Zimbus Breezhaler

Patient Information Leaflet: Information for the User

Zimbus Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules

indacaterol/glycopyrronium/mometasone furoate

Please read all of this leaflet carefully before you start using this medicine, as 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 pass it on to other people, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

What Zimbus Breezhaler is and how it works
Zimbus 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 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 problems. Corticosteroids also help prevent asthma attacks.

What Zimbus Breezhaler is used for
Zimbus Breezhaler is used regularly as a treatment for asthma in adults.
Asthma is a serious, persistent lung disease in which the muscles surrounding the small airways in the lungs tighten (bronchoconstriction) and become inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness, and coughing.
You must use Zimbus Breezhaler every day, not only when you have breathing difficulties or other asthma symptoms. This will ensure adequate control of your asthma. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
If you have any questions about how Zimbus Breezhaler works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before using Zimbus Breezhaler

Follow your doctor's instructions carefully.
Do not use Zimbus 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, consult your doctor.

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

• if you have heart problems, including irregular or fast heartbeat;
• if you have thyroid gland problems;
• if you have been diagnosed with diabetes or have high blood sugar levels;
• if you suffer from epileptic seizures or convulsions;
• if you have severe kidney problems;
• if you have severe liver problems;
• if you have low potassium levels in your blood;
• if you have an eye condition called narrow-angle glaucoma;
• if you have difficulty urinating;
• if you have active or untreated pulmonary tuberculosis (TB), or any other long-standing or untreated infection.

During treatment with Zimbus 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 Zimbus 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, skin rash, itching, or hives (signs of an allergic reaction);
• eye pain or discomfort, temporary blurred vision, seeing halos (colored rings around lights), or colored vision, accompanied by red eyes (signs of an acute attack of narrow-angle glaucoma).

Children and adolescents
This medicine should 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 Zimbus 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 Zimbus 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 might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will advise you whether you can use Zimbus Breezhaler.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
Zimbus 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 Zimbus Breezhaler

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

• Zimbus Breezhaler is for inhalation 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 that pack.
• Dispose of the inhaler after using all capsules from each 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 Zimbus 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 you take the medicine.
• Your doctor will decide whether use of the sensor and App is appropriate for you.
• The electronic sensor for Zimbus Breezhaler must be attached to the base of the Zimbus Breezhaler inhaler.
• The sensor confirms that you have used the Zimbus Breezhaler inhaler by recording and monitoring actuations of the inhaler and the whistle sound of the capsule rotating during inhalation, but it does not monitor the actual intake of the medicine dose.
• The sensor must be used with the Propeller App, downloaded onto a smartphone or other compatible device. The sensor connects to the Propeller App via Bluetooth.
• For further information on how to use the Zimbus Breezhaler sensor and the App, read the

Instructions for use provided in the sensor packaging and in the App.

• When all capsules from a Zimbus Breezhaler package have been used, transfer the sensor to the new inhaler included in the next Zimbus Breezhaler package.

If symptoms do not improve
If asthma does not improve or worsens after starting treatment with Zimbus Breezhaler, consult your doctor.
If you use more Zimbus 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 Zimbus Breezhaler
If you have forgotten to inhale a dose at your usual time, inhale one as soon as possible on the same day. Then take the next dose the following day at your usual time. Do not inhale two doses on the same day.
If you stop treatment with Zimbus Breezhaler
Do not stop using Zimbus Breezhaler without consulting your doctor. Asthma symptoms may return if you stop using it.
If you have any questions about the use of this medicine, consult 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 can be serious
Stop using Zimbus 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 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 difficulty breathing and tightness in the chest with wheezing or coughing (asthma exacerbation)

Common: may affect up to 1 in 10 people

• oral thrush (sign of candidiasis). After using 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, stomach 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
• high blood sugar levels (hyperglycaemia)
• skin itching
• difficulty and pain when urinating (sign of dysuria)
• clouding of the eye's 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zimbus 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 just before use.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
• If the pack contains an electronic sensor for Zimbus 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 Zimbus 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 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 components of the capsule are monohydrate lactose and magnesium stearate (see “Zimbus 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 Zimbus Breezhaler and package contents
This pack contains an inhaler and capsules in blister packs. 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 above two black bands on the body of the capsule, and a logo printed in black 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 about 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
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
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 Gebro Pharma, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 205 86 86 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 499 7400
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 Zimbus Breezhaler

Before using the Zimbus Breezhaler inhaler, read these instructions for use completely.

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

Step 1a: Step 2a: Step 3a: Check that the capsule
Remove the cap Puncture the capsule once Exhale is empty
completely Open the inhaler to
Hold the inhaler in an Do not blow into the see if any powder remains upright position. mouthpiece. in the capsule.
Puncture the capsule by
pressing firmly on both If powder remains in the
side buttons capsule:
simultaneously • close the inhaler.
• repeat steps 3a to 3d.

When the capsule is
punctured, you should hear a
With powder Empty
clicking sound.
Puncture the capsule only
once.

Step 1b: Step 3b:
Open the inhaler Inhale the 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.
Step 2b:
Release the side buttons

Inhale as quickly and
deeply as possible.
During inhalation, you will
hear a humming sound.
You may taste the medicine
when inhaling.

Step 1c: Remove the empty capsule
Remove the capsule Discard the empty capsule
Separate one blister cavity into household waste.
from the rest of the strip. Close the inhaler and
Peel off the protective replace the cap.
foil from the cavity and
remove the capsule.
Do not push the capsule
through the foil.
Do not swallow the capsule.
Step 3c:
Hold your breath
Hold your breath for up to
5 seconds.
Step 3d:
Rinse your mouth
After each dose, rinse your
mouth with water and spit.

Important information

• Zimbus Breezhaler capsules must always be stored in the blister and only removed immediately before use. Never insert the
• Do not push the capsule capsule directly into the mouthpiece to remove it from the blister.
• Do not swallow the capsule.

• Do not use Zimbus Breezhaler capsules with any other inhaler.
• Do not use the Zimbus Breezhaler inhaler for any other medicine capsules.
• Never place the capsule in your mouth or into the inhaler's mouthpiece.
• 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 the capsules with wet hands.
• Never wash the inhaler with water.

The Zimbus Breezhaler package contains: Frequently asked questions How to clean the inhaler

• one Zimbus Breezhaler inhaler; Wipe the outside and
• one or more blisters, each containing Why didn’t the inhaler make the inside of the mouthpiece a sound when I inhaled?** with a clean, dry, lint-free 10 Zimbus Breezhaler capsules for use with the inhaler. cloth to remove any powder residue.

The capsule may become stuck in the chamber. If this happens, gently tap the base of the inhaler to loosen the capsule. Inhale the medicine again by repeating steps 3a to 3d.
Disposal
What should I do if powder of the inhaler after use
remains in the capsule? After all capsules have been
You did not receive a full dose used, the inhaler should be of medicine. discarded. Ask your pharmacist for advice on how to dispose of unused medicines and inhalers.
I coughed after inhalation – what does this mean?
This may happen.
As long as the capsule is
empty, you have received a
sufficient dose of medicine.
I felt small pieces of the
capsule on my tongue – what does this mean?
This may happen. It is not
harmful. The likelihood of the
capsule breaking into small
pieces increases if the
capsule is punctured more
than once.