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AstraZeneca

Hirobriz Breezhaler
indacaterol

Package leaflet: Information for the user


Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.


What Hirobriz Breezhaler looks like and content of the pack

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


above a blue bar and a blue company logo (image) printed below the blue bar.


The following pack sizes are available: Carton containing 10 capsules and 1 inhaler. Carton containing 30 capsules and 1 inhaler.

Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler).


Not all pack sizes or strengths may be available in your country.

Marketing Authorisation 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


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For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

Lietuva

SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50


България

Novartis Bulgaria EOOD Тел.: +359 2 489 98 28

Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11


Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00


Danmark

Novartis Healthcare A/S Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc. Tel: +356 2122 2872


Deutschland

Novartis Pharma GmbH Tel: +49 911 273 0

Nederland

Novartis Pharma B.V. Tel: +31 88 04 52 111


Eesti

SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810

Norge

Novartis Norge AS Tlf: +47 23 05 20 00


Ελλάδα

Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH Tel: +43 1 86 6570


España

Laboratorios Farmacéuticos ROVI, S.A.

Tel.: +34 91 375 62 30

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600


Hrvatska

Novartis Hrvatska d.o.o. Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01


Ireland

Novartis Ireland Limited Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc. Tel: +386 1 300 75 50


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439


Italia

Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200


Κύπρος

Novartis Pharma Services Inc. Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB Tel: +46 8 732 32 00


Latvija

SIA Novartis Baltics Tel: +371 67 887 070

United Kingdom (Northern Ireland)

Novartis Ireland Limited Tel: +44 1276 698370


This leaflet was last revised in


INSTRUCTIONS FOR USE OF HIROBRIZ BREEZHALER INHALER


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Please read the full Instructions for Use before using the Hirobriz Breezhaler.


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Insert Pierce and release Inhale deeply Check capsule is empty


1 2 3 Check


Step 1a:

Pull off cap

Step 2a:

Pierce capsule once Hold the inhaler upright. Pierce capsule by firmly pressing both side buttons at the same time. You should hear a noise as the capsule is pierced. Only pierce the capsule once.

Step 3a:

Breathe out fully Do not blow into the inhaler.

Check capsule is empty Open the inhaler to see if any powder is left in the capsule.


If there is powder left in the capsule:


Step 1b:

Open inhaler


Step 2b:

Release side buttons

Step 3b:

Inhale medicine deeply Hold the inhaler as shown in the picture. Place the mouthpiece in your mouth and close your lips firmly around it.

Do not press the side buttons.


Powder Empty remaining

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Step 1c:

Remove capsule

Remove one capsule from

the blister.

Do not swallow the

capsule.


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Step 1d:

Insert capsule

Never place a capsule

directly into the mouthpiece.


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Step 1e:

Close inhaler

Breathe in quickly and as

deeply as you can. During inhalation you will hear a whirring noise.

You may taste the medicine as you inhale.


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Step 3c:

Hold breath

Hold your breath for up

to 5 seconds.

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Remove empty capsule Put the empty capsule in your household waste.


Close the inhaler and replace the cap.

Important Information

  • Hirobriz Breezhaler capsules must always be stored in the blister card

  • Do not swallow the capsule.

  • Do not use the Hirobriz Breezhaler capsules with

  • Do not use the Hirobriz Breezhaler inhaler to take any other capsule medicine.

  • Never place the capsule into your mouth or the mouthpiece of the

  • 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 capsules with wet hands.

  • Never wash your inhaler with water.

and only removed immediately before use.

any other inhaler.

inhaler.

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Your Hirobriz Breezhaler Inhaler pack contains:

  • One Hirobriz Breezhaler inhaler

  • One or more blister cards, each containing either 6 or 10 Hirobriz Breezhaler capsules to be used in the inhaler


Capsule

chamber Mouthpiece


Cap Screen


Side

buttons Blister

Base


Inhaler Inhaler base Blister Card

Frequently Asked Questions


Why didn’t the inhaler make a noise when I inhaled?

The capsule may be stuck

in the capsule chamber. If this happens, carefully loosen the capsule by tapping the base of the inhaler. Inhale the medicine again by repeating steps 3a to 3c.


What should I do if there is powder left inside the capsule?

You have not received

enough of your medicine. Close the inhaler and repeat steps 3a to 3c.


I coughed after inhaling

– does this matter?

This may happen. As long

as the capsule is empty you have received enough of your medicine.


I felt small pieces of the capsule on my tongue – does this matter?

This can happen. It is not

harmful. The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once.

Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash your inhaler with water.

Disposing of the inhaler after use

Each inhaler should be

disposed of after all capsules have been used. Ask your pharmacist how to dispose of medicines and inhalers that are no longer required.