Bevespi Aerosphere - patient leaflet, side effects, dosage

1. What Bevespi Aerosphere is and what it is used for

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 ingredients directly to the airways in your lungs as you breathe in. It will help to reduce the effects of COPD on your everyday life.

2. What you need to know before you use Bevespi Aerosphere

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:

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

o diuretics (such as furosemide or hydrochlorothi­azide) used for high blood pressure, o 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:

o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o 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.

3. How to use Bevespi Aerosphere

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, talk to your doctor or pharmacist.

4. Possible side effects

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:

o swelling of your face, particularly around your mouth (swelling of your tongue or

throat may make it difficult to swallow);

o rash or hives together with difficulty breathing o 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Bevespi Aerosphere

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.

6. Contents of the pack and other information

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.

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 Sodertalje

Sweden

Manufacturer

AstraZeneca Dunkerque Production

224 Avenue de la Dordogne

Dunkerque

59640

France

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

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

Belgie/Belgiqu­e/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 Efcnrapua Acmpa3eHeKa Etnrapua EOOfl Ten.: +359 24455000 Česká republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111

Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 Luxembourg/Lu­xemburg AstraZeneca S.A./N.V. Tel/Tel: +32 2 370 48 11 Magyarorszag AstraZeneca Kft. Tel.: +36 1 883 6500

Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH Tel: +49 41 03 7080	Nederland AstraZeneca BV Tel: +31 79 363 2222
Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00
EXXáSa AstraZeneca A.E. Tql: +30 210 6871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7100	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog AXéKTop Oap^aKeuTiK^ At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in < {MM/YYYY }><{month YYYY }>.

Other sources of information

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

Instructions for use

Bevespi Aerosphere, 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate

Read this instructions for use and the package leaflet before you start using Bevespi Aerosphere and each time you get a new inhaler. There may be new information. This information should be used alongside a discussion with your doctor about your medical condition and treatment.

Important Information:

• For inhalation use only.
• Use Bevespi Aerosphere exactly as your doctor tells you to.
• Talk to your doctor or pharmacist if you have any questions about the use of your inhaler.

|The parts of your Bevespi Aerosphere inhaler (See Figure 1 ):|

• Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an

actuator.

o Do not use the Bevespi Aerosphere actuator with any other medicine.

o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.

SIDE VIEW

TOP VIEW

Dose indicator display window

Pointer

Press here

Figure 1

• Bevespi Aerosphere comes with a dose indicator on the top of the pressurised container (See

Figure 1 ). The dose indicator display window shows how many puffs of medicine you have left. A puff of medicine is released each time you press the centre of the dose indicator.

Before you use Bevespi Aerosphere for the first time|

Before you use Bevespi Aerosphere for the first time, make sure that the pointer on the dose indicator is pointing to the right of the “120” inhalation mark in the dose indicator display window (See Figure 1 ).

• The pointer points to 120 after 10 puffs are delivered from Bevespi Aerosphere. This means that

there are 120 puffs of medicine left in the pressurised container (See Figure 2a ).

• The pointer points between 100 and 120 after you use 10 more puffs. This means that there are

110 puffs of medicine left in the pressurised container (See Figure 2b ).

• The pointer points to 100 after you take 10 more puffs. This means that there are 100 puffs of

medicine left in the pressurised container (See Figure 2c).

• The dose indicator display window will move after every 10 puffs. The number in the dose

indicator display window will change after every 20 puffs.

Figure 2d

• The colour in the dose indicator display window will change to red, as shown in the shaded

area, when there are only 20 puffs of medicine left in your inhaler (See Figure 2d ).

• When the arrow reaches ‘0’, you must stop using your inhaler. Your inhaler may not feel empty

and it may seem as though it still works. However, you will not get the right amount of medicine if you keep using it.

[Preparing your Bevespi Aerosphere inhaler for use:|

• Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet

(desiccant).

o Take the Bevespi Aerosphere inhaler out of the foil pouch.

o Throw away the pouch and the drying packet. Do not use the inhaler if the drying agent has leaked out of its packet.

Figure 3

[Priming your Bevespi Aerosphere inhaler:

Before you use Bevespi Aerosphere for the first time, you must prime the inhaler.

• Remove the cap from the mouthpiece (See Figure 3). Check inside the mouthpiece before you

use the inhaler to make sure it is clear.

• Hold the inhaler upright, away from your face and shake it well (See Figure 4).

Figure 4

• Press down firmly on the centre of the dose indicator until the pressurised container stops

moving in the actuator. This will release a puff of medicine from the mouthpiece (See Figure 5 ). You may hear a soft click from the dose indicator as it counts down during use.

Figure 5

• Repeat the priming steps 3 more times (See Figure 4 and Figure 5). Shake the inhaler well

before each priming puff.

• After priming 4 times, the dose indicator should be pointing to the right of “120” and your

inhaler is now ready to use.

[Using your Bevespi Aerosphere inhaler:

Step 1 : Remove the cap from the mouthpiece (See Figure 6 ).

Figure 6

Step 2 : Shake the inhaler well before each use (See Figure 7 ).

Figure 7

Step 3 : Hold the inhaler with the mouthpiece pointing towards you and breathe out as fully as you comfortably can through your mouth (See Figure 8 ).

Figure 8

Step 4 : Close your lips around the mouthpiece and tilt your head back, keeping your tongue below the mouthpiece (See Figure 9 ).

Figure 9

Step 5 : While breathing in deeply and slowly, press down on the centre of the dose indicator until the pressurised container stops moving in the actuator and a puff of medicine has been released (See Figure 10 ). Then stop pressing the dose indicator.

Figure 10

Step 6 : When you have finished breathing in, remove the mouthpiece from your mouth. Hold your breath as long as you comfortably can, up to 10 seconds (See Figure 11 ).

Figure 11

Step 7 : Breathe out gently (See Figure 12 ). Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere.

Figure 12

Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13 ).

|How to clean your Bevespi Aerosphere inhaler :|

Clean the inhaler once each week for the first 3 weeks. It is very important to keep your inhaler clean so that medicine does not build-up and block the spray through the mouthpiece (See Figure 14 ).

Figure 15

Step 2 : Take the cap off the mouthpiece.

Step 3: Hold the actuator under the tap and run warm water through it for about 30 seconds. Turn the actuator upside down and rinse the actuator again through the mouthpiece for about 30 seconds (See Figure 16 ).

Figure 16

Step 4: Shake off as much water from the actuator as you can.

Step 5: Look into the actuator and the mouthpiece to make sure any medicine build-up has been completely washed away. If there is any built-up medicine, repeat Steps 3 to 5 in the section.

Step 6: Let the actuator air-dry overnight (See Figure 17 ). Do not put the pressurised container back into the actuator if it is still wet.

Figure 17

Step 7: When the actuator is dry, gently press the pressurised container down in the actuator (See Figure 18 ). Do not press down too hard on the pressurised container. This could cause a puff of medicine to be released.

Figure 18

Step 8: Re-prime your Bevespi Aerosphere inhaler after each cleaning. To re-prime the inhaler, shake the inhaler well and press down on the centre of the dose indicator twice to release a total of 2 puffs into the air away from your face. Your inhaler is now ready to use.

If you do not use your Beves pi Aerosphere for more than 7 days or if exposed to low| temperatures or is dropped:^^^^^^^^­^^^^^^^^^^^^^^^^^^^^^^^^H

If you do not use your Bevespi Aerosphere for more than 7 days, or if the inhaler is exposed to low temperatures or has been dropped, you will need to re-prime it before use.

To re-prime the inhaler, shake the inhaler well and press down on the centre of the dose indicator twice to release a total of 2 puffs into the air away from your face. Your inhaler is now ready to use.

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