• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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.

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.

• 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.

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:

• 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.

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.

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.

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.

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)

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 Scheme at 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.

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.

• 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.

• Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an actuator.
  • Do not use the Bevespi Aerosphere actuator with any other medicine.
  • Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.

• 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, 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.

• 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.

• Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant).
  • Take the Bevespi Aerosphere inhaler out of the foil pouch.
  • Throw away the pouch and the drying packet. Do not use the inhaler if the drying agent has leaked out of its packet.

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).

• 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.

• 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.

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 exposed to low temperatures or is dropped:

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.