This combination product contains two medications glycopyrronium and Indacaterol. Glycopyrronium belongs to the group of medications known as anticholinergics. Indacaterol belongs to the group of medications known as long-acting bronchodilators. These medications work in different ways to relax the muscles in the walls of the small air passages in the lungs, keeping the air passage open and making it easier to breathe.

Ultibro Breezhaler is used for the maintenance treatment of COPD (Chronic Obstructive Pulmonary Disease) (COPD), including emphysema and chronic Bronchitis. Regular daily use is important for Ultibro Breezhaler to be effective. Ultibro Breezhaler is also used to help prevent flare-ups (worsening of symptoms) for people who have COPD and have a history of these events. It will not relieve an episode of increased difficulty breathing.

Ultibro Breezhaler may be available under multiple brand names and/or in several different forms. Any specific brand name of Ultibro Breezhaler may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Ultibro Breezhaler may not be used for all of the conditions discussed here.

Your doctor may have suggested Ultibro Breezhaler for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Ultibro Breezhaler, speak to your doctor. Do not stop taking Ultibro Breezhaler without consulting your doctor.

Do not give Ultibro Breezhaler to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Ultibro Breezhaler if their doctor has not prescribed it.

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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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Ultibro Breezhaler. If you are concerned about side effects, discuss the risks and benefits of Ultibro Breezhaler with your doctor.

The following side effects have been reported by at least 1% of people taking Ultibro Breezhaler. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• cavities
• cough
• Diarrhea
• difficulty falling asleep
• dizziness
• Dry Mouth
• headache
• heartburn
• hoarseness
• muscle spasms
• nausea
• nosebleeds
• runny or stuffy nose
• skin rash, itchiness
• sore mouth
• sore throat
• tiredness
• upset stomach
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• feeling of pressure or pain in cheeks or forehead
• Fever
• high blood pressure
• irregular or fast heartbeat
• pain in muscles, joints or bones
• swollen ankles, feet, or hands
• symptoms of decreased amount of potassium in the blood (e.g., irregular heartbeat, muscle weakness and spasms, general feeling of being unwell)
• symptoms of Glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of an upper respiratory tract infection (Sinusitis; sinus congestion, sneezing, coughing, headache, with or without fever)
• symptoms of urinary retention (e.g. difficulty passing urine, frequent urination, urination in a weak stream or drips)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• tingling or numbness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• crushing chest pain (signs of not enough blood and oxygen getting to the heart)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• sudden worsening of shortness of breath after using inhaler
• swelling of the tongue, lips, face, and throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Ultibro Breezhaler.

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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

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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.

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