Prospect: information for the user

Trydonis 88micrograms/5micrograms/9micrograms powder for inhalation

dipropionato de beclometasona/fumarato de formoterol dihidrato/glicopirronio

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section4.

1.What is Trydonis and for what it is used

2.What you need to know before starting to use Trydonis

3.How to use Trydonis

4.Possible adverse effects

5.Storage of Trydonis

6.Contents of the package and additional information

Trydonis is a medication to help breathe that contains three active ingredients:

• dipropionate of beclometasone,
• formoterol dihydrate fumarate and
• glycopyrrolate.

Beclometasone dipropionate belongs to a group of medications called corticosteroids, which act by reducing inflammation and irritation in the lungs.

Formoterol and glycopyrrolate are medications called long-acting bronchodilators. They act in different ways to relax the muscles of the respiratory tract, helping to widen them and allowing you to breathe more easily.

Regular treatment with these three active ingredients helps to alleviate and prevent symptoms such as difficulty breathing, wheezing, and coughing in adult patients with chronic obstructive pulmonary disease (COPD).COPD is a serious long-term disease in which the airways become blocked and the air sacs inside the lungs are damaged, causing difficulty breathing.Trydonis may reduce exacerbations (worsening) of COPD symptoms. COPD is a serious long-term disease in which the airways become blocked and the air sacs inside the lungs are damaged, causing difficulty breathing.

No use Trydonis

If you are allergic to beclomethasone dipropionate, formoterol fumarate dihydrate, or glycopyrrolate, or any of the other components of this medication (listed in section6).

Warnings and Precautions

Trydonis is used as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Do not use this medication to treat a sudden episode of difficulty breathing or wheezing.

If your breathing worsens

If you experience a worsening of difficulty breathing or wheezing immediately after inhaling the medication, discontinue treatment with the Trydonis inhaler and use your rescue inhaler immediately. Contact your doctor immediately. Your doctor will evaluate your symptoms and, if necessary, may change your treatment.

See also section4. Possible side effects.

If your COPD worsens

If your symptoms worsen or are difficult to control (e.g., if you are using your rescue inhaler more frequently) or if your rescue inhaler does not improve your symptoms, contact your doctor immediately. Your COPD may be worsening, and your doctor may need to prescribe a different treatment.

Consult your doctor or pharmacist before starting to use Trydonis:

• If you have any heart problems, such as angina (chest pain), a recent heart attack (myocardial infarction), heart failure, coronary artery disease, heart valve disease, or any other heart anomaly, or if you have a condition called hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition in which the heart muscle is abnormal).

• If you have arrhythmias, such as irregular heartbeat, rapid pulse, or palpitations, or if your electrocardiogram (ECG) is abnormal.

• If you have atherosclerosis (narrowing of the arteries), high blood pressure, or an aneurysm (an abnormal swelling of the wall of a blood vessel).

• If you have an overactive thyroid gland.

• If you have low potassium levels in your blood (hypokalemia). The combination of Trydonis with certain medications for COPD or other medications, such as diuretics, may cause a significant drop in potassium levels in your blood. Your doctor may want to measure your potassium levels in your blood from time to time.

• If you have any liver or kidney disease.

• If you have diabetes. High doses of formoterol may increase blood glucose levels, so you may need additional blood tests to determine your blood sugar levels when you start using this medication and from time to time during treatment.

• If you have a tumor of the adrenal gland (pheochromocytoma).

• If you are to receive anesthesia. Depending on the type of anesthesia, you may need to discontinue treatment with Trydonis at least 12hours before anesthesia.

• If you have received or are receiving treatment for tuberculosis (TB) or if you have a chest infection.

• If you have a condition called narrow-angle glaucoma.

• If you have difficulty urinating.

• If you have a mouth or throat infection.

If you are in any of the above circumstances, inform your doctor before starting to use Trydonis.

If you have or have had any health problems, allergies, or if you are unsure whether you can use Trydonis, consult your doctor or pharmacist before starting to use the inhaler.

If you are already using Trydonis

If you are using Trydonis or high doses of other inhaled corticosteroids for prolonged periods and experience a stressful situation (e.g., if you are hospitalized after an accident, have a severe injury, or before surgery), you may need more medication. In such situations, your doctor may need to increase your corticosteroid dose to cope with the stress and may prescribe corticosteroids in the form of tablets or injections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Do not administer this medication to children and adolescents under 18years.

Other medications and Trydonis

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications similar to Trydonis used to treat your COPD.

Some medications may increase the effects of Trydonis, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Do not use this medication with a beta-blocker(used to treat certain heart problems such as angina or to reduce blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing. Beta-blockers (including eye drops) may reduce the effects of formoterol or make them disappear completely. On the other hand, the use of other beta2 agonists (which act in the same way as formoterol) may increase the effects of formoterol.

The use of Trydonis with:

• medications to treat

• arrhythmias (quinidine, disopyramide, procainamide),
• allergic reactions (antihistamines),
• depression or mental disorders such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine) and phenothiazines may cause some changes in the electrocardiogram (ECG, heart tracing). They may also increase the risk of arrhythmias (ventricular arrhythmias).

• medications to treat Parkinson's disease (levodopa), medications to treat an underactive thyroid gland (levothyroxine), medications containing oxytocin (which causes uterine contractions) and alcohol may increase the likelihood of formoterol's adverse effects on the heart.

• monoamine oxidase inhibitors (MAOIs), including medications with similar properties such as furazolidone and procarbazine, used to treat mental disorders, may cause an increase in blood pressure.

• medications to treat heart disease (digoxin) may cause a drop in potassium levels in the blood.This may increase the likelihood of arrhythmias.

• other medications used to treat COPD (theophylline, aminophylline, or corticosteroids) and diuretics may also cause a drop in potassium levels.

• some anesthetics may increase the risk of arrhythmias.

Pregnancy and breastfeeding

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

You should only use Trydonis during pregnancy if your doctor advises you to. It is best to avoid using Trydonis during delivery due to the inhibitory effects of formoterol on uterine contractions.

You should not use Trydonis during breastfeeding. You and your doctor should decide whether to stop breastfeeding or stop treatment after considering the benefits of breastfeeding for your baby and the benefits of treatment for you.

Driving and operating machinery

It is unlikely that Trydonis will affect your ability to drive and operate machinery.

Trydonis contains lactose

Lactose contains small amounts of milk proteins, which may cause allergic reactions.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is two inhalations in the morning and two inhalations at night.

If you think the medication is not very effective, consult your doctor.

If you have been using another inhaler containing beclometasone dipropionate in the past, consult your doctor, as the effective dose of beclometasone dipropionate in Trydonis for the treatment of chronic obstructive pulmonary disease may be lower than that of other inhalers.

Administration route

Trydonis is for inhalation use.

You must inhale the medication through the mouth, which takes the medication directly to the lungs.

Usage instructions

To consult the information on the packaging contents, see section 6.

If the packaging contents do not match the description in section 6, return the inhaler to the person who supplied it and obtain a new one.

• Do not remove the inhaler from the pouch if you do not intend to use it immediately.
• Use the inhaler always in the indicated way.
• Keep the cap closed until you need to take a dose from the inhaler.

• When not using the inhaler, keep it in a clean and dry place.

• Do not attempt to disassemble the inhaler under any circumstances.

A. Essential characteristics of the inhaler

Taking a dose from the inhaler involves three steps: opening, inhaling, closing.

B. Before using a new inhaler

1. Open the pouch and remove the inhaler.

2. Inspect the inhaler.

3. Check the dose counter window. If the inhaler is new, you will see “120” in the dose counter window.

C. How to use the inhaler

C.1. Open

1. Hold the inhaler firmly in a vertical position.

2. Check the number of doses remaining: any number between “1” and “120” indicates that there are doses remaining.

3. Open the cap completely.

4. Before inhaling, breathe out as slowly and comfortably as possible.

C.2. Inhale

Always, if possible, stand or sit upright to perform the inhalation.

1. Hold the inhaler, bring it to the mouth, and place the lips around the mouthpiece.

2. Perform a strong and deep inhalation through the mouth.

3. Remove the inhaler from the mouth.

4. Hold your breath for 5 to 10 seconds or as long as you feel comfortable.

5. Breathe out slowly.

• If you are not sure you are receiving your dose correctly, contact your pharmacist or doctor.

C.3. Close

1. Place the inhaler back in a vertical position and close the cap completely.

2. Check that the dose counter has decreased by one unit.

• If you are not sure that the dose counter has decreased by one unit after an inhalation, wait until the next scheduled dose and take it normally. Do not take an additional dose.

3. If you need to take another dose, repeat steps C.1 to C.3.

D. Cleaning

• Normally, it is not necessary to clean the inhaler.
• If necessary, you can clean the inhaler after use with a dry cloth or paper towel.
• • Do not clean the inhaler with water or other liquids. Keep it dry.

If you use more Trydonis than you should

It is essential to take the dose as indicated by your doctor. Do not exceed the prescribed dose without consulting your doctor first.

If you use more Trydonis than you should, the side effects described in section 4 may appear.

Inform your doctor if you have used more Trydonis than you should and if you experience any of these symptoms. Your doctor may want to perform some blood tests.

If you forget to use Trydonis

Use it as soon as you remember. If it is almost time for the next dose, do not administer the missed dose, but only the next dose at the correct time. Do not double the dose.

If you interrupt treatment with Trydonis

It is essential to use Trydonis every day. Do not interrupt treatment with Trydonis or reduce the dose, even if you feel better or do not have symptoms. If you want to do this, consult your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

There is a risk of worsening breathing difficulty and immediate sibilance after using Trydonis, known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs, you should interrupt treatment with Trydonis and use your rescue inhaler with rapid action to treat breathing difficulty and sibilance. You should contact your doctor immediately.

Inform your doctor immediately

• if you experience allergic reactions such as skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), skin redness, skin swelling or mucous membrane swelling, especially on the eyes, face, lips, and throat (may affect up to 1 in 1,000 people).
• if you experience eye pain or discomfort, transient blurred vision, halos, or colored images associated with red eyes. These may be signs of an acute angle-closure glaucoma crisis (may affect up to 1 in 10,000 people).

Inform your doctor if you notice any of the following symptoms during the use of Trydonis, as they may be due to a lung infection (may affect up to 1 in 10 people):

• fever or chills
• increased mucus production, change in mucus color
• increased cough or breathing difficulty

Thepossible side effectsare listed below according to their frequency.

Frequent(may affect up to 1 in 10 people)

• sore throat
• nasal secretion or congestion and sneezing
• oral thrush. Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help prevent these side effects
• hoarseness
• headache
• urinary tract infection

Infrequent(may affect up to 1 in 100 people)

Rare(may affect up to 1 in 1,000 people)

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

• low platelet count
• sensation of choking or breathing difficulty
• hand and foot swelling
• growth delay in children and adolescents

Frequency not known(cannot be estimated from available data)

The use of inhaled corticosteroids at high doses for a prolonged period may cause, in very rare cases, effects on the body:

• problems with adrenal gland function (adrenal suppression)
• decreased bone mineral density (bone thinning)
• clouding of the lens (cataract)

Trydonis does not contain an inhaled corticosteroid at high doses, but your doctor may want to measure your cortisol levels in the blood from time to time.

The following side effects may also occur when using inhaled corticosteroids at high doses for a prolonged period, but their frequency is currently unknown (cannot be estimated from available data):

• depression
• sensation of concern, nervousness, overexcitement, or irritability

These effects are more likely to occur in children.

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 leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es..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 this medication after the expiration date that appears on the label and on the box after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Store the inhaler in the original packaging to protect it from humidity and only remove it from the pouch immediately before the first use.

After the first opening of the pouch, the medication must be used within a period of 6weeks and stored in a dry place. Use the adhesive label on the outer box to note the date when you opened the pouch and attach this label to the bottom of the inhaler.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help to protect the environment.

Composition of Trydonis

The active principles are: beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrrolate.

Each dose released (the dose that comes out of the oral inhaler) contains 88 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate, and 9 micrograms of glycopyrrolate (in the form of 11 micrograms of bromide of glycopyrrolate).

Each measured dose contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate, and 10 micrograms of glycopyrrolate (in the form of 12.5 micrograms of bromide of glycopyrrolate).

The other components are: lactose monohydrate (see section 2) and magnesium stearate.

Appearance of the product and contents of the package

Trydonis is a white to almost white powder for inhalation.

It is supplied in a white plastic inhaler called NEXThaler with a gray cover for the oral inhaler and a counter for the inhalations.

Each inhaler is packaged in a closed protective bag.

Trydonis is available in packages containing one inhaler and multiple packages containing two or three inhalers, which provide 120 inhalations each (120, 240, or 360 inhalations).

Only some package sizes may be commercially available.

Marketing Authorization Holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Responsible for manufacturing

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma

Italy

Chiesi SAS

2 rue des Docteurs Alberto et Paolo Chiesi

41260 La Chaussée Saint Victor

France

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

Last review date of this leaflet: December 2024

Other sources of information

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