ONBREZ BREEZHALER 300 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 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Onbrez Breezhaler is and what it is used for
2. What you need to know before you use Onbrez Breezhaler
3. How to use Onbrez Breezhaler
4. Possible side effects
5. Storing Onbrez Breezhaler
6. Contents of the pack and other 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 medicines called bronchodilators. When inhaled, it relaxes the muscles 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 help adults who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles around the airways tighten, making it harder to breathe. This medicine relaxes these muscles in the lungs, making it easier to breathe in and out.

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

Do not use Onbrez Breezhaler

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

Warnings and precautions

Consult your doctor or pharmacist before you start using 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 problems (thyrotoxicosis).
• if you have diabetes.

During treatment with Onbrez Breezhaler,

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

Children and adolescents

Onbrez Breezhaler must notbe given to childrenor adolescents under 18years of age.

Other medicines and Onbrez Breezhaler

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

Especially, tell your doctor if you are using:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Do not use Onbrez Breezhaler unless your doctor tells you to.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

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

Onbrez Breezhaler contains lactose

This medicine contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to use Onbrez Breezhaler

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

How much Onbrez Breezhaler to use

• The usual dose is to inhale the contents of one capsule each day. Your doctor will tell you whether to use the 150 microgram or 300 microgram capsule, depending on your condition and how you respond to treatment. Do not use more than the dose your doctor has told you.
• Use your inhaler at the same time each day, the effects last for 24 hours. This will ensure that you always have enough medicine in your body 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 pack, you will find an inhaler and capsules (in a blister pack) that contain the medicine in powder form for inhalation. The Onbrez Breezhaler inhaler will allow you to inhale the medicine contained in one capsule.
• Use the capsules only with the inhaler provided in this pack (Onbrez Breezhaler inhaler). The capsules should be kept in the blister pack until you need to use them.
• When you start a new pack, use the new Onbrez Breezhaler inhaler provided in the pack.
• 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 leaflet.

If you use more Onbrez Breezhaler than you should

If you have inhaled too much Onbrez Breezhaler or if someone has used your capsules, tell your doctor immediately or go to the nearest emergency room. Show the Onbrez Breezhaler pack. Medical attention may be needed. 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 to continue treatment with Onbrez Breezhaler

• Continue using your treatment with Onbrez Breezhaler for as long as your doctor tells you.
• 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.

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

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. Tell 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 10 patients)

• 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 10 patients)

• 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 the muscles, bones, or joints

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

• fast heartbeat
• tingling or numbness
• muscle pain

Some people may occasionally cough shortly after inhaling the medicine. Coughing is a common symptom in COPD. If you experience coughing shortly after inhaling the medicine, 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 instructed.

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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Onbrez 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 on the blister after “EXP”. The expiry date is the last day of the month stated.

Do not store above 30°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package 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.

Appearance of Onbrez Breezhaler and Package Contents

In this package, 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 package sizes are available:

Carton containing 10 capsules and 1 inhaler.

Carton containing 30 capsules and 1 inhaler.

Multiple package containing 2 packages (each containing 30 capsules and 1 inhaler).

Multiple package containing 3 packages (each containing 30 capsules and 1 inhaler).

Multiple package containing 30 packages (each containing 10 capsules and 1 inhaler).

Not all package 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 medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER