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 this medication. If you are concerned about side effects, discuss the risks and benefits of Onbrez Breezhaler (Indacaterol) with your doctor.

The following side effects have been reported by at least 1% of people taking Onbrez Breezhaler (Indacaterol). 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.

• cough
• headache
• irritation or pain of the mouth or throat
• muscle cramps
• nausea
• upper respiratory tract infection (e.g., runny nose, sore throat)

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

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

• COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during treatment
• rapid or pounding heartbeat

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

• bronchospasm with wheezing or coughing and difficulty breathing
• breathing problems worsen quickly
• symptoms of low potassium levels (e.g., muscle weakness, muscle spasms, or an abnormal heart rhythm)
• symptoms of an allergic reaction (e.g., fainting from Low Blood Pressure, rash or itching or swelling of the 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 Onbrez Breezhaler (Indacaterol).

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.