Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to formoterol fumarate dihydrate, glycopyrronium, budesonide or any of the other ingredients of this medicine (listed in section 6).

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.

• you have high blood pressure or heart problems
• you have diabetes
• you have a lung infection
• you have problems with your thyroid gland
• you have low levels of potassium in your blood
• you have prostate problems or any problems passing urine
• you have an eye problem called ‘angle-closure glaucoma’
• you have kidney or liver problems.

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:

• medicines called beta-blockers (such as atenolol or propranolol), that may be used for high blood pressure or heart problems, or to treat glaucoma (such as timolol)
• medicines which are used to treat fungal infections – such as ketoconazole or itraconazole
• medicines which are used to treat HIV infection – such as ritonavir or cobicistat
• medicines that lower the amount of potassium in your blood, such as:
  • corticosteroids that you take by mouth (such as prednisolone),
  • diuretics – medicines that increase urine production (such as furosemide or hydrochlorothiazide), which can be used for treating high blood pressure,
  • some medicines used to treat breathing problems (such as theophylline) – called ‘methylxanthines’,
• any medicines that work in the same way as Trixeo Aerosphere – such as tiotropium, ipratropium, aclidinium, umeclidinium or salmeterol, arformoterol, vilanterol, olodaterol or indacaterol. Do not use Trixeo Aerosphere if you already use these medicines.
• medicines which are used to treat heart rhythm problems – such as amiodarone
• medicines which can change some electrical activity of the heart (called the ‘QT interval’) – such as medicines for:
  • depression (such as monoamine oxidase inhibitors or tricyclic antidepressants),
  • bacterial infections (such as erythromycin, clarithromycin or 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 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.

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.

Uncommon (may affect up to 1 in 100 people)

Immediate breathing difficulties:

• if you get breathing difficulties straight after using Trixeo Aerosphere, such as tightness of the chest, coughing, wheezing or feeling breathless, stop using this medicine and tell your doctor straight away.

Allergic reactions:

• 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. 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)

• thrush in the mouth (a fungal infection). Rinsing your mouth out with water immediately after using Trixeo Aerosphere may help prevent this.
• feeling anxious
• difficulty sleeping
• feeling sick (nausea)
• headache
• coughing or a hoarse voice
• muscle cramps
• awareness of your heart beating (palpitations)
• high blood sugar levels (as shown in tests)
• painful and frequent urination (may be signs of a urinary tract infection)
• pneumonia (infection of the lung).

Tell your doctor if you have any of the following while using Trixeo Aerosphere, they could be symptoms of a lung infection:

• fever or chills,
• increased mucus production, change in mucus colour,
• increased cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• shaking, tremor or feeling dizzy
• dry mouth, or mild irritation in the throat
• bruising of the skin
• feeling restless, nervous or agitated
• depression
• fast heart beat or uneven heart beat
• chest pain or tightening in the chest (angina pectoris)

Very rare (may affect up to 1 in 10,000 people)

• changes in behaviour
• an effect on the adrenal gland

Not known (frequency cannot be estimated from the available data):

• blurred vision
• clouding of the lens of your eyes (signs of cataract)
• increased pressure in the eye (glaucoma)
• swelling of your face, particularly around your mouth (swelling of your tongue or throat may make it difficult to swallow)

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.

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.

• For oral inhalation use only
• Prepare your inhaler for its first time use by priming it
• Rinse your yellow actuator weekly
• Take 2 puffs of medicine in the morning and 2 puffs of medicine in the evening

• Do not store above 30°C. Store in a dry place
• Do not store in a humid environment, such as a bathroom
• Keep your inhaler and all medicines out of the sight and reach of children

Puff indicator

Attached to the top of the pressurised canister.

Pressurised Canister (inside)

Holds the medicine.

Actuator

Contains the pressurised canister.

Mouthpiece

Sprays the medicine.

Mouthpiece cover

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.

Pointer

Points to number of puffs remaining

Yellow zone

Order a new inhaler when the pointer is in the yellow zone

Red 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.

• Order a new inhaler when the pointer on the puff indicator is in the yellow zone.

Throw away your inhaler following local guidelines when:

• puff indicator shows 0

or

• 3 months after your inhaler has been removed from the foil pouch

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.

• Before you use your inhaler for the first time, prime it so that you will get the right amount of medicine when you use it.

Prime 1

Remove mouthpiece cover.

Prime 2

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:

• after rinsing the actuator
• if dropped
• if not used for more than 7 days

To re-prime, spray 2 Test-puffs, shaking before each Test-puff.

• Daily Dose: 2 puffs in the morning and 2 puffs in the evening.
• Rinse mouth with water after the 2 puffs to prevent fungal infection.

Step 1

Remove mouthpiece cover. Check the mouthpiece for foreign objects and remove objects before use.

Step 2

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.

Step 3

Repeat Step 2 for a second puff

Step 4

Put mouthpiece cover back on.

Step 5

Rinse mouth with water. Spit out water. Do not swallow.

• Rinse yellow actuator weekly so that medicine does not build up and block the spray through the mouthpiece.
• Do not allow the canister to get wet.
• Re-prime after rinsing.

Rinse 1

Remove canister and set aside. Do not allow the canister to get wet.

Rinse 2

Remove mouthpiece cover.

Rinse 3

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.

Rinse 4

Shake off as much water as you can.

Do not dry with a towel or tissue.

Rinse 5

Look into the actuator and mouthpiece for medicine build-up. If there is any build-up, repeat steps Rinse 3 through 5.

Rinse 6

Air-dry, preferably overnight. Do not put the canister back into the actuator if it is still wet.

Rinse 7

When dry, replace the mouthpiece cover first and then gently press the canister down into the actuator.

Rinse 8

Re-prime the inhaler by spraying 2 Test-puffs, shaking before each Test-puff.