and should not be used more than once daily. Always have a short-acting beta2-agonist with you to treat sudden symptoms.
Do not use ARCAPTA NEOHALER unless your health care provider has taught you how to use the inhaler and you understand how to use it correctly. Use ARCAPTA NEOHALER exactly as your health care provider tells you to use it.
Do not use ARCAPTA NEOHALER more often than it is prescribed for you or with other LABA medicines. Do not stop using ARCAPTA NEOHALER or other medicines to control or treat your COPD unless told to do so by your health care provider because your symptoms might get worse. Your health care provider will change your medicines as needed.
Get emergency medical care if your breathing problems worsen quickly, you need to use your rescue medication more often than usual, or your rescue medication does not work as well to relieve your symptoms.
Do not use ARCAPTA NEOHALER if you are allergic to indacaterol or any of the ingredients in ARCAPTA NEOHALER. Ask your health care provider if you are not sure.
Tell your health care provider about all of your health conditions, including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
- are allergic to ARCAPTA NEOHALER or any of its ingredients, any other medicines, or food products. ARCAPTA NEOHALER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy
Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. ARCAPTA NEOHALER and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your health care provider if you take LABA medicines (including formoterol, salmeterol, vilanterol, indacaterol, olodaterol).
ARCAPTA can cause serious side effects, including:
- sudden shortness of breath (that may be life-threatening) immediately after use of ARCAPTA NEOHALER
- increased blood pressure
- fast or irregular heartbeat (palpitations)
- chest pain
- serious allergic reactions, including rash; hives; swelling of the tongue, lips, and face; and difficulties breathing or swallowing. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction
- changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm
Common side effects of ARCAPTA NEOHALER include runny nose, cough, sore throat, headache, and nausea.
These are not all of the possible side effects with ARCAPTA NEOHALER. Tell your health care provider if you get any side effect that bothers you or that does not go away.
Do not swallow ARCAPTA capsules. ARCAPTA capsules are for inhalation only with the NEOHALER device. Never place a capsule in the mouthpiece of the NEOHALER device.
ARCAPTA capsules should always be stored in the blister strip and only removed immediately before use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive.
How to get more information:
- Talk to your health care provider
- Visit www.ARCAPTA.com to obtain the FDA-approved product labeling
- Call 1-888-394-7377
For additional information, please see full Prescribing Information, including BOXED WARNING and Medication Guide, for ARCAPTA NEOHALER at www.ARCAPTA.com.
ARCAPTA® NEOHALER® (indacaterol) is a medicine called a long-acting beta2-adrenergic agonist, or LABA. ARCAPTA NEOHALER is used long term, once each day, in controlling symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.