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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Trydonis 88micrograms/5micrograms/9micrograms inhalation powder

beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Trydonis is and what it is used for
2. What you need to know before using Trydonis
3. How to use Trydonis
4. Possible side effects
5. How to store Trydonis
6. Contents of the pack and other information

1. What Trydonis is and what it is used for

Trydonis is a medicine to help you breathe that contains three active substances:

• beclometasone dipropionate,
• formoterol fumarate dihydrate, and
• glycopyrronium.

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

Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They work in different ways to relax the muscles in the airways, helping to widen them and allowing you to breathe more easily.

Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing, and cough 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 in breathing.

2. What you need to know before using Trydonis

Do not use Trydonis

If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and/or glycopyrronium or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Trydonis is used as maintenance treatment for obstructive lung disease. Do not use this medicine to treat a sudden attack of breathing difficulty or wheezing.

If your breathing worsens

If you experience a worsening of breathing difficulty or wheezing immediately after inhaling the medicine (respirations with a whistling sound), stop treatment with the Trydonis inhaler and use your fast-acting “rescue” inhaler immediately. You must contact your doctor right away. Your doctor will assess your symptoms and, if necessary, may change your treatment.

See also section 4. Possible side effects.

If your lung disease worsens

If your symptoms worsen or become 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 lung disease 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, heart pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the heart arteries (coronary artery disease), heart valve disease or any other heart abnormality, or if you have a condition called obstructive hypertrophic cardiomyopathy (also known as HCM, a disease in which the heart muscle is abnormal).

• you have heart rhythm disorders, such as irregular heartbeat, rapid pulse rate, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.

• you have narrowing of the arteries (also known as arteriosclerosis), high blood pressure, or an aneurysm (an abnormal bulging of the wall of a blood vessel).

• you have an overactive thyroid gland.

• you have low levels of potassium in the blood (hypokalaemia). The combination of Trydonis with certain other lung medicines or medicines such as diuretics (medicines that cause the body to lose water, used to treat heart disease or high blood pressure) may cause a marked decrease in potassium levels in the blood. Therefore, your doctor may wish to measure your blood potassium levels from time to time.

• you have any liver or kidney disease.

• you have diabetes. High doses of formoterol may increase blood glucose, so additional blood tests may be needed to monitor your blood sugar levels when you start using this medicine and periodically during treatment.

• you have a tumour of the adrenal gland (known as phaeochromocytoma).

• you are going to receive an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop treatment with Trydonis at least 12 hours before anaesthesia.

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

• you have an eye condition called narrow-angle glaucoma.

• you have difficulty urinating.

• you have an infection in the mouth or throat.

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

If you have or have had any health problems or 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 admitted to hospital after an accident, have a serious injury, or before surgery), you may need additional medication. In such situations, 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 give this medicine to children and adolescents under 18 years of age.

Other medicines and Trydonis

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines similar to Trydonis used for your lung condition.

Some medicines may increase the effects of Trydonis, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Do not use this medicine with a beta-blocker (used to treat certain heart conditions such as angina or to lower blood pressure) unless your doctor has selected a beta-blocker that does not affect your breathing. Beta-blockers (including beta-blockers in eye drops) may reduce or completely block the effects of formoterol. On the other hand, using other beta2-agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol.

The combined use of Trydonis with:

• medicines used to treat

• abnormal heart rhythms (quinidine, disopyramide, procainamide),

• allergic reactions (antihistamines),

• symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazide), 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 heart rhythm disturbances (ventricular arrhythmias).

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

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

• medicines used to treat heart disease (digoxin) may cause a decrease in potassium levels in the blood. This may increase the likelihood of abnormal heart rhythms.

• other medicines used to treat obstructive lung disease (theophylline, aminophylline or corticosteroids) and diuretics may also cause a drop in potassium levels.

• certain anaesthetics may increase the risk of abnormal heart rhythms.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

You should not use Trydonis while breastfeeding. You and your doctor must decide whether to stop breastfeeding or stop treatment, taking into account the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

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

Trydonis contains lactose

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

3. How to use Trydonis

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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 medicine is not working well enough, consult your doctor.

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

Route of administration

Trydonis is for inhalation use only.

You should inhale the medicine through your mouth, which delivers the medicine directly to the lungs.

Instructions for use

For information about the contents of the package, see section 6.

If the contents of the package do not match those described 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.

• Always use the inhaler as directed.

• Keep the cover closed until you need to take a dose from the inhaler.

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

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

A. Essential features of the inhaler

Taking a dose from the inhaler involves three steps: open, inhale, close.

B. Before using a new inhaler

1. Open the pouch and remove the inhaler.

• Do not use the inhaler if the pouch is not sealed or shows any damage; return it to the pharmacist who supplied it and obtain a new one.
• Use the label on the box to record the date on which you opened the pouch.

2. Inspect the inhaler.

• If the inhaler appears broken or damaged, return it to the pharmacist who supplied it and obtain a new one.

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

• Do not use the new inhaler if the number shown is less than “120”; return it to the pharmacist who supplied it and obtain a new one.

C. How to use the inhaler

C.1. Open

1. Hold the inhaler firmly in an upright position.

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

• If the dose counter window shows “0”, no doses remain; discard the inhaler and obtain a new one.

3. Fully open the cover.

4. Before inhaling, breathe out as fully as comfortably possible.

• Do not breathe out through the inhaler.

C.2. Inhale

Whenever possible, stand up or sit upright when taking the inhalation.

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

• Do not cover the air vent when holding the inhaler.
• Do not inhale through the air vent.

2. Take a strong, deep breath in through your mouth.

• You may notice a taste when taking the dose.
• You may hear or feel a click when taking the dose.
• Do not inhale through your nose.
• Do not remove the inhaler from your lips during inhalation.

3. Remove the inhaler from your mouth.

4. Hold your breath for 5 to 10 seconds, or as long as comfortably possible.

5. Breathe out slowly.

• Do not breathe out through the inhaler.

• If you are unsure whether you received your dose correctly, contact your pharmacist or doctor.

C.3. Close

1. Place the inhaler back in an upright position and fully close the cover.

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

• If you are not sure whether the dose counter has decreased by one unit after an inhalation, wait until your next scheduled dose and take it as normal. 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 may clean the inhaler after use with a dry cloth or dry paper tissue.
  • Do not clean the inhaler with water or other liquids. Keep it dry.

If you use more Trydonis than you should

It is important that you take the dose exactly as prescribed by your doctor. Do not exceed the prescribed dose without first consulting your doctor.

If you use more Trydonis than you should, adverse effects described in section 4 may occur.

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

If you forget to use Trydonis

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

If you stop using Trydonis

It is important to use Trydonis every day. Do not stop using Trydonis or reduce the dose, even if you feel better or have no symptoms. If you wish to do so, consult your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

There is a risk of worsening breathing difficulty and wheezing immediately after using Trydonis, known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs, you must stop treatment with Trydonis and promptly use your fast-acting "rescue" inhaler to treat the breathing difficulty and wheezing. You must 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, swelling of the skin or mucous membranes, especially of 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, visual halos, or colored images associated with red eyes. These may be signs of an acute attack of narrow-angle glaucoma (may affect up to 1 in 10,000 people).

Inform your doctor if you notice any of the following symptoms during treatment with 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 worsening of breathing difficulty

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

Frequent (may affect up to 1 in 10 people)

• sore throat
• nasal discharge or congestion and sneezing
• fungal infections of the mouth. Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help prevent these adverse effects
• hoarseness
• headache
• urinary tract infection

Uncommon (may affect up to 1 in 100 people)

flu sinus inflammation nasal itching, discharge, or congestion fungal infections of the throat or food pipe (esophagus) fungal infections of the vagina agitation tremor dizziness disturbances or reduction in taste sensation numbness ear inflammation irregular heartbeat changes in electrocardiogram (ECG) unusually fast heartbeat and heart rhythm disorders palpitations (awareness of abnormal heartbeat) facial flushing increased blood flow to certain body tissues asthma attack dry cough and productive cough

throat irritation nosebleeds redness of the pharynx dry mouth diarrhea difficulty swallowing nausea upset stomach stomach discomfort after meals burning sensation in the lips dental caries skin rash, hives, skin itching inflammation of the mouth lining with or without ulcers increased sweating muscle cramps and muscle pain pain in arms or legs chest pain involving muscles, bones, or joints fatigue increased blood pressure decrease in levels of certain blood components: certain white blood cells called granulocytes, potassium, or cortisol increase in levels of certain blood components: glucose, C-reactive protein, platelet count, insulin, free fatty acids, or ketones

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

fungal infections in the chest decreased appetite sleep disorders (sleeping too little or too much) chest tightness or pressure sensation of missed heartbeat or extra heartbeats, unusually slow heartbeat asthma attack

bleeding from a blood vessel into the surrounding tissues decrease in blood pressure weakness pain at the back of the mouth and throat inflammation of the pharynx dry throat painful and frequent urination difficulty and pain during urination inflammation of the kidneys

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

• low level of certain blood cells called platelets
• feeling of suffocation or difficulty breathing
• swelling of hands and feet
• growth retardation in children and adolescents

Frequency not known (cannot be estimated from available data)

• blurred vision

The use of inhaled corticosteroids at high doses over a prolonged period of time may, in very rare cases, cause systemic effects:

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

Trydonis does not contain a high-dose inhaled corticosteroid, but your doctor may occasionally wish to measure your blood cortisol levels.

The following adverse effects may also occur when high-dose inhaled corticosteroids are used over a prolonged period of time, but their frequency is currently unknown (cannot be estimated from available data):

• depression
• feelings of worry, nervousness, overexcitement, or irritability

These effects are more likely in children.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trydonis

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

Do not use this medicine after the expiry date stated on the label and the carton after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep the inhaler in its original packaging to protect it from moisture, and only remove it from the pouch immediately before first use.

After the pouch has first been opened, the medicine must be used within 6 weeks and stored in a dry place. Use the adhesive label from the outer carton to record the date you opened the pouch, and attach this label to the bottom of the inhaler.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Trydonis

The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.

Each delivered dose (the dose that exits the mouthpiece) contains 88 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms of glycopyrronium bromide).

Each metered dose contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide).

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

Appearance of the product and contents of the pack

Trydonis is a white to almost white inhalation powder.

It is supplied in a white plastic inhaler called NEXThaler, with a grey mouthpiece cover and a dose counter.

Each inhaler is packed in a sealed protective bag.

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

Some pack sizes may not be marketed.

Marketing Authorisation Holder

Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer

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

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

Belgium/Belgium/Belgium Chiesi sa/nv Tel/Tel: + 32 (0)2 788 42 00	Lithuania Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
	Luxembourg/Luxembourg Chiesi sa/nv Tel/Tel: + 32 (0)2 788 42 00
Czech Republic Chiesi CZ s.r.o. Tel: + 420 261221745	Hungary Chiesi Hungary Kft. Tel.: + 36-1-429 1060
Denmark Chiesi Pharma AB Tlf: + 46 8 753 35 20	Malta Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Germany Chiesi GmbH Tel: + 49 40 89724-0	Netherlands Chiesi Pharmaceuticals B.V. Tel: + 31 88 501 64 00
Estonia Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919	Norway Chiesi Pharma AB Tlf: + 46 8 753 35 20
Greece Chiesi Hellas AEBE Tel: + 30 210 6179763	Austria Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Spain Laboratorios BIAL, S.A. Tel: + 34 91 562 41 96	Poland Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1421
France Chiesi S.A.S. Tél: + 33 1 47688899	Portugal Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Croatia Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919	Romania Chiesi Romania S.R.L. Tel: + 40 212023642
Ireland Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791	Slovenia CHIESI SLOVENIJA, d.o.o. Tel: + 386-1-43 00 901
Iceland Chiesi Pharma AB Sími: +46 8 753 35 20	Slovakia Chiesi Slovakia s.r.o. Tel: + 421 259300060
Italy Chiesi Italia S.p.A. Tel: + 39 0521 2791	Finland Chiesi Pharma AB Puh/Tel: +46 8 753 35 20
Cyprus Chiesi Farmaceutici S.p.A. Τηλ: + 39 0521 2791	Sweden Chiesi Pharma AB Tel: +46 8 753 35 20
Latvia Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919

Date of the most recent review of this leaflet: December 2024

Other sources of information

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