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Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms, pressurised inhalation, suspension
Trixeo Aerosphere® 5 micrograms/7.2 micrograms/160 micrograms, pressurised inhalation, suspension
formoterol fumarate dihydrate/glycopyrronium/budesonide
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
Instructions for use
Trixeo Aerosphere contains three active substances: formoterol fumarate dihydrate, glycopyrronium, and budesonide.
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.
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.
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 if you think any of these may apply to you.
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.
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:
If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Trixeo 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 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.
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.
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.
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.
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 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).
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.
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:
Uncommon (may affect up to 1 in 100 people)
Immediate breathing difficulties:
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.
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)
Tell your doctor if you have any of the following while using Trixeo Aerosphere, they could be symptoms of a lung infection:
Uncommon (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data):
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 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 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.
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.
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.
This leaflet was last revised in 10/2022
© AstraZeneca 2022
TRIXEO and AEROSPHERE are registered trademarks of the AstraZeneca group of companies.
RSP 22 0106
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Product name Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension
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Read prior to using inhaler
(formoterol fumarate dihydrate, glycopyrronium and budesonide)
Pressurised inhalation, suspension
For oral inhalation use
Please read these instructions carefully.
Your Trixeo Aerosphere (called “inhaler” in this leaflet) may be different from inhalers you have used before.
Attached to the top of the pressurised canister.
Pressurised Canister (inside)
Holds the medicine.
Contains the pressurised canister.
Sprays the medicine.
Protects the mouthpiece when the inhaler is not in use.
The puff indicator will count down by 1 each time you spray a puff of medicine.
Points to number of puffs remaining
Order a new inhaler when the pointer is in the yellow zone
Throw away your inhaler when the pointer is at 0 in the red zone
Do not try to take a puff when the pointer is at 0 because you will not receive a full dose.
Throw away your inhaler following local guidelines when:
Do not reuse or use the actuator with medicine canisters from other inhalers.
Do not puncture or throw the canister into a fire or incinerator.
Remove mouthpiece cover.
Shake the inhaler well and spray 1 Test-puff into the air facing away from you. Repeat for a total of 4 Test-puffs, shaking before each Test-puff.
Extra puffs are provided for priming. Do not skip priming.
Re-prime your inhaler:
To re-prime, spray 2 Test-puffs, shaking before each Test-puff.
Remove mouthpiece cover. Check the mouthpiece for foreign objects and remove objects before use.
Shake the inhaler well before each puff.
Breathe out fully.
Place mouthpiece into mouth and close lips around the mouthpiece. Tilt your head back, keeping your tongue below the mouthpiece.
Start to breathe in deeply and slowly while spraying 1 puff. Continue breathing in until you cannot any more.
Hold breath for as long as you can, up to 10 seconds.
Repeat Step 2 for a second puff
Put mouthpiece cover back on.
Rinse mouth with water. Spit out water. Do not swallow.
Remove canister and set aside. Do not allow the canister to get wet.
Remove mouthpiece cover.
Run warm water through the mouthpiece for 30 seconds and then through the top of the actuator for 30 seconds. Rinse for 60 seconds in total.
Shake off as much water as you can.
Do not dry with a towel or tissue.
Look into the actuator and mouthpiece for medicine build-up. If there is any build-up, repeat steps Rinse 3 through 5.
Air-dry, preferably overnight. Do not put the canister back into the actuator if it is still wet.
When dry, replace the mouthpiece cover first and then gently press the canister down into the actuator.
Re-prime the inhaler by spraying 2 Test-puffs, shaking before each Test-puff.