Hirobriz Breezhaler

Package leaflet: Information for the user

Hirobriz Breezhaler 150 micrograms powder for inhalation, hard capsules, 300 micrograms powder for inhalation, hard capsules

indacaterol
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Hirobriz Breezhaler is and what it is used for
2. What you need to know before taking Hirobriz Breezhaler
3. How to take Hirobriz Breezhaler
4. Possible side effects
5. How to store Hirobriz Breezhaler
6. Contents of the pack and other 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 in the walls of the small
airways of the lungs. This helps to open up the airways, making breathing easier.
What Hirobriz Breezhaler is used for
Hirobriz Breezhaler is used to help breathing in adult patients who have difficulty breathing due to a chronic lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles around the airways tighten. This makes breathing difficult. This medicine relaxes the muscles in the lungs, making it easier for air to flow in and out of the lungs.

2. What you should know before taking Hirobriz Breezhaler

Do not take 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 taking Hirobriz Breezhaler

• if you suffer from asthma (in this case you must not use Hirobriz Breezhaler);
• if you have heart problems;
• if you suffer from epilepsy;
• if you have thyroid problems (thyrotoxicosis);
• if you have diabetes (high blood sugar levels).

During treatment with Hirobriz Breezhaler,

• stop taking the medicine and inform your doctor immediately if, shortly after taking the medicine, you experience chest tightness, coughing, wheezing, or shortness of breath. These may be signs of a condition called bronchospasm.
• inform your doctor immediately if your COPD symptoms (shortness of breath, wheezing, cough) do not improve or worsen.

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 take any other medicines.
In particular, inform your doctor if you are taking:

• medicines for breathing problems that are similar to Hirobriz Breezhaler (e.g. medicines such as salmeterol and formoterol). The risk of side effects may be higher.
• 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 lower potassium levels in the blood. These include: o steroids (e.g. prednisolone); o diuretics used for high blood pressure, such as hydrochlorothiazide; o medicines for breathing problems such as theophylline.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
You must not take Hirobriz Breezhaler unless advised by your doctor.
Ask your doctor or pharmacist for advice before taking 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 diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Hirobriz Breezhaler

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much Hirobriz Breezhaler to take

• The usual dose is the inhalation of the contents of one capsule daily. Your doctor will tell you whether to take a 150 microgram capsule or a 300 microgram capsule, depending on your condition and how you respond to treatment. Do not take more medicine than your doctor has prescribed.
• Use the inhaler every day at the same time; the effects last for 24 hours. This ensures that there is always an adequate amount of 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

• This pack contains an inhaler and capsules (in blisters) which contain 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 (the 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 new pack.
• Dispose of each inhaler after all capsules have been used.
• Do not swallow the capsules.
• Read the instructions at the end of this leaflet for further information on how to use the inhaler.

If you take more Hirobriz Breezhaler than you should
If you have inhaled too much Hirobriz Breezhaler or if someone else has used your capsules, inform your doctor immediately or go to the nearest emergency room. Show the Hirobriz Breezhaler pack. Medical treatment may be necessary. You may notice that your heart is beating faster than usual, or you may experience headache, drowsiness, nausea, or vomiting.

If you forget to take Hirobriz Breezhaler
If you forget to inhale a dose, take the next dose at the usual time the following day. Do not take a double dose to make up for the missed dose.

How long to continue treatment with Hirobriz Breezhaler

• Continue treatment with Hirobriz Breezhaler for as long as your doctor advises.
• COPD is a long-term condition and you must take Hirobriz Breezhaler every day, not only when you have difficulty breathing or other COPD symptoms. If you have any doubts about how long you should continue treatment with Hirobriz Breezhaler, ask your doctor or pharmacist.

If you have any questions about how to use 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 can be serious. Inform your doctor immediately

• if you have a feeling of tightness in the chest (common);
• if you have high blood sugar levels (diabetes). If you feel tired, very thirsty or hungry (without gaining weight) and do not urinate as usual (common);
• if you have an irregular heartbeat (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 shortness of breath or coughing (uncommon).

Other side effects may include:
Very common side effects (may affect more than 1 in 10 people)

• cold-like symptoms. You may have all or many of the following symptoms: sore throat, runny nose, stuffy nose, sneezing, cough, headache.

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

• feeling of pressure or pain in the cheeks and forehead (inflammation of the paranasal sinuses)
• runny nose
• cough
• sore throat
• headache
• dizziness
• palpitations
• muscle spasm
• swelling of the hands, ankles and feet (oedema)
• itching/rash
• chest pain
• muscle, bone or joint pain.

Uncommon side effects (may affect up to 1 in 100 people)

• fast heartbeat
• tingling or numbness
• muscle pain.

Some people may sometimes cough immediately after inhaling the medicine. Coughing is a common symptom in COPD. If you cough shortly after inhaling the medicine, do not be concerned. Check the inhaler to see if the capsule is empty and you have taken the full dose. If the capsule is empty, do not worry. If the capsule is not empty, you should inhale again, as described in the instructions.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 "Scad." and "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture, and remove only at the time of use.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine 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 other information

What Hirobriz Breezhaler contains

• Each Hirobriz Breezhaler 150 microgram capsule contains 150 micrograms of indacaterol, as indacaterol maleate. The other components include lactose monohydrate and the capsule shell is made of gelatin. The components of the black printing ink are: shellac (E904), black iron oxide (E172), propylene glycol (E1520), concentrated ammonia solution.
• Each Hirobriz Breezhaler 300 microgram capsule contains 300 micrograms of indacaterol, as indacaterol maleate. The other components include lactose monohydrate and the capsule shell is made of gelatin. The components of the blue printing ink are: shellac (E904), brilliant blue FCF (E133), propylene glycol (E1520), titanium dioxide (E171), black iron oxide (E172).

Description of the appearance of Hirobriz Breezhaler and contents of the pack
This pack contains an inhaler and capsules, which are housed in a blister. The capsules are
transparent (colourless) and contain a white powder.

• Hirobriz Breezhaler 150 microgram capsules have the product code “ IDL 150 ” printed in black over a black band and the company logo printed in black below the black band.
• Hirobriz Breezhaler 300 microgram capsules have the product code “ IDL 300 ” printed in blue over a blue band and the company logo printed in blue below the blue band.

The following pack sizes are available:
Carton containing 10 capsules and 1 inhaler.
Carton containing 30 capsules and 1 inhaler.
Multiple pack consisting of 2 cartons (each containing 30 capsules and 1 inhaler).
Multiple pack consisting of 3 cartons (each containing 30 capsules and 1 inhaler).
Multiple pack consisting of 30 cartons (each containing 10 capsules and 1 inhaler).
Not all pack sizes may be marketed.

Marketing Authorization 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 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Laboratorios Farmacéuticos ROVI, S.A. Novartis Poland Sp. z o.o.
Tel.: +34 91 375 62 30 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor ehf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

INSTRUCTIONS FOR USE OF THE HIROBRIZ BREEZHALER INHALER

Read the instructions for use completely before using Hirobriz Breezhaler.

Insert Pierce and release Inhale Check that the
deeply capsule is empty
Verif
1 2 3
y

Step 1a: Step 2a: Step 3a: Check that the capsule
Remove the cap Pierce the capsule only Exhale is empty
once completely Open the inhaler to
Hold the inhaler in Do not blow into the check whether powder
an upright position. mouthpiece. remains in the capsule.
Pierce the capsule by
pressing firmly on both
side buttons
simultaneously.
When the capsule is If powder remains in the
pierced, a clicking sound capsule:
should be heard. • close the inhaler;
Pierce the capsule only • repeat steps 3a to 3c
once.

Step 1b: Step 3b:

Open the inhaler Inhale deeply
With powder Empty
the medicine
Hold the inhaler as
shown in the picture.
Place the mouthpiece in
your mouth and close
Step 2b: your lips firmly around it.
Release the side Do not press the side
buttons buttons while inhaling.
Inhale as quickly and

deeply as possible.
During inhalation, you

will hear a humming sound.
You may taste the medicine
when inhaling.

Step 1c: Remove the empty capsule

Remove the capsule Discard the empty capsule
Remove a capsule from into household waste.
the blister. Close the inhaler and
Do not swallow the replace the cap.
capsule. Step 3c:
Hold your breath
Hold your breath for
up to 5 seconds.

Important information

• Hirobriz Breezhaler capsules must always be stored in the blister and only removed immediately before use.
• Do not swallow the capsule.
• Do not use Hirobriz Breezhaler capsules with any other inhaler.
• Do not use the Hirobriz Breezhaler inhaler to inhale capsules of any other medicine.
• Never place the capsule in your mouth or directly into the inhaler mouthpiece.
• Do not press the side buttons more than once.
• Do not blow into the mouthpiece.
• Do not press the side buttons while inhaling through the mouthpiece.
• Do not handle the capsules with wet hands.
• Never wash the inhaler with water.

The Hirobriz Breezhaler package contains: Frequently asked questions How to clean the inhaler

• One Hirobriz Breezhaler inhaler
• One or more blisters, each containing 6 or 10 Hirobriz Breezhaler capsules for use with the inhaler Why didn’t the inhaler
  make a sound when I
  inhaled?
  Wipe the outside and inside of the mouthpiece with a clean, dry, lint-free cloth to remove any
  powder residue. The capsule may become stuck.

in the compartment. If powder residue remains,

this occurs, gently tap the inhaler to loosen the capsule. Keep the inhaler dry. Never wash the inhaler with water.
Tap the base of the inhaler gently. Inhale the medication again, repeating steps from step 3a to

3c.
Disposal
What should I do if powder remains in the capsule after using the inhaler?
If powder remains in the capsule after use, you have not received a sufficient dose of medicine. Close the inhaler and repeat steps 3a to 3c.
After all capsules have been used, the inhaler should be disposed of. Ask your pharmacist for advice on how to dispose of medicines and inhalers that you no longer use.

I coughed after inhaling – what does this mean?
This may happen. As long as the capsule is empty, you have received a sufficient dose of medicine.

I felt small pieces of the capsule on my tongue – what does this mean?
This may happen. It is not harmful. The likelihood that the capsule breaks into small pieces increases if the capsule is pierced more than once.