Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zimbus

Document Subject

Generated Narrative: MedicinalProductDefinition mpd184441eaf6370e77e170ec9c0dc05db

identifier: http://ema.europa.eu/identifier/EU/1/20/1440/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zimbus Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d184441eaf6370e77e170ec9c0dc05db

identifier: http://ema.europa.eu/identifier/EU/1/20/1440/001-005

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zimbus

Attesters

Instructions for use of Zimbus Breezhaler inhaler

What is in this leaflet:

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

What Zimbus Breezhaler is and how it works Zimbus Breezhaler contains three active substances:

• indacaterol
• glycopyrronium
• mometasone furoate

Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They work in different ways to relax 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 they are taken regularly, they help 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 Zimbus Breezhaler is used for Zimbus Breezhaler is used regularly as treatment for asthma in adults.

Asthma is a serious, long-term lung disease where the muscles around 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 Zimbus 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 Zimbus Breezhaler works or why this medicine has been prescribed for you, ask your doctor.

Follow all the doctor s instructions carefully.

Do not use Zimbus Breezhaler

• if you are allergic to indacaterol, glycopyrronium, 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 Zimbus 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 severe kidney problems.
• if you have severe liver problems.
• if you have a low level of potassium in your blood.
• if you have an eye problem called angle-closure glaucoma.
• if you have difficulty passing urine.
• if you have tuberculosis (TB) of the lung, or any long standing or untreated infections.

During treatment with Zimbus 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 Zimbus 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).
• eye pain or discomfort, temporary blurring of vision, visual haloes (seeing bright circles around lights) or coloured images in association with red eyes (signs of an attack of angle-closure glaucoma).

Children and adolescents Do not give this medicine to children or adolescents (below the age of 18 years) because it has not been studied in this age group.

Other medicines and Zimbus 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 Zimbus 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 Zimbus Breezhaler.

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

Zimbus 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.

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 Zimbus Breezhaler to inhale 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 Zimbus Breezhaler every day, even when your asthma is not troubling you.

When to inhale Zimbus Breezhaler Inhale Zimbus 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 Zimbus Breezhaler

• Zimbus 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 pack contains a sensor for Zimbus Breezhaler

• The sensor and App are not required in order for you to take your medicine. The sensor does not need to be connected to the App when taking your medicine.
• Your doctor will decide whether use of the sensor and App is appropriate for you.
• The electronic sensor for Zimbus Breezhaler is to be attached to the base of the Zimbus Breezhaler inhaler.
• The sensor confirms that you have used the Zimbus Breezhaler inhaler by recording and monitoring its actuations and the whirring noise of the spinning capsule during inhalation but it will not monitor whether you have received the dose of your medicine.
• The sensor is to be used with the Propeller App on your smart phone or another suitable device. The sensor links with the Propeller App via Bluetooth.
• Please read the instructions for use provided in the sensor pack and the App for more information on how to use the sensor for Zimbus Breezhaler and the App.
• After all Zimbus Breezhaler capsules in a pack have been used, move the sensor to the new inhaler in the next Zimbus Breezhaler pack.

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

If you use more Zimbus 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 Zimbus 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 Zimbus Breezhaler Do not stop using Zimbus 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be serious Stop using Zimbus 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).

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

• oral thrush (sign of candidiasis). After you have finished taking your dose, rinse your mouth with water or a mouthwash solution and then spit this out. This will help to prevent thrush.
• a frequent urge to urinate and pain or burning when urinating (signs of urinary tract infection)
• headache
• fast heart beat
• cough
• voice alteration (hoarseness)
• diarrhoea, 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 every 100 people

• dry mouth
• rash
• high level of sugar in the blood
• skin itching
• difficulty and pain when passing urine (signs of dysuria)
• clouding of the lens of your eyes (signs of cataract)

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.

• 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 or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
• If your pack contains an electronic sensor for Enerzair Breezhaler, see the Instructions for Use provided in the sensor pack for detailed instructions on how to store and when to discard it.

What Zimbus Breezhaler contains

• 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 furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 114 micrograms of indacaterol (as acetate), 58 micrograms of glycopyrronium bromide (equivalent to 46 micrograms of glycopyrronium) and 136 micrograms of mometasone furoate.
• The other ingredients are lactose monohydrate and magnesium stearate (see Zimbus Breezhaler contains lactose in section 2).

What Zimbus Breezhaler looks like and contents of the pack In this pack, you will find an inhaler together with capsules in blisters. Some packs also contain a sensor device. The capsules are transparent and contain a white powder. They have a black product code IGM150-50-160 printed above two black bars on the body with a logo printed in black and surrounded by a black bar on the cap.

The following pack sizes are available: Single pack containing 10 x 1, 30 x 1 or 90 x 1 hard capsules, together with 1 inhaler. Pack containing 30 x 1 hard capsules, together with 1 inhaler and 1 sensor. Multipacks comprising 15 cartons, each containing 10 x 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 Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Laboratorios Gebro Pharma, S.A. Tel: +34 93 205 86 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Laborat rio Medinfar - Produtos Farmac uticos, S.A. Tel: +351 21 499 7Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: