ONBREZ BREEZHALER 150 micrograms INHALATION POWDER (HARD CAPSULE)

Introduction

Package Leaflet: Information for the User

Onbrez Breezhaler150micrograms inhalation powder (hard capsule)

Onbrez Breezhaler 300microgramsinhalation powder (hard capsule)

indacaterol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Onbrez Breezhaler is and what it is used for
2. What you need to know before starting to use Onbrez Breezhaler
3. How to use Onbrez Breezhaler
4. Possible side effects
5. Storage of Onbrez Breezhaler
6. Package contents and additional information

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

What Onbrez Breezhaler is

Onbrez Breezhaler contains the active substance indacaterol, which belongs to a group of medications called bronchodilators. When inhaled, it relaxes the muscles of the walls of the small airways in the lungs. This helps to open up the airways, making it easier to breathe in and out.

What Onbrez Breezhaler is used for

Onbrez Breezhaler is used to facilitate breathing in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles surrounding the airways contract, making breathing difficult. This medication relaxes these muscles in the lungs, making it easier to breathe in and out.

2. What you need to know before starting to use Onbrez Breezhaler

Do not use Onbrez Breezhaler

• if you are allergic to indacaterol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Onbrez Breezhaler

• if you have asthma (in this case, you should not use Onbrez Breezhaler).
• if you have heart problems.
• if you have epilepsy.
• if you have thyroid gland problems (thyrotoxicosis).
• if you have diabetes.

During treatment with Onbrez Breezhaler,

• Stop using the medication and inform your doctor immediatelyif you notice chest tightness, coughing, wheezing, or difficulty breathing immediately after using the medication. These may be signs of a condition called bronchospasm.
• Inform your doctor immediatelyif your COPD symptoms (difficulty breathing, wheezing, coughing) do not improve or worsen.

Children and adolescents

Onbrez Breezhaler should notbe administered to childrenor adolescents under 18years of age.

Other medications and Onbrez Breezhaler

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

Especially, inform your doctor if you are using:

• medications for respiratory problems that are similar to Onbrez Breezhaler (i.e., medications such as salmeterol and formoterol). You may be more likely to experience side effects.
• medications called beta-blockers that are used for high blood pressure or other heart problems (such as propranolol), or for a eye problem called glaucoma (such as timolol).
• medications that decrease the amount of potassium in the blood. These include:
• • corticosteroids (e.g., prednisolone),
  • diuretics used for high blood pressure, such as hydrochlorothiazide,
  • medications for respiratory problems such as theophylline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Onbrez Breezhaler unless your doctor advises you to.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Onbrez Breezhaler contains lactose

This medication contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to use Onbrez Breezhaler

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Amount of Onbrez Breezhaler to use

• The usual dose is to inhale the contents of one capsule each day. Your doctor will indicate whether you should use the 150 microgram or 300 microgram capsule, depending on your condition and response to treatment. Do not use more than the amount indicated by your doctor.
• Use your inhaler at the same time each day, the effects last for 24 hours. This ensures that you always have enough medication in your system to help you breathe more easily throughout the day and night. It will also help you remember to use it.

How to use Onbrez Breezhaler

• In this package, you will find an inhaler and capsules (in blister packs) that contain the medication in powder form for inhalation. The Onbrez Breezhaler inhaler will allow you to inhale the medication contained in one capsule.
• Use the capsules only with the inhaler provided in this package (Onbrez Breezhaler inhaler). The capsules should be kept in the blister pack until you need to use them.
• When starting a new package, use the new Onbrez Breezhaler inhaler provided in the package.
• Discard the inhaler once all the capsules have been used.
• Do not swallow the capsules.
• For more information on how to use the inhaler, read the instructions at the end of this package leaflet.

If you use more Onbrez Breezhaler than you should

If you have inhaled too much Onbrez Breezhaler or if someone uses your capsules, inform your doctor immediately or go to the nearest emergency center. Show the Onbrez Breezhaler package. Medical attention may be necessary. You may notice that your heart beats faster than normal, or you may have a headache, feel drowsy, nauseous, or vomit.

If you forget to use Onbrez Breezhaler

If you forget to inhale a dose, inhale one at the usual time the next day. Do not inhale a double dose to make up for forgotten doses.

How long you should continue your treatment with Onbrez Breezhaler

• Continue using your treatment with Onbrez Breezhaler for the time indicated by your doctor.
• COPD is a long-term disease, and you should use Onbrez Breezhaler every dayand not just when you have breathing problems or other COPD symptoms.

Consult your doctor or pharmacist if you have any doubts about how long you should continue your treatment with Onbrez Breezhaler.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious. Inform your doctor immediately

• if you have chest pain (frequent).
• if you have high blood sugar levels (diabetes). You will feel tired, very thirsty, and hungry (without gaining weight) and urinate more than usual (frequent).
• if you have irregular heartbeats (uncommon).
• if you have symptoms of an allergic reaction such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
• if you have difficulty breathing with wheezing or coughing (uncommon).

Other side effects may include:

Very common side effects (may affect more than 1 in 10patients)

• flu-like symptoms. You may have all or most of the following effects: sore throat, runny nose, stuffy nose, sneezing, coughing, headache.

Common side effects (may affect up to 1 in 10patients)

• feeling of pain or pressure in the cheeks and forehead (sinusitis)
• runny nose
• coughing
• sore throat
• headache
• dizziness
• palpitations
• muscle spasms
• swelling of hands, ankles, and feet (edema)
• itching/skin rash
• chest pain
• pain in muscles, bones, or joints

Uncommon side effects (may affect up to 1 in 100patients)

• rapid heartbeat
• tingling or numbness
• muscle pain

Some people may occasionally cough shortly after inhaling the medication. Coughing is a common symptom in COPD. If you experience coughing shortly after inhaling the medication, do not worry. Check your inhaler to see if the capsule is empty and that you have received the full dose. If the capsule is empty, there is no need to worry. If the capsule is not empty, inhale again as indicated.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Onbrez Breezhaler

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package and blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture and do not remove until just before use.

Do not use this medication if you notice that the package is damaged or shows signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Contents and Additional Information

Composition ofOnbrez Breezhaler

• Each 150 microgram Onbrez Breezhaler capsule contains 150 micrograms of indacaterol as indacaterol maleate. The other ingredients include lactose and the gelatin capsule.
• Each 300 microgram Onbrez Breezhaler capsule contains 300 micrograms of indacaterol as indacaterol maleate. The other ingredients include lactose and the gelatin capsule.

Aspect of Onbrez Breezhaler and Container Contents

In this container, you will find an inhaler, along with capsules in a blister pack. The capsules are transparent (colorless) and contain a white powder.

• The 150 microgram Onbrez Breezhaler capsules have a product code “IDL150” printed in blackabove a blackline and the company logo () printed in blackbelow it.
• The 300 microgram Onbrez Breezhaler capsules have a product code “IDL300” printed in blueabove a blueline and the company logo () printed in bluebelow it.

The following container sizes are available:

Carton containing 10 capsules and 1 inhaler.

Carton containing 30 capsules and 1 inhaler.

Multiple container that contains 2 containers (each containing 30 capsules and 1 inhaler).

Multiple container that contains 3 containers (each containing 30 capsules and 1 inhaler).

Multiple container that contains 30 containers (each containing 10 capsules and 1 inhaler).

Not all container sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica SA

Ronda de Santa Maria 158

08210 Barberà del Vallès, Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

You can request more information about this medication 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 drug is available on the European Medicines Agency website: http://www.ema.europa.eu

INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER