Indacaterol; Glycopyrrolate powder for inhalation

What is this medication?

INDACATEROL; GLYCOPYRROLATE (IN da CA ter ol; glye koe PYE roe late) inhalation is a combination of 2 medicines that help to open up the airways of your lungs. This medicine is used to treat chronic obstructive pulmonary disease (COPD). Do NOT use for an acute COPD attack.

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

COMMON BRAND NAME(S): Utibron 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
• glaucoma
• heart disease
• high blood pressure
• history of an irregular heartbeat
• kidney disease
• liver disease
• prostate disease or problems passing urine
• seizures
• thyroid disease
• an unusual or allergic reaction to indacaterol, glycopyrrolate, milk, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is used in a special inhaler. 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. This medicine is not approved for use in children.

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 the medicine with any of the following medications:

• cisapride
• dronedarone
• other medicines that contain long-acting beta-2 agonists (LABAs) like formoterol, indacaterol, olodaterol, salmeterol, vilanterol
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• antihistamines for allergy, cough, and cold
• certain medicines for bladder problems like oxybutynin and tolterodine
• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for depression, anxiety, or psychotic disturbances
• diuretics
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• other medicines that contain an anticholinergic like aclidinium, ipratropium, glycopyrrolate, tiotropium, umeclidinium
• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone
• 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 doctor for regular check ups. Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse. If you need your short-acting inhalers more often, call your doctor right away. Do not take more medicine than directed.

Do not get the this medicine in your eyes. It can cause irritation, pain, or blurred vision.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Clean the inhaler as directed in the patient information sheet that comes with 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 like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision, eye pain
• muscle cramps or muscle pain
• nervousness
• pain or difficulty passing urine or change in the amount of urine
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heart beat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination
• tremor

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

• back pain
• cough
• runny nose
• sore throat

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 20 and 25 degrees C (68 and 77 degrees F). Keep in a dry place. Protect from moisture. Keep capsules in the foil blister pack until you are ready to use in the inhaler. Do not store the capsules in the inhaler. Always use the new inhaler that comes with your new medication pack with each refill. 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.