What are some facts about UTIBRON NEOHALER?

UTIBRON NEOHALER is a COPD treatment that combines two types of medicine

UTIBRON NEOHALER combines a LABA medicine (indacaterol) and an anticholinergic medicine (glycopyrrolate).

  • LABA and anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. This makes it hard to breathe.
  • UTIBRON NEOHALER is used to treat chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

In clinical studies,* twice-daily UTIBRON NEOHALER improved breathing for up to 12 hours per dose.

Improves lung function.
UTIBRON NEOHALER does not relieve sudden symptoms of COPD and should not be used more than twice daily. Always have a short-acting beta2-agonist with you to treat sudden symptoms.

Can improve your health-related quality of life.
In a questionnaire, people taking UTIBRON NEOHALER reported their overall health-related quality of life improved after they began treatment.

UTIBRON 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 indacaterol (one of the medicines in UTIBRON 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.

UTIBRON NEOHALER can cause serious side effects, including:

  • Sudden shortness of breath (that may be life-threatening) immediately after use of UTIBRON 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
  • New or worsened eye problems, including acute narrow-angle glaucoma (symptoms may include eye pain or discomfort, blurred vision, red eyes, nausea or vomiting, seeing halos or bright colors around lights)
  • New or worsened urinary retention (symptoms may include difficulty urinating, urinating frequently, painful urination, urination in a weak stream or drips)
  • 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 UTIBRON NEOHALER include sore throat and runny nose, high blood pressure, and back pain.

These are not all of the possible side effects with UTIBRON NEOHALER. Tell your health care provider about any side effect that bothers you or that does not go away.

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.

*In two clinical studies, 2038 adults with COPD who had similar lung functions were evaluated.

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