Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bevespi

Document Subject

Generated Narrative: MedicinalProductDefinition mp66d0f8336ebe13789d32bc377e6bfe5e

identifier: http://ema.europa.eu/identifier/EU/1/18/1339/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-66d0f8336ebe13789d32bc377e6bfe5e

identifier: http://ema.europa.eu/identifier/EU/1/18/1339/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - bevespi

Attesters

Instructions for use

What is in this leaflet

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

Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate. These belong to a group of medicines called long-acting bronchodilators.
Bevespi Aerosphere is used to make breathing easier for adults who have a lung disease called chronic obstructive pulmonary disease (COPD). COPD is a long-term disease of the airways in the lungs, which is often caused by smoking. In COPD, the muscles around the airways tighten which makes breathing difficult. The medicine prevents the tightening of the muscles around the airways, making it easier for air to get in and out of the lungs. Bevespi Aerosphere delivers the active substances directly to the airways in your lungs as you breathe in. It will help to reduce the effects of COPD on your everyday life.

Do not use Bevespi Aerosphere if

you are allergic to glycopyrronium, formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere. Warnings and precautions Bevespi Aerosphere is used regularly for long-term treatment of COPD. Do not use this medicine 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 Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm. Talk to your doctor or pharmacist before using Bevespi Aerosphere if you have asthma. Do not use this medicine for asthma you have heart problems you have diabetes you have low levels of potassium in the blood you have thyroid gland problems (called thyrotoxicosis ) you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma) you have prostate problems, or difficulty passing urine you have kidney or liver problems Always tell your doctor about other health problems. Children and adolescents Bevespi Aerosphere is not for use in children or adolescents below 18 years of age. Other medicines and Bevespi Aerosphere Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines may affect how this medicine works, or make it more likely that you will have side effects. These include:

any medicines that work in the same way as Bevespi Aerosphere, such as medicines containing active substances such as tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol, or indacaterol. Ask your doctor or pharmacist if you are not sure. It is not recommended to use Bevespi Aerosphere together with these medicines;

medicines that lower potassium in your blood. These include:* corticosteroids that you take by mouth (such as prednisolone),* diuretics (such as furosemide or hydrochlorothiazide) used for high blood pressure,* some medicines used to treat breathing conditions called methylxanthines (such as theophylline);

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

medicines which can prolong QT interval (a change in the electrical activity of the heart). These include medicines for the treatment of:* depression (such as monoamine oxidase inhibitors or tricyclic antidepressants),* bacterial infections (such as erythromycin, clarithromycin, 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 Bevespi 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 Bevespi Aerosphere. Do not use Bevespi Aerosphere if you are pregnant unless your doctor tells you that you can. Do not use Bevespi Aerosphere 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 and use machines. However, dizziness and nausea are common side effects which may occur. If this occurs, do not drive or use machines.

Always take 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. It is important to use Bevespi Aerosphere every day, even if you have no COPD symptoms at the time. How to use Bevespi Aerosphere is for inhalation use. Please read the instructions for use at the end of this leaflet. If you are not sure of how to use Bevespi Aerosphere, contact your doctor or pharmacist. Using Bevespi Aerosphere with a spacer If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist. You may be able to use a spacer with your inhaler. If you use more Bevespi Aerosphere than you should If you have used more Bevespi Aerosphere than you should, talk to a doctor or pharmacist immediately. You may need medical attention. You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache or feel nauseous (sick). If you forget to use Bevespi 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. If you stop using Bevespi Aerosphere This medicine is for long-term use. 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, first talk to your doctor. 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. Serious side effects Stop using Bevespi Aerosphere and seek immediate medical care if you notice any of the following symptoms: Uncommon (may affect up to 1 in 100 people)* 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. Other possible side effects Common (may affect up to 1 in 10 people) headache dry mouth feeling sick (nausea) painful and frequent urination (may be signs of urinary tract infection) muscle cramps chest pain anxiety feeling dizzy Uncommon (may affect up to 1 in 100 people) shaking or tremor high blood sugar levels agitation feeling restless difficulty sleeping fast or irregular heart beat difficulty passing urine (urinary retention) 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 this medicine 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. The inhaler can be used for up to 3 months after first opening the pouch. Write the date the pouch is opened on the inhaler label in the space provided. Do not store above 30oC. Warning: Do not break, puncture or burn the pressurised container, even when apparently empty. Do not expose to temperatures higher than 50oC. 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 Bevespi Aerosphere contains The active substances are glycopyrronium and formoterol fumarate dihydrate. Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate. This corresponds to a metered dose (i.e. the dose leaving the valve) of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and 5.8 microgram of formoterol fumarate dihydrate. The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride. What Bevespi Aerosphere looks like and contents of the pack Bevespi Aerosphere is a pressurised inhalation, suspension. Bevespi Aerosphere comes as a pressurised container with a dose indicator, supplied with a white plastic actuator body and mouthpiece (see Figure 1 of the Instructions for Use at the end of this leaflet). The mouthpiece is covered with an orange protective cap. Bevespi Aerosphere is supplied in a foil pouch that contains a drying packet (desiccant) and packed into a carton. The active ingredients are present in a pressurised suspension inside the pressurised container. Bevespi Aerosphere is available in packs containing 1 inhaler with 120 puffs and in multipacks comprising 3 inhalers, each containing 120 puffs. Not all pack sizes may be marketed. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca Dunkerque Production 224 Avenue de la Dordogne 59640 Dunkerque France 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 Tecnimede - Sociedade T cnico-Medicinal, S.A. Tel: +351 21 041 41 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Ireland AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Slovenija 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. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: