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The product code(s) for this leaflet is: PLGB 17901/0309.
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Bevespi Aerosphere® 7.2 micrograms / 5 micrograms pressurised inhalation, suspension
glycopyrronium / formoterol fumarate dihydrate
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
Instructions for use
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.
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.
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
Always tell your doctor about other health problems.
Bevespi Aerosphere is not for use in children or adolescents below 18 years of age.
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:
If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
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.
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.
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.
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.
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 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).
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:
These symptoms may be signs of an allergic reaction which may become serious.
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
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 Yellow Card website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 30°C.
Warning: Do not break, puncture or burn the pressurised container, even when apparently empty. Do not expose to temperatures higher than 50°C.
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.
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.
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.
This leaflet was last revised in August 2022
© AstraZeneca 2022
BEVESPI AEROSPHERE is a registered trademark of the AstraZeneca group of companies.
RSP 22 0061
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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.
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).
Before you use Bevespi Aerosphere for the first time, you must prime the inhaler.
Step 1: Remove the cap from the mouthpiece (See Figure 6).
Step 2: Shake the inhaler well before each use (See 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).
Step 4: Close your lips around the mouthpiece and tilt your head back, keeping your tongue below the mouthpiece (See 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.
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).
Step 7: Breathe out gently (See Figure 12). Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere.
Step 8: Replace the cap over the mouthpiece right away after use (See Figure 13).
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).
Step 1: Take the pressurised container out of the actuator (See Figure 15). Do not clean the pressurised container or let it get wet.
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).
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.
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.
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 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.