The recommended dose for people 18 years of age and older is:
- Inhalation of the contents of one capsule once daily

Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They relax the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When they are taken regularly, it helps the small airways to remain open.
Mometasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce the swelling and irritation in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.

Side effects may include:

• a frequent urge to urinate and pain or burning when urinating (signs of urinary tract infection)
• headache
• sore throat or pain and irritation in the back of the mouth and throat
• cough
• hoarseness and changes to your voice
• diarrhea, abdominal cramps, nausea, and vomiting (gastroenteritis)
• dry mouth
• rash
• muscle spasm
• pain in muscles, bones or joints
• fever
• itchy skin

Do not use Enerzair® 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 Enerzair® Breezhaler®. Talk about any health conditions or problems you may have, including if you:

• have heart problems such as:
  • an irregular or fast heartbeat
  • palpitations 
  • chest pain
  • an abnormal electrical signal called “prolongation of the QT interval”
• are taking similar medicines for your lung disease
• have low or high blood pressure
• if you have problems with your thyroid or adrenal glands
• if you have ever been told you have diabetes or high blood sugar
• have been taking other corticosteroids by mouth or inhalation
• have a fungal infection (thrush) in your mouth or throat
• have or have ever had pulmonary tuberculosis
• have chronic or untreated infections
• if you have seizures
• if your potassium levels are low
• if you have severe liver or kidney problems
• if you have narrow-angle glaucoma

You should avoid getting the powder in the capsules into your eyes. If you do, it may cause:

• eye pain and/or discomfort,
• temporary blurring of vision, and/or
• coloured images in association with red eyes

If you have narrow-angle glaucoma, getting the powder in your eyes may cause it to get worse. It can also cause acute narrow-angle glaucoma. If you develop any of these symptoms, talk to your doctor right away.
Risk of Bone Fractures: When using this medication for or long-term treatment, you may be at risk of:

• breaking a bone
• osteoporosis 

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 also have regular eye exams.

Drug Interactions:

The following may interact with Enerzair® Breezhaler®:

• medicines that prolong QT interval (your hearts electrical signal) including medicines used in the treatment of depression (e.g. tricyclic antidepressants, monoamine oxidase inhibitors)
• any medicines that may be similar to ENERZAIR BREEZHALER (contain similar ingredients) used to treat your lung disease. Using these together with ENERZAIR BREEZHALER may increase the risk of experiencing possible side effects
• atropine or other medications that contain a short-acting, or a long-acting muscarinic antagonist (LAMA) (such as ipratropium, tiotropium, aclidinium, umeclidinium)
• medicines that decrease the level of potassium in your blood. These include:
  • diuretics e.g. hydrochlorothiazide
  • other bronchodilators or steroids (e.g. prednisone)
• beta blockers used to treat high blood pressure or other heart problems (e.g. propranolol) or to treat glaucoma (e.g. timolol)
• medicine used to treat fungal infections (e.g., ketoconazole or itraconazole)
• medicine used to treat HIV infection (e.g., ritonavir, nelfinavir or cobicistat)

Pregnancy: Animal reproduction studies have not been conducted with this product.  Consult with doctor/pharmacist before use.

Breastfeeding:  The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Consult with doctor/pharmacist before use.