March 28, 2015

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Onbrez Breezhaler


DIN (Drug Identification Number)


What side effects are possible with Onbrez Breezhaler?

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 this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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 cramp
  • 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 check with your doctor or 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 this medication.

Are there any other precautions or warnings for Onbrez 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 this medication.

Asthma: The safety and efficacy of this medication 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. 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 indacaterol, seek immediate medical attention.

Lactose allergy: This medication 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 this medication. Speak to your doctor if you have any concerns.

Medical conditions: Discuss with your doctor how this medication 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, if you have any of the following conditions:

  • diabetes
  • epilepsy (seizures)
  • heart problems such as rapid or irregular heart beat or abnormal electrical signal called "prolongation of the QT interval"
  • high blood pressure
  • thyroid gland problems

Sudden symptoms of COPD: 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.

Pregnancy: This medication 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 indacaterol passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication is not to be used by children age 18 and under.

What other drugs could interact with Onbrez Breezhaler?

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

  • beta-blockers (e.g., metoprolol, propranolol, timolol)
  • corticosteroid medications (e.g., prednisone)
  • diuretics (also known as "water pills"; e.g., hydrochlorothiazide, indapamide)
  • monoamine oxidase inhibitors (e.g. maprotiline, moclobemide, selegiline)
  • other medications that belong to the long-acting beta agonists class (e.g., formoterol, salmeterol)
  • theophylline
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)

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.

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