BEMRIST 125 MCG/62.5 MCG Inhalation powder, hard capsule

Зміст інструкції

1. Bemrist Breezhaler 125 micrograms/62.5 micrograms powder for inhalation, hard capsules
2. Bemrist Breezhaler 125 micrograms/260 micrograms powder for inhalation, hard capsules
   1. What is Bemrist Breezhaler and what it is used for
   2. What you need to know before using Bemrist Breezhaler
   3. How to take Bemrist Breezhaler
   4. Possible side effects
   5. How to store Bemrist Breezhaler
   6. Contents of the pack and other information

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

Read this leaflet carefully before you start to use 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 it is used for

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 and relaxes the muscles of the
small airways in the lungs. This helps to open the airways, making
breathing easier. When taken regularly, it helps the small airways in the lungs to
remain open.
Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). The
corticosteroids reduce swelling and irritation (inflammation) of the small airways
in the lungs and in this way gradually relieve breathing problems. The
corticosteroids also help to prevent asthma attacks.

What is Bemrist Breezhaler used for
Bemrist Breezhaler is used regularly as a treatment for asthma in adults and adolescents
(age 12 years or older).
Asthma is a serious and persistent lung disease in which the muscles around the small
airways in the lungs narrow (bronchoconstriction) and become inflamed. Symptoms
come and go and include shortness of breath, wheezing, a feeling of tightness in the chest, and cough.
You should use Bemrist Breezhaler every day, following your doctor's instructions and not only when you have
difficulty breathing or other asthma symptoms. This will allow you adequate asthma control.
You should not use this medicine to relieve a sudden attack of shortness of breath or
wheezing.
If you have any questions about how Bemrist Breezhaler works or why this medicine has been
prescribed to you, please ask your doctor.

2. What you need to know before using Bemrist Breezhaler

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 ingredients of this medicine (listed in section 6). If you think you may be allergic, contact your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse beforeusing Bemrist Breezhaler if any of the
following applies to you:

• if you have heart problems, including irregular or fast heartbeat;
• if you have problems with your thyroid gland;
• if you have been told you have diabetes or high blood sugar levels;
• if you suffer from seizures or convulsions;
• if you have low levels of potassium in your blood;
• if you have severe liver problems;
• if you have pulmonary tuberculosis (TB) or any ongoing or untreated infection.

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

• chest tightness, coughing, wheezing, or shortness of breath shortly 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, rash, itching, and hives (signs of an allergic reaction).

Children and adolescents
This medicine should not be given to children under 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 taking, have recently taken, or might take any other
medicines. In particular, tell your doctor or pharmacist if you are taking:

• medicines that lower potassium levels in the blood. These medicines include diuretics (which increase urine production and can be used to treat high blood pressure, for example, hydrochlorothiazide), other bronchodilators such as methylxanthines used for breathing problems (for example, theophylline), or corticosteroids (for example, prednisolone);
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression);
• any medicine that may be similar to Bemrist Breezhaler (containing similar active ingredients); 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 (for example, propranolol) or to treat glaucoma (for example, 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, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine. Your doctor will tell you if you can
use Bemrist Breezhaler.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.

Bemrist Breezhaler contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Bemrist Breezhaler

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

How much Bemrist Breezhaler to inhale
Bemrist Breezhaler capsules are available in three different dosages. Your doctor will decide which
dosage is most suitable for you.
The usual dose is to inhale the contents of one capsule each day. One inhalation per day is sufficient. Do not use more medicine than advised by your doctor.
You should use Bemrist Breezhaler every day, even when your asthma does not cause 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. 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 containing the medicine. The inhaler allows you to inhale the medicine contained in the capsule. Use the capsules only with the inhaler provided in this pack. The capsules must remain in the blister until you use them.
• To open the blister, remove the protective film by lifting it, do not push the capsulethrough the film.
• When you start a new pack, use the new inhaler contained in the new pack.
• Dispose of the inhaler contained in each pack after using all the capsules in the pack.
• Do not swallow the capsules.

how to use the inhaler.
If your symptoms do not improve
If your asthma does not improve or gets worse after starting to use Bemrist Breezhaler, contact your
doctor.

If you use more Bemrist Breezhaler than you should
If you accidentally inhaled too much medicine, contact your doctor or the nearest hospital
immediately. Medical care may be needed.

If you forget to use Bemrist Breezhaler
If you forgot to inhale a dose at the usual time, inhale one as soon as possible on that
same day. Then inhale the next dose the following day at the usual time. Do not inhale two doses in
the same day.

If you stop taking Bemrist Breezhaler
Do not stop using Bemrist Breezhaler without consulting your doctor. Your asthma symptoms may
return 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 can be serious
Stop using Bemrist Breezhaler and seek immediate medical attention 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.

• swelling, especially 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, talk to your doctor, pharmacist or nurse.

Very common:may affect more than 1 in 10 people

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

Common:may affect up to 1 in 10 people

• change in voice (hoarseness)
• blocked nose
• sneezing, cough (upper respiratory tract infection)
• headache
• muscle, bone or joint pain (signs of musculoskeletal pain)

Uncommon:may affect up to 1 in 100

• fast heartbeat
• oral thrush (sign of candidiasis)
• high blood sugar levels (hyperglycemia)
• muscle spasm
• itchy skin
• skin rash
• clouding of the lens of the eyes (sign 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 through 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 that is stated on the package and on the blister after “scad”/“EXP”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30° C.
• Keep the capsules in the original blister to protect them from light and moisture and only remove them at the time of use.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bemrist Breezhaler contains

• The active ingredients 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 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 acetate (equivalent to
150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose
(the dose 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 acetate (equivalent to
150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose
(the dose released from the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol
and 260 micrograms of mometasone furoate.

• The other ingredients are lactose monohydrate (see “Bemrist Breezhaler contains lactose” in paragraph 2) and gelatin (capsule shell).
• The 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.

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

The following packs are available:
Single pack containing 10 x 1 or 30 x 1 hard capsules and 1 inhaler.
Multipack consisting of 3 packs, each containing 30 x 1 hard capsules and 1 inhaler.
Multipack consisting of 15 packs, each containing 10 x 1 hard capsules and 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 Nuremberg
Germany
For further information on this medicine, 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

България
Novartis Bulgaria EOOD
Тел: +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

Magyarország
Novartis Hungária 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

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +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
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine 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.

InsertPierce and releaseInhale
deeply
Check that the
capsule is empty
23