Atectura Breezhaler: Uses, Side Effects and Dosage

What is ATECTURA BREEZHALER used for?

ATECTURA BREEZHALER a combination of a long-acting beta₂-adrenergic agonist (LABA) and an inhaled corticosteroid (ICS). It is used to treat asthma in adults and adolescents (12 years of age and older) with reversible obstructive airways disease.

You should only take this medication if your:

• asthma is not adequately controlled on a long-term asthma medication (such as a ICS) or
• disease condition requires treatment with both a LABA and ICS

You should not take this medication:

• if you can manage your asthma by occasionally using a rapid onset, short duration, inhaled beta₂-agonist or
• if you can manage your asthma by using ICS along with occasional use of a rapid onset, short duration, inhaled beta₂-agonist or
• for the relief of the sudden (acute) symptoms of asthma (i.e. as rescue therapy for the treatment of sudden episodes of bronchospasm)

How does ATECTURA BREEZHALER work?

ATECTURA BREEZHALER contains two medicinal ingredients:

• indacaterol – a long-acting beta₂ agonist (LABA)
• mometasone furoate – an inhaled corticosteroid (ICS)

Indacaterol belongs 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 it is 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 gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.

What are the ingredients in ATECTURA BREEZHALER?

Medicinal ingredients: indacaterol (as acetate) and mometasone furoate

Non-medicinal ingredients: gelatin and lactose (as monohydrate)

ATECTURA BREEZHALER comes in the following dosage forms:

Capsules for oral inhalation: 150 mcg / 80 mcg, 150 mcg / 160 mcg and 150 mcg / 320 mcg indacterol (as acetate) and mometasone furoate

Do not use ATECTURA BREEZHALER if:

• you are allergic to or have had an allergic reaction to:

  • indacaterol
  • mometasone furoate
  • any other ingredients in ATECTURA BREEZHALER
  • lactose or milk proteins

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

• have heart problems such as:

  • an irregular or fast heartbeat (arrhythmia)
  • sensations that your heart has skipped a beat or added an extra beat (palpitations)
  • your heart muscle does not get enough blood (myocardial ischemia)
  • chest pain (angina)
  • an abnormal electrical signal called “prolongation of the QT interval”
• are taking similar medicines for your lung disease
• 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 or have ever had pulmonary tuberculosis

• have chronic or untreated infections:

  • bacterial infection
  • viral infection
  • fungal infection
  • parasitic infection
  • herpes simplex infection of the eye
• suffer from seizures or fits
• have low potassium levels in your blood
• have severe liver problems
• have acutely deteriorating asthma, which may be a life-threatening condition
• have a severe allergy to lactose or milk proteins

Other warnings you should know about:

General: When LABA medicines are used alone without an ICS, they increase the risk of hospitalization and death from asthma problems. ATECTURA BREEZHALER contains both a LABA and ICS. Studies showed that when a LABA and ICS are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

ATECTURA BREEZHALER does not relieve the sudden (acute) symptoms of asthma. You should always have a short-acting bronchodilator medicine (“rescue” inhaler) (such as salbutamol) with you to treat your sudden symptoms. If you do not have an inhaled, short acting bronchodilator, contact your doctor to have one prescribed for you. Use the medication as directed by your doctor.

Stop taking ATECTURA BREEZHALER and get medical help right away if you have any of the following:

• tightness of the chest, coughing, wheezing or feeling breathlessness immediately after inhaling ATECTURA BREEZHALER (signs of paradoxical bronchospasm).
• trouble breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction).

Do not stop taking ATECTURA BREEZHALER without talking to your doctor. You should 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.

These could be warning signs that your condition may be worsening.

Pregnancy: Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Your doctor will discuss the potential risks of taking this medicine with you and whether you can use ATECTURA BREEZHALER.

Breast-feeding: It is not known whether the ingredients of ATECTURA BREEZHALER can pass into breast milk. If you are breast-feeding, check with your doctor before you take ATECTURA BREEZHALER.

Risk of Bone Fractures: When using medicines like ATECTURA BREEZHALER for long term treatment, you may be at risk of:

• breaking a bone
• osteoporosis (brittle bones)

Eye disorders: Medicines like ATECTURA BREEZHALER 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.

Chicken pox and measles: You should avoid exposure to chicken pox and measles, and notify your doctor if are exposed. This is important if you are taking any corticosteroid and your immune system is not functioning well (if you have difficulty in fighting an infection).

Monitoring and Laboratory Tests: your doctor may monitor you and perform the tests to check your:

• potassium levels in your blood. Low levels of potassium have been seen in people taking beta-agonist therapies, which may increase your risk of heart arrhythmia.
• blood sugar levels. High blood glucose levels have been seen in people taking beta-agonist medicines. This is important if you are diabetic.

Slower growth in adolescents: All corticosteroids, especially when used for a long time, may possibly interfere with the usual growth pattern in children and adolescents. You may want to discuss this with your doctor.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ATECTURA BREEZHALER:

• medicines used in the treatment of depression (e.g. tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs))
• any medicines that may be similar to ATECTURA BREEZHALER (contain similar ingredients) used to treat your lung disease. Using these together with ATECTURA BREEZHALER may increase the risk of experiencing possible side effects

• medicines that decrease the level of potassium in your blood. These include:

  • diuretics (also known as “water pills”) and are used to treat high blood pressure (e.g. hydrochlorothiazide)
  • other bronchodilators such as methylxantines used for breathing problems (e.g. theophylline) or steroids (e.g. predislolone)
• 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)
• medicines that prolong your QT interval (your hearts electrical signal)

How to take ATECTURA BREEZHALER:

Important:

• The capsules are for oral inhalation only. DO NOT SWALLOW.
• ATECTURA BREEZHALER does not relieve sudden symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your doctor to have one prescribed for you
• Always use this medicine exactly as your doctor has told you. Do not stop using it unless your doctor tells you to.
• It is important that you continue to take ATECTURA BREEZHALER regularly even if you feel fine and do not have any symptoms
• If your asthma is not getting better or it gets worse after you have started using ATECTURA BREEZHALER, talk to your doctor.

There are 3 doses of ATECTURA BREEZHALER:

• 150 mcg / 80 mcg
• 150 mcg / 160 mcg
• 150 mcg / 320 mcg

Your doctor will decide which dose is right for you.

Usual dose:

Adults and Adolescents 12 years of age and older: Inhale the contents of 1 capsule once a day at about the same time each day. Rinse your mouth with water after each dose. Do not swallow the water.

Instructions for Use:

This part of the leaflet explains how to use and care for your ATECTURA BREEZHALER inhaler. Please read carefully and follow these instructions.

Please read the full Instructions for Use before using the ATECTURA BREEZHALER.

If you have any questions, ask your doctor or pharmacist.

Your ATECTURA BREEZHALER Inhaler pack contains:

• 1 inhaler device
• Blister cards containing the ATECTURA BREEZHALER capsules to be used in the inhaler

Base Cap Side buttons Blister Screen Capsule chamber Inhaler Inhaler base Blister card Mouthpiece

Steps:

Insert	Pierce and release	Inhale deeply	Check capsule is empty
			Check
1	2	3
Step 1a: Pull off cap	Step 2a: Pierce capsule once Hold the inhaler upright. Pierce capsule by firmly pressing both side buttons at the same time.	Step 3a: Breathe out fully Do not blow into the inhaler.	Check capsule is empty Open the inhaler to see if any powder is left in the capsule. If there is powder left in the capsule: Close the inhaler. Repeat steps 3a to 3d.

	You should hear a noise as the capsule is pierced. Only pierce the capsule once.		Powder Empty remaining
Step 1b: Open inhaler	Step 2b: Release side buttons	Step 3b: Inhale medicine deeply Hold the inhaler as shown in the picture. Place the mouthpiece in your mouth and close your lips firmly around it. Do not press the side buttons.
		Breathe in quickly and as deeply as you can. During inhalation you will hear a whirring noise. You may taste the medicine as you inhale.
Step 1c: Remove capsule Separate one of the blisters from the blister card. Peel open the blister and remove the capsule. Do not push the capsule through the foil. Do not swallow the capsule.		Step 3c: Hold breath Hold your breath for up to 5 seconds. Step 3d : Rinse mouth Rinse your mouth with	Remove empty capsule Put the empty capsule in your household waste. Close the inhaler and replace the cap.

water after each dose and spit it out.
Step 1d: Insert capsule Never place a capsule directly into the mouthpiece.			Important Information ATECTURA BREEZHALER capsules must always be stored in the blister card and only removed immediately before use. Do not push the capsule through the foil to remove it from the blister. Do not swallow the capsule. Do not use the ATECTURA BREEZHALER capsules with any other inhaler. Do not use the ATECTURA BREEZHALER inhaler to take any other capsule medicine. Never place the capsule into your mouth or the mouthpiece of the inhaler. Do not press the side buttons more than once. Do not blow into the mouthpiece. Do not press the side buttons while inhaling through the mouthpiece. Do not handle capsules with wet hands. Never wash your inhaler with water.
Step 1e: Close inhaler

Overdose:

Symptoms of an overdose include:

• fast heart rate
• feeling shaky
• sensations that your heart has skipped a beat or added an extra beat
• an irregular or fast heartbeat
• headache
• nausea
• vomiting
• feeling drowsy

Missed Dose:

If you forget to inhale a dose, inhale the dose as soon as possible. Then inhale the next dose at the usual time. Do not inhale two doses on the same day.

What are possible side effects from using ATECTURA BREEZHALER?

These are not all the possible side effects you may have when taking ATECTURA BREEZHALER. If you experience any side effects not listed here, tell your healthcare professional.

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

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Keep this medicine out of the sight and reach of children.
• At room temperature (15-30°C) in the original package to protect from moisture and light. Remove capsules from the package only when ready to use.
• Do not use after the expiry date shown on the box.

If you want more information about ATECTURA BREEZHALER:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.novartis.ca, the distributor’s website www.valeopharma.com or by calling 1-855-694-0151.

Last Revised Nov-12-2021

ATECTURA and BREEZHALER are registered trademarks.