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Oslif Breezhaler (indacaterol maleate) – Package leaflet - R03AC18

Updated on site: 09-Oct-2017

Medication nameOslif Breezhaler
ATC CodeR03AC18
Substanceindacaterol maleate
ManufacturerNovartis Europharm Ltd.  

Package leaflet: Information for the user

Oslif Breezhaler 150 microgram inhalation powder, hard capsules

Oslif 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.

-Keep this leaflet. You may need to read it again.

-If you have further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Oslif Breezhaler is and what it is used for

2.What you need to know before you use Oslif Breezhaler

3.How to use Oslif Breezhaler

4.Possible side effects

5.How to store Oslif Breezhaler

6.Contents of the pack and other information

1.What Oslif Breezhaler is and what it is used for

What Oslif Breezhaler is

Oslif 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 Oslif Breezhaler is used for

Oslif Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD the muscles around the airways tighten. This makes breathing difficult. This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs.

2. What you need to know before you use Oslif Breezhaler

Do not use Oslif Breezhaler

-if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Oslif Breezhaler

if you have asthma (in this case you should not use Oslif Breezhaler).

if you have heart problems.

if you have epilepsy.

if you have thyroid gland problems (thyrotoxicosis).

if you have diabetes.

During treatment with Oslif 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.

Children and adolescents

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

Other medicines and Oslif Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, please tell your doctor if you are using:

medicines for breathing problems that are similar to Oslif Breezhaler (i.e. medicines such as salmeterol and formoterol). 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: o steroids (e.g. prednisolone),

o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, o medicines for breathing problems such as theophylline.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Oslif 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 Oslif Breezhaler will affect your ability to drive and use machines.

Oslif Breezhaler contains lactose

This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

3.How to use Oslif Breezhaler

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much Oslif 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 Oslif Breezhaler

In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder. The Oslif Breezhaler inhaler enables you to inhale the medicine contained in a capsule.

Only use the capsules with the inhaler provided in this pack (Oslif Breezhaler inhaler). The capsules should remain in the blister until you need to use them.

When you start a new pack, use the new Oslif 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 Oslif Breezhaler than you should

If you have inhaled too much Oslif Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. Show the pack of Oslif Breezhaler. Medical attention may be needed. You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit.

If you forget to use Oslif 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 Oslif Breezhaler

Keep using your treatment with Oslif Breezhaler for as long as your doctor tells you.

COPD is a long-term disease and you should use Oslif 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 Oslif Breezhaler, talk to your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious. Tell your doctor immediately

if you get crushing chest pain, (common).

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 (common).

if you get irregular heart beat (uncommon).

if you get symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).

if you have difficulty breathing with wheezing or coughing (uncommon).

Other side effects may include:

Very common side effects (may affect more than 1 in 10 people)

cold-like symptoms. You may get all or most of the following: sore throat, runny nose, blocked nose, sneezing, coughing, 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 sinuses)

runny nose

cough

sore throat

headache

dizziness

palpitations

muscle spasm

swollen 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 heart beat

tingling or numbness

muscle pain

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Oslif Breezhaler

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. 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 this medicine if you notice that the pack is damaged or show signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Oslif Breezhaler contains

-Each Oslif Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.

-Each Oslif Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.

What Oslif 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.

Oslif Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo () printed below the black bar.

Oslif Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo () 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

Frimley Business Park

Camberley GU16 7SR

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:

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

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. Pharma

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 26 37 82 111

 

Eesti

Norge

Novartis Pharma Services Inc.

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

Ferrer Internacional, S.A.

Novartis Poland Sp. z o.o.

Tel: +34 93 600 37 00

Tel.: +48 22 375 4888

France

Portugal

Pierre Fabre Médicament

Laboratório Medinfar - Produtos Farmacêuticos,

Tél: +33 1 49 10 96 18

S.A.

 

Tel: +351 21 499 7400

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 hf.

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

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

INSTRUCTIONS FOR USE OF OSLIF BREEZHALER INHALER

Please read the following instructions carefully to learn how to use and care for your Oslif Breezhaler inhaler.

Only use the Oslif Breezhaler inhaler contained in this pack. Do not use Oslif Breezhaler capsules with any other inhaler, and do not use Oslif Breezhaler inhaler to take any other capsule medicine.

When you start a new pack, only use the new Oslif 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 Oslif Breezhaler pack:

Each Oslif Breezhaler pack contains:

one Oslif Breezhaler inhaler

one or more blister containing Oslif Breezhaler capsules to be used in the inhaler.

The Oslif Breezhaler inhaler enables you to inhale the medicine contained in an Oslif Breezhaler capsule.

Mouthpiece

Cap

Screen

 

 

 

 

 

 

 

Button

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Base

 

 

 

 

 

 

 

 

Blisters

 

 

 

 

 

 

 

Capsule chamber

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oslif 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 Oslif Breezhaler inhaler.

Mark daily dose tracker:

On the inside of the pack there is a daily dose tracker. Put a mark in today’s box if it helps to remind you of when your next dose is due.

REMEMBER:

Do not swallow Oslif Breezhaler capsules.

Only use the Oslif Breezhaler inhaler contained in this pack.

Oslif Breezhaler capsules must always be stored in the blister, and only removed immediately before use.

Never place a Oslif Breezhaler capsule directly into the mouthpiece of the Oslif Breezhaler inhaler.

Do not press the side buttons more than once.

Never blow into the mouthpiece of the Oslif Breezhaler inhaler.

Always release the push buttons before inhalation.

Never wash the Oslif Breezhaler inhaler with water. Keep it dry. See “How to clean your inhaler”.

Never take the Oslif Breezhaler inhaler apart.

Always use the new Oslif Breezhaler inhaler that comes with your new pack. Dispose of each inhaler after 30 days of use.

Do not store the capsules in the Oslif Breezhaler inhaler.

Always keep the Oslif Breezhaler inhaler and 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.

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