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AstraZeneca

Enurev Breezhaler
glycopyrronium bromide

Package leaflet: Information for the user


Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

glycopyrronium

(as glycopyrronium bromide)


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


What Enurev Breezhaler looks like and contents of the pack

Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder. They have the product code “GPL50” printed in black above and a company logo (image) printed in black below a black bar.


Each pack contains a device called an inhaler, together with capsules in blisters. Each blister strip contains either 6 or 10 hard capsules.


The following pack sizes are available:

Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.


Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers. Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers. Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers. Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.


Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building

Elm Park, Merrion Road Dublin 4

Ireland


Manufacturer

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764 08013 Barcelona

Spain


Novartis Pharma GmbH Roonstraße 25

D-90429 Nuremberg Germany


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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

Ferrer Internacional, S.A. Tel: +34 93 600 37 00

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 Enurev Breezhaler inhaler


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Please read the full Instructions for Use before using the Enurev 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:

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Your Seebri Breezhaler Inhaler pack contains:

  • One Seebri Breezhaler inhaler

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


Capsule Mouthpiece

Cap chamber

Screen Side

buttons

Base Blister


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.