What Onbrez Breezhaler contains
- Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. The other ingredients are lactose and gelatin.
- Each Onbrez Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate. The other ingredients are lactose and gelatin.
What Onbrez Breezhaler looks like and content of the pack
In this pack, you will find an inhaler, together with capsules in blister strips. The capsules are clear and colourless and contain a white powder.
Onbrez Breezhaler 150 microgram capsules are clear and colourless. They have a black product code IDL 150 printed above and a black company logo printed below a black bar. Onbrez Breezhaler 300 microgram capsules are clear and colourless. They have a blue product code IDL 300 printed above and a blue company logo printed below a blue bar.
The following pack sizes are available:
Carton containing 10 capsules (1x10 capsule blister strips) and 1 inhaler.
Carton containing 30 capsules (3x10 capsule blister strips) 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
West Sussex, RH12 5AB
Novartis Pharma GmbH
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11
Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00
eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217
Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111
Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00
Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570
Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888
España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600
France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. 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 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200
357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00
Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50
This leaflet was last approved in
INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER
Please read the following instructions carefully to learn how to use and care for your Onbrez Breezhaler inhaler.
Only use the Onbrez Breezhaler inhaler contained in this pack. Do not use Onbrez Breezhaler capsules with any other inhaler, and do not use Onbrez Breezhaler inhaler to take any other capsule medicine. When you start a new pack, only use the new Onbrez Breezhaler inhaler that is supplied in the pack. Dispose of each inhaler after 30 days of use. Ask your pharmacist how to dispose of medicines and inhalers no longer required. Do not swallow the capsules. The powder in the capsules is for you to inhale.
Your Onbrez Breezhaler pack:
Each Onbrez Breezhaler pack contains:
- one Onbrez Breezhaler inhaler
- one or more blister strips containing Onbrez Breezhaler capsules to be used in the inhaler.
The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in an Onbrez Breezhaler capsule.
Mouthpiece Cap Screen Button Base Blisters Capsule chamber
Onbrez Breezhaler inhaler Blister Inhaler base
How to use your inhaler
Pull off the cap.
Open inhaler Hold the base of the inhaler firmly and tilt the mouthpiece. This opens the inhaler.
Prepare capsule. Immediately before use, with dry hands, remove one capsule from the blister.
Insert capsule Place the capsule into the capsule chamber. Never place a capsule directly into the mouthpiece.
Close the inhaler Close the inhaler until you hear a click.
Pierce the capsule Hold the inhaler upright with the mouthpiece pointing up. Pierce the capsule by firmly pressing together both side buttons at the same time. Do this only once. You should hear a click as the capsule is being pierced.
Release the side buttons fully.
Breathe out Before placing the mouthpiece in your mouth, breathe out fully. Do not blow into the mouthpiece.
Inhale the medicine To breathe the medicine deeply into your airways Hold the inhaler as shown in the picture. The side buttons should be facing left and right. Do not press the side buttons. Place the mouthpiece in your mouth and close your lips firmly around the mouthpiece. Breathe in rapidly but steadily and as deeply as you can.
Note As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise. You will experience a sweet flavour as the medicine goes into your lungs. Additional information Occasionally, very small pieces of the capsule can get past the screen and enter your mouth. If this happens, you may be able to feel these pieces on your tongue. It is not harmful if these pieces are swallowed or inhaled. The chances of the capsule shattering will be increased if the capsule is accidentally pierced more than once step 6.
If you do not hear a whirring noise:
The capsule may be stuck in the capsule chamber. If this happens:
- Open the inhaler and carefully loosen the capsule by tapping the base of the inhaler. Do not press the side buttons.
- Inhale the medicine again by repeating steps 8 and 9.
Hold breath After you have inhaled the medicine Hold your breath for at least 5-10 seconds or as long as you comfortably can while taking the inhaler out of your mouth. Then breathe out. Open the inhaler to see if any powder is left in the capsule. If there is powder left in the capsule Close the inhaler. Repeat steps 8, 9, 10 and 11.
Most people are able to empty the capsule with one or two inhalations.
Some people may occasionally cough briefly soon after inhaling the medicine. If you do, don?t worry. As long as the capsule is empty, you have received enough of your medicine.
After you have finished taking your medicine Open the mouthpiece again, remove the empty capsule by tipping it out of the capsule chamber. Put the empty capsule in your household waste. Close the inhaler and replace the cap. Do not store the capsules in the Onbrez Breezhaler inhaler.
Mark daily dose tracker On the inside of the pack there is a daily dose tracker. Put a mark in todays box if it helps to remind you of when your next dose is due.
Do not swallow Onbrez Breezhaler capsules. Only use the Onbrez Breezhaler inhaler contained in this pack. Onbrez Breezhaler capsules must always be stored in the blister, and only removed immediately before use. Never place a Onbrez Breezhaler capsule directly into the mouthpiece of the Onbrez Breezhaler inhaler. Do not press the side buttons more than once. Never blow into the mouthpiece of the Onbrez Breezhaler inhaler. Always release the push buttons before inhalation. Never wash the Onbrez Breezhaler inhaler with water. Keep it dry. See How to clean your inhaler. Never take the Onbrez Breezhaler inhaler apart. Always use the new Onbrez Breezhaler inhaler that comes with your new Onbrez Breezhaler medication pack. Dispose of each inhaler after 30 days of use. Do not store the capsules in the Onbrez Breezhaler inhaler. Always keep the Onbrez Breezhaler inhaler and Onbrez Breezhaler capsules in a dry place.
How to clean your inhaler
Clean your inhaler once a week.
- Wipe the mouthpiece inside and outside to remove any powder with a clean, dry lint-free cloth. - Do not wash your inhaler with water. Keep it dry.
- Do not take the inhaler apart.