Atectura® is intended for use in patients 12 years of age and older.
 - Inhalation of the contents of one capsule of the 150/80 microgram strength once daily is recommended in patients who require a combination of a long-acting beta2-agonist and a low dose of inhaled corticosteroid.
 - Inhalation of the contents of one capsule of the 150/160 microgram or 150/320 microgram strengths once daily is recommended in patients who require a combination of a long-acting beta2-agonist and a medium or high dose of inhaled corticosteroid.
 - The maximum recommended dose is 150/320 micrograms once daily.

Mometasone furoate is a corticosteroid used to treat swelling and inflammation in the breathing passages.

Indacaterol maleate is a long-acting beta2-agonist for use as a long-term, once-daily maintenance bronchodilator. It relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the airways for 24 hours, making it easier for air to get in and out and prevent symptoms, such as wheezing and shortness of breath.

Indacaterol has a rapid onset of action and a long duration of action.

Side effects may include:

• headache
• sore throat or pain and irritation in the back of the mouth and throat
• hoarseness and changes to your voice
• muscle, bone and joint pain
• muscle spasms
• itching of the skin
• rash

Stop using this medication and get medical help right away if you have any of the following:

• tightness of the chest, coughing, wheezing or feeling breathlessness immediately after inhalation of this medication
• trouble breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction).

Talk to your doctor right away if:

• There is a change in your symptoms such as more coughing, attacks of wheezing, chest tightness, or an unusual increase in the severity of the breathlessness.
• You are using increasing amounts of your fast acting ‘reliever’ medicine.

Do not use Atectura® Breezhaler® if:
If you are allergic to or have had an allergic reaction to:

• any of the ingredients in this product
• lactose or milk proteins

To help avoid side effects and ensure proper use, talk to your healthcare professional before you use Atectura® Breezhaler®. Talk about any health conditions or problems you may have, including if you:

• have heart problems such as
  • arrhythmias
  • palpitations
  • myocardial ischemia
  • angina
• have low or high blood pressure
• have thyroid gland problems or disease
• have problems with your adrenal glands
• have diabetes or high blood sugar
• have eye problems such as glaucoma, cataracts, blurry vision or other changes in vision
• have been taking other corticosteroids by mouth or by inhalation
• have a fungal infection (thrush) in your mouth or throat
• have seizures 
• have low potassium levels in your blood
• have severe liver problems
• have acutely deteriorating asthma, which may be a life-threatening condition

Risk of Bone Fractures: When using this medication for long term treatment, you may be at risk of:

• breaking a bone
• osteoporosis (brittle bones)

Eye disorders: This medication can cause eye disorders:

• Cataracts: clouding of the lens in the eye, blurry vision, eye pain
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss
• Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision.

Contact your healthcare professional if you experience blurry vision or other vision problems. You should have regular eye exams.

Drug Interactions:

The following may interact with Atectura® Breezhaler®:

• tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs))
• medicines that decrease the level of potassium in your blood. These include:
  • diuretics (e.g. hydrochlorothiazide)
  • bronchodilators used by mouth such (e.g.)heophylline or steroids (e.g. prednisone)
• beta blockers
• ketoconazole or itraconazole)
• medications used to treat HIV infection (e.g., ritonavir, nelfinavir or cobicistat

Use in pregnancy and breastfeeding: No human data available. Data from animal studies suggests low risk