IMPORTANT SAFETY INFORMATION and INDICATION for UTIBRON NEOHALER
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 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.
Use UTIBRON NEOHALER exactly as your health care provider tells you to use it. Do not use UTIBRON NEOHALER more often than it is prescribed for you.
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.
Do not use UTIBRON NEOHALER if you are allergic to indacaterol, glycopyrrolate, or any of the ingredients in UTIBRON NEOHALER. Ask your health care provider if you are not sure.
Tell your health care provider about all of your health conditions, including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- have liver problems
- have kidney problems
- have eye problems such as glaucoma
- have prostate or bladder problems, or problems passing urine
- have any other medical conditions
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
- are allergic to UTIBRON NEOHALER or any of its ingredients, any other medicines, or food products. UTIBRON 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 health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. UTIBRON NEOHALER and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your health care provider if you take:
- anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate)
- LABA medicines (including formoterol, salmeterol, vilanterol, indacaterol, olodaterol)
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.
Do not swallow UTIBRON capsules. UTIBRON capsules are for inhalation only with the NEOHALER device. Never place a capsule in the mouthpiece of the NEOHALER device.
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
- Visit www.UTIBRON.com to obtain the FDA-approved product labeling
- Call 1-888-394-7377
For additional information, please see full Prescribing Information, including BOXED WARNING and Medication Guide, for UTIBRON NEOHALER, or visit www.UTIBRON.com.
INDICATION
UTIBRON™ NEOHALER® (indacaterol and glycopyrrolate) is a combination of a long-acting beta2-agonist, or LABA, medicine (indacaterol) and an anticholinergic medicine (glycopyrrolate). UTIBRON NEOHALER is used long term, twice each day (morning and evening), to treat the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.