Bemrist Breezhaler - patient leaflet, side effects, dosage

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 the airways and makes it easier for air to get in and out of the lungs. When it is taken regularly, it helps the small airways to remain open.

Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids).

Corticosteroids reduce the swelling and irritation (inflammation) in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.

What Bemrist Breezhaler is used for

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

Asthma is a serious, long-term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstric­tion) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough.

You should use Bemrist Breezhaler every day and not only when you have breathing problems or other symptoms of asthma. This will ensure that it controls your asthma properly. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.

If you have any questions about how Bemrist Breezhaler works or why this medicine has been prescribed for you, ask your doctor.

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

Follow all the 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, ask your doctor for advice.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Bemrist Breezhaler if any of the following applies to you:

• – if you have heart problems, including an irregular or fast heartbeat.

• – if you have thyroid gland problems.

• – if you have ever been told you have diabetes or high blood sugar.

• – if you suffer from seizures or fits.

• – if you have a low level of potassium in your blood.

• – if you have severe liver problems.

• – if you have tuberculosis (TB) of the lung, or any long-standing or untreated infections.

During treatment with Bemrist Breezhaler

Stop using this medicine and get medical help immediately if you have any of the following:

• – tightness of the chest, coughing, wheezing or breathlessness immediately after using Bemrist

Breezhaler (signs the medicine is unexpectedly tightening the airways, known as paradoxical bronchospasm).

• – difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and

hives (signs of allergic reaction).

Children and adolescents

Do not give this medicine to children below 12 years of age because 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 decrease the level of potassium in your blood. These include diuretics (which

increase urine production and can be used to treat high blood pressure, e.g.

hydrochlorothi­azide), other bronchodilators such as methylxanthines used for breathing problems (e.g. theophylline) or corticosteroids (e.g. prednisolone).

• – tricyclic antidepressants or monoamine oxidase inhibitors (medicines used in the treatment of

depression).

• – any medicines that may be similar to Bemrist Breezhaler (contain similar active substances);

using them together may increase the risk of possible side effects.

• – medicines called beta blockers used to treat high blood pressure or other heart problems (e.g.

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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you whether you can use Bemrist Breezhaler.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive and use machines.

Bemrist Breezhaler contains lactose

This medicine contains about 25 mg of lactose per capsule. If you have been told by your doctor that you have an intolerance to some sugars, speak with your doctor before taking this medicine.

3. How to use Bemrist Breezhaler

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

How much Bemrist Breezhaler to inhale

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

The usual dose is to inhale the content of one capsule each day. You only need to use the medicine once a day. Do not use more than your doctor tells you to use.

You should use Bemrist Breezhaler every day, even when your asthma is not troubling you.

When to inhale Bemrist Breezhaler

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

How to inhale Bemrist Breezhaler

• – Bemrist Breezhaler is for inhalation use.

• – In this pack, you will find an inhaler and capsules that contain the medicine. The inhaler enables

you to inhale the medicine in the capsule. Only use the capsules with the inhaler provided in this pack. The capsules should remain in the blister until you need to use them.

• – Peel the backing away from the blister to open it, do not push the capsule through the foil.

• – When you start a new pack, use the new inhaler supplied in this new pack.

• – Dispose of the inhaler in each pack after all capsules in that pack have been used.

• – Do not swallow the capsules.

• –

Please read the instructions for use on the other side of this leaflet for more information

on how to use the inhaler.

If your symptoms do not improve

If your asthma is not getting better or if it gets worse after you have started using Bemrist Breezhaler, talk to your doctor.

If you use more Bemrist Breezhaler than you should

If you accidently inhale too much of this medicine, contact your doctor or hospital for advice 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 one as soon as possible on that day. Then inhale the next dose at the usual time on the next day. 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 could be serious

Stop using Bemrist Breezhaler and get medical help immediately if you have any of the following:

Common: may affect up to 1 in every 10 people

• – difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching and

hives (signs of allergic reaction).

Uncommon: may affect up to 1 in every 100 people

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

Other side effects

Other side effects include the following listed below. If these side effects become severe, please tell your doctor, pharmacist or nurse.

Very common: may affect more than 1 in 10 people

• – sore throat

• – runny nose

• – sudden difficulty breathing and feeling of tightness in chest with wheezing or coughing

Common: may affect up to 1 in every 10 people

• – voice alteration (hoarseness)

• – blocked nose

• – sneezing, cough

• – headache

• – pain in muscles, bones or joints (signs of musculoskeletal pa­in)

Uncommon: may affect up to 1 in every 100 people

• – fast heart beat

• – oral thrush (sign of candidiasis)

• – high level of sugar in the blood

• – muscle spasm

• – skin itching

• – rash

• – clouding of the lens of your eyes (signs of cataract)

• – blurred vision

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 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 in order to protect from light and moisture, and do not

remove until immediately before use.

• – Do not throw away any medicines via wastewater. 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 Bemrist Breezhaler contains

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

Bemrist Breezhaler 125 microgram­s/62.5 micrograms

Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 80 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) 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 acetate (equivalent to 150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) 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 acetate (equivalent to 150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.

• – The other ingredient is lactose monohydrate (see “Bemrist Breezhaler contains lactose” in

• section 2).

What Bemrist Breezhaler looks like and content 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.

• – Bemrist Breezhaler 125 microgram­s/62.5 micrograms capsules have a blue product code

“IM150–80” printed above one blue bar on the body with a logo printed in blue and surrounded by two blue bars on the cap.

• – Bemrist Breezhaler 125 microgram­s/127.5 micro­grams capsules have a grey product code

“IM150–160” printed on the body with a logo printed in grey on the cap.

• – Bemrist Breezhaler 125 micrograms/260 micrograms capsules have a black product code

“IM150–320” printed above two black bars on the body with a logo printed in black and surrounded by two black bars on the cap.

The following pack sizes are available:

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

Multipacks comprising 3 cartons, each containing 30 × 1 hard capsules together with 1 inhaler. Multipacks comprising 15 cartons, each containing 10 × 1 hard capsules together with 1 inhaler.

Not all pack sizes may be available in your country.

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

RoonstraBe 25

D-90429 Nuremberg

Germany

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

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Efc^rapufl Novartis Bulgaria EOOD Ten: +359 2 489 98 28	Luxembourg/Lu­xemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Česká republika Novartis s.r.o. Tel: +420 225 775 111	Magyarorszag Novartis Hungaria Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
EÀÀàôa Novartis (Hellas) A.E.B.E. Tql: +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Laboratorios Gebro Pharma, S.A. Tel: +34 93 205 86 86	Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Laboratorio Medinfar – Produtos Farmacêuticos, S.A. Tel: +351 21 499 7400

Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL 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
Island	Slovenská republika
Vistor hf.	Novartis Slovakia s.r.o.
Simi: +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
Knnpoç	Sverige
Novartis Pharma Services Inc.	Novartis Sverige AB
Tql: +357 22 690 690	Tel: +46 8 732 32 00
Latvija	United Kingdom (Northern Ireland)
SIA Novartis Baltics	Novartis Ireland Limited
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 web site:

.

Instructions for Use of Bemrist Breezhaler

Please read full instructions for use of Bemrist Breezhaler inhaler before use.

Pierce and release

Inhale deeply Check capsule is empty

Step 3d :

Rinse mouth

Rinse your mouth with water after each dose and spit it out.

Important Information

• Bemrist Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Do not push the capsule through the foil to remove it from the blister.
• Do not swallow the capsule.
• Do not use the Bemrist Breezhaler capsules with any other inhaler.
• Do not use the Bemrist Breezhaler inhaler to take any other capsule medicine.
• Never place the capsule into your mouth or the mouthpiece of the inhaler.
• Do not press the side buttons more than once.
• Do not blow into the mouthpiece.
• Do not press the side buttons while inhaling through the mouthpiece.
• Do not handle capsules with wet hands.
• Never wash your inhaler with water.
• One Bemrist Breezhaler inhaler
• One or more blister cards, each containing

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