Enverzaire Breezhaler

Patient Information Leaflet: Instructions for the User

Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms powder for inhalation, hard capsules

indacaterol/glycopyrronium/mometasone furoate

Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

What Enerzair Breezhaler is and how it works
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 in the small airways of the lungs. This helps to open up the airways, making breathing easier. When taken regularly, they help keep the small airways in the lungs open.
Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids).
Corticosteroids reduce swelling and irritation (inflammation) in the small airways of the lungs, thereby gradually relieving breathing difficulties. Corticosteroids also help prevent asthma attacks.
What Enerzair Breezhaler is used for
Enerzair Breezhaler is used regularly as a treatment for asthma in adults.
Asthma is a serious, long-term lung disease in which the muscles surrounding the small airways in the lungs become narrowed (bronchoconstriction) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness, and coughing.
You must use Enerzair Breezhaler every day, not only when you have breathing problems or other asthma symptoms. This will ensure adequate asthma control. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
If you have any questions about how Enerzair Breezhaler works or why this medicine has been prescribed for you, speak to your doctor.

2. What you need to know before using 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 are allergic, consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Enerzair Breezhaler if any
of the following apply to you:

• if you have heart problems, including irregular or rapid heartbeat;
• if you have thyroid gland problems;
• if you have been diagnosed with diabetes or have high blood sugar levels;
• if you suffer from epilepsy or seizures;
• if you have severe kidney problems;
• if you have severe liver problems;
• if you have low levels of potassium in your blood;
• if you have a type of eye disease called closed-angle glaucoma;
• if you have difficulty urinating;
  • if you have pulmonary tuberculosis (TB), or any long-standing or untreated infection.

During treatment with Enerzair Breezhaler
Stop using the medicine and seek immediate medical help if any
of the following occur:

• chest tightness, cough, wheezing, or shortness of breath immediately after using Enerzair Breezhaler (signs that the medicine is unexpectedly narrowing the airways, known as paradoxical bronchospasm);
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, rash, itching, or hives (signs of an allergic reaction);
• eye pain or discomfort, temporary blurred vision, halos (seeing bright circles around lights), or colored vision accompanied by red eyes (signs of an acute closed-angle glaucoma attack).

Children and adolescents
This medicine must not be given to children or adolescents (under 18 years of age) as it has not been studied in this age group.
Other medicines and Enerzair Breezhaler
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. In particular, inform your doctor or pharmacist if you are taking:

• medicines that lower potassium levels 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 problems (e.g. theophylline), or corticosteroids (e.g. prednisolone);
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression);
• any medicine similar to Enerzair Breezhaler (containing similar active substances); using them together may increase the risk of possible side effects;
• medicines called beta-blockers, used to treat high blood pressure or other heart problems (e.g. 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 infections).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine. Your doctor will tell you whether you can
use Enerzair Breezhaler.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
Enerzair Breezhaler contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact them before taking this medicine.

3. How to take Enerzair Breezhaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
How much Enerzair Breezhaler to inhale
The usual dose is inhalation of the contents of one capsule every day. One inhalation per day is
sufficient. Do not use more medicine than your doctor has recommended.
You must use Enerzair Breezhaler every day, even when your asthma does not cause any problems.
When to inhale Enerzair Breezhaler
Use Enerzair Breezhaler every day at the same time. This will help you control your symptoms during
the day and night. It will also help you remember to take it.
How to inhale Enerzair Breezhaler

• Enerzair Breezhaler is for inhalation use only.
• This pack contains an inhaler and capsules containing 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 must remain in the blister until you are ready to use them.
• To open the blister, peel off the protective film by lifting it up. Do not push the capsule through the film.
• When starting a new pack, use the new inhaler provided in the new pack.
  • Discard the inhaler from each pack after using all the capsules in that pack.
• Do not swallow the capsules.
• Read the instructions on the other side of this leaflet for further information on how to use the inhaler.

If the pack contains a sensor for Enerzair Breezhaler

• The sensor and the App are not essential for taking the medicine. It is not necessary for the sensor to be connected to the App when taking the medicine.
• Your doctor will decide whether use of the sensor and App is appropriate for you.
• The electronic sensor for Enerzair Breezhaler must be attached to the base of the Enerzair Breezhaler inhaler.
• The sensor confirms that you have used the Enerzair Breezhaler inhaler by recording and monitoring actuations of the inhaler and the whistle sound of the rotating capsule during inhalation, but it does not monitor the actual intake of the medicine dose.
• The sensor must be used with the Propeller App, downloaded on a smartphone or other compatible device. The sensor connects to the Propeller App via Bluetooth.
• For further information on how to use the Enerzair Breezhaler sensor and the App, read the instructions for use provided in the sensor packaging and within the App.
• When all capsules in a pack of Enerzair Breezhaler have been used, transfer the sensor to the new inhaler included in the next pack of Enerzair Breezhaler.

If symptoms do not improve
If your asthma does not improve or worsens after starting Enerzair Breezhaler, contact your
doctor.
If you use more Enerzair Breezhaler than you should
If you have accidentally inhaled too much medicine, contact your doctor or the nearest
hospital immediately. Medical treatment may be required.
If you forget to use Enerzair Breezhaler
If you have forgotten to inhale a dose at your usual time, inhale one as soon as possible on the same
day. Then inhale your next dose the following day 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 without first consulting your doctor. Your asthma symptoms may
return if you stop using it.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious
Stop using Enerzair Breezhaler and seek 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, rash, itching and hives (signs of an allergic reaction).

Other side effects
Other side effects are listed below. If these side effects become severe, consult your doctor, pharmacist or nurse.
Very common: may affect more than 1 in 10 people

• sore throat
• runny nose (nasopharyngitis)
• sudden breathing difficulty and chest tightness with wheezing or coughing (asthma exacerbation)

Common: may affect up to 1 in 10 people

• oral thrush (sign of candidiasis). After inhaling the medicine, rinse your mouth with water or a mouthwash and spit it out. This will help prevent oral thrush.
• frequent urge to urinate, and pain or burning when urinating (signs of urinary tract infection)
• headache
• fast heartbeat
• cough
• voice changes (hoarseness)
• diarrhoea, abdominal cramps, nausea and vomiting (gastroenteritis)
• pain in muscles, bones or joints (signs of musculoskeletal pain)
• muscle spasm
• fever
• upper respiratory tract infection
• oropharyngeal pain

Uncommon: may affect up to 1 in 100 people

• dry mouth
• skin rash
• elevated blood sugar levels (hyperglycaemia)
• skin itching
• difficulty and pain when urinating (sign of dysuria)
• clouding of the eye lens (sign of cataract)

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

5. How to store 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 “Scad”/“EXP”. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Keep the capsules in the original blister to protect them from light and moisture, and only remove them from the blister immediately before use.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
• If the pack contains an electronic sensor for Enerzair Breezhaler, read the instructions for use supplied in the sensor pack for detailed information on how to store and dispose of the sensor.

6. Package contents and other information

What Enerzair Breezhaler contains

• The active substances 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 from the mouthpiece of the inhaler) 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 components of the capsule are lactose monohydrate and magnesium stearate (see “Enerzair Breezhaler contains lactose” in section 2).
• The ingredients of the capsule shell are hypromellose, carrageenan, potassium chloride, yellow iron oxide (E172), indigo carmine (E132), purified water and printing ink. The ingredients of the printing ink are black iron oxide (E172), isopropyl alcohol, propylene glycol (E150), hypromellose (E464) and purified water.

Description of the appearance of Enerzair Breezhaler and contents of the pack
This pack contains an inhaler and capsules in blisters. Some packs also contain a sensor. The capsules are transparent and contain a white powder. The capsules have the product code “IGM150-50-160” printed in black over two black bands on the body of the capsule and a logo printed in black and surrounded by a black band on the cap of the capsule.
The following pack sizes are available:
Single pack containing 10 x 1, 30 x 1 or 90 x 1 hard capsules and 1 inhaler.
Pack containing 30 x 1 hard capsules, 1 inhaler and 1 sensor.
Multiple pack consisting of 15 cartons, each containing 10 x 1 hard capsules and 1 inhaler.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
APONTIS PHARMA Deutschland GmbH & Co. Novartis Pharma B.V.
KG Tel: +31 88 04 52 111
Tel: +49 2173 8955 4949

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Laboratorios Menarini, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 462 88 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Jaba Recordati, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 432 95 00

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Instructions for use of Enerzair Breezhaler

Before using the Enerzair Breezhaler inhaler, read these instructions for use completely.
These instructions are also available by scanning the QR code or visiting the website:
www.breezhaler-asthma.eu/enerzair
“QR code to be included”

Insert Pierce and release Inhale Check that the
deeply capsule is empty
2 3
Verification