BEMRIST BREEZHALER 125 micrograms/62.5 micrograms INHALATION POWDER (HARD CAPSULE)

Introduction

Package Leaflet: Information for the User

Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder (hard capsule)

Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder (hard capsule)

Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder (hard capsule)

indacaterol/mometasone furoate

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 any further questions, ask your doctor, pharmacist, or nurse.
• 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Bemrist Breezhaler is and what it is used for
2. What you need to know before you use Bemrist Breezhaler
3. How to use Bemrist Breezhaler
4. Possible side effects
5. Storing Bemrist Breezhaler
6. Contents of the pack and other information

Instructions for using the Bemrist Breezhaler inhaler

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

What Bemrist Breezhaler is and how it works

Bemrist Breezhaler contains two active substances called indacaterol and mometasone furoate.

Indacaterol belongs to a group of medicines called bronchodilators. It relaxes the muscles of the small airways in the lungs. This helps to open up the airways and makes it easier to breathe in and out. When used regularly, it helps to keep the small airways in the lungs open.

Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) of the small airways in the lungs and in this way gradually relieve breathing problems. Corticosteroids also help to prevent asthma attacks.

What Bemrist Breezhaler is used for

Bemrist Breezhaler is used as a regular treatment for asthma in adults and adolescents (12 years of age and older).

Asthma is a serious, chronic lung disease in which the muscles around the smaller airways tighten (bronchoconstriction) and become inflamed. The symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing.

You should use Bemrist Breezhaler every day as directed by your doctor and not just when you have breathing problems or other asthma symptoms. This will help to keep your asthma under control. Do not use this medicine to relieve a sudden attack of shortness of breath or wheezing.

Ask your doctor if you have any questions about how Bemrist Breezhaler works or why you have been prescribed this medicine.

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

Follow your doctor's instructions carefully.

Do not use Bemrist Breezhaler

• if you are allergic to indacaterol, mometasone furoate, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse beforeusing Bemrist Breezhaler if any of the following apply to you:

• if you have heart problems including a fast or irregular heartbeat,
• if you have thyroid problems,
• if you have been told you have diabetes or high blood sugar levels,
• if you have seizures or fits,
• if you have low potassium levels in your blood,
• if you have severe kidney problems,
• if you have pulmonary tuberculosis (TB) or any other long-standing or untreated infection.

During treatment with Bemrist Breezhaler

Stop using this medicine and seek medical help immediatelyif you experience any of the following:

• chest tightness, cough, wheezing, or difficulty breathing immediately after using Bemrist Breezhaler (signs that the medicine has unexpectedly constricted the airways, known as paradoxical bronchospasm),
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and hives (signs of an allergic reaction).

Children and adolescents

Do not give this medicine to children under 12 years of age as it has not been studied in this age group.

Other medicines and Bemrist Breezhaler

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, tell your doctor or pharmacist if you are using:

• medicines that lower the amount of potassium in the blood. These include diuretics (which increase urine production and may be used to treat high blood pressure, e.g., hydrochlorothiazide), other bronchodilators such as methylxanthines used for respiratory disorders (e.g., theophylline), or corticosteroids (e.g., prednisolone).
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression).
• any medicine that may be similar to Bemrist Breezhaler (containing similar active substances); as their use together may increase the risk of side effects.
• medicines called beta-blockers which may be used for high blood pressure or other heart problems (such as propranolol), or to treat glaucoma (e.g., timolol).
• ketoconazole or itraconazole (medicines used to treat fungal infections).
• ritonavir, nelfinavir, or cobicistat (medicines used to treat HIV infection).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will decide whether you can use Bemrist Breezhaler.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Bemrist Breezhaler contains lactose

This medicine contains approximately 25 mg of lactose per capsule. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to use Bemrist Breezhaler

Follow the instructions for administration of this medicine given by your doctor or pharmacist carefully. If you are in doubt, consult your doctor or pharmacist again.

How much Bemrist Breezhaler to inhale

There are three different doses of Bemrist Breezhaler capsules. Your doctor will decide which one is best for you.

The usual dose is to inhale the contents of one capsule each day. You only need to inhale the medicine once a day. Do not use more doses than your doctor has prescribed.

You should use Bemrist Breezhaler every day, even if your asthma is not bothering you.

When to inhale Bemrist Breezhaler

Inhale Bemrist Breezhaler at the same time each day. This will help you control your symptoms throughout the day and night. It will also help you remember to use it.

How to inhale Bemrist Breezhaler

• Bemrist Breezhaler is for inhalation use only.
• In this pack, you will find an inhaler and capsules that contain the medicine. The inhaler allows you to inhale the medicine from the capsule. Use the capsules only with the inhaler provided in this pack. The capsules should be kept in the blister pack until you need to use them.
• Peel back the foil to open the blister pack, do not push the capsule through the foil.
• When starting a new pack, use the new inhaler provided in the pack.
• Discard the inhaler from each pack once you have used all the capsules.
• Do not swallow the capsules.
• For more information on how to use the inhaler, please read the instructions at the end of this leaflet.

If your symptoms do not improve

If your asthma does not improve or even gets worse after you have started using Bemrist Breezhaler, talk to your doctor.

If you use more Bemrist Breezhaler than you should

If you accidentally inhale too much of this medicine, contact your doctor or hospital immediately. Medical attention may be needed.

If you forget to use Bemrist Breezhaler

If you miss a dose at the usual time, inhale it as soon as you can on that day. Then, the next day, inhale the next dose at the usual time. Do not inhale two doses on the same day.

If you stop using Bemrist Breezhaler

Do not stop using Bemrist Breezhaler unless your doctor tells you to. Your asthma symptoms may come back if you stop using it.

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

Stop using Bemrist Breezhaler and seek medical help immediately if you experience any of the following:

Common:may affect up to 1 in 10 people

• difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and hives (signs of an allergic reaction).

Uncommon:may affect up to 1 in 100 people

• swelling of the tongue, lips, face, or throat (possible signs of angioedema)

Other side effects

The following is a list of other side effects. If these side effects become serious, please talk to your doctor, pharmacist, or nurse.

Very common:may affect more than 1 in 10 people

• throat pain
• nasal discharge
• sudden difficulty breathing and feeling of chest tightness with wheezing or coughing

Common:may affect up to 1 in 10 people

• voice changes (hoarseness)
• nasal congestion
• sneezing, cough
• headache
• pain in the muscles, bones, or joints (signs of musculoskeletal pain)

Uncommon:may affect up to 1 in 100 people

• fast heartbeat
• mouth sores (signs of oral candidiasis)
• high blood sugar levels
• muscle spasms
• itching
• skin rash
• clouding of the lenses of your eyes (signs of cataract)
• blurred vision

Reporting of side effects

If you experience 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. Storing Bemrist 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 the capsules in the original blister pack to protect them from light and moisture and do not remove them until just before use.
• 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 protect the environment.

6. Contents of the pack and additional information

Composition of Bemrist Breezhaler

• The active substances are indacaterol (as acetate) and mometasone furoate.

Bemrist Breezhaler 125 micrograms/62.5 micrograms

Each capsule contains 173 micrograms of indacaterol as acetate (equivalent to 150 micrograms of indacaterol) and 80 micrograms of mometasone furoate. The delivered dose (the dose that is released from the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 62.5 micrograms of mometasone furoate.

Bemrist Breezhaler 125 micrograms/127.5 micrograms

Each capsule contains 173 micrograms of indacaterol as acetate (equivalent to 150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose (the dose that is released from the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 127.5 micrograms of mometasone furoate.

Bemrist Breezhaler 125 micrograms/260 micrograms

Each capsule contains 173 micrograms of indacaterol as acetate (equivalent to 150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose (the dose that is released from the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.

• The other component of the powder for inhalation is (see the section “Bemrist Breezhaler contains lactose” in section 2).

Appearance and pack contents

In this pack, you will find an inhaler together with capsules in blisters. The capsules are transparent and contain a white powder.

• The Bemrist Breezhaler 125 micrograms/62.5 micrograms capsules have a product code “IM150-80” printed in blue above a blue bar on the body and the logo printed in blue and surrounded by two blue bars on the cap.
• The Bemrist Breezhaler 125 micrograms/127.5 micrograms capsules have a product code “IM150-160” printed in grey on the body and a logo printed in grey on the cap.
• The Bemrist Breezhaler 125 micrograms/260 micrograms capsules have a product code “IM150-320” printed in black above two black bars on the body and a logo printed in black and surrounded by two black bars on the cap.

The following pack sizes are available:

Single pack containing 10 x 1 or 30 x 1 hard capsules, together with 1 inhaler.

Multiple packs containing 3 boxes, each with 30 x 1 capsules together with 3 inhalers.

Multiple packs containing 15 boxes, each with 10 x 1 capsules together with 1 inhaler.

Not all pack sizes may be marketed.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

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

Instructions for use of the Bemrist Breezhaler inhaler

Please read the complete Instructions for Use of the Bemrist Breezhaler inhaler before using it.