Ultibro Breezhaler

Glycopyrronium - indacaterol is inhaled into the lungs through the mouth. Do not swallow Ultibro Breezhaler.

The recommended adult dose of glycopyrronium - indacaterol is to inhale the contents of one capsule once daily, using the Breezhaler™ inhaler device that comes in the package with the medication. Your health care professional should show you how to use the device. If you are not sure about how to use the device, contact your doctor or pharmacist for advice.

When used regularly, Ultibro Breezhaler helps to prevent episodes of severe difficulty breathing.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Ultibro Breezhaler be taken exactly as prescribed by your doctor. Ultibro Breezhaler will not reverse an episode of troubled breathing. If you experience shortness of breath, use your short-acting bronchodilator.

If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. Severe blood pressure and heart problems may occur if glycopyrronium - indacaterol is used more often than one inhalation once daily.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Ultibro Breezhaler at room temperature in its original packaging. Remove the capsule from the blister packaging only when you are ready to inhale your dose. When you start a new package of medication, discard the old inhaler device and use the new one that is provided. Protect Ultibro Breezhaler from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause sore throat; it may cause a cough. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each capsule with a transparent yellow cap and natural transparent body containing a white-to-practically-white powder, with the product code "IGP110.50" printed in blue under two blue bars on the body and the company logo printed in black on the cap, contains 143 µg of indacaterol maleate equivalent to 110 µg of indacaterol and 63 µg of glycopyrronium bromide equivalent to 50 µg of glycopyrronium. The delivered dose is equivalent to 85 µg indacaterol and 43 µg glycopyrronium. Nonmedicinal ingredients: lactose monohydrate, magnesium stearate; capsule shell: hypromellose, purified water, carrageenan, potassium chloride, and FD&C Yellow No. 5/Tartrazine.

Do not use glycopyrronium - indacaterol if you:

• are allergic to indacaterol, glycopyrronium or any ingredients of the medication
• are severely allergic to lactose or milk proteins
• have been prescribed Ultibro Breezhaler to treat Asthma

There may be an interaction between glycopyrronium - indacaterol and any of the following:

• aclidinium
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• atropine
• azelastine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• belladonna
• Benztropine
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• beta 2 agonists (e.g., salmeterol, formoterol)
• Betahistine
• botulinum toxin
• cannabis
• clidinium
• cocaine
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclobenzaprine
• Darifenacin
• dexmethylphenidate
• Dimenhydrinate
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, Amiloride)
• Domperidone
• Donepezil
• Dronedarone
• Epinephrine
• Flecainide
• Flavoxate
• Galantamine
• Glucagon
• HIV protease inhibitors (e.g., atazanavir, indinavir, lopinavir, ritonavir)
• ipratropium
• ketotifen
• Linezolid
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• medications that increase blood levels of potassium (e.g., potassium chloride, salt substitutes containing potassium)
• Methadone
• Metoclopramide
• Methylphenidate
• Mirabegron
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nasal decongestants (e.g., oxymetazoline, xylometazoline)
• Nitroglycerin
• orphenadrine
• Oxybutynin
• phenylephrine
• procainamide
• Propafenone
• Pseudoephedrine
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Rivastigmine
• scopolamine
• Solifenacin
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tiotropium
• Tolterodine
• Topiramate
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• umeclidinium
• Vandetanib
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Ultibro Breezhaler. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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.

This product must be inhaled by mouth. Carefully follow the package's instructions. If needed, ask your pharmacist for additional information or for a demonstration. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up.