114 micrograms / 46 micrograms / 136 micrograms inhalation powder , hard capsules 
indacaterol / glycopyrronium / mometasone furoate (indacaterol./glycopyrron./mometason. Fur.).

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Enerzair Breezhaler is and what it is used for 
2. What you need to know before you use Enerzair Breezhaler 
3. How to use Enerzair Breezhaler 
4. Possible side effects 
5. How to store Enerzair Breezhaler 6. Contents of the pack 
and other information 

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

What Enerzair Breezhaler is and how it works

Enerzair Breezhaler contains three active substances:

  • indacaterol
  • glycopyrronium
  • mometasone furoate

Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They do in different ways so that the muscles in the small airways in the lungs relax. This helps to dilate the airways so that it is easier for the air to get in and out of the lungs. Taking the medicine regularly helps to keep the small airways constantly open.

Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids ). Corticosteroids are anti-inflammatory. They reduce the swelling and irritation ( inflammation en) in the small airways in the lungs and thus gradually reduce the breathing problems. Corticosteroids also help prevent asthma attacks.

What Enerzair Breezhaler is used for

Enerzair Breezhaler is regularly used to treat asthma in adults.

Asthma is a serious, chronic lung disease in which the muscles around the small airways contract ( bronchoconstriction ) and become inflamed. The symptoms come and go and can be shortness of breath, wheezing, tightness in the chest, and cough.

Use Enerzair Breezhaler every day as prescribed by your doctor, not only when you have difficulty breathing or have other asthma symptoms. That way, you can have good control over your asthma. This medicine should not be used to relieve a sudden attack of shortness of breath or wheezing.

Ask your doctor if you are wondering how Enerzair Breezhaler works or why the medicine has been prescribed for you.

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

Follow your doctor’s instructions carefully.

Do not use Enerzair Breezhaler

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

Warnings and cautions

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

  • you have heart problems, e.g. irregular or rapid heartbeat
  • you have thyroid problems
  • you have ever been informed that you have diabetes or high blood sugar
  • you have seizures
  • you have severe kidney problems
  • you have severe liver problems
  • you have low potassium in your blood
  • You have an eye disease called angle-closure glaucoma
  • you have difficulty urinating
  • you have pulmonary tuberculosis or any other long-term or untreated infection.

Under treatment with Enerzair Breezhaler

Stop using this medicine and seek immediate medical attention if you have any of the following:

  • chest tightness, coughing, wheezing, or shortness of breath shortly after taking Enerzair Breezhaler (evidence that the medicine has caused an unexpected narrowing of the airways, called paradoxical bronchospasm )
  • difficulty breathing or swallowing, swelling of the tongue, lips, or face, rash, itching, and hives (signs of allergic reaction )
  • pain or discomfort in the eyes, temporary blurred vision, halophenomas (light rings around light sources), or colored vision phenomena associated with red eyes (signs of an attack of angle-closure glaucoma).

Children and young people

Do not give this medicine to children or adolescents (under 18 years of age) as it has not been studied in this age group.

Other medicines and Enerzair Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must tell your doctor or pharmacist if you are taking:

  • drugs that lower potassium levels in the blood. These include diuretics (so-called ” diuretics ” that increase urine production and can be used for high blood pressure, such as hydrochlorothiazide ), other bronchodilators such as methylxanthines used for respiratory problems (eg theophylline), or corticosteroids (eg prednisolone ).
  • tricyclic antidepressants or monoamine oxidase inhibitors ( antidepressants ).
  • any medicine that may be similar to Enerzair Breezhaler (contains the same active substances). Using both medicines at the same time may increase the risk of side effects.
  • so-called beta-blockers used for high blood pressure and other heart problems (eg propranolol), or the treatment of glaucoma (eg timolol ).
  • ketoconazole or itraconazole (used to treat fungal infections).
  • ritonavir, nelfinavir or kobicistat (used for HIV – infection ).

Pregnancy and breastfeeding

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 using this medicine. Your doctor will tell you if you can take Enerzair Breezhaler or not.

Driving and using machines

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

Enerzair Breezhaler contains lactose

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

3. How to use Enerzair Breezhaler

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much Inerzair Breezhaler to inhale

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

Use Enerzair Breezhaler every day, even if you do not experience any problems with your asthma.

When to inhale Enerzair Breezhaler

Inhale Enerzair Breezhaler at the same time each day. It helps keep your symptoms under control around the clock. It also makes it easier to remember to take the medicine.

How to inhale Enerzair Breezhaler

  • Enerzair Breezhaler should be used for inhalation.
  • This pack contains an inhaler and capsules that contain the medicine. Using the inhaler, you can inhale the medicine into the capsule. Use only the capsules with the inhaler provided with the package. The capsules should remain in the blister until you use them.
  • Pull the back of the blister to open it, do not push the capsule through the foil.
  • When starting a new pack, use the new inhaler in the new pack.
  • Discard the inhaler provided in the package when all the capsules in the package have been used.
  • Do not swallow the capsules.
  • Read the instructions on the other side of this leaflet for more information on using the inhaler.

If your Enerzair Breezhaler pack also contains a sensor

  • The sensor and the app are not necessary for you to be able to take your medicine. The sensor does not have to be connected to the app when you take the medicine.
  • Your doctor will decide if the sensor and the app are suitable for you to use.
  • The electronic sensor for the Enerzair Breezhaler must be attached to the bottom of the Enerzair Breezhaler inhaler.
  • The sensor checks that you have used Enerzair Breezhaler correctly by detecting and monitoring the activation and hissing sound from the spinning capsule during inhalation but does not monitor that you have received the dose you are taking the medicine.
  • The sensor should be used together with the Propeller app in your smartphone or any other suitable device. The sensor links to the Propeller app via Bluetooth.
  • Read the instruction manual that comes with the sensor packaging and the app for more information on how to use the sensor for Enerzair Breezhaler and the app.
  • When all the capsules in a pack of Enerzair Breezhaler have been used, the sensor should be moved to the new inhaler that comes with the next Enerzair Breezhaler pack.

If your symptoms do not improve

If your asthma does not get better or if you get worse after starting Enerzair Breezhaler, talk to your doctor.

If you use more Enerzair Breezhaler then you should  

If you have inhaled too much of this medicine, contact your doctor or hospital immediately for advice. You may need medical attention.

If you forget to use Enerzair Breezhaler

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

If you stop using Enerzair Breezhaler

Do not stop using Enerzair Breezhaler unless your doctor tells you to. Your asthma symptoms may return if you stop using the medicine.

If you have any further questions on the use of this product, 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 Enerzair Breezhaler and seek medical attention immediately if you get any of the following:

Common: may affect up to 1 in 10 users

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

Other side effects are

Other side effects that may occur are listed below. If these side effects get serious, talk to your doctor, pharmacist, or nurse.

Very common: may affect more than 1 user in 10

  • sore throat
  • Runny nose
  • sudden difficulty breathing and feeling of pressure over the chest with wheezing or coughing

Common: may affect up to 1 in 10 users

  • fungal infection of the mouth ( oral candidiasis). After taking your dose, rinse your mouth with water or mouthwash solution and then spit it out. This will help you avoid getting fungus in your mouth.
  • frequent urination and pain or burning when urinating (signs of urinary tract infection)
  • headache
  • fast heartbeat
  • cough
  • voice changes (hoarseness)
  • diarrhea, abdominal cramps, nausea, and vomiting ( gastroenteritis )
  • pain in muscles, bones, or joints (signs of musculoskeletal pain)
  • muscle spasm
  • fever

Uncommon: may affect up to 1 in 100 people

  • dry mouth
  • rash
  • high blood sugar
  • itching of the skin
  • problems and pain when urinating (signs of dysuria )
  • cloudiness in the lens of the eye (signs of cataracts)

5. How to store Enerzair 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 expiration date is the last day of the specified month.
  • No special temperature instructions.
  • Store the capsules in the original package (blister). Sensitive to light and moisture. Remove from blister immediately before use.
  • Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
  • If your package contains an electronic sensor for Enerzair Breezhaler, read the operating instructions in the sensor package for detailed instructions on how to store it and when to dispose of it.

6. Contents of the packaging and other information

Content declaration

  • The active substances are indacaterol (as acetate), glycopyrronium (as bromide), and mometasone furoate. Each capsule contains 150 micrograms of indacaterol (as acetate), 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms glycopyrronium), and 160 micrograms of mometasone furoates. Each dose delivered (the dose leaving the mouthpiece of the inhaler) contains 114 micrograms of indacaterol (as acetate), 58 microgram of ms glycopyrronium bromide (equivalent to 46 micrograms glycopyrronium), and 136 micrograms of mometasone furoate.
  • The other ingredients are lactose monohydrate and magnesium stearate (see “Enerzair Breezhaler contains lactose” in section 2).

What the medicine looks like and the contents of the pack

This pack contains an inhaler together with blister capsules. Some packages also contain a sensor. The capsules are transparent and contain a white powder. They have the product code “IGM150‑50‑160” printed in black above two black lines on the lower part and a logo printed in black surrounded by a black line on the upper part.

Pack sizes:

Pack of 10 x 1, 30 x 1 or 90 x 1 hard capsules and 1 inhaler.

Pack of 30 x 1 hard capsules and 1 inhaler and 1 sensor.

Multipack consisting of 15 cartons with 10 x 1 hard capsules and 1 inhaler in each carton.

Not all pack sizes may be available in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Pharmacéutica, SA

Ronda de Santa Maria, 158

08210 Barberà del Vallés (Barcelona)

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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