Bemrist Breezhaler

Package leaflet: Information for the user

Bemrist Breezhaler 125 micrograms/62.5 micrograms powder for inhalation, hard capsules

Bemrist Breezhaler 125 micrograms/127.5 micrograms powder for inhalation, hard capsules
Bemrist Breezhaler 125 micrograms/260 micrograms powder for inhalation, hard capsules
indacaterol/mometasone furoate
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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. How to store Bemrist Breezhaler
6. Contents of the pack and other information
   Instructions for use of the Bemrist Breezhaler inhaler

1. What is Bemrist Breezhaler and what is it 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 and relaxes the muscles in the small airways of the lungs. This helps to open up the airways, making breathing easier. When taken regularly, it helps keep the small airways in the lungs open.
Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce swelling and irritation (inflammation) in the small airways of the lungs, thereby gradually relieving breathing problems. Corticosteroids also help prevent asthma attacks.

What Bemrist Breezhaler is used for
Bemrist Breezhaler is used regularly as a treatment for asthma in adults and adolescents (aged 12 years and older).
Asthma is a serious, long-term lung disease in which the muscles surrounding the small airways of the lungs tighten (bronchoconstriction) and become inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness, and coughing.
You must use Bemrist Breezhaler every day as directed by your doctor, not only when you have breathing difficulties or other asthma symptoms. This will help you achieve adequate asthma control.
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, consult your doctor.

2. What you need to know before using 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 before using Bemrist Breezhaler if any of the following apply to you:

• if you have heart problems, including irregular or rapid heartbeat;
• if you have thyroid gland problems;
• if you have been diagnosed with diabetes or have high blood sugar levels;
• if you suffer from epileptic seizures or convulsions;
• if you have low potassium levels in your blood;
• if you have severe liver problems;
• if you have active or untreated pulmonary tuberculosis (TB), or any long-standing or untreated infection.

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

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

Children and adolescents
This medicine must not be given to children under 12 years of age, as it has not been studied in this age group.
Other medicines and Bemrist Breezhaler
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are using:

• medicines that lower potassium levels in the blood. These include diuretics (which increase urine production and may be used to treat high blood pressure, for example hydrochlorothiazide), other bronchodilators such as methylxanthines used for respiratory problems (e.g. theophylline), or corticosteroids (e.g. prednisolone);
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression);
• any medicine similar to Bemrist Breezhaler (containing 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 infections).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will advise you whether you can use Bemrist Breezhaler.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machinery.
Bemrist Breezhaler contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Bemrist Breezhaler

Always use this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
How much Bemrist Breezhaler to inhale
Bemrist Breezhaler capsules are available in three different strengths. Your doctor will decide which
strength is most suitable for you.
The usual dose is the inhalation of the contents of one capsule daily. Only one inhalation per day is
required. Do not use more medicine than your doctor has prescribed.
You must use Bemrist Breezhaler every day, even when your asthma is not causing you problems.
When to inhale Bemrist Breezhaler
Use Bemrist Breezhaler every day at the same time. This will help you control your symptoms during
the day and night, and will also help you remember to take it.
How to inhale Bemrist Breezhaler

• Bemrist Breezhaler is for inhalation only.
• This pack contains an inhaler and capsules containing 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 must remain in the blister until you are ready to use them.
• To open the blister, peel back the protective film, do not push the capsule through the film.
• When starting a new pack, use the new inhaler provided in that pack.
• Dispose of the inhaler from each pack after using all the capsules in the pack.
• Do not swallow the capsules.
• Read the instructions on the other side of this leaflet for further information on how to use the inhaler.

If symptoms do not improve
If your asthma does not improve or worsens after starting Bemrist Breezhaler, contact your
doctor.
If you use more Bemrist Breezhaler than you should
If you accidentally inhale too much medicine, contact your doctor or the nearest hospital immediately.
Medical treatment may be required.
If you forget to use Bemrist Breezhaler
If you have forgotten to inhale a dose at your usual time, inhale one as soon as possible on the same
day. Then take your next dose the following day at your usual time. Do not inhale two doses on the
same day.
If you stop using Bemrist Breezhaler
Do not stop using Bemrist Breezhaler without first consulting your doctor. Your asthma symptoms may
return if you stop using it.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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:
Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

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

Other side effects
Other side effects are listed below. If these side effects become severe, consult your doctor, pharmacist or nurse.
Very common: may affect more than 1 in 10 people

• sore throat
• runny nose (nasopharyngitis)
• sudden difficulty breathing and feeling of tightness in the chest with wheezing or coughing (asthma exacerbation)
• oropharyngeal pain

Common: may affect up to 1 in 10 people

• voice disorder (hoarseness)
• nasal congestion
• sneezing, cough (upper respiratory tract infection)
• headache
• muscle, bone or joint pain (signs of musculoskeletal pain)

Uncommon: may affect up to 1 in 100 people

• fast heartbeat
• oral thrush (sign of candidiasis)
• high blood sugar levels (hyperglycaemia)
• muscle spasm
• skin itching
• skin rash
• clouding of the eye lens (sign of cataract)
• blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the carton and on the blister after "exp"/"EXP". The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Keep the capsules in the original blister to protect them from light and moisture, and remove them from the blister only at the time of use.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 released from 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 released from 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 released from the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol
and 260 micrograms of mometasone furoate.

• The other components are lactose monohydrate (see “Bemrist Breezhaler contains lactose” in section 2) and gelatin (capsule shell).
• Components of the printing ink are:

Bemrist Breezhaler 125 micrograms/62.5 micrograms
Lacquer, brilliant blue FCF (E133), propylene glycol (E1520), titanium dioxide (E171) and iron oxide black (E172).
Bemrist Breezhaler 125 micrograms/127.5 micrograms
Lacquer, titanium dioxide (E171), iron oxide black (E172), propylene glycol (E1520), iron oxide yellow (E172) and ammonium hydroxide (E527).
Bemrist Breezhaler 125 micrograms/260 micrograms
Lacquer, iron oxide black (E172), propylene glycol (E1520) and ammonium hydroxide (E527).

Description of the appearance of Bemrist Breezhaler and contents of the pack
This pack contains an inhaler and capsules in blisters. The capsules are transparent and contain a white powder.

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

The following pack sizes are available:
Single pack containing 10 x 1 or 30 x 1 hard capsules and 1 inhaler.
Multiple pack consisting of 3 cartons, each containing 30 x 1 hard capsules and 1 inhaler.
Multiple pack consisting of 15 cartons, each containing 10 x 1 hard capsules and 1 inhaler.
Not all pack sizes may be marketed.

Marketing Authorization 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 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD 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.
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 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal 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
Laboratorios Gebro Pharma, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 205 86 86 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

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
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Instructions for use of Bemrist Breezhaler

Before using the Bemrist Breezhaler inhaler, read the instructions for use completely.

Insert Puncture and release Inhale Check that the
deeply capsule is empty
2 3