Utibron inhalation powder contains a combination of glycopyrrolate and indacaterol. Glycopyrrolate is an anticholinergic. Indacaterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.

Utibron Neohaler is used long term to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

Utibron Neohaler is not for use in treating asthma.

Indacaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risk.

You should not use Utibron Neohaler if you are allergic to glycopyrrolate, indacaterol, milk proteins, or if you have asthma.

Utibron Neohaler is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Indacaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Utibron Neohaler is not for use in treating asthma.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

Use Utibron Neohaler exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides.

Utibron Neohaler is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

Utibron Neohaler is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load one capsule into the inhaler device each time you use the medicine. Pushing the buttons on the side of the Neohaler device will pierce the capsule and release the medicine into the inhaler chamber.

Do not swallow the capsule or place it in your mouth. The capsule is for use only with the Neohaler inhalation device.

Use only the inhaler device provided with your medicine or you may not get the correct dose. Use the new inhaler each time you get your prescription refilled.

You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance:

-1 inhalation (glycopyrrolate 15.6 mcg-indacaterol 27.5 mcg) orally TWICE a day (in the morning and in the evening)

Comments:
-For each inhalation, administer the content of 1 capsule using the Neohaler device.
-More frequent administration or a greater number of inhalations (more than 1 capsule twice a day) is not recommended. Do not use 2 capsules at one time.

You should not use Utibron Neohaler if you are allergic to glycopyrrolate or indacaterol or if you have:

• allergy to milk proteins; or

• asthma.

To make sure Utibron Neohaler is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• liver or renal disease;

• glaucoma;

• diabetes;

• a thyroid disorder;

• bladder obstruction or other urination problems; or

• any food or drug allergies.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Utibron Neohaler.

This medicine is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two capsules at one time. Do not use more than 2 capsules in one 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache, and nervousness.

Do not use a second inhaled bronchodilator that contains indacaterol or a similar medicine (such as arformoterol, formoterol, olodaterol, salmeterol, or vilanterol).

Get emergency medical help if you have signs of an allergic reaction to Utibron Neohaler: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your condition;

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• wheezing, choking, or other breathing problems after using this medicine;

• painful or difficult urination, or urinating more often;

• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common Utibron Neohaler side effects may include:

• back pain;

• runny nose, sore throat; or

• high blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with glycopyrrolate and indacaterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.