HIROBRIZ BREEZHALER 300 micrograms INHALATION POWDER (HARD CAPSULE)

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 this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

What is Hirobriz Breezhaler

Hirobriz 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 Hirobriz Breezhaler is used for

Hirobriz 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 contract, making it difficult 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 start using Hirobriz Breezhaler

Do not use Hirobriz Breezhaler

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

Warnings and precautions

Talk to your doctor or pharmacist before you start using Hirobriz Breezhaler

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

During treatment with Hirobriz 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

Hirobriz Breezhaler must notbe given to children or adolescents under 18 years of age.

Other medicines and Hirobriz 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 Hirobriz 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.

You should not use Hirobriz Breezhaler unless your doctor tells you to.

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

Driving and using machines

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

Hirobriz Breezhaler contains lactose

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

3. How to use Hirobriz Breezhaler

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor or pharmacist again.

How much Hirobriz 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 micrograms or 300 micrograms 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 Hirobriz 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 Hirobriz Breezhaler inhaler will allow 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 be kept in the blister pack until you need to use them.
• When you start a new pack, use the new Hirobriz 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 package leaflet.

If you use more Hirobriz Breezhaler than you should

If you have inhaled too much Hirobriz Breezhaler or if someone uses your capsules, tell your doctor immediately or go to the nearest emergency room. Show the Hirobriz 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 Hirobriz 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 Hirobriz Breezhaler

• Continue using your treatment with Hirobriz Breezhaler for as long as your doctor tells you.
• COPD is a long-term disease and you should use Hirobriz 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 Hirobriz 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 (common).
• if you have high blood sugar levels (diabetes). You will feel tired, very thirsty, and hungry (without gaining weight) and urinate more than usual (common).
• 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 people)

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

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

• feeling of pain or pressure in the cheeks and forehead (sinusitis)
• runny nose
• cough
• 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 people)

• 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 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and blister pack 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 immediately before use. Do not use this medicine if you notice 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

Hirobriz Breezhaler Composition

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

Appearance of Hirobriz 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 Hirobriz Breezhaler capsules have a product code

"IDL 150" printed in blackabove a blackline and the company logo () printed in blackbelow it.

• The 300 microgram Hirobriz Breezhaler capsules have a product code "IDL 300" 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).

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited Vista Building

Elm Park, Merrion Road Dublin 4

Ireland

ManufacturerNovartis 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

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

HIROBRIZ BREEZHALER INHALER INSTRUCTIONS FOR USE

Read the complete Instructions for Use before using Hirobriz Breezhaler.