Product Information for the User

Bemrist Breezhaler 125 micrograms/62.5 micrograms Powder for Inhalation (Hard Capsule)

Bemrist Breezhaler 125 micrograms/127.5 micrograms Powder for Inhalation (Hard Capsule)

Bemrist Breezhaler 125 micrograms/260 micrograms Powder for Inhalation (Hard Capsule)

indacaterol/mometasone furoate

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

Instructions for Use of the Bemrist Breezhaler Inhaler

What is Bemrist Breezhaler and how it works

Bemrist Breezhaler contains two active ingredients 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 the airways and facilitate the entry and exit of air from the lungs. When used regularly, it helps to keep the small airways of 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 gradually alleviate respiratory problems. Corticosteroids also help to prevent asthma attacks.

How Bemrist Breezhaler is used

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

Asthma is a chronic severe lung disease in which the muscles surrounding the smallest airways constrict (bronchoconstriction) and become inflamed. Symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing.

You must use Bemrist Breezhaler every day as instructed by your doctor and not just when you have respiratory problems or other asthma symptoms. This will ensure proper control of your asthma. Do not use this medicine to relieve a sudden attack of choking or wheezing.

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

Follow all of your doctor's instructions carefully.

Do not use Bemrist Breezhaler

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

Warnings and precautions

Consult your doctor, pharmacist, or nursebeforeusing Bemrist Breezhaler if any of the following situations apply to you:

• if you have heart problems, including rapid or irregular heartbeat,
• if you have thyroid gland problems,
• if you have ever been told you have diabetes or high blood sugar levels,
• if you suffer from seizures or attacks,
• 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 medication and seek medical help immediatelyif you experienceany of the following situations:

• chest tightness, cough, wheezing, or immediate difficulty breathing after using Bemrist Breezhaler (signs of unexpected narrowing of 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 administer this medication to children under 12 years of age because it has not been studied in this age group.

Other medications and Bemrist Breezhaler

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. In particular, inform your doctor or pharmacist if you are using:

• medications that decrease 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 (medications used to treat depression).
• any medication that may be similar to Bemrist Breezhaler (containing active substances similar to indacaterol); since their concurrent use may increase the risk of adverse effects.
• beta-blockers that may be used to treat 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 (medications used to treat HIV infection).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Your doctor will inform you if you can use Bemrist Breezhaler.

Driving and operating machinery

This medication is unlikely to affect your ability to drive and operate machinery.

Bemrist Breezhaler contains lactose

This medication contains approximately 25 mg of lactose per capsule. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount of 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 every day. You only need to inhale the medication once a day. Do not use more doses than indicated by your doctor.

You must use Bemrist Breezhaler every day, even if your asthma does not bother you.

When to inhale Bemrist Breezhaler

Inhale Bemrist Breezhaler at the same time every 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.
• In this package, you will find an inhaler and capsules containing the medication. The inhaler allows you to inhale the medication from the capsule. Use the capsules only with the inhaler provided in this package. The capsules must be kept in the blister pack until you need to use them.
• Remove the foil from the blister pack to open it, do not press the capsule through the foil.
• When starting a new package, use the new inhaler provided in the package.
• Dispose of the inhaler from each package 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 worsens after starting to use Bemrist Breezhaler, consult your doctor.

If you use more Bemrist Breezhaler than you should

If you accidentally inhale too much of this medication, contact your doctor or hospital immediately. You may need medical attention.

If you forget to use Bemrist Breezhaler

If you forget to inhale a dose at the usual time, inhale it as soon as possible on the same day. Then, the next day, inhale the next one at the usual time. Do not inhale two doses on the same day.

If you interrupt treatment with Bemrist Breezhaler

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

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

Frequent:can affect up to 1 in 10 people

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

Less frequent:can affect up to 1 in 100 people.

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

Other side effects

The following are other side effects. If these side effects become severe, please consult your doctor, pharmacist, or nurse.

Very frequent:can affect more than 1 in 10 people

• sore throat
• nasal secretion
• sudden difficulty breathing and feeling of oppression in the chest with wheezing or cough

Frequent:can affect up to 1 in 10 people

• voice alteration (hoarseness)
• nasal congestion
• stuffy nose, cough
• headache
• muscle, bone, or joint pain (signs of musculoskeletal pain)

Less frequent:can affect up to 1 in 100 people

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and the blister pack after «CAD»/«EXP». The expiration date is the last day of the month indicated.
• Do not store at a temperature 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 through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Bemrist Breezhaler

• The active principles 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 released dose (the dose released by 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 released dose (the dose released by 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 released dose (the dose released by the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.

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

Appearance of the product and contents of the pack

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

• The capsules of Bemrist Breezhaler 125 micrograms/62.5 micrograms 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 capsules of Bemrist Breezhaler 125 micrograms/127.5 micrograms have a product code “IM150-160” printed in grey on the body and a logo printed in grey on the cap.
• The capsules of Bemrist Breezhaler 125 micrograms/260 micrograms 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:

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

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

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

Only some 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

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: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 use.