Oslif Breezhaler 150 micrograms powder for inhalation (hard capsule)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oslif Breezhaler 150 micrograms powder for inhalation (hard capsule)

Oslif Breezhaler 300 micrograms powder for inhalation (hard capsule)

indacaterol

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Oslif Breezhaler is and what it is used for
2. What you need to know before using Oslif Breezhaler
3. How to use Oslif Breezhaler
4. Possible adverse effects
5. How to store Oslif Breezhaler

Contents of the pack and other information

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

What is Oslif Breezhaler

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

What Oslif Breezhaler is used for

Oslif Breezhaler is used to make breathing easier in adult patients who have difficulty breathing due to a lung disease known as chronic obstructive pulmonary disease (COPD). In COPD, the muscles surrounding the airways tighten, making breathing difficult. This medicine relaxes those muscles in the lungs, making it easier for air to move in and out.

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

Do not use Oslif Breezhaler

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Oslif Breezhaler

• if you have asthma (in this case, you must 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 inform your doctor immediately if you experience chest tightness, cough, wheezing, or difficulty breathing right after using the medicine. These may be signs of a condition called bronchospasm.
• Inform your doctor immediately if your COPD symptoms (difficulty breathing, wheezing, cough) do not improve or worsen.

Children and adolescents

Oslif Breezhaler must not be given to children or adolescents under 18 years of age.

Other medicines and Oslif Breezhaler

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

In particular, inform your doctor if you are taking:

• medicines for breathing problems that are similar to Oslif Breezhaler (i.e. medicines such as salmeterol and formoterol). You may be more likely to experience adverse effects.

• medicines called beta-blockers used for high blood pressure or other heart problems (such as propranolol), or for an eye condition called glaucoma (such as timolol).

• medicines that reduce the amount of potassium in the blood. These include:

• corticosteroids (e.g. prednisolone),

• diuretics used for high blood pressure, such as hydrochlorothiazide,

• 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 become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Oslif Breezhaler unless your doctor tells you to do so.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Oslif Breezhaler is unlikely to affect your ability to drive or operate machinery.

Oslif Breezhaler contains lactose

This medicine contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to use Oslif Breezhaler

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Amount of Oslif Breezhaler you should use

• The usual dose is to inhale the contents of one capsule every day. Your doctor will determine whether you should use the 150 microgram capsule or the 300 microgram capsule, depending on your condition and how you respond to treatment. Do not use more than the amount prescribed by your doctor.
• 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 remember to take it.

How to use Oslif Breezhaler

• This package contains an inhaler and capsules (in blister packs) containing the medicine as an inhalation powder. The Oslif Breezhaler inhaler allows you to inhale the medicine contained in a capsule.
• Use the capsules only with the inhaler provided in this package (Oslif Breezhaler inhaler). The capsules should remain in the blister pack until you are ready to use them.
• When starting a new package, use the new Oslif Breezhaler inhaler provided in the package.
• Discard the inhaler once all capsules have been used.
• Do not swallow the capsules.
• For more information on how to use the inhaler, read the instructions at the end of this leaflet.

If you use more Oslif Breezhaler than you should

If you have inhaled too much Oslif Breezhaler or if someone else uses your capsules, inform your doctor immediately or go to the nearest emergency department. Bring the Oslif Breezhaler package with you. Medical attention may be necessary. You may notice that your heart is beating faster than normal, or you may experience headache, drowsiness, nausea, or vomiting.

If you forget to use Oslif Breezhaler

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

How long you should continue treatment with Oslif Breezhaler

• Continue using Oslif Breezhaler for as long as your doctor prescribes.
• COPD is a long-term condition, and you must use Oslif Breezhaler every day, not only when you have breathing difficulties or other COPD symptoms.

Consult your doctor or pharmacist if you have any questions about how long you should continue treatment with Oslif Breezhaler.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious. Inform your doctor immediately

• if you have a tight pain in the chest (frequent).
• if you have high levels of sugar in the blood (diabetes). You will feel tired, very thirsty and hungry (without weight gain) and will urinate more than normal (frequent).
• if you have irregular heartbeats (uncommon).
• if you have 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 adverse effects may include:

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

• flu-like symptoms. You may have all or most of the following effects: sore throat, runny nose, nasal congestion, sneezing, cough, headache.

Common adverse effects (may affect up to 1 in 10 people)

• feeling of pain or pressure in the cheeks and forehead (sinus inflammation)
• 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 adverse effects (may affect up to 1 in 100 people)

• fast heartbeat
• tingling or numbness
• muscle pain

Some people may occasionally cough shortly after inhaling the medicine. Coughing is a common symptom in COPD. If you experience coughing shortly 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 cause for concern. If the capsule is not empty, inhale again as directed.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oslif Breezhaler

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

Do not use this medicine after the expiry date stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture, and do not remove until immediately before use.

Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oslif Breezhaler

• Each 150 microgram capsule of Oslif Breezhaler contains 150 micrograms of indacaterol as indacaterol maleate. The other components include lactose and the gelatin capsule.
• Each 300 microgram capsule of Oslif Breezhaler contains 300 micrograms of indacaterol as indacaterol maleate. The other components include lactose and the gelatin capsule.

Appearance of Oslif Breezhaler and contents of the pack

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

• The 150 microgram capsules of Oslif Breezhaler have a product code “IDL 150” printed in black above a black line and the company logo () printed in black below the same line.
• The 300 microgram capsules of Oslif Breezhaler have a product code “IDL 300” printed in blue above a blue line and the company logo () printed in blue below the same line.

The following pack sizes are available:

Carton containing 10 capsules and 1 inhaler.

Carton containing 30 capsules and 1 inhaler.

Multiple pack containing 2 packs (each containing 30 capsules and 1 inhaler).

Multiple pack containing 3 packs (each containing 30 capsules and 1 inhaler).

Multiple pack containing 30 packs (each containing 10 capsules and 1 inhaler).

Only certain pack sizes may be marketed.

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

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

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

Date of the most recent review of this leaflet:

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 THE OSLIF BREEZHALER INHALER

Read the Instructions for Use in full before using Oslif Breezhaler.