Enerzair Breezhaler 114 micrograms / 46 micrograms / 136 micrograms inhalation powder, hard capsules
indacaterol / glycopyrronium / mometasone furoate (indacaterol./glycopyrron./mometasone. Fur.).
1. What Enerzair Breezhaler Is And What Enerzair Breezhaler 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 this 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 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 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 daily as your doctor prescribes, not only when you have difficulty breathing or other asthma symptoms. That way, you can have good control over your asthma. This medicine should not 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
- Have you 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
Please 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 the following:
- 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 (e.g., theophylline), or corticosteroids (e.g., 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 simultaneously may increase the risk of side effects.
- So-called beta-blockers are used for high blood pressure and other heart problems (e.g., propranolol) or the treatment of glaucoma (e.g., 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 breastfeeding, 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 your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. Enerzair Breezhaler How To Use
- 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 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 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 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 medicine.
- The sensor should be used with the Propeller app on your smartphone or any other suitable device. The sensor links to the Propeller app via Bluetooth.
- Read the instruction manual with the sensor packaging and the app for more information on using 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 with the next Enerzair Breezhaler pack.
If your symptoms do not improve
Talk to your doctor if your asthma does not get better or if you get worse after starting Enerzair Breezhaler.
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 about the use of this product, ask your doctor or pharmacist.
4. Possible Enerzair Breezhaler Side Effects
This medicine can cause side effects like all medicines, 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
- With difficulty breathing or swallowing
- Swelling of the tongue, lips, or face, rash
- Itching
- Hives (signs of allergic reaction )
Other side effects are
Other side effects that may occur are listed below. Talk to your doctor, pharmacist, or nurse if these side effects get serious.
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 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 sight and reach of children.
- Do not use this medicine after the expiry date 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 that are 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 of 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 micrograms of ms glycopyrronium bromide (equivalent to 46 micrograms glycopyrronium), and 136 micrograms of mometasone furoate.
- The other enerzair 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 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 branches tell: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
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| 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 |