Ultibro Breezhaler

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ultibro Breezhaler.

Asthma: The safety and efficacy of Ultibro Breezhaler have not been established for people with asthma. Indacaterol belongs to the class of medication called long-acting beta-agonists (LABA). LABAs have been shown in a study to increase the risk of asthma related deaths. Ultibro Breezhaler should not be used to treat asthma.

Diabetes: Ultibro Breezhaler may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Ultibro Breezhaler.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

Glaucoma: Glycopyrronium may cause symptoms of glaucoma (increased pressure in the eye) to worsen. If you have glaucoma, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

Heart rhythm: Glycopyrronium - indacaterol can cause changes to the normal rate and rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), or taking other medications that can cause heart rhythm problems, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Ultibro Breezhaler to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

Potassium levels: Decreases in blood levels of potassium may occur with normal use of glycopyrronium - indacaterol. This rarely causes problems, but potassium levels should be monitored by your doctor. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor.

Prevention only: Glycopyrronium - indacaterol is not useful for treating acute symptoms (as a "rescue" medication). It is meant for prevention purposes only. Short-acting medications such as salbutamol, terbutaline, or formoterol are required for relief of breathing symptoms as instructed by your doctor and should be available at all times.

Seizure disorders: People who have a history of seizures may find that they experience seizures more often. If you have a history of seizure disorders, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

Thyroid disease: People with an overactive thyroid gland may find that they are more sensitive to the effects of indacaterol. If you have thyroid problems, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

Urinary tract problems: Ultibro Breezhaler can cause increased difficulty with urine flow and urinary retention. If you have an enlarged prostate gland or other condition that makes it difficult to pass urine, discuss with your doctor how Ultibro Breezhaler may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ultibro Breezhaler, and whether any special monitoring is needed.

If you experience difficulty starting to urinate or have pain when you urinate, speak with your doctor as soon as possible.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctors immediately about what to do if any of the following situations occur (they may be signs of seriously worsening COPD):

• decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
• need for more inhalations than usual of short-acting, inhaled bronchodilators

Pregnancy: Ultibro Breezhaler should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ultibro Breezhaler, contact your doctor immediately.

Breast-feeding: It is not known if glycopyrronium - indacaterol passes into breast milk. If you are a breast-feeding mother and are taking Ultibro Breezhaler, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ultibro Breezhaler have not been established for children.