Important Safety Information for ARCAPTA NEOHALER
ARCAPTA® NEOHALER® [ar-CAP-tuh] (indacaterol) Inhalation Powder, for oral inhalation use
This summary does not include all information about ARCAPTA NEOHALER and is not meant to take the place of discussions with your healthcare provider about your treatment. Please read this important information carefully before you start taking ARCAPTA NEOHALER. Discuss any questions about ARCAPTA NEOHALER with your healthcare provider.
What is ARCAPTA NEOHALER?
ARCAPTA NEOHALER is a prescription, long-acting beta2-adrenergic agonist (LABA) medicine. ARCAPTA NEOHALER is used long term and once each day to improve symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults with COPD. COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
LABA medicines such as ARCAPTA NEOHALER help the muscles around the airways in your lungs stay relaxed to help control COPD symptoms such as wheezing, coughing, chest tightness, and shortness of breath.
Who should not use ARCAPTA NEOHALER?
Do not use ARCAPTA NEOHALER if you:
- have sudden symptoms of COPD. ARCAPTA NEOHALER should not be used as rescue therapy. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed.
- have asthma. It is not known if ARCAPTA NEOHALER is safe and effective in people with asthma.
- are allergic to indacaterol, or any of the ingredients in ARCAPTA NEOHALER (see below). Ask your healthcare provider if you are not sure.
- Active ingredient: indacaterol
- Inactive ingredients: lactose monohydrate (contains milk proteins)
- ARCAPTA NEOHALER should not be used by children. It is not known if ARCAPTA NEOHALER is safe and effective for children.
What warnings should I know about ARCAPTA NEOHALER?
ARCAPTA NEOHALER can cause serious side effects, including:
- People with asthma, who take LABA medicines such as ARCAPTA NEOHALER, have an increased risk of death from asthma problems.
- It is not known if LABA medicines, such as ARCAPTA NEOHALER, increase the risk of death in people with COPD. Get emergency medical care if:
- breathing problems worsen quickly.
- you use your rescue inhaler medicine, but it does not relieve your breathing problems.
- sudden shortness of breath immediately after use. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop using ARCAPTA NEOHALER. Call your healthcare provider or go to the nearest hospital emergency room right away.
- life-threatening paradoxical bronchospasm, which means your airway passages may narrow and breathing may become difficult. Stop using ARCAPTA NEOHALER immediately.
- serious allergic reactions. Stop using ARCAPTA NEOHALER if you get any of the following symptoms:
- swelling of the tongue, lips, and face
- difficulty breathing or swallowing
- effects on your heart. Symptoms may include:
- fast or irregular heartbeat (palpitations)
- increased blood pressure
- chest pain
- 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.
If you have these side effects, stop taking ARCAPTA NEOHALER and call your healthcare provider or get emergency medical treatment right away before taking another dose.
Do not exceed the recommended dose. Excessive use of ARCAPTA NEOHALER, or use with other LABAs, can result in undesirable increase in anticholinergic activity.
If your COPD symptoms worsen over time, do not increase your dose of ARCAPTA NEOHALER. Call your healthcare provider.
What should I tell my healthcare provider before using ARCAPTA NEOHALER?
Before using ARCAPTA NEOHALER, tell your healthcare provider about all your medical 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. It is not known if ARCAPTA NEOHALER can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if the medicine in ARCAPTA NEOHALER passes into your breast milk or if it can harm your baby.
- 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 healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. ARCAPTA NEOHALER may affect the way other medicines work, and other medicines can affect how ARCAPTA NEOHALER works. Using ARCAPTA NEOHALER with other medicines may cause serious side effects.
Especially tell your healthcare provider if you take other LABA medicines (including formoterol, arformoterol, salmeterol, vilanterol, indacaterol, olodaterol).
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use ARCAPTA NEOHALER?
Read the step-by-step instructions for using ARCAPTA NEOHALER found in the Prescribing Information and the Medication Guide.
- Do not use ARCAPTA NEOHALER unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
- Use ARCAPTA NEOHALER exactly as your healthcare provider tells you to use it.
- Always use the new NEOHALER inhaler that is provided with each new prescription.
- Do not swallow ARCAPTA capsules.
- Only use ARCAPTA capsules with the NEOHALER inhaler.
- Use 1 ARCAPTA capsule inhaled through the NEOHALER inhaler once each day (at the same time of day).
- If you miss a dose of ARCAPTA NEOHALER, take it as soon as you remember. Take your next dose at the usual time. Do not take more than one dose in 24 hours.
- ARCAPTA capsules should always be stored in the blister strip and only removed immediately before use.
- Do not stop using ARCAPTA NEOHALER or other medicines to control or treat your COPD unless told to do so by your healthcare provider. Your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with ARCAPTA NEOHALER, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.
- Do not use ARCAPTA NEOHALER:
- more often than prescribed.
- at higher dose than prescribed.
- with other LABA medicines.
What are the possible side effects with ARCAPTA NEOHALER?
- See "What warnings should I know about ARCAPTA NEOHALER?""
Common side effects of ARCAPTA NEOHALER include: runny nose, cough, sore throat, headache, and nausea.
These are not all the side effects of ARCAPTA NEOHALER. Tell your healthcare provider about any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. 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 or pharmacist.
- Visit www.ARCAPTA.com to obtain the FDA-approved product labeling.
- Call Sunovion at 1-888-394-7377.
*Restrictions and eligibility requirements apply. Eligible patients may pay as little as $10 co-pay, equaling a savings of up to $250 off each ARCAPTA NEOHALER prescription fill for up to a 30-day supply. Limited to 12 qualifying prescription fills per calendar year. Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Cash-paying patients will save up to $250 off the cost of their prescription. This program is not health insurance. ARCAPTA NEOHALER Savings Terms and Conditions apply.