Onbrez Breezhaler 300 micrograms inhalation powder (hard capsule)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Onbrez Breezhaler 150 micrograms inhalation powder (hard capsule)

Onbrez Breezhaler 300 micrograms inhalation powder (hard capsule)

indacaterol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Onbrez Breezhaler is and what it is used for
2. What you need to know before using Onbrez Breezhaler
3. How to use Onbrez Breezhaler
4. Possible side effects
5. How to store 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 in the walls of the small airways of the lungs. This helps to open up the airways, making it easier for air to flow in and out.

What Onbrez Breezhaler is used for

Onbrez Breezhaler is used to help 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 medicine relaxes those muscles in the lungs, making it easier for air to move in and out.

2. What you need to know before using Onbrez Breezhaler

Do not use Onbrez Breezhaler

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

Warnings and precautions

Talk to 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 gland problems (thyrotoxicosis).
• if you have diabetes.

During treatment with Onbrez Breezhaler,

• Stop using the medicine and contact your doctor immediately if you experience chest tightness, cough, wheezing, or difficulty breathing right after using the medicine. These may be signs of a condition called bronchospasm.
• Contact your doctor immediately if your COPD symptoms (difficulty breathing, wheezing, cough) do not improve or worsen.

Children and adolescents

Onbrez Breezhaler must not be given to children or adolescents under 18 years of age.

Other medicines and Onbrez Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, tell your doctor if you are taking:

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

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Onbrez Breezhaler is unlikely to affect your ability to drive or operate machinery.

Onbrez Breezhaler contains lactose

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

3. How to use Onbrez Breezhaler

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Amount of Onbrez Breezhaler that you should use

• The usual dose is to inhale the contents of one capsule every day. Your doctor will determine whether 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 prescribed by your doctor.
• Use your inhaler at the same time each day, as the effects last for 24 hours. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you remember to take it.

How to use Onbrez Breezhaler

• In this package, you will find an inhaler and capsules (in blister packs) containing the medicine as a powder for inhalation. The Onbrez Breezhaler inhaler allows you to inhale the medicine contained in one capsule.
• Use the capsules only with the inhaler provided in this package (Onbrez Breezhaler inhaler). The capsules should remain in the blister until you are ready to use them.
• When starting a new package, use the new Onbrez Breezhaler inhaler provided in the package.
• Dispose of the inhaler once all 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 else uses your capsules, inform your doctor immediately or go to the nearest emergency department. Show the Onbrez Breezhaler package. Medical attention may be required. You may notice that your heart beats faster than normal, or you may experience headache, drowsiness, nausea, or vomiting.

If you forget to use Onbrez Breezhaler

If you forget to inhale a dose, inhale one at your usual time the following day. Do not inhale a double dose to make up for a missed dose.

How long you should continue treatment with Onbrez Breezhaler

• Continue using Onbrez Breezhaler for as long as your doctor prescribes.
• COPD is a long-term condition, and you must use Onbrez Breezhaler every day, not only when you have breathing difficulties or other COPD symptoms.

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

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

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

Some adverse effects may be serious. Inform your doctor immediately if:

• you have a tight feeling in the chest (frequent).
• 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).
• you have irregular heartbeat (uncommon).
• you have symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
• you have difficulty breathing with wheezing or coughing (uncommon).

Other adverse effects may include:

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

• flu-like symptoms. You may experience all or most of the following: sore throat, runny nose, nasal congestion, sneezing, cough, headache.

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

• feeling of pain or pressure in the cheeks and forehead (sinus inflammation)
• runny nose
• cough
• sore throat
• headache
• dizziness
• palpitations
• muscle spasm
• swollen hands, ankles and feet (edema)
• itching/rash
• chest pain
• pain in muscles, bones or joints

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

• rapid heartbeat
• tingling or numbness
• muscle pain

Occasionally, some people may 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 cause for concern. If the capsule is not empty, inhale again as directed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V.

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

5. Storage of Onbrez Breezhaler

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Onbrez Breezhaler

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

Appearance of Onbrez Breezhaler and contents of the pack

This pack contains an inhaler together with capsules in blister packs. The capsules are transparent (colourless) and contain a white powder.

• The 150 microgram capsules of Onbrez Breezhaler have the product code “IDL150” printed in black above a black line and the company logo () printed in black below the same line.
• The 300 microgram capsules of Onbrez Breezhaler have the product code “IDL300” printed in blue above a blue line and the company logo () printed in blue below the same line.

The following pack sizes are available:

Carton pack containing 10 capsules and 1 inhaler.

Carton pack containing 30 capsules and 1 inhaler.

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on 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