Hirobriz Breezhaler 300 micrograms powder for inhalation (hard capsule)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hirobriz Breezhaler 150 micrograms inhalation powder (hard capsule)

Hirobriz Breezhaler 300 micrograms inhalation powder (hard capsule)

indacaterol

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

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

Leaflet contents

1. What Hirobriz Breezhaler is and what it is used for
2. What you need to know before using Hirobriz Breezhaler
3. How to use Hirobriz Breezhaler
4. Possible adverse effects
5. How to store Hirobriz Breezhaler
6. Contents of the pack and other information

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

What Hirobriz Breezhaler is

Hirobriz 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 air passages, making it easier for air to flow in and out.

What Hirobriz Breezhaler is used for

Hirobriz Breezhaler is used to help breathing in adult patients who have difficulty breathing due to a lung disease known as chronic obstructive pulmonary disease (COPD). In COPD, the muscles around the airways tighten, making breathing difficult. This medicine relaxes those muscles in the lungs, allowing air to flow in and out more easily.

2. What you need to know before using Hirobriz Breezhaler

Do not use Hirobriz 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 Hirobriz Breezhaler

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

During treatment with Hirobriz Breezhaler,

• Stop using the medicine and tell 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.
• Tell your doctor immediately if your COPD symptoms (difficulty breathing, wheezing, cough) do not improve or get worse.

Children and adolescents

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

Other medicines and Hirobriz 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 Hirobriz 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 eyes 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 Hirobriz Breezhaler unless your doctor tells you to do so.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Hirobriz Breezhaler will affect your ability to drive or operate machinery.

Hirobriz Breezhaler contains lactose

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

3. How to use Hirobriz Breezhaler

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

Amount of Hirobriz Breezhaler that you should use

• The usual dose is to inhale the contents of one capsule daily. Your doctor will tell you 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. 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 Hirobriz Breezhaler

• This pack contains an inhaler and capsules (in blister packs) containing the medicine as a powder for inhalation. The Hirobriz Breezhaler inhaler allows you to inhale the medicine contained in one capsule.
• Use the capsules only with the inhaler provided in this pack (Hirobriz Breezhaler inhaler). The capsules should remain in the blister until you are ready to use them.
• When starting a new pack, use the new Hirobriz Breezhaler inhaler provided in the pack.
• 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 Hirobriz Breezhaler than you should

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

If you forget to use Hirobriz Breezhaler

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

How long you should continue treatment with Hirobriz Breezhaler

• Continue your treatment with Hirobriz Breezhaler for as long as your doctor tells you to.
• COPD is a long-term condition and you must use Hirobriz Breezhaler every day, not only when you have breathing problems or other COPD symptoms.

Consult your doctor or pharmacist if you have any questions about how long you should continue treatment with Hirobriz 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 heartbeats (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 people)

• 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 people)

• 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 people)

• 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 adverse effects, 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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hirobriz 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.

Keep 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hirobriz Breezhaler

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

Appearance of Hirobriz Breezhaler and contents of the pack

In this pack, you will find a inhaler together with capsules in blister packs. The capsules are transparent (colourless) and contain a white powder.

• The 150 microgram Hirobriz Breezhaler capsules have a product code "IDL 150" printed in black above a black line, and the company logo () printed in black below the same line.

• The 300 microgram Hirobriz Breezhaler capsules have a product code "IDL 300" 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 containing 10 capsules and 1 inhaler. Carton 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 some pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer responsible for production
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 further information regarding this medicinal product, 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 HIROBRIZ BREEZHALER INHALER

Read the complete Instructions for Use before using Hirobriz Breezhaler.