Important Safety Information for UTIBRON NEOHALER
UTIBRON® NEOHALER® [yoo-TEE-bron] (indacaterol and glycopyrrolate) Inhalation Powder, for oral inhalation use
This summary does not include all information about UTIBRON NEOHALER and is not meant to take the place of discussions with your healthcare provider about your treatment. Please read this important information carefully before you start taking UTIBRON NEOHALER. Discuss any questions about UTIBRON NEOHALER with your healthcare provider.
What is UTIBRON NEOHALER?
UTIBRON NEOHALER is a prescription, combined anticholinergic and long-acting beta2-adrenergic agonist (LABA) medicine. UTIBRON NEOHALER is used long term and twice each day (morning and evening) to improve symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults with COPD. COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
LABA and anticholinergic medicines such as UTIBRON NEOHALER help the muscles around the airways in your lungs stay relaxed to help control COPD symptoms such as wheezing, coughing, chest tightness, and shortness of breath.
Who should not use UTIBRON NEOHALER?
Do not use UTIBRON NEOHALER if you:
- have sudden symptoms of COPD. UTIBRON NEOHALER should not be used as rescue therapy. 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.
- are allergic to indacaterol, glycopyrrolate, or any of the ingredients in UTIBRON NEOHALER (see below). Ask your healthcare provider if you are not sure.
- Active ingredients: indacaterol maleate, glycopyrrolate
- Inactive ingredients: lactose monohydrate (contains milk proteins) and magnesium stearate
- have asthma. It is not known if UTIBRON NEOHALER is safe and effective in people with asthma.
- UTIBRON NEOHALER should not be used by children. It is not known if UTIBRON NEOHALER is safe and effective for children.
What warnings should I know about UTIBRON NEOHALER?
UTIBRON NEOHALER can cause serious side effects, including:
If you have these side effects, stop taking UTIBRON NEOHALER and call your healthcare provider or get emergency medical treatment right away before taking another dose.
Do not exceed the recommended dose. Excessive use of UTIBRON NEOHALER, or use with other LABAs or anticholinergic medications, can result in undesirable increase in anticholinergic activity.
If your COPD symptoms worsen over time, do not increase your dose of UTIBRON NEOHALER. Call your healthcare provider.
What should I tell my healthcare provider before using UTIBRON NEOHALER?
Before using UTIBRON NEOHALER, tell your healthcare provider about all your medical 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. UTIBRON NEOHALER may make glaucoma worse.
- have prostate or bladder problems, or problems passing urine. UTIBRON NEOHALER may make these problems worse.
- are pregnant or plan to become pregnant. It is not known if UTIBRON NEOHALER can harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if the medicine in UTIBRON NEOHALER passes into your breast milk or if it can harm your baby.
- 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 healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. UTIBRON NEOHALER may affect the way other medicines work, and other medicines can affect how UTIBRON NEOHALER works. Using UTIBRON NEOHALER with other medicines may cause serious side effects.
Especially tell your healthcare provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate), or LABA medicines (including formoterol, arformoterol, salmeterol, vilanterol, indacaterol, olodaterol).
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use UTIBRON NEOHALER?
Read the step-by-step instructions for using UTIBRON NEOHALER found in the Prescribing Information and the Medication Guide.
- Do not use UTIBRON NEOHALER unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
- Use UTIBRON NEOHALER exactly as your healthcare provider tells you to use it.
- Always use the new NEOHALER inhaler that is provided with each new prescription.
- Do not swallow UTIBRON capsules.
- Only use UTIBRON capsules with the NEOHALER inhaler.
- Use 1 UTIBRON capsule inhaled through the NEOHALER inhaler twice each day (1 capsule in the morning and 1 capsule in the evening).
- If you miss a dose of UTIBRON NEOHALER, take it as soon as you remember. Take your next dose at the usual time.
- Do not use 2 capsules at 1 time.
- Do not use more than 2 capsules in a day.
- UTIBRON capsules should always be stored in the blister strip and only removed immediately before use. Peel the backing foil away from the blister to open it, do not push the capsule through the foil.
- Do not stop using UTIBRON NEOHALER or other medicines to control or treat your COPD unless told to do so by your healthcare provider. Your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with UTIBRON NEOHALER, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.
- Do not use UTIBRON NEOHALER:
- more often than prescribed.
- at higher dose than prescribed.
- with other anticholinergic medicines.
What are the possible side effects with UTIBRON NEOHALER?
- See "What warnings should I know about UTIBRON NEOHALER?"
Common side effects of UTIBRON NEOHALER include: sore throat and runny nose, high blood pressure, and back pain.
These are not all the side effects of UTIBRON NEOHALER. Tell your healthcare provider about any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. 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 healthcare provider or pharmacist.
- Visit www.Utibron.com to obtain the FDA-approved product labeling.
- Call Sunovion at 1-888-394-7377.
*Restrictions and eligibility requirements apply. Eligible patients may pay as little as $10 co-pay, equaling a savings of up to $250 off each UTIBRON NEOHALER prescription fill for up to a 30-day supply. Limited to 12 qualifying prescription fills per calendar year. Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Cash-paying patients will save up to $250 off the cost of their prescription. This program is not health insurance. UTIBRON NEOHALER Savings Terms and Conditions apply.