Onbrez Breezhaler

Package leaflet: Information for the user

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

indacaterol
Please read all of 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Onbrez Breezhaler is and what it is used for
2. What you need to know before taking Onbrez Breezhaler
3. How to take 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 air passages in
the lungs. This helps to open up the airways, making breathing easier.
What Onbrez Breezhaler is used for
Onbrez 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 become narrowed, making breathing difficult. This medicine relaxes the muscles in the lungs, making it easier for air to move into and out of the lungs.

2. What you need to know before taking Onbrez Breezhaler

Do not take 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 taking Onbrez Breezhaler

• if you suffer from asthma (in this case you must not use Onbrez 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 Onbrez Breezhaler,

• stop taking the medicine and inform your doctor immediately if, shortly after taking the medicine, you feel tightness in the chest, develop cough, breathlessness or shortness of breath. These may be signs of a condition called bronchospasm.
• inform your doctor immediately if your COPD symptoms (breathlessness, shortness of breath, 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
Inform 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 Onbrez 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 eye called glaucoma (such as timolol).
• medicines that lower potassium levels in the blood. These include: corticosteroids (e.g. prednisolone); diuretics used for high blood pressure, such as hydrochlorothiazide; or medicines for breathing problems such as theophylline.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Onbrez Breezhaler unless advised to do so by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Onbrez Breezhaler will affect your ability to drive or use machinery.
Onbrez Breezhaler contains lactose
This medicine contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Onbrez Breezhaler

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

How much Onbrez Breezhaler to take

• The usual dose is inhalation of the contents of one capsule per day. 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 recommended.
• Use the inhaler at the same time each day; the effects last for 24 hours. This ensures that there is always a sufficient 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 Onbrez Breezhaler

• This pack contains an inhaler and capsules (in blisters) 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 pack (the Onbrez Breezhaler inhaler). The capsules should remain in the blister until you are ready to use them.
• When starting a new pack, use the new Onbrez Breezhaler inhaler provided in the new pack.
• Dispose of each inhaler after all capsules have been used.
• Do not swallow the capsules.
• Refer to the instructions at the end of this leaflet for further information on how to use the inhaler.

If you take more Onbrez Breezhaler than you should
If you have inhaled too much Onbrez Breezhaler or if someone else has used your capsules, inform your doctor immediately or go to the nearest emergency room. Show the Onbrez 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 Onbrez 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 Onbrez Breezhaler

• Continue treatment with Onbrez Breezhaler for as long as your doctor advises.
• COPD is a long-term condition and you must take Onbrez 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 Onbrez Breezhaler, ask your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious. Immediately inform your doctor

• 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 breathlessness or coughing (uncommon).

Other possible side effects 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
• pain in 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 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 must inhale again, as described in the instructions.
Reporting of side effects
If you experience any side effect, 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 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 "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 in use. This will help protect the environment.

6. Package contents and other information

What Onbrez Breezhaler contains

• Each 150 microgram Onbrez Breezhaler 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 300 microgram Onbrez Breezhaler 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 Onbrez Breezhaler and package contents
This pack contains an inhaler and capsules, which are held in a blister. The capsules are
transparent (colourless) and contain a white powder.

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

Available pack sizes:
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 about 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
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 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 ONBREZ BREEZHALER INHALER

Read the instructions for use completely before using Onbrez Breezhaler.

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

Discard the empty capsule
into household waste.