Trixeo Aerosphere

Package leaflet: Information for the patient

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

for inhalation, pressurised
formoterol fumarate dihydrate/glycopyrronium/budesonide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Trixeo Aerosphere is and what it is used for
2. What you need to know before using 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

1. What Trixeo Aerosphere is and what it is used for

Trixeo Aerosphere contains three active substances called: formoterol fumarate dihydrate, glycopyrronium, and budesonide.

• Formoterol fumarate dihydrate and glycopyrronium belong to a group of medicines called "bronchodilators". They work in different ways to prevent the muscles around the airways from tightening, making it easier for air to flow in and out of the lungs.
• Budesonide belongs to a group of medicines called "corticosteroids". These work by reducing inflammation in the lungs.

Trixeo Aerosphere is an inhaler used in 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 to improve COPD symptoms such as breathlessness, wheezing, and cough. Trixeo Aerosphere may also prevent exacerbations (flare-ups) of COPD.
Trixeo Aerosphere releases the active substances into the lungs during inhalation. Using this medicine regularly twice daily will help reduce the impact of COPD on your daily life.

2. What you need to know before using 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 (listed in section 6).

Warnings and precautions
Trixeo Aerosphere is used as long-term maintenance treatment for COPD. Do not use it to treat sudden breathing difficulties or wheezing.
Sudden breathing difficulties
If you experience chest tightness, cough, shortness of breath, or wheezing immediately after using Trixeo Aerosphere, stop using it immediately and contact your doctor straight away (see "Serious unwanted effects" at the beginning of section 4 for more information).
If shortness of breath, chest tightness, wheezing, or cough worsens while using Trixeo Aerosphere, continue using Trixeo Aerosphere but contact your doctor as soon as possible, as additional treatment may be needed.
Talk to your doctor before using Trixeo Aerosphere if:

• you have heart problems or high blood pressure
• you have diabetes
• you have a lung infection
• you have thyroid problems
• you have low levels of potassium in your blood
• you have prostate problems or any difficulty urinating
• you have a condition in the eyes called “closed-angle glaucoma”
• you have liver or kidney problems
  Talk to your doctor if you think you fall into any of these categories.

Children and adolescents
Trixeo Aerosphere has not been studied in children and adolescents. Do not give this medicine to children or adolescents under 18 years of age.
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 over-the-counter medicines and herbal supplements. Trixeo Aerosphere may affect how some medicines work. In addition, some medicines may affect how Trixeo Aerosphere works, or increase the likelihood of you experiencing side effects.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines called beta-blockers (such as atenolol or propranolol), which may be used for high blood pressure or heart problems, or for the treatment of glaucoma (such as timolol)
• medicines used to treat fungal infections, such as ketoconazole or itraconazole
• medicines used to treat HIV infections, such as ritonavir or cobicistat
• medicines that reduce potassium levels in the blood such as:
  • oral corticosteroids (such as prednisolone),
  • diuretic medicines that increase urine production (such as furosemide or hydrochlorothiazide), which may be used to treat high blood pressure,
  • some medicines used to treat breathing problems (such as theophylline), called “methylxanthines”,
• any medicine that works in the same way as Trixeo Aerosphere, such as tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, arformoterol, vilanterol, olodaterol, or indacaterol. Do not use Trixeo Aerosphere if you are already using these medicines
• medicines used to treat heart rhythm problems, such as amiodarone
• medicines that may alter the electrical activity of the heart (called “QT interval”), for example medicines for:
  • depression (such as monoamine oxidase inhibitors or tricyclic antidepressants),
  • bacterial infections (such as erythromycin, clarithromycin, or telithromycin),
  • allergic reactions (antihistamines).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist before using Trixeo Aerosphere.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Trixeo Aerosphere during pregnancy unless your doctor has specifically advised you to do so.
Do not use this medicine while breastfeeding unless your doctor has specifically advised you to do so.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machinery. However, dizziness is an uncommon side effect to consider when driving or operating machinery.

3. How to use Trixeo Aerosphere

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much medicine to take
The recommended dose is two sprays twice daily: two sprays in the morning and two sprays in the evening.
It is important to use Trixeo Aerosphere every day, even if you do not currently have symptoms of COPD.

Important: Always rinse your mouth with water after using Trixeo Aerosphere. This helps remove any medicine that may remain in your mouth. Spit out the rinsing water—do not swallow it.

How to use it
Trixeo Aerosphere is for inhalation use only.
Please read carefully the "Instructions for use" at the end of this leaflet. If you are not sure how to use Trixeo Aerosphere, consult your doctor or pharmacist.

Using Trixeo Aerosphere with a spacer
You may find it difficult to inhale and press the inhaler at the same time. In this case, consult your doctor or pharmacist. You may find it helpful to use a "spacer" device with your inhaler.

If you use more Trixeo Aerosphere than you should
If you have used more Trixeo Aerosphere than prescribed, contact your doctor or pharmacist immediately. You may require medical treatment. You may notice your heart beating faster than usual, tremors, vision problems, dry mouth, headache, or a feeling of being unwell (nausea).

If you forget to use Trixeo Aerosphere
Do not take a double dose to make up for a forgotten dose. Take the medicine as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose. Do not take more than two sprays twice daily on the same day.

If you stop using Trixeo Aerosphere
This medicine is intended for long-term use. Use this medicine for the duration prescribed by your doctor. It will only be effective as long as you continue using it.
Do not stop treatment unless instructed by your doctor, even if you feel better, because your symptoms may worsen. If you plan to stop treatment, consult your doctor first.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Serious side effects
Uncommon (may affect up to 1 in 100 people)
Sudden breathing difficulties :

• if you experience difficulty breathing immediately after using Trixeo Aerosphere, such as chest tightness, cough, wheezing or shortness of breath, stop using this medicine and contact your doctor immediately .

Allergic reactions :

• swelling of the face, particularly around the mouth (swelling of the tongue or throat which may make swallowing difficult)
• skin rash or hives with difficulty breathing
• sudden feeling of fainting
  These symptoms could be signs of an allergic reaction which may become severe. Stop using this medicine and contact your doctor immediately if you experience any of the serious side effects listed above.

Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• candidiasis (a fungal infection) in the mouth. Rinsing your mouth with water immediately after using Trixeo Aerosphere may help prevent this condition
• feeling of anxiety
• difficulty sleeping
• malaise (nausea)
• headache
• cough or hoarseness
• muscle cramps
• awareness of heartbeat (palpitations)
• elevated blood sugar levels (as shown in tests)
• painful and frequent urination (may be a sign of a urinary tract infection)
• pneumonia (lung infection). Inform your doctor if you experience any of the following symptoms while using Trixeo Aerosphere, as they may indicate a lung infection:
  • fever or chills
  • increased mucus production, change in mucus colour
  • worsening cough or breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• tremor or dizziness
• dry mouth or mild throat irritation
• bruising of the skin
• feeling restless, nervous or agitated
• depression
• rapid or irregular heartbeat
• chest pain or chest tightness (angina pectoris)
• difficulty urinating

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 the eye (signs of cataract)
• increased pressure in the eye (glaucoma)
• swelling of the face, particularly around the mouth (swelling of the tongue or throat which may make swallowing difficult)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. 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, the bag, and the
pressurised container after “Exp”. The expiry date refers to the last day of that month.
After opening the bag, the inhaler must be used within 3 months.
Keep the inhaler inside the sealed bag; remove the inhaler from the sealed bag only
immediately before first use. On the day the bag is opened, write the date on the label of the inhaler 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 use.
Do not pierce, break, or burn the pressurised container, even if it appears to be empty. Do not use or
store near sources of heat or open flames.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Trixeo Aerosphere contains
The active substances are formoterol fumarate dihydrate, glycopyrronium bromide, and budesonide.
Each single inhalation delivers a metered dose (the dose exiting the mouthpiece) of
5 micrograms of formoterol fumarate dihydrate, 9 micrograms of glycopyrronium bromide, equivalent
to 7.2 micrograms of glycopyrronium, and 160 micrograms of budesonide.
This corresponds to a delivered dose (i.e. the dose leaving the valve) of 5.3 micrograms of
formoterol fumarate dihydrate, 9.6 micrograms of glycopyrronium bromide, equivalent
to 7.7 micrograms of glycopyrronium, and 170 micrograms of budesonide.
The other ingredients are norflurane, 1,2-distearoyl-sn-glycero-3-phosphocholine, and calcium chloride.
This medicinal product contains fluorinated greenhouse gases. Each inhaler contains 10.6 g of norflurane
(HFC-134a), equivalent to 0.015 tonnes of CO₂e (global warming potential = 1,430).

Description of the appearance of Trixeo Aerosphere and package contents
Trixeo Aerosphere is a pressurised suspension for inhalation.
Trixeo Aerosphere is supplied as a container with a dose indicator, fitted with a yellow plastic actuator and mouthpiece. The mouthpiece is covered with a removable grey protective cap.
Trixeo Aerosphere is provided in an aluminium pouch containing a desiccant sachet (drying agent), and packaged in a cardboard box.
Trixeo Aerosphere is available in packs containing 1 inhaler with 120 sprays, and in multiple packs comprising 3 containers, each containing 1 inhaler with 120 sprays. Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca Dunkerque Production
224 Avenue de la Dordogne
Dunkerque
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Read before using the inhaler

INSTRUCTIONS FOR USE

TRIXEO AEROSPHERE

formoterol fumarate dihydrate/glycopyrronium/budesonide
Pressurised inhalation, suspension
For inhalation use
Please read these instructions carefully.
Trixeo Aerosphere (referred to as "inhaler" in this leaflet) may differ from inhalers
you have used previously.
Important information

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

Storage of the inhaler

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

Components of the inhaler
Dose indicator

Attached to the top of the pressurised canister.
Pressurised canister (inside)
Contains the medicine.
Actuator
Holds the pressurised canister.
Mouthpiece
Releases the medicine.
Mouthpiece cap
Protects the mouthpiece when the inhaler is not in use.
Reading the dose indicator

The dose indicator will count down by 1 each time you take a puff of medicine.

Pointer
Indicates the number of doses remaining
Yellow zone
Order a new inhaler when the
pointer is in the yellow zone
Red zone
Discard the inhaler when the pointer
is at 0 in the red zone

Do not attempt to take a puff when the pointer is at 0, as you will not receive a complete dose.
Order a new inhaler

• Order a new inhaler when the dose indicator pointer enters the yellow zone.

Discard the inhaler
Dispose of the inhaler according to local guidelines when:

• the dose indicator shows 0, or
• 3 months after removing the inhaler from the aluminium foil pouch

Do not reuse or use the actuator with medicine canisters from other inhalers.
Do not pierce or throw the canister into fire or an incinerator.
BEFORE FIRST USE – Prime the inhaler 4 times before first use

• Before using the inhaler for the first time, prime it to ensure the correct amount of medicine is delivered when used.

Priming step 1
Remove the cap from the mouthpiece.

Priming step 2
Shake the inhaler well and release one test puff into the air, directing it away from you. Repeat for a total of 4 test puffs, shaking before each test puff.

4 times in total
Shake and release the test puffs

Extra doses are provided for priming. Do not skip the priming step.

Re-prime the inhaler: To re-prime, release 2 test puffs,

• after rinsing the actuator, shaking it before each test puff.
• if the inhaler is dropped
• if not used for more than 7 days 2 times in total Shake and release the test puffs

DAILY USE, morning and evening – Taking the medicine

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

Step 1
Remove the cap from the mouthpiece. Check for foreign objects in the mouthpiece and remove them before use.

Step 2
Shake the inhaler well before each dose.	Breathe out fully.	Place the mouthpiece in your mouth and close your lips around it. Tilt your head back slightly, keeping your tongue under the mouthpiece.	Begin to breathe in slowly and deeply while releasing one dose. Continue to breathe in until your lungs are full.	Hold your breath as long as possible, up to 10 seconds.10sec

Step 3	Step 4	Step 5
Repeat Step 2 for a second actuation	Replace the cap on the mouthpiece.	Rinse mouth with water. Spit out the water. Do not swallow.

WEEKLY RINSING – Rinse the dispenser once a week

• Rinse the yellow dispenser weekly to prevent the medicine from building up and blocking the spray through the mouthpiece.
• Do not let the container get wet.
• Re-prime after rinsing.

Rinse 1	Rinse 2
Remove the container and set it aside. Do not allow the container to get wet.	Remove the mouthpiece cap.
Rinse 3	Rinse 4
Run warm water through the mouthpiece for 30 seconds, then through the top part of the dispenser for 30 seconds. Rinse for a total of 60 seconds.30sec30sec	Shake off as much water as possible. Do not dry with a towel or handkerchief.
Rinse 5	Rinse 6
Inspect inside the dispenser and mouthpiece for any medication buildup. If buildup is present, repeat steps 3 to 5.	Allow to air dry, preferably overnight. Do not reinsert the container into the dispenser if it is still wet.

Rinse 7 Rinse 8
When dry, first reposition the Reload the inhaler by performing 2 test
mouthpiece cap and then gently sprays, shaking before each test spray.
push the canister into the actuator.

Twice in total
Shake and perform
the test sprays