Trydonis 87 micrograms/5 micrograms/9 micrograms solution for inhalation in pressurised container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation solution

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 of 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 ingredients 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 (breathing with a whistling sound) immediately after inhaling the medicine, stop treatment with the Trydonis inhaler and use your "rescue" fast-acting 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 HOCM, a disease in which the heart muscle is abnormal).

• if 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.

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

• if you have an overactive thyroid gland.

• if you have low levels of potassium in your blood (hypokalaemia). The combination of Trydonis with certain other medicines for COPD or medicines such as diuretics (medicines that cause your body to lose water, used to treat heart disease or high blood pressure) may cause a marked decrease in blood potassium levels. Therefore, your doctor may wish to measure your blood 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 glucose, so additional blood tests to monitor your blood sugar levels may be needed when you start using this medicine and occasionally during treatment.

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

• if 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.

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

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

• if you have difficulty urinating.

• if you have an infection in your 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 over long 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 manage 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 disease.

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 problems 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 (levothyroxine), medicines 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 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 blood potassium levels. This may increase the likelihood of abnormal heart rhythms.

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

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

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

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 childbirth 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 use machines.

Trydonis contains ethanol:

Trydonis contains 8.856 mg of alcohol (ethanol) per actuation, equivalent to 17.712 mg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol contained in this medicine does not produce any noticeable effect.

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 doses in the morning and two doses in the evening.

If you think the medicine is not working effectively 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 COPD may be lower than that from 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.

This medicine is contained in a pressurized canister within a plastic inhaler with a mouthpiece.

Trydonis is available in two pack sizes:

• a pack providing 120 doses
• a pack providing 180 doses

If you have been prescribed a pack providing 120 doses

There is a counter on the back of the inhaler, which indicates how many doses remain. Each time you press the canister, one dose of medicine is released and the counter decreases by one. Avoid dropping the inhaler, as this could cause the counter to decrement.

If you have been prescribed a pack providing 180 doses

There is an indicator on the back of the inhaler, which indicates how many doses remain. Each time you press the canister, one dose of medicine is released and the indicator rotates slightly. The number of remaining doses is displayed in intervals of 20. Avoid dropping the inhaler, as this could cause the counter to decrement.

Checking the inhaler

Before using the inhaler for the first time, you should check it as follows to ensure it is working properly.

1. Depending on the pack size prescribed to you, check that the dose counter reads 121 and that the dose indicator reads 180
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 firmly press the canister to release one dose
5. Check the dose counter or dose indicator. When checking the inhaler for the first time, the counter should read:

How to use the inhaler

Stand up or sit upright when inhaling.

IMPORTANT: Do not perform steps 2 to 5 too quickly.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean, i.e., free from dust or dirt.
2. Breathe out as slowly and deeply as possible to empty your lungs.
3. Hold the inhaler upright with the mouthpiece pointing downwards and place the mouthpiece between your teeth without biting it. Then seal your lips around the mouthpiece, with your tongue lying flat beneath it.
4. Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4–5 seconds). Just after starting to inhale, press firmly down on the top of the pressurized canister to release one dose.
5. Hold your breath for as long as you can, then remove the inhaler from your mouth and breathe out slowly. Do not exhale through the inhaler.
6. Check that the dose counter (120 doses) has decreased by one unit or that the dose indicator (180 doses) has rotated slightly.

For a second dose, keep the inhaler in an upright position for about half a minute, then repeat steps 2 to 5.

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

After use, replace the protective cap.

To prevent 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 get a new inhaler

You should get a replacement when the counter or indicator shows the number 20. Stop using the inhaler when the counter or indicator shows 0, as any remaining medication in the inhaler may be insufficient to deliver a complete dose.

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

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

It is important that you read the leaflet provided with the AeroChamber Plus spacer device and carefully follow its instructions for use and cleaning.

Cleaning the Trydonis inhaler

You should clean the inhaler once a week.

1. Do not remove the pressurized canister from the inhaler and do not use water or other liquids to clean it.
2. Remove the protective cap from the mouthpiece by pulling it off the inhaler.
3. Wipe the inside and outside of the mouthpiece and inhaler with a clean, dry cloth or paper tissue.
4. Replace the mouthpiece protective cap.

If you use more Trydonis than you should

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

If you use more Trydonis than you should, the 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 or reduce your treatment with Trydonis, 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 cause adverse effects, although not everybody gets 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 use your fast-acting “rescue” inhaler without delay 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, nasal 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)

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

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 the 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 inhaled corticosteroids are used at high doses 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 reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, 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 on the carton after CAD/EXP. The expiry date is the last day of the month indicated.

Do not freeze.

Do not expose to temperatures above 50°C.

Do not pierce the pressurised container.

Before dispensing:

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

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

Medicines should not be disposed of via drains or in household waste. Ask your pharmacist how to dispose of packaging and medicines 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 emitted from the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms of glycopyrronium bromide).

Each metered dose (the dose released from the valve) 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: anhydrous ethanol (see section 2), hydrochloric acid, propellant: norflurane.

This medicinal product contains fluorinated greenhouse gases.

Each 120-dose inhaler contains 10.37 g of norflurane (HFC-134a), equivalent to 0.015 tonnes of CO2 (global warming potential GWP = 1430).

Each 180-dose inhaler contains 14.259 g of norflurane (HFC-134a), equivalent to 0.02 tonnes of CO2 (global warming potential GWP = 1430).

Nature and contents of the container

Trydonis is a solution for inhalation in a pressurised container.

Trydonis is supplied in an aluminium-coated pressurised container fitted with a metering valve. The pressurised container is placed inside a plastic inhaler device. The device includes a mouthpiece with a plastic protective cap and either a dose counter (packs with 120 doses) or a dose indicator (packs with 180 doses).

Each pack contains one pressurised container delivering either 120 or 180 doses. Additionally, multiple packs are available containing 240 doses (2 pressurised containers with 120 doses each) or 360 doses (3 pressurised containers with 120 doses each).

Only certain pack sizes may be commercially available.

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

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Wien

Austria

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

Date of the most recent review of this leaflet:

Other sources of information

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