Prospecto: information for the user

Zimbus Breezhaler 114micrograms/46micrograms/136microgramspowder for inhalation (hard capsule)

indacaterol/glycopirronio/furoate of mometasone

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

1. What isZimbus Breezhalerand for what it is used

2. What you need to know before starting to useZimbus Breezhaler

3. How to useZimbus Breezhaler

4. Possible adverse effects

5. Storage ofZimbus Breezhaler

6. Contents of the package and additional information

Instructions for use of the Zimbus Breezhaler inhaler

What is Zimbus Breezhaler and how it works

Zimbus Breezhaler contains three active ingredients:

• indacaterol
• glycopyrrolate
• mometasone furoate

Indacaterol and glycopyrrolate belong to a group of medications called bronchodilators. They act in different ways to relax the muscles of the small airways in the lungs. This helps to open the airways and facilitate the entry and exit of air from the lungs. When used regularly, they help to keep the small airways of the lungs open.

Mometasone furoate belongs to a group of medications called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) of the small airways in the lungs and thereby gradually alleviate respiratory problems. Corticosteroids also help to prevent asthma attacks.

What is Zimbus Breezhaler used for

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

Asthma is a chronic severe lung disease in which the muscles surrounding the smallest airways constrict (bronchoconstriction) and become inflamed. Symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing.

You should use Zimbus Breezhaler every day as instructed by your doctor and not just when you have respiratory problems or other asthma symptoms. This will ensure proper control of your asthma. Do not use this medication to relieve a sudden attack of choking or wheezing.

Consult your doctor if you have any doubts about how Zimbus Breezhaler works or why you have been prescribed this medication.

Follow all of your doctor's instructions carefully.

Do not use Zimbus Breezhaler

• if you are allergic to indacaterol, glycopyrronium, mometasone furoate, or any of the other components of this medication (listed in section6). If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nursebeforeusing Zimbus Breezhaler if any of the following situations apply to you:

• if you have heart problems, including rapid 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 attacks,
• 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 type of eye disorder called closed-angle glaucoma,
• if you have difficulty urinating,
• if you havelung tuberculosis (TB)or any other infection that has not been treated.

During treatment with Zimbus Breezhaler

Stop using this medication and seek medical help immediatelyif you experience any of the following situations:

• chest tightness, cough, wheezing, or immediate difficulty breathing after using Zimbus Breezhaler (signs of unexpected narrowing of 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, temporary blurred vision, halos around lights, or colored images associated with eye redness (signs of a narrow-angle glaucoma attack).

Children and adolescents

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

Other medications and Zimbus Breezhaler

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. In particular, inform your doctor or pharmacist if you are using:

• medications that decrease 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 xanthines used for respiratory disorders (e.g. theophylline) or corticosteroids (e.g. prednisolone).
• tricyclic antidepressants or monoamine oxidase inhibitors (medications used to treat depression).
• any medication that may be similar to Zimbus Breezhaler (containing active substances similar to indacaterol); since their concurrent use may increase the risk of adverse effects.
• beta-blockers that may be used to treat high blood pressure or other heart problems (such as propranolol), or to treat glaucoma (e.g. timolol).
• ketoconazole or itraconazole (medications used to treat fungal infections).
• ritonavir, nelfinavir, or cobicistat (medications used to treat HIV infection).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Your doctor will inform you if you can use Zimbus Breezhaler.

Driving and operating machinery

This medication is unlikely toaffect your ability to drive and operate machinery.

Zimbus Breezhaler contains lactose

This medication contains approximately25mg of lactose per capsule.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount of Zimbus Breezhaler to inhale

The usual dose is to inhale the contents of one capsule every day. You only need to inhale the medication once a day. Do not use more doses than indicated by your doctor.

You must use Zimbus Breezhaler every day, even if you do not feel discomfort due to asthma.

When to inhale Zimbus Breezhaler

Inhale Zimbus Breezhalerat the same time every day.This will help you control your symptoms throughout the day and night. It will also help you remember to use it.

How to inhaleZimbus Breezhaler

• Zimbus Breezhaleris for inhalation use..
• In this package, you will find an inhaler and capsules containing the medication. The inhaler allows you to inhale the medication from the capsule. Use the capsules only with the inhaler provided in this package. The capsules must be kept in the blister pack until you need to use them.
• Remove the foil from the blister pack to open it,do not press the capsule through the foil.
• When starting a new package, use the new inhaler provided in the package.
• Dispose of the inhaler from each package 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 package contains a sensor for Zimbus Breezhaler

• The sensor and the application are not necessary for you to administer your medication. It is not necessary to connect the sensor to the application when using your medication.
• Your doctor will decide if the use of the sensor and the application is suitable for you.
• The electronic sensor for Zimbus Breezhaler connects to the base of the Zimbus Breezhaler inhaler.
• The sensor confirms that you have used the Zimbus Breezhaler inhaler by recording and monitoring the actions and noise produced by the capsule as it turns during inhalation, but it does not monitor whether you have received your medication dose.
• The sensor should be used with the Propeller application on your mobile phone or any other suitable device. The sensor connects to the Propeller application via Bluetooth.
• For more information on how to use the sensor for Zimbus Breezhaler and the application, please read the usage instructions provided in the package with the sensor and application.
• Once you have used all the Zimbus Breezhaler capsules from a package, transfer the sensor to the new inhaler in the next Zimbus Breezhaler package.

If your symptoms do not improve

If your asthma does not improve or even worsens after starting to use Zimbus Breezhaler, consult your doctor.

If you use more Zimbus Breezhalerthan you should

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

If you forget to use Zimbus Breezhaler

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

If you interrupt treatment with Zimbus Breezhaler

Do not stop using Zimbus Breezhaler unless your doctor tells you to. Your asthma symptoms may reappear if you stop using it.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

Stop using Zimbus Breezhaler and seek medical help immediately if you experience any of the following:médicainmediately

Frequent:can affect up to 1 in 10people

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

Other side effects

The following are other side effects. If these side effects become severe, please consult your doctor, pharmacist, or nurse.

Very frequent:can affect more than 1 in 10people

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

Frequent:can affect up to 1 in 10people

• oral ulcers (signs of candidiasis). After inhaling your dose, rinse your mouth with water or a mouthwash solution and spit. This will help prevent ulcers.
• urgent need to urinate and pain or burning while urinating (signs of urinary tract infection)
• headache
• rapid heart rate
• cough
• voice alteration (hoarseness)
• diarrhea, abdominal cramps, nausea, and vomiting (gastroenteritis)
• muscle, bone, or joint pain (signs of musculoskeletal pain)
• muscle spasms
• fever

Rare:can affect up to 1 in 100people.

• dry mouth
• skin rash
• high blood sugar levels
• itching
• difficulty and pain while urinating (signs of dysuria)
• clouding of your eye lenses (signs of cataract)

Reporting side effects

If you experience any type of side effect, consult your doctor,pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theAppendix Vnational notification system included in theMediante the communication of side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and the blister pack after «CAD»/«EXP». The expiration date is the last day of the month indicated.
• Do not store at a temperature 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 through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
• If your container contains an electronic sensor for Zimbus Breezhaler, please refer to the usage instructions provided with the sensor container for detailed instructions on how to store it and when to dispose of it.

Composition of Zimbus Breezhaler

• The active principles are indacaterol (as acetate), glycopyrrolate (as bromide), and mometasone furoate..Each capsule contains 150micrograms of indacaterol (as acetate), 63micrograms of bromide of glycopyrrolate (equivalent to 50micrograms of glycopyrrolate) and 160micrograms of mometasone furoate. Each released dose (the dose that releases from the inhaler mouthpiece) contains 114micrograms of indacaterol (as acetate), 58micrograms of bromide of glycopyrrolate (equivalent to 46micrograms of glycopyrrolate) and 136micrograms of mometasone furoate.
• The other components are lactose monohydrate and magnesium stearate (see the section “Zimbus Breezhaler contains lactose” in section 2).

Appearance of the productand contents of the pack

In this pack, you will find an inhaler together with capsules in blisters. Some packs 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 pack sizes are available:

Single pack containing 10x1, 30x1 or 90x1capsules, together with 1inhaler.

Pack containing 30x1capsule, together with 1inhaler and 1sensor

Multiple packs containing 15 boxes, each with 10x1capsules together with 1inhaler.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublín 4

Irlanda

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

España

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nüremberg

Alemania

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for use of the Zimbus Breezhaler inhaler

Please read the complete Instructions for Use of the Zimbus Breezhaler inhaler before use.