Prospect: information for the user

Hirobriz Breezhaler 150 micrograms powder for inhalation (hard capsule)

Hirobriz Breezhaler 300 micrograms powder for inhalation (hard capsule)

indacaterol

Read this prospect carefully before starting to use this medicine, 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 medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

What is Hirobriz Breezhaler

Hirobriz 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 Hirobriz Breezhaler used for

Hirobriz 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 hard to breathe. This medicine relaxes these muscles in the lungs, making it easier for air to enter and leave.

Do not use Hirobriz Breezhaler

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use 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 (hyperthyroidism).
• if you have diabetes.

During treatment with Hirobriz Breezhaler,

• Stop using the medication and inform your doctor immediatelyif you experience chest tightness, cough, rapid breathing, or difficulty breathing immediately after using the medication. 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

Hirobriz Breezhalershould not beadministered tochildren or adolescents under 18 years of age.

Other medications and Hirobriz Breezhaler

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

Especially, inform your doctor if you are using:

• respiratory medications similar to Hirobriz Breezhaler (such as salmeterol and formoterol). You may be more likely to experience adverse effects.
• beta-blockers used for high blood pressure or other heart problems (such as propranolol), or for a condition called glaucoma (such as timolol).
• medications 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 medications 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 medication.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Hirobriz Breezhaler is unlikely to affect your ability to drive and operate machinery.

Hirobriz Breezhaler contains lactose

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

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 Hirobriz Breezhaler to use

• The usual dose is to inhale the contents of a 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 Hirobriz Breezhaler

• In this package, you will find an inhaler and capsules (in blister packs) containing the medication powder for inhalation. The Hirobriz Breezhaler inhaler will allow you to inhale the medication contained in a capsule.
• Use the capsules only with the inhaler provided in this package (Hirobriz Breezhaler inhaler). The capsules must be kept in the blister pack until you need to use them.
• When starting a new package, use the new Hirobriz 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 leaflet.

If you use more Hirobriz Breezhaler than you should

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

If you forgot to use Hirobriz 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 you should continue your treatment with Hirobriz Breezhaler

• Continue using your treatment with Hirobriz Breezhaler for the time your doctor tells you.
• COPD is a long-term disease, and you must use Hirobriz Breezhalerevery dayand 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 Hirobriz Breezhaler.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Some side effects can be serious. Inform your doctor immediately

• If you have a squeezing pain in the chest (frequent).
• If you have high levels of sugar in the blood (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, urticaria, 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 10 patients)

• Flu-like symptoms. You may have all or most of the following effects: sore throat, runny nose, stuffy nose, sneezing, coughing, headache.

Frequent side effects (may affect up to 1 in 10 patients)

• Sensation 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
• Pain in the muscles, bones or joints

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

• Fast heart rate
• Tickling 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 thenational notification system included in theApédiceV. 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 at a temperature above 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 packaging is damaged or shows signs of deterioration.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and of the medications that you no longer need. In this way, you will help protect the environment.

Composition of Hirobriz Breezhaler

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

Appearance of Hirobriz Breezhaler and contents of the package

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

• The 150 micrograms capsules of Hirobriz Breezhaler have a product code

“IDL 150” printed inblackabove a black lineand the company logo ()printed inblackbelow the same.

• The 300 micrograms capsules of Hirobriz Breezhaler have a product code“IDL 300” printed inblueabove a blue lineand the company logo ()printed inbluebelow the same.

The following package sizes are available:

Carton containing 10 capsules and 1 inhaler. Carton containing 30 capsules and 1 inhaler.

Multiple pack containing 2 packages (each containing 30 capsules and 1 inhaler). Multiple pack containing 3 packages (each containing 30 capsules and 1 inhaler). Multiple pack 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

Responsible for manufacturingNovartis 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:

Last update 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 INHALER OF HIROBRIZ BREEZHALER

Read the complete Instructions for Use before using Hirobriz Breezhaler.