Indacaterol/glycopyrrolate (By breathing)

Utibron Neohaler

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with other inhaled medicines, including arformoterol, budesonide/formoterol, formoterol, salmeterol, or vilanterol.
• Some foods and medicines can affect how indacaterol/glycopyrrolate works. Tell your doctor if you are using any of the following:
  • Beta-blocker medicine
  • Diuretic (water pill)
  • MAO inhibitor
  • TCA medicine for depression
  • Steroid (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

Capsule

• Your doctor or other health caregiver should show you how to use this medicine. Use it at the same time every day. Do not use more medicine or use it more often than instructed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Utibron™ capsules should be used only with the Neohaler® device. Do not swallow the capsule. Do not use the device with any other medicine.
• Do not remove the capsule from the blister pack until you are ready to use it. Use the capsule right away once you have opened a blister pack.
• After you have used a dose, remove the used capsule and throw it away.
• Use a new inhaler with each refill of your medicine. Do not use the inhaler with any other medicine.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose. Do not use more than 2 capsules in 24 hours.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

Glycopyrrolate (glye-koe-PIR-oh-late), Indacaterol (in-da-KAT-er-ol)

Treats chronic obstructive pulmonary disease (COPD).

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, eye pain, seeing halos around objects
• Chest pain, fast, pounding, or uneven heartbeat
• Decrease in how much or how often you urinate, difficult or painful urination
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Increased hunger or thirst
• Increased trouble breathing

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, asthma, diabetes, glaucoma, heart disease, high blood pressure, heart rhythm problems (such as QT prolongation), an overactive thyroid, prostate problems, trouble urinating, or seizures. Tell your doctor if you are allergic to milk.
• This medicine may cause the following problems:
  • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
  • Heart rhythm changes
  • High blood sugar levels
  • Low potassium levels
• Do not use this medicine for a sudden COPD attack. Make sure you always have your rescue medicine with you to treat sudden symptoms. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.