Prospect: information for the user

Onbrez Breezhaler150micrograms powder for inhalation (hard capsule)

Onbrez Breezhaler 300micrograms powder for inhalation (hard capsule)

indacaterol

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should 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 or pharmacist, even if they do not appear in this prospect. See section 4.

1.What is Onbrez Breezhaler and how it is used

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

3.How to use Onbrez Breezhaler

4.Possible adverse effects

5.Storage of Onbrez Breezhaler

6.Contents of the package and additional information

What is Onbrez Breezhaler

Onbrez Breezhaler contains the active ingredient indacaterol which belongs to a group of medicines 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 for air to enter and leave.

What is Onbrez Breezhaler used for

Onbrez Breezhaler is used to help make breathing easier for adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles that surround the airways contract, making it difficult to breathe. This medicine relaxes these muscles in the lungs, making it easier for air to enter and leave.

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 starting to use Onbrez Breezhaler

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

During treatment with Onbrez Breezhaler,

• Stop using the medicine and inform your doctor immediatelyif you experience chest tightness, cough, rapid breathing or immediate difficulty breathing after using the medicine. These may be signs of a condition called bronchospasm.
• Inform your doctor immediatelyif your COPD symptoms (difficulty breathing, rapid breathing, cough) do not improve or worsen.

Children and adolescents

Onbrez Breezhalermust notbe administered tochildrenor adolescents under 18years of age.

Other medicines and Onbrez Breezhaler

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

Especially, inform your doctor if you are using:

• respiratory medicines similar to Onbrez Breezhaler (such as salmeterol and formoterol). You may be more likely to have side effects.
• medicines called beta-blockers used for high blood pressure or other heart problems (such as propranolol), or for a eye problem 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,
  • respiratory medicines such as theophylline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Onbrez Breezhaler unless your doctor tells you to.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

It is unlikely that Onbrez Breezhaler will affect your ability to drive and use machines.

Onbrez Breezhaler contains lactose

This medicine contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Amount of Onbrez Breezhaler to use

• The usual dose is to inhale the contents of one capsule every day. Your doctor will tell you if you should use the 150 microgram capsule or the 300 microgram capsule depending on your condition and how you respond to treatment. Do not use more than the amount indicated by your doctor.
• Use your inhaler at the same time every day, the effects last for 24 hours. This ensures that there is always enough medication 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 package, you will find an inhaler and capsules (in blister) containing the medication powder for inhalation. The Onbrez Breezhaler inhaler will allow you to inhale the medication contained in a capsule.
• Use the capsules only with the inhaler provided in this package (Onbrez Breezhaler inhaler). The capsules must be kept in the blister until you need to use them.
• When starting a new package, use the new Onbrez Breezhaler inhaler provided in the package.
• Dispose of 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 prospectus.

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, experience nausea, or vomit.

If you forgot to use Onbrez Breezhaler

If you forgot to inhale a dose, inhale one at the usual time the next day. Do not inhale a double dose to compensate for the missed doses.

How long to continue treatment with Onbrez Breezhaler

• Continue using your treatment with Onbrez Breezhaler for the time your doctor tells you.
• COPD is a long-term disease, and you must use Onbrez Breezhaler every day and not just when you have respiratory problems or other COPD symptoms.

Consult your doctor or pharmacist if you have 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.

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

Some side effects may be serious. Inform your doctor immediately

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

Other side effects may include:

Frequent 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 (inflammation of the sinuses)
• runny nose
• coughing
• sore throat
• headache
• dizziness
• palpitations
• muscle spasms
• swollen hands, ankles and feet (edema)
• itching/skin rash
• chest pain
• muscle, bone or joint pain

Infrequent 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 medicine. Coughing is a common symptom in asthma. 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 indicated.

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 the national notification system included in theAnnex V. By reporting side effects, you can contribute to providing more information about 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 on the blister after “EXP”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

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

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

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.

Composition ofOnbrez Breezhaler

• Cada capsule of 150micrograms of Onbrez Breezhaler contains 150micrograms of indacaterol as indacaterol maleate. The other components include lactose and gelatin capsule.
• Cada capsule of 300micrograms of Onbrez Breezhaler contains 300micrograms of indacaterol as indacaterol maleate. The other components include lactose and gelatin capsule.

Regarding Onbrez Breezhaler and packaging contents

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

• The capsules of 150micrograms of Onbrez Breezhaler have a product code “IDL150” printed inblackabove a black line and the company logo () printed inblackbelow the same.
• The capsules of 300micrograms of Onbrez Breezhaler have a product code “IDL300” printed inblueabove a blue line and the company logo () printed inbluebelow the same.

The following package sizes are available:

Carton containing 10capsules and 1inhaler.

Carton containing 30capsules and 1inhaler.

Multiple pack containing 2packs (each containing 30capsules and 1inhaler).

Multiple pack containing 3packs (each containing 30capsules and 1inhaler).

Multiple pack containing 30packs (each containing 10capsules and 1inhaler).

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublín 4

Irlanda

Responsible for Manufacturing

Novartis Farmacéutica SA

Ronda de Santa Maria 158

08210 Barberà del Vallès, Barcelona

España

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Alemania

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Date of the last review of this leaflet:

Other sources of information

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

INSTRUCTIONS FOR USE OF THE ONBREZ BREEZHALER INHALER