Trixeo aerosphere 5 microgramos/7,2 microgramos/160 microgramos suspension para inhalacion en envase a presion

Product Information for the Patient

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

inhalation in a pressurized container

formoterol fumarate dihydrate/glycopyrronium/budesonide

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. How to Use Trixeo Aerosphere

1. Possible Adverse Effects
2. Storage of Trixeo Aerosphere

1. Contents of the Container and Additional Information
2. Usage Instructions

Trixeo Aerosphere contains three active ingredients called formoterol fumarate dihydrate, glycopyrronio, and budesonide.

• Formoterol fumarate dihydrate and glycopyrronio belong to a group of medications called «bronchodilators». They act by inhibiting the constriction of the muscles of the respiratory airways to facilitate the entry and exit of air from the lungs.

• Budesonide belongs to a group of medications called «corticosteroids», which act by reducing inflammation of the lungs.

Trixeo Aerosphere is an inhaler used in adults with a lung disease called «chronic obstructive pulmonary disease» (or «COPD»), a chronic disease of the respiratory airways of the lungs.

Trixeo Aerosphere is used to facilitate breathing and improve symptoms of COPD such as shortness of breath, wheezing, and cough. Trixeo Aerosphere may also prevent attacks (exacerbations) of COPD.

When inhaled, Trixeo Aerosphere releases the active ingredients into the lungs. If you use this medication regularly twice a day, it will help reduce the effects of COPD on your daily life.

Do not use Trixeo Aerosphere

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

Warnings and precautions

Trixeo Aerosphere is used as long-term maintenance treatment for chronic obstructive pulmonary disease (COPD).Do not usefor sudden onset of difficulty breathing or wheezing.

Immediate breathing difficulty

If you experience chest tightness, cough, wheezing, or immediate difficulty breathing after using Trixeo Aerosphere,stop using it and inform your doctor immediately(see «Serious adverse reactions» at the beginning of section 4 for more information).

If your breathing difficulty, chest tightness, wheezing, or cough worsen during treatment with Trixeo Aerosphere, you should continue using Trixeo Aerosphere, but contact your doctor as soon as possible, as you may need additional treatment.

Consult your doctor before using Trixeo Aerosphere if:

• you have high blood pressure or heart problems
• you are diabetic
• you have a lung infection
• you have thyroid problems
• you have low potassium levels in your blood
• you have prostate problems or any difficulty urinating
• you have a condition called «angle-closure glaucoma»
• you have kidney or liver problems

Consult your doctor if you think any of these may apply to you.

Children and adolescents

Trixeo Aerosphere has not been studied in children and adolescents. Do not administer this medication to children or adolescents under 18 years of age.

Other medications and Trixeo Aerosphere

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes those obtained without a prescription and herbal products. This is because Trixeo Aerosphere may affect the mechanism of action of other medications. Additionally, some medications may affect the mechanism of action of Trixeo Aerosphere or increase the likelihood of adverse reactions.

Inform your doctor or pharmacist if you are taking any of the following medications:

• beta-blockers (such as atenolol or propranolol), which may be used to treat high blood pressure or heart problems, or to treat glaucoma (such as timolol)
• medications used to treat fungal infections, such as ketoconazole or itraconazole
• medications used to treat HIV infection, such as ritonavir or cobicistat
• medications that reduce the amount of potassium in the blood, such as:

• oral corticosteroids (such as prednisolone)
• diuretics – medications that increase urine production (such as furosemide or hydrochlorothiazide), which may be used to treat high blood pressure
• some medications used to treat respiratory problems (such as theophylline), known as «methylxanthines»

• any medication that acts 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 are already using these medications.
• medications used to treat heart rhythm problems, such as amiodarone
• medications that may alter the electrical activity of the heart (known as «QT interval»), such as:

If you are in any of the above circumstances, or if you are unsure, consult your doctor or pharmacist before using Trixeo Aerosphere.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use Trixeo Aerosphere if you are pregnant unless your doctor tells you to.

Do not use this medication if you are breastfeeding unless your doctor tells you to.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive or operate machinery. However, dizziness is a rare side effect that should be taken into account when driving or operating machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

What amount should be used

The recommended dose is two inhalations twice a day - two inhalations in the morning and two inhalations at night.

It is essential to use Trixeo Aerosphere every day, even if you do not have symptoms of COPD at that time.

Remember:Always rinse your mouth with water after inhaling Trixeo Aerosphere. This allowsto remove any remaining medication in the mouth. After rinsing, spit out the water; do not swallow it.

Mode of use

Trixeo Aerosphere is for inhalation use.

Read the «Instructions for use» that appear at the end of this leaflet. If you are unsure how to use Trixeo Aerosphere, consult your doctor or pharmacist.

Using Trixeo Aerosphere with a spacer

You may find it difficult to breathe and press the inhaler at the same time. If this occurs, ask your doctor or pharmacist for advice. It may be helpful to use a «spacer» with the inhaler.

If you use more Trixeo Aerosphere than you should

If you have used more Trixeo Aerosphere than you should, consult your doctor or pharmacist immediately. You may need medical attention. You may notice that your heart beats faster than usual or that you have tremors, visual disturbances, dry mouth, headache, or nausea.

If you forget to use Trixeo Aerosphere

Do not take a double dose to make up for the missed doses. Use it as soon as you remember.

However, if there is little time left for the next administration, skip the missed dose. Do not use more than two inhalations twice a day on the same day.

If you interrupt treatment with Trixeo Aerosphere

This medication is for long-term use. Use this medication for the time your doctor tells you to. It will only be effective while you use it.

Do not stop using it unless your doctor tells you to, even if you feel better, as symptoms may worsen. If you want to interrupt treatment, talk to your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. With this medicine, the following side effects may occur:

Severe side effects

Rare(may affect up to 1 in 100 people)

Immediate respiratory difficulty:

• If you experience immediate difficulty breathing after using Trixeo Aerosphere, such as chest tightness, cough, wheezing, or shortness of breath,stop using this medicineandinform your doctor immediately.

Allergic reactions:

• swelling of the face, especially around the mouth (swelling of the tongue or throat may cause difficulty swallowing)
• skin rash or urticaria accompanied by difficulty breathing

• sudden feeling of fainting

These symptoms may be signs of an allergic reaction that can be severe. Stop using this medicine and seek medical assistance immediately if you notice the severe side effects mentioned above.

Other side effects

Inform your doctor or pharmacist if you notice any of the following side effects:

Common(may affect up to 1 in 10 people)

• oral candidiasis (a fungal infection). This can be prevented by rinsing your mouth immediately after inhaling Trixeo Aerosphere.
• anxiety

• difficulty sleeping
• nausea
• headache
• cough or snoring
• muscle cramps

• perception of heartbeats (palpitations)

• high blood sugar levels (detected by analysis)
• painful urination and increased frequency of urination (may be signs of a urinary tract infection)

• pneumonia (lung infection).

Inform your doctor if you experience any of the following symptoms while on treatment with

Trixeo Aerosphere, as they may be indicative of a lung infection:

• fever or chills,
• increased mucus production, change in mucus color,

• increased cough or greater difficulty breathing.

Rare(may affect up to 1 in 100 people)

• shaking or feeling of dizziness
• dry mouth or mild throat irritation
• appearance of bruises on the skin

• feeling of restlessness, nervousness, or agitation
• depression

• rapid or irregular heartbeats

• chest pain or chest tightness (angina pectoris)

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

• changes in behavior
• effects on the adrenal glands

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

• blurred vision
• loss of transparency of the cornea (signs of cataract)
• increased pressure in the eyes (glaucoma)
• swelling of the face, especially around the mouth (swelling of the tongue or throat may cause difficulty swallowing)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Trixeo Aerosphere after the expiration date that appears on the box, bag, and pressurized container after CAD/EXP. The expiration date is the last day of the month indicated.

Once the bag is opened, the inhaler must be used within a period of 3 months.

Keep the inhaler inside the sealed bag; only open the bag to remove the inhaler immediately before the first use. On the day the bag is opened, note the date on the inhaler label, in the space reserved for this purpose.

Do not store at a temperature above 30 °C. Store in a dry place.

For best results, the inhaler must be at room temperature before use.

Do not break, pierce, or burn the pressurized container, even if it appears to be empty. Do not use or store near a heat source or open flame.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of Trixeo Aerosphere

The active principles are formoterol fumarate dihydrate, glycopyrrolate, and budesonide.

Each individual inhalation provides a released dose (the dose that comes out of the mouthpiece) of 5 micrograms of formoterol fumarate dihydrate, 9 micrograms of bromide of glycopyrrolate equivalent to 7.2 micrograms of glycopyrrolate, and 160 micrograms of budesonide.

The other components are norflurane, 1,2-diesteroyl-sn-glycero-3-phosphocholine, and calcium chloride.

This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.6 g of norflurane (HFC-134a) corresponding to 0.015 tonnes of CO2 equivalent (global warming potential GWP = 1 430).

Appearance of the product and contents of the pack

Trixeo Aerosphere is a suspension for inhalation in a pressurized container.

Trixeo Aerosphere is presented in a cartridge with a dose indicator, provided with a yellow plastic adapter and a white mouthpiece. The mouthpiece is covered by a removable grey protective cap.

Trixeo Aerosphere is supplied in an aluminium foil pouch containing a desiccant sachet, and packaged in a cardboard box.

Each inhaler contains 120 puffs. In addition, there are multiple pack sizes containing 3 pressurised inhalers with 120 puffs each.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca Dunkerque Production

224 Avenue de la Dordogne

Dunkerque

59640

France

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

Read before using the inhaler

INSTRUCTIONS FOR USE

TRIXEO AEROSPHERE

(formoterol fumarate dihydrate, glycopyrrolate, and budesonide)

Suspension for inhalation in a pressurized container

Use by oral inhalation

Please read these instructions carefully.

Trixeo Aerosphere (referred to as "inhaler" in this leaflet) may be different from other inhalers you have used before.

Important information

• Only for use by oral inhalation
• Prepare your inhaler for first use by priming
• Wipe the yellow adapter weekly
• Perform 2 inhalations of the medication in the morning and 2 inhalations of the medication in the evening

Storage of your inhaler

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

Parts of your inhaler

Reading the dose indicator

Order a new inhaler

• Order a new inhaler when the arrow of the dose indicator is in the yellow zone.

Dispose of your inhaler

Dispose of your inhaler according to local guidelines when:

• The dose indicator marks 0

or

• More than 3 monthshave passed since removing the inhaler from the aluminium foil pouch

Do not reuse the adapter or use it with cartridges of other inhalers.

Do not pierce the cartridge or dispose of it in a fire or incinerator.

BEFORE FIRST USE – Prime your inhaler 4 times before first use

• Before using your inhaler for the first time, prepare it to receive the correct amount of medication when you use it.

DAILY USE, morning/evening – Inhale your medication

• Daily dose: 2 inhalations in the morning and 2 inhalations in the evening.
• Wash your mouth with water after the 2 inhalations to prevent fungal infections.

WEEKLY CLEANING – Wipe your adapter once a week

• Wipe the yellow adapter weeklyto prevent the medication from accumulating and blocking the release through the mouthpiece.
• Do not allow the cartridge to get wet.
• Re-prime after cleaning.