Onbrez Breezhaler 150 microgram inhalation powder, hardcapsules

What Onbrez Breezhaler is

Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators. When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the airways, making it easier to get air in and out.

What Onbrez Breezhaler is used for

Onbrez Breezhaler is used in adults who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). It helps you breathe more easily and minimise the effects of COPD.

Follow all the doctor?s instructions carefully. They may differ from the general information contained in this leaflet.

Do not use Onbrez Breezhaler

• if you are allergic (hypersensitive) to indacaterol, to lactose or to gelatin. If this applies to you, tell your doctor without taking Onbrez Breezhaler. If you think you may be allergic, ask your doctor for advice.

Take special care with Onbrez Breezhaler if you have asthma in this case you should not use Onbrez Breezhaler. if you have heart problems. if you have epilepsy. if you have thyroid gland problems thyrotoxicosis. if you have diabetes. If any of the above applies to you or you are not sure, tell your doctor before using Onbrez Breezhaler.

Onbrez Breezhaler should not be given to children or adolescents below the age of 18 years.

During treatment with Onbrez Breezhaler,

- Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm.
- Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, please tell your doctor if you are using:
- medicines for breathing problems that are similar to Onbrez Breezhaler. You may be more likely to get side effects.
- medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). - medicines that lower the amount of potassium in your blood. These include:

• steroids (e.g. prednisolone),
• diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide,
• medicines for breathing problems such as theophylline.

Using Onbrez Breezhaler with food and drink

You can inhale Onbrez Breezhaler anytime before or after food or drink.

Pregnancy and breast-feeding

If you are pregnant or think that you may be pregnant, or if you are breast-feeding, tell your doctor before using Onbrez Breezhaler. You should not use Onbrez Breezhaler unless your doctor tells you so.

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 and use machines.

Always use Onbrez Breezhaler exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Onbrez Breezhaler to use

- The usual dose is to inhale the content of one capsule each day. Your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment. Do not use more than your doctor tells you to use. - Use your inhaler at the same time each day, the effects last for 24 hours. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you to remember to use it.

How to use Onbrez Breezhaler In this pack, you will find an inhaler and capsules in blister strips that contain the medicine as inhalation powder. The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in a capsule. Only use the capsules with the inhaler provided in this pack Onbrez Breezhaler inhaler. The capsules should remain in the blister strip until you need to use them. When you start a new pack, use the new Onbrez Breezhaler inhaler that is supplied in the pack. Dispose of each inhaler after 30 days of use. Do not swallow the capsules. Please read the instructions at the end of this leaflet for more information about how to use the inhaler.

If you use more Onbrez Breezhaler than you should

If you have inhaled too much Onbrez Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. Show the pack of Onbrez Breezhaler. Medical attention may be needed.

If you forget to use Onbrez Breezhaler

If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not inhale a double dose to make up for a forgotten dose.

How long to continue your treatment with Onbrez Breezhaler

- Keep using your treatment with Onbrez Breezhaler for as long as your doctor tells you. - COPD is a long-term disease and you should use Onbrez Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
If you have questions about how long to continue your treatment with Onbrez Breezhaler, talk to your doctor or pharmacist.

Like all medicines, Onbrez Breezhalercan cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

Some side effects may be serious. Tell your doctor immediately

- if you get crushing chest pain, or irregular heart beat.
- if you get high levels of sugar in your blood (diabetes). You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual.

Other side effects may include:

Common side effects feeling of pressure or pain in the cheeks and forehead inflammation of the sinuses runny nose cough sore throat headache cold-like symptoms. You may get all or most of the following sore throat, runny nose, blocked nose, sneezing, coughing and a headache. muscle spasm difficulty to breathe as with bronchitis swollen hands, ankles and feet oedema

Uncommon side effects

- tingling or numbness
- chest pain

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Some people occasionally cough soon after inhaling the medicine. Cough is a common symptom in COPD. If you experience coughing briefly after inhaling the medicine, do not worry. Check your inhaler to see if the capsule is empty and that you have received the full dose. If the capsule is empty, there is no need for concern. If the capsule is not empty then inhale again as directed.

Keep out of the reach and sight of children.
Do not use after the expiry date shown on the box and blister strip. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture and do not remove until immediately before use.
Do not use Onbrez Breezhaler if you notice that the pack is damaged or show signs of tampering. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

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

Lietuva
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.

Additional information

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.

REMEMBER:

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.