Indacaterol and Glycopyrrolate

Serious side effects have been reported with this medication including the following:

• Sudden shortness of breath immediately after use of indacaterol/glycopyrrolate. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Utibron Neohaler and call your healthcare provider or go to the nearest hospital emergency room right away.
• Serious allergic reactions. Stop using indacaterol/glycopyrrolate and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of the tongue, lips, and face
  • difficulty breathing or swallowing
• Effects on your heart such as fast or irregular heartbeat (palpitations), increased blood pressure, and chest pain
• New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
  • eye pain or discomfort o nausea or vomiting
  • blurred vision
  • red eyes
  • seeing halos or bright colors around lights

If you have these symptoms, stop using indacaterol/glycopyrrolate and call your healthcare provider right away before taking another dose.

• New or worsened urinary retention. People who use indacaterol/glycopyrrolate may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
  • difficulty urinating
  • painful urination
  • urinating frequently
  • urination in a weak stream or drips

If you have these symptoms, stop using indacaterol/glycopyrrolate and call your healthcare provider right away before using another dose.

• 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.
• Increased risk of death from asthma problems. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as indacaterol 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. Call your healthcare provider if breathing problems worsen over time while using indacaterol/glycopyrrolate. You may need a different treatment. Get emergency medical care if:
• breathing problems worsen quickly
• you use your rescue inhaler medicine, but it does not relieve your breathing problems

Indacaterol/glycopyrrolate is not used to treat sudden symptoms of COPD. 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 for you.

Indacaterol/glycopyrrolate is not for the treatment of asthma. It is not known if this medication is safe and effective in people with asthma.

Indacaterol/glycopyrrolate should not be used in children. It is not known if this medication is safe and effective in children younger than 18 years of age.

Do not take this medication if you:

• are allergic to this medication or to any of its ingredients
• have asthma and not using a long-term asthma controller medication. This medication is not indicated for the treatment of asthma. 

Use indacaterol and glycopyrrolate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Use indacaterol and glycopyrrolate at the same time of day.
• Do not swallow capsule. The contents of the capsule will be breathed into the lungs.
• Be sure your hands are dry before you touch this medicine.
• Only use the device that comes with indacaterol and glycopyrrolate. Do not use any other devices.
• Take the capsule out of the foil right before use.
• Do not breathe out into the puffer (inhaler). Put the cap back on after you use your dose.
• Do not wash the device. Always keep mouthpiece dry.
• Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
• If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
• Use new puffer (inhaler) with each refill.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses on the same day.

• Store at room temperature.
• Store capsules in the original container. Use right after opening.
• Do not store capsules in the puffer (inhaler).
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Animal reproduction studies have not been conducted with this combination. Refer to individual monographs.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience pharyngitis, rhinitis, rhinorrhea, or back pain. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), angina, tachycardia, arrhythmia, severe headache, severe dizziness, passing out, painful urination, change in amount of urine passed, urinary retention, difficult urination, difficulty swallowing, vision changes, eye pain, severe eye irritation, red eyes, seeing halos or bright colors around lights, severe nausea, severe vomiting, difficulty breathing, wheezing, or cough (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.