ENERZAIR BREEZHALER 114 mcg/46 mcg/136 mcg inhalation powder (hard capsule)

Introduction

Package Leaflet: Information for the User

Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms powder for inhalation (hard capsule)

indacaterol/glycopyrronium/mometasone furoate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Enerzair Breezhaler and what is it used for
2. What you need to know before you use Enerzair Breezhaler
3. How to use Enerzair Breezhaler
4. Possible side effects
5. Storing Enerzair Breezhaler
6. Contents of the pack and other information

Instructions for using the Enerzair Breezhaler inhaler

1. What is Enerzair Breezhaler and what is it used for

What is Enerzair Breezhaler and how does it work

Enerzair Breezhaler contains three active substances:

• indacaterol
• glycopyrronium
• mometasone furoate

Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They work in different ways to relax the muscles of the small airways in the lungs. This helps to open up the airways and makes it easier to breathe in and out. When used regularly, they help the small airways in the lungs to stay open.

Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) of the small airways in the lungs and in this way gradually relieve breathing problems. Corticosteroids also help to prevent asthma attacks.

What is Enerzair Breezhaler used for

Enerzair Breezhaler is used as a regular treatment for asthma in adults.

Asthma is a serious, chronic lung disease in which the muscles around the smaller airways tighten (bronchoconstriction) and become inflamed. The symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing.

You should use Enerzair Breezhaler every day as directed by your doctor and not just when you have breathing problems or other symptoms of asthma. This will help to adequately control your asthma. Do not use this medicine to relieve a sudden attack of shortness of breath or wheezing.

Talk to your doctor if you have any questions about how Enerzair Breezhaler works or why you have been prescribed this medicine.

2. What you need to know before you use Enerzair Breezhaler

Follow your doctor's instructions carefully.

Do not use Enerzair Breezhaler

• if you are allergic to indacaterol, glycopyrronium, mometasone furoate, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse beforeusing Enerzair Breezhaler if any of the following apply to you:

• if you have heart problems, including a fast or irregular heartbeat,
• if you have thyroid problems,
• if you have been told you have diabetes or high blood sugar levels,
• if you have seizures or fits,
• if you have severe kidney problems,
• if you have severe liver problems,
• if you have low potassium levels in your blood,
• if you have a condition called narrow-angle glaucoma,
• if you have difficulty urinating,
• if you have pulmonary tuberculosis (TB) or any other long-standing or untreated infection.

During treatment with Enerzair Breezhaler

Stop using this medicine and get immediate medical helpif you experience any of the following:

• chest tightness, coughing, wheezing, or difficulty breathing immediately after using Enerzair Breezhaler (signs that the medicine has unexpectedly constricted the airways, known as paradoxical bronchospasm),
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and hives (signs of an allergic reaction),
• eye pain or discomfort, blurred vision, halos, or colored images in association with redness of the eyes (signs of an acute attack of narrow-angle glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents (under 18 years of age) because it has not been studied in this age group.

Other medicines and Enerzair Breezhaler

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, tell your doctor or pharmacist if you are using:

• medicines that decrease the amount of potassium in the blood. These include diuretics (which increase urine production and may be used to treat high blood pressure, e.g., hydrochlorothiazide), other bronchodilators such as methylxanthines used for respiratory disorders (e.g., theophylline), or corticosteroids (e.g., prednisolone).
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression).
• any medicine that may be similar to Enerzair Breezhaler (containing similar active substances); as their combined use may increase the risk of side effects.
• medicines called beta-blockers that may be used for high blood pressure or other heart problems (such as propranolol), or to treat glaucoma (e.g., timolol).
• ketoconazole or itraconazole (medicines used to treat fungal infections).
• ritonavir, nelfinavir, or cobicistat (medicines used to treat HIV infection).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will decide whether you can use Enerzair Breezhaler.

Driving and using machines

Enerzair Breezhaler is unlikely to affect your ability to drive or use machines.

Enerzair Breezhaler contains lactose

This medicine contains approximately 25 mg of lactose per capsule. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Enerzair Breezhaler

Follow the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

How much Enerzair Breezhaler to inhale

The usual dose is to inhale the contents of one capsule each day. You only need to inhale the medicine once a day. Do not use more than the dose prescribed by your doctor.

You should use Enerzair Breezhaler every day, even if you do not feel unwell due to asthma.

When to inhale Enerzair Breezhaler

Inhale Enerzair Breezhaler at the same time each day. This will help you control your symptoms throughout the day and night. It will also help you remember to use it.

How to inhale Enerzair Breezhaler

• Enerzair Breezhaler is for inhalation use only.
• In this pack, you will find an inhaler and capsules that contain the medicine. The inhaler allows you to inhale the medicine from the capsule. Use the capsules only with the inhaler provided in this pack. The capsules should be kept in the blister pack until you need to use them.
• Peel off the foil from the blister to open it, do not push the capsule through the foil.
• When you start a new pack, use the new inhaler provided in the pack.
• Discard the inhaler from each pack once you have used all the capsules.
• Do not swallow the capsules.
• For more information on how to use the inhaler, please read the instructions at the end of this leaflet.

If your pack contains an electronic sensor for Enerzair Breezhaler

• The sensor and the app are not needed for you to take your medicine. The sensor does not need to be connected to the app when you use your medicine.
• Your doctor will decide if using the sensor and the app is right for you.
• The electronic sensor for Enerzair Breezhaler attaches to the base of the Enerzair Breezhaler inhaler.
• The sensor confirms that you have used the Enerzair Breezhaler inhaler by recording and monitoring the actions and noise made by the capsule when it is turned during inhalation, but it does not monitor whether you have received your dose of medicine.
• The sensor should be used with the Propeller app on your mobile phone or any other suitable device. The sensor links to the Propeller app via Bluetooth.
• For more information on how to use the sensor for Enerzair Breezhaler and the app, please read the instructions for use provided with the pack containing the sensor and the app.
• Once you have used all the Enerzair Breezhaler capsules from one pack, transfer the sensor to the new inhaler in the next pack of Enerzair Breezhaler.

If your symptoms do not improve

If your asthma does not improve or even gets worse after you have started using Enerzair Breezhaler, talk to your doctor.

If you use more Enerzair Breezhaler than you should

If you accidentally inhale too much of this medicine, contact your doctor or hospital immediately. Medical attention may be needed.

If you forget to use Enerzair Breezhaler

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

If you stop using Enerzair Breezhaler

Do not stop using Enerzair Breezhaler unless your doctor tells you to. Your asthma symptoms may come back if you stop using it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious

Stop using Enerzair Breezhaler and get immediate medical help if you experience any of the following:

Common:may affect up to 1 in 10 people

• difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and hives (signs of an allergic reaction).

Other side effects

The following are other side effects. If these side effects become serious, talk to your doctor, pharmacist, or nurse.

Very common:may affect more than 1 in 10 people

• sore throat
• nasal discharge
• sudden difficulty breathing and feeling of chest tightness with wheezing or coughing

Common:may affect up to 1 in 10 people

• oral thrush (signs of candidiasis). After you have inhaled your dose, rinse your mouth with water or a mouthwash and spit. This will help prevent thrush.
• urgent need to urinate and pain or burning when urinating (signs of urinary tract infection)
• headache
• fast heartbeat
• coughing
• voice changes (hoarseness)
• diarrhea, abdominal cramps, nausea, and vomiting (gastroenteritis)
• muscle, bone, or joint pain (signs of musculoskeletal pain)
• muscle spasms
• fever

Uncommon:may affect up to 1 in 100 people

• dry mouth
• skin rash
• high blood sugar levels
• itching
• difficulty and pain when urinating (signs of dysuria)
• clouding of the lenses in your eyes (signs of cataract)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Enerzair Breezhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date is the last day of the month stated.
• Do not store above 30°C.
• Store the capsules in the original blister pack to protect them from light and moisture and do not remove them until just before use.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
• If your pack contains an electronic sensor for Enerzair Breezhaler, please refer to the instructions for use provided with the pack containing the sensor for detailed instructions on how to store and when to dispose of it.

6. Container contents and additional information

Enerzair Breezhaler composition

• The active ingredients are indacaterol (as acetate), glycopyrronium (as bromide), and mometasone furoate. Each capsule contains 150 micrograms of indacaterol (as acetate), 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium), and 160 micrograms of mometasone furoate. Each delivered dose (the dose released by the inhaler mouthpiece) contains 114 micrograms of indacaterol (as acetate), 58 micrograms of glycopyrronium bromide (equivalent to 46 micrograms of glycopyrronium), and 136 micrograms of mometasone furoate.
• The other ingredients are lactose monohydrate and magnesium stearate (see the section "Enerzair Breezhaler contains lactose" in section 2).

Product appearance and container contents

In this container, you will find an inhaler along with capsules in blisters. Some containers also contain a sensor. The capsules are transparent and contain a white powder. They have the product code "IGM150-50-160" printed in black above two black bars on the body and with the product logo printed in black and surrounded by a black bar on the cap.

The following container sizes are available:

Single container containing 10 x 1, 30 x 1, or 90 x 1 hard capsules, along with 1 inhaler. Container containing 30 x 1 hard capsules, along with 1 inhaler and 1 sensor.

Multiple containers that contain 15 boxes, each with 10 x 1 capsules along with 1 inhaler.

Only some container sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Enerzair Breezhaler inhaler instructions for use

Please read the complete Instructions for Use of the Enerzair Breezhaler inhaler before using it.These instructions are available by scanning the QR code or visiting the website: www.breezhaler-asthma.eu/enerzair

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