Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - trixeo

Document Subject

Generated Narrative: MedicinalProductDefinition mpc320b0f7ef6b0e703d9abd8eff34bf82

identifier: http://ema.europa.eu/identifier/EU/1/20/1498/002 120 actuations

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension

type: Full name

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part: nan

type: Invented name part

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part: nan

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c320b0f7ef6b0e703d9abd8eff34bf82

identifier: http://ema.europa.eu/identifier/EU/1/20/1498/002 120 actuations

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - trixeo

Attesters

Instructions for use

What is in this leaflet

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

Trixeo Aerosphere contains three active substances: formoterol fumarate dihydrate, glycopyrronium, and budesonide.

Formoterol fumarate dihydrate and glycopyrronium belong to a group of medicines called bronchodilators . They work in different ways to prevent tightening of the muscles around the airways, making it easier for air to get in and out of the lungs.

Budesonide belongs to a group of medicines called corticosteroids . These work by reducing inflammation in your lungs. Trixeo Aerosphere is an inhaler that is used for adults with a lung disease called chronic obstructive pulmonary disease (or COPD ), a long-term disease of the airways in the lungs. Trixeo Aerosphere is used to make breathing easier and improve symptoms of COPD such as shortness of breath, wheezing and cough. Trixeo Aerosphere can also prevent flare-ups (exacerbations) of COPD. Trixeo Aerosphere delivers the active substances into your lungs as you breathe in. If you use this medicine regularly twice a day, it will help to reduce the effects of COPD on your everyday life.

Do not use Trixeo Aerosphere

if you are allergic to formoterol fumarate dihydrate, glycopyrronium, budesonide or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Trixeo Aerosphere is used as a long-term maintenance treatment for COPD. Do not use it to treat a sudden attack of breathlessness or wheezing. Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Trixeo Aerosphere, stop using it and tell your doctor straight away (see Serious side effects at the top of Section 4 for more information). If your breathlessness, tightness of the chest, wheezing or coughing is getting worse while using Trixeo Aerosphere, you should continue to use Trixeo Aerosphere but contact your doctor as soon as possible, as you may need additional treatment. Talk to your doctor before using Trixeo Aerosphere if:

you have high blood pressure or heart problems

you have diabetes

you have a lung infection

you have problems with your thyroid gland

you have low levels of potassium in your blood

you have prostate problems or any problems passing urine

you have an eye problem called angle-closure glaucoma

you have kidney or liver problems. Talk to your doctor if you think any of these may apply to you. Children and adolescents Trixeo Aerosphere has not been studied in children and adolescents. Do not give this medicine to children or adolescents below the age of 18 years. Other medicines and Trixeo Aerosphere Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines. This is because Trixeo Aerosphere can affect the way some medicines work. Also some medicines can affect how Trixeo Aerosphere works, or make it more likely that you will have side effects. Tell your doctor or pharmacist if you are taking any of the following:

medicines called beta-blockers (such as atenolol or propranolol), that may be used for high blood pressure or heart problems, or to treat glaucoma (such as timolol)

medicines which are used to treat fungal infections such as ketoconazole or itraconazole

medicines which are used to treat HIV infection such as ritonavir or cobicistat

medicines that lower the amount of potassium in your blood, such as:

corticosteroids that you take by mouth (such as prednisolone),

diuretics medicines that increase urine production (such as furosemide or hydrochlorothiazide), which can be used for treating high blood pressure,

some medicines used to treat breathing problems (such as theophylline) called methylxanthines ,

any medicines that work in the same way as Trixeo Aerosphere such as tiotropium, ipratropium, aclidinium, umeclidinium or salmeterol, arformoterol, vilanterol, olodaterol or indacaterol. Do not use Trixeo Aerosphere if you already use these medicines.

medicines which are used to treat heart rhythm problems such as amiodarone

medicines which can change some electrical activity of the heart (called the QT interval ) such as medicines for:

depression (such as monoamine oxidase inhibitors or tricyclic antidepressants),

bacterial infections (such as erythromycin, clarithromycin or telithromycin),

allergic reactions (anti-histamines). If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Trixeo Aerosphere. 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 or pharmacist for advice before taking this medicine. Do not use Trixeo Aerosphere if you are pregnant unless your doctor tells you that you can. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can. Driving and using machines It is unlikely that this medicine will affect your ability to drive or use machines. However, dizziness is an uncommon side effect which should be taken into account when driving or using machines.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to use The recommended dose is two puffs twice a day two puffs in the morning and two puffs in the evening. It is important to use Trixeo Aerosphere every day even if you have no COPD symptoms at the time. Remember: Always rinse your mouth with water after using Trixeo Aerosphere. This is to remove any medicine which is left in the mouth. Spit this water out do not swallow. How to use Trixeo Aerosphere is for inhalation use. Please read the Instructions for Use at the end of this leaflet. If you are not sure how to use Trixeo Aerosphere, talk to your doctor or pharmacist. Using Trixeo Aerosphere with a spacer You may find it difficult breathing in and pressing the inhaler at the same time. If this happens, talk to your doctor or pharmacist. It may help to use a spacer with your inhaler. If you use more Trixeo Aerosphere than you should If you have used more Trixeo Aerosphere than you should, talk to a doctor or pharmacist straight away. You may need medical attention. You may notice that your heart is beating faster than usual, you feel shaky, you have problems with your sight, you have a dry mouth or you have a headache or feel sick (nausea). If you forget to use Trixeo Aerosphere Do not take a double dose to make up for a forgotten dose. Take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not take more than two puffs twice a day on the same day. If you stop using Trixeo Aerosphere This medicine is for long-term use. Use this medicine for as long as your doctor tells you to. It will only be effective as long as you are using it. Do not stop unless your doctor tells you to even if you feel better as your symptoms may get worse. If you want to stop treatment, talk to your doctor first. If you have any further questions on the use of this medicine, talk to your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Serious side effects Uncommon (may affect up to 1 in 100 people) Immediate breathing difficulties:

if you get breathing difficulties straight after using Trixeo Aerosphere, such as tightness of the chest, coughing, wheezing or feeling breathless, stop using this medicine and tell your doctor straight away. Allergic reactions:

swelling of your face, particularly around your mouth (swelling of your tongue or throat may make it difficult to swallow)

rash or hives together with difficulty breathing

suddenly feeling faint These symptoms may be signs of an allergic reaction which may become serious. Stop using this medicine and call for medical help straight away if you notice the serious side effects above. Other side effects Tell your doctor or pharmacist if you notice any of the following side effects: Common (may affect up to 1 in 10 people)

thrush in the mouth (a fungal infection). Rinsing your mouth out with water immediately after using Trixeo Aerosphere may help prevent this.

feeling anxious

difficulty sleeping

feeling sick (nausea)

headache

coughing or a hoarse voice

muscle cramps

awareness of your heart beating (palpitations)

high blood sugar levels (as shown in tests)

painful and frequent urination (may be signs of a urinary tract infection)

pneumonia (infection of the lung). Tell your doctor if you have any of the following while using Trixeo Aerosphere, they could be symptoms of a lung infection:

fever or chills,

increased mucus production, change in mucus colour,

increased cough or increased breathing difficulties. Uncommon (may affect up to 1 in 100 people)

shaking, tremor or feeling dizzy

dry mouth, or mild irritation in the throat

bruising of the skin

feeling restless, nervous or agitated

depression

fast heart beat or uneven heart beat

chest pain or tightening in the chest (angina pectoris) Very rare (may affect up to 1 in 10,000 people)

changes in behaviour

an effect on the adrenal gland Not known (frequency cannot be estimated from the available data):

blurred vision

clouding of the lens of your eyes (signs of cataract)

increased pressure in the eye (glaucoma)

swelling of your face, particularly around your mouth (swelling of your tongue or throat may make it difficult to swallow) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 Trixeo Aerosphere after the expiry date which is stated on the carton, pouch and pressurised container after EXP . The expiry date refers to the last day of that month. After opening the pouch, the inhaler must be used within 3 months. Keep the inhaler inside the sealed pouch only remove the inhaler from the sealed pouch immediately before first use. On the day the pouch is opened, write the date on the inhaler label in the space provided. Do not store above 30 C. Store in a dry place. For best results, the inhaler should be at room temperature before you use it. Do not break, puncture or burn the pressurised container, even when apparently empty. Do not use or store near heat or open flames. 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.

What Trixeo Aerosphere contains The active substances are formoterol fumarate dihydrate, glycopyrronium and budesonide. Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 5 micrograms of formoterol fumarate dihydrate, 9 micrograms glycopyrronium bromide equivalent to 7.2 micrograms glycopyrronium and 160 micrograms of budesonide. The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride. What Trixeo Aerosphere looks like and contents of the pack Trixeo Aerosphere is a pressurised inhalation, suspension. Trixeo Aerosphere comes as a canister with a dose indicator, supplied with a yellow plastic actuator body and white mouthpiece. The mouthpiece is covered with a removable grey protective cap. Trixeo Aerosphere is supplied in a foil pouch that contains a drying packing (desiccant) and packed into a carton. Each inhaler contains 120 puffs. Additionally, there are multipacks containing 3 pressurised containers with 120 puffs, each. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca Dunkerque Production 224 Avenue de la Dordogne Dunkerque 59France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: