Prospecto: information for the user

Trydonis 87micrograms/5micrograms/9micrograms solution for inhalation in a pressurized container

dipropionato de beclometasona/fumarato de formoterol dihidrato/glicopirronio

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

• Keep this prospectus, 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 should not give it to other people 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 prospectus. 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 container and additional information

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

• 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 principles helps to alleviate and prevent symptoms such as difficulty breathing, wheezing, and coughing in adult patients with chronic obstructive pulmonary disease (COPD). 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 beclometasone 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 worsening of breathing difficulty or wheezing.

If your breathing worsens:

If you experience a worsening of breathing difficulty or wheezing (breathing sounds like a whistle) just after inhaling the medication, stop treatment with the Trydonis inhaler and use your rescue inhaler immediately. Contact your doctor right away. Your doctor will evaluate your symptoms and may change your treatment if necessary.

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, see 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 abnormality, or if you have a condition called hypertrophic obstructive cardiomyopathy (HOCM, a condition in which the heart muscle is abnormal).

• If you have irregular heart rhythms, a rapid heart rate, or palpitations, or if your electrocardiogram (ECG) is abnormal.

• If you have narrowed arteries (also known as arteriosclerosis), high blood pressure, or an aneurysm (an abnormal bulge in a blood vessel wall).

• If you have an overactive thyroid gland.

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

• If you have any liver or kidney disease.

• If you have diabetes. High doses of formoterol may increase blood sugar 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 (also known as pheochromocytoma).

• If you are to receive anesthesia. Depending on the type of anesthesia, you may need to stop using Trydonis at least 12hours before the procedure.

• 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 cases, your doctor may need to increase your corticosteroid dose to cope with the stress and may prescribe it 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 old.

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 HIV medications: 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 work in the same way as formoterol) may increase the effects of formoterol.

The use of Trydonis with:

• medications to treat

• abnormal heart rhythms (quinidine,disopyramide, procainamide),
• allergic reactions (antihistamines),
• depression symptoms or mental disorders such as monoamine oxidase inhibitors (e.g.,phenelzine and isocarboxazid), tricyclic antidepressants (e.g.,amitriptyline and imipramine) and phenothiazines

may cause changes in the electrocardiogram (ECG, heart tracing). They may also increase the risk of abnormal heart rhythms (ventricular arrhythmias).

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

• 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 abnormal heart rhythms.

• disulfiram, a medication used to treat people with alcoholism (alcohol problems) or metronidazole, an antibiotic to treat infections in your body may cause side effects (e.g., nausea, vomiting, stomach pain) due to the small amount of alcohol in Trydonis.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become 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 ethanol:

Trydonis contains 8.856 mg of alcohol (ethanol) in each puff, which is equivalent to 17.712 mg per dose of two puffs. The amount in two puffs of this medication is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medication has no perceptible effect.

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

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

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

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

Administration route

Trydonis is for inhalation use.

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

This medication is contained in a pressurized container within a plastic inhaler with a mouthpiece.

Trydonis is available in three packaging sizes:

• one package that provides 60doses
• one package that provides 120doses
• one package that provides 180doses

If you have been prescribed a package that provides 60doses or 120doses

There is a counter on the back of the inhaler, which indicates how many doses are left. Each time you press the container to pressure, a dose of medication will be released and the counter will decrease by one unit. Avoid dropping the inhaler as this could cause the counter to decrease.

If you have been prescribed a package that provides 180doses

There is an indicator on the back of the inhaler, which indicates how many doses are left. Each time you press the container to pressure, a dose of medication will be released and the counter will turn a little. The number of remaining doses is shown in intervals of20. Avoid dropping the inhaler as this could cause the counter to decrease.

Checking the inhaler

Before using the inhaler for the first time, you must check it in the following way to ensure it works properly.

1. Depending on the size of the package you have been prescribed, check that the reading on the dose counter is 61 or 121 and that the reading on the dose indicator is180
2. Remove the protective cap from the mouthpiece
3. Hold the inhaler vertically with the mouthpiece at the bottom
4. Point the mouthpiece away from you and press the container firmly to pressure to release a dose
5. Check the dose counter or dose indicator. If you are checking the inhaler for the first time, the counter should indicate:

How to use the inhaler

Stand up or sit up straight to perform the inhalation.

IMPORTANT: do not perform steps2 to 5 too quickly.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean, i.e., there are no powder or dirt residues.
2. Breathe out as slowly and deeply as possible to empty the lungs.
3. Hold the inhaler straight with the mouthpiece down and place the mouthpiece between the teeth without biting it. Then, place the lips around the mouthpiece, with the tongue flat under the same.
4. Breathe in slowly and deeply through the mouth to fill the lungs with air (this should take about 4‑5seconds). Just after starting to inhale, press the container firmly to pressure to release a dose.
5. Hold the breath as long as possible and, finally, remove the inhaler from the mouth and breathe out slowly. Do not expel the air through the inhaler.
6. Check the dose counter (60/120doses) has decreased by one unit or that the dose indicator (180doses) has turned a little.

To take the second dose, hold the inhaler straight for about half a minute and then repeat steps2 to 5.

If some gas escapes from the top of the inhaler or from the corner of the lips, it means that Trydonis will not reach your lungs as it should. Take another dose following the instructions starting again from step 2.

After using it, put the protective cap back on.

To avoid a fungal infection in the mouth and throat, rinse your mouth or gargle with water without swallowing or brush your teeth after each use of the inhaler.

When to acquire a new inhaler

You should acquire a replacement when the counter or indicator shows the number20. Stop using the inhaler when the counter or indicator shows a 0, as any remaining medication in the inhaler may be insufficient to provide a full dose.

If you have difficulty holding, it may be easier to hold the inhaler with both hands: place the two index fingers on the top of the inhaler and the two thumbs on the bottom of the inhaler.

If you find it difficult to use the inhaler while starting to inhale, you can use the spacer device AeroChamber Plus. Consult your doctor or pharmacist about this device.

It is essential to read the prospectus provided with the AeroChamber Plus device and follow its instructions for use and cleaning carefully.

Cleaning the Trydonis inhaler

You must clean the inhaler once a week.

1.Do not remove the container from the inhaler or use water or other liquids to clean it.

2.Remove the protective cap from the mouthpiece by pulling it away from the inhaler.

3.Clean the mouthpiece and inhaler inside and out with a clean and dry cloth or paper towel.

4.Put the protective cap back on the mouthpiece.

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 section4 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 the treatment with Trydonis

It is essential to use Trydonis every day. Do not interrupt the 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 (affecting up to 1 in 1,000 people). If this occurs, you should interrupt treatment with Trydonis and use your quick-acting rescue inhaler to treat breathing difficulty and sibilance. You should contact your doctor immediately.

Inform your doctor immediately

• if you experience allergic reactions such as skin rashes, itching, skin eruptions (affecting up to 1 in 100 people), skin redness, skin swelling, or mucous membrane swelling, especially in the eyes, face, lips, and throat (affecting 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 (affecting 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 pulmonary infection (affecting up to 1 in 10 people):

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

The possible side effects are listed below according to their frequency.

Frequent(affecting up to 1 in 10 people):

• sore throat
• nasal secretion or congestion and sneezing
• oral fungal infections. 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(affecting up to 1 in 100 people):

Rare(affecting up to 1 in 1,000 people):

Very rare(affecting 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 unknown(cannot be estimated from available data):

• blurred vision

The use of inhaled corticosteroids in high doses for a prolonged period may cause, in 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 in 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 in 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 the Spanish System for the Vigilance 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 freeze.

Do not expose to temperatures above 50°C.

Do not pierce the pressurized container.

Before dispensing:

Store in refrigerator (between 2°C and 8°C).

After dispensing (after receiving this medication from your pharmacist):

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

Composition of Trydonis

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

Each released dose (the dose that comes out of the oral inhaler) contains 87 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 (the dose that comes out of the valve) 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: anhydrous ethanol (see section 2), hydrochloric acid, propellant: norflurano.

This medicine contains fluorinated greenhouse gases.

Each inhaler of 60 puffs contains 6.481 g of norflurano (HFC-134a) corresponding to 0.009 tonnes of CO2 equivalent (global warming potential PCG = 1430).

Each inhaler of 120 puffs contains 10.37 g of norflurano (HFC-134a) corresponding to 0.015 tonnes of CO2 equivalent (global warming potential PCG = 1430).

Each inhaler of 180 puffs contains 14.259 g of norflurano (HFC-134a) corresponding to 0.02 tonnes of CO2 equivalent (global warming potential PCG = 1430).

Appearance of the product and contents of the package

Trydonis is a pressurized solution for inhalation.

Trydonis is presented in a pressurized container (aluminium-coated) with a dosing valve. The pressurized container is inserted in a plastic inhaler. This includes a mouthpiece with a plastic protective cap and a dose counter (packs with 60 and 120 doses) or a dose indicator (packs with 180 doses).

Each pack contains a pressurized container that provides 60 doses, 120 doses or 180 doses. There are also multi-pack containers that contain 240 doses (2 pressurized containers with 120 doses each) or 360 doses (3 pressurized containers with 120 doses each).

Only some pack sizes may be marketed.

Marketing authorization holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturers responsible

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma

Italy

Chiesi SAS

Rue Faraday

ZA des Gailletrous

41260 La Chaussée Saint Victor

France

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Wien

Austria

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: November 2024

Other sources of information

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