Onbrez Breezhaler

The recommended adult dose of Onbrez Breezhaler (Indacaterol) is the contents of 1 capsule (75 µg) inhaled through the mouth with the provided inhalation device once a day at the same time every day. Continue using Onbrez Breezhaler (Indacaterol) even when you have no breathing problems or other symptoms of COPD. Only use Onbrez Breezhaler (Indacaterol) with the inhalation device contained within the same pack. Do not swallow the Onbrez Breezhaler (Indacaterol) capsules. Ask your pharmacist to demonstrate how to use the inhalation device.

Onbrez Breezhaler (Indacaterol) may be inhaled on an empty stomach or after food or drink.

This medication must not be used as a rescue medication to treat sudden, severe symptoms of COPD. Consult your doctor or pharmacist for advice about rescue medications that are appropriate for you.

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 using the medication without consulting your doctor.

It is important to use Onbrez Breezhaler (Indacaterol) exactly as prescribed by your doctor. 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 inhale 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 Onbrez Breezhaler (Indacaterol) at room temperature, protect the capsules from light and moisture, and keep it out of 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.

Each clear, colourless, hard gelatin capsule for inhalation contains Onbrez Breezhaler (Indacaterol) maleate equivalent to 75 µg of Onbrez Breezhaler (Indacaterol). It has a black product code "IDL 75" printed on one side of the capsule and a symbol on the other side. Onbrez Breezhaler (Indacaterol) comes with an inhalation device. Non-medicinal ingredients: lactose monohydrate; shell: gelatine.

Do not use Onbrez Breezhaler (Indacaterol) if you:

• are allergic to Onbrez Breezhaler (Indacaterol) or any ingredients of the medication
• have Asthma
• are experiencing sudden, severe symptoms of COPD
• are under the age of 18

There may be an interaction between Onbrez Breezhaler (Indacaterol) and any of the following:

• Alfuzosin
• amantadine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• Anagrelide
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apomorphine
• Atomoxetine
• “azole” antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-blockers (e.g., Metoprolol, Propranolol, Timolol)
• Betahistine
• beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)

• caffeine
• chloral hydrate
• chloroquine
• cisapride
• oral corticosteroid medications (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• dipivefrin
• Disopyramide
• Domperidone
• dopamine
• Dronedarone
• Epinephrine
• Famotidine
• Fingolimod
• Flecainide
• formoterol
• Galantamine
• Linezolid
• lithium
• loop diuretics (water pills; bumetanide, Furosemide)
• lopinavir
• Loxapine
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• Mefloquine
• Methadone
• Methylphenidate
• Metoclopramide
• Metronidazole
• Mirabegron
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• norepinephrine
• Octreotide
• Paliperidone
• pentamidine
• Pimozide
• Primaquine
• procainamide
• Propafenone
• Romidepsin
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• ritonavir
• saquinavir
• selective serotonin reuptake inhibitors (ssris; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• sulfamethoxazole
• Tacrolimus
• Tamoxifen
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• thiazide diuretics (water pills; e.g., Hydrochlorothiazide, Indapamide, Metolazone)
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine) Trimethoprim
• tyrosine kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib)
• Venlafaxine

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 this medication. 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 Onbrez Breezhaler (Indacaterol).

Asthma: The safety and efficacy of Onbrez Breezhaler (Indacaterol) have not been established for people with asthma. Onbrez Breezhaler (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. Onbrez Breezhaler (Indacaterol) should not be used to treat asthma.

Bronchospasm: Occasionally, inhaled medications may cause the airways to spasm and close up (bronchospasm), which makes breathing even more difficult and can be life-threatening. If you experience increased difficulty breathing after using a dose of Onbrez Breezhaler (Indacaterol), seek immediate medical attention.

Diabetes: Onbrez Breezhaler (Indacaterol) may cause a loss of blood glucose control and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Onbrez Breezhaler (Indacaterol).

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

Heart problems: Onbrez Breezhaler (Indacaterol) can cause increased heart rate and blood pressure, as well as rapid or irregular heart beat or abnormal electrical signal called “prolonged QT interval". These effects may worsen symptoms of heart disease. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Onbrez Breezhaler (Indacaterol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Low potassium levels: Onbrez Breezhaler (Indacaterol) may cause decreased levels of potassium in the blood. This can cause abnormal heart rhythms, weakness, fatigue, muscle cramps or Constipation. If you experience any of these symptoms, contact your doctor.

Lactose allergy: Onbrez Breezhaler (Indacaterol) contains lactose (milk sugar) and a small amount of milk proteins. It is possible that people who have a severe milk protein allergy may have an allergic reaction to Onbrez Breezhaler (Indacaterol). Speak to your doctor if you have any concerns.

Seizures: If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Onbrez Breezhaler (Indacaterol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onbrez Breezhaler (Indacaterol), and whether any special monitoring is needed.

Sudden symptoms of COPD: Onbrez Breezhaler (Indacaterol) is not a "reliever" or "rescue" medication. If you start developing acute symptoms such as breathlessness, wheezing, and cough, you should use your "reliever" medication for rapid relief of your symptoms. It is very important that you have your "reliever" medication with you at all times. Seek emergency medical help if your breathing problems worsen quickly or if you use your rescue medication but it does not relieve your breathing problems.

Thyroid gland problems: If you have thyroid disease, discuss with your doctor how Onbrez Breezhaler (Indacaterol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onbrez Breezhaler (Indacaterol), and whether any special monitoring is needed.

Pregnancy: Onbrez Breezhaler (Indacaterol) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

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

Children: The safety and effectiveness of using Onbrez Breezhaler (Indacaterol) have not been established for people age 18 and under.