How does Trixeo Aerosphere work?

• Trixeo Aerosphere contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
• Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.
• Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. This means that it blocks muscarinic receptors in muscle cells in the airways. Because these receptors help control the contraction of muscles, glycopyrronium causes the muscles of the airways to relax, helping to keep the airways open.
• Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system (the body’s natural defences) by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby keeping the airways clear and allowing the patient to breathe more easily.

What you need to know before you use Trixeo Aerosphere

Do not use Trixeo Aerosphere

• if you are allergic to formoterol fumarate dihydrate, glycopyrronium, budesonide or any of the other ingredients of this medicine.

Warnings and precautions

• 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.

Immediate breathing difficulties

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.

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 before using Trixeo Aerosphere if:

• 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.

Children and adolescents

• 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.

Other medicines and Trixeo Aerosphere

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.

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 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.

Driving and using machines

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.

How to use Trixeo Aerosphere

Always use 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 – 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.

How to use

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 use more Trixeo Aerosphere than you should

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).

If you forget to use Trixeo 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 on the same day.

If you stop using Trixeo Aerosphere

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.

Possible side effects

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:

• 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.

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

How to store Trixeo Aerosphere

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:

• 6 weeks – for an inhaler that contains 56 puffs
• 3 months – for an inhaler than contains 120 puffs.

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.

References:

https://www.sps.nhs.uk/medicines/budesonide-formoterol-glycopyrronium/

https://www.medicines.org.uk/emc/product/12028/smpc#gref

https://www.medicines.org.uk/emc/product/12028/pil#gref

https://www.medicines.ie/medicines/trixeo-aerosphere-5-micrograms-7-2-micrograms-160-micrograms-pressurised-inhalation-suspension-35110/spc

https://www.astrazeneca.com/media-centre/press-releases/2020/trixeo-aerosphere-approved-in-the-eu-for-copd.html