What is Utibron Neohaler?
Utibron Neohaler combines a long-acting beta2 adrenergic agonist (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.
- Utibron Neohaler is for long-term use and should be taken, 2 times each day, to improve symptoms of COPD for better breathing.
- Utibron Neohaler 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.
- Utibron Neohaler is not for the treatment of asthma. It is not known if Utibron Neohaler is safe and effective in people with asthma.
- Utibron Neohaler should not be used in children. It is not known if Utibron Neohaler is safe and effective in children.
What is the most important thing I should know about Utibron Neohaler?
Do not swallow Utibron capsules. Utibron capsules are used only with the Neohaler inhaler that comes with Utibron Neohaler. Do not place a capsule in the mouthpiece of the Neohaler inhaler.
Who should not use Utibron Neohaler?
Do not use Utibron Neohaler if you:
- have asthma.
- are allergic to indacaterol, glycopyrrolate, or any of the ingredients in Utibron Neohaler. Ask your healthcare provider if you are not sure. See “What are the ingredients in Utibron Neohaler?” at the end of this Patient Information guide for a complete list of ingredients in Utibron Neohaler.
What should I tell my healthcare provider before using Utibron Neohaler?
Before using Utibron Neohaler, tell your healthcare provider about all of 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 your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. Utibron Neohaler may make these problems worse.
- have any other medical conditions.
- 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 medicines in Utibron Neohaler pass into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will take Utibron Neohaler or 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 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.
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 that comes with Utibron Neohaler.
- 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. Do not use Utibron Neohaler more often than prescribed for you.
- Do not swallow Utibron capsules. Only use Utibron capsules with the Utibron Neohaler inhaler.
- Use 1 Utibron capsule inhaled through the Neohaler inhaler 2 times each day (1 capsule in the morning and 1 capsule in the evening).
- To make sure that the full dose has been taken, you should open the inhaler to check that there is no powder left in the capsule. As long as the capsule is empty, you have received 1 full dose.
- If you miss a dose of Utibron Neohaler, take it as soon as you remember. Take your next dose at your usual time.
- Do not use 2 capsules at one 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.
- Always use the new Neohaler inhaler that is provided with each new prescription.
- Utibron Neohaler does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have a rescue inhaler prescribed for you.
- Do not stop using Utibron Neohaler or other medicines to control or treat your COPD unless told to do so by your healthcare provider because 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.
What are the possible side effects of Utibron Neohaler?
Utibron Neohaler can cause serious side effects, including:
- people with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as indacaterol (one of the medicines in Utibron Neohaler), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
- Call your healthcare provider if breathing problems worsen over time while using Utibron Neohaler. You may need a different treatment.
- Get emergency medical care if:
- your breathing problems worsen quickly
- you use your rescue inhaler medicine, but it does not relieve your breathing problems
- COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of Utibron Neohaler, instead call your healthcare provider.
- using too much of a LABA medicine may cause:
- chest pain
- fast and irregular heartbeat
- tremor
- increased blood pressure
- headache
- nervousness
- sudden shortness of breath immediately after use of Utibron Neohaler. 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 Utibron Neohaler 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
- swelling of the tongue, lips, and face
- hives
- difficulty breathing or swallowing
- effects on your heart
- fast or irregular heartbeat, awareness of a heartbeat
- chest pain
- increased blood pressure
- 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
- blurred vision
- red eyes
- nausea or vomiting
- seeing halos or bright colors around lights
If you have these symptoms, stop taking Utibron Neohaler and call your healthcare provider right away before taking another dose.
- new or worsened urinary retention. People who use Utibron Neohaler 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
- urinating frequently
- painful urination
- urination in a weak stream or drips
If you have these symptoms, stop taking Utibron Neohaler 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.
Common side effects of Utibron Neohaler include sore throat and runny nose, high blood pressure, and back pain.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Utibron Neohaler. For more information, ask your healthcare provider or pharmacist.
Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Utibron Neohaler
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Utibron Neohaler for a condition for which it was not prescribed. Do not give Utibron Neohaler to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.
For more information about Utibron Neohaler or to report side effects, go to www.Utibron.com or call 1-888-394-7377.
How should I store Utibron Neohaler?
- Store Utibron Neohaler (inhaler and blister-packaged capsules) at room temperature between 68°F and 77°F (20°C and 25°C).
- Do not remove Utibron capsules from the blister card it comes in until you are ready to use a dose of Utibron Neohaler.
- Do not store Utibron capsules in the Neohaler inhaler.
- Keep Utibron Neohaler in a dry place away from light and moisture.
Keep Utibron Neohaler and all medicines out of the reach of children.
What are the ingredients in Utibron Neohaler?
Active ingredients: indacaterol maleate, glycopyrrolate
Inactive ingredients: lactose monohydrate (contains milk proteins) and magnesium stearate.
