Leaflet: information for the user

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

dipropionato de beclometasona/fumarato de formoterol dihidrato/glicopirronio

Read this leaflet carefully before you start using this medicine, because 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 must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What is Trimbow and what it is used for

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

3.How to use Trimbow

4.Possible side effects

5.Storage of Trimbow

6.Contents of the pack and additional information

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

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

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

Formoterol and glycopyrronium are medications called long-acting bronchodilators. They act 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 ingredients helps to relieve and prevent symptoms such as difficulty breathing, wheezing, and cough 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.Trimbow 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 Trimbow

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

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

If your breathing worsens

If you experience a worsening of breathing or wheezing immediately after inhaling the medication, stop treatment with the Trimbow inhaler and use your rescue inhaler right away. Contact your doctor immediately. 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, 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 Trimbow:

• 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 (HOCM), a disease 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 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 Trimbow 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 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 treatment with Trimbow 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 eye problem 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 Trimbow.

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

If you are already using Trimbow

If you are using Trimbow 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 them 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 Trimbow

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 Trimbow used to treat your COPD.

Some medications may increase the effects of Trimbow, 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 beta-blockers in 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.

Concomitant use of Trimbow with:

• medications for treating

• abnormal heart rhythms (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, cardiac tracing). They may also increase the risk of abnormal heart rhythms (ventricular arrhythmias).

• medications for treating Parkinson's disease (levodopa), medications for treating 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 for treating heart disease (digoxin) may cause a drop in potassium levels in the blood.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.

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 Trimbow during pregnancy if your doctor advises you to. It is best to avoid using Trimbow during delivery due to formoterol's inhibitory effects on uterine contractions.

You should not use Trimbow 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 Trimbow will affect your ability to drive and operate machinery.

Trimbow 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. 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 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 Trimbow for the treatment of chronic obstructive pulmonary disease may be lower than that of other inhalers.

Administration route

Trimbow is for inhalation use.

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

Instructions for use

To consult the information on the contents of the package, see section6.

If the contents of the package do not match the description in section6, return the inhaler to the person who supplied it and obtain a new one.

• Do notremove the inhaler from the package 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 notattempt to disassemble the inhaler under any circumstances.

A.Essential characteristics of the inhaler

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

B.Before using a new inhaler

1.Open the package 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

Whenever 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 the breath for 5 to 10seconds or as long as it is comfortable.

5.Breathe out slowly.

• If you are unsure of 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 unsure 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, the inhaler does not need to be cleaned.
• If necessary, you can clean the inhaler after use with a dry cloth or paper towel.
• • Do notclean the inhaler with water or other liquids. Keep it dry.

If you use more Trimbow than you should

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

If you use more Trimbow than you should, the side effects described in section4 may appear.

Inform your doctor if you have used more Trimbow 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 Trimbow

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 Trimbow

It is essential to use Trimbow every day. Do not interrupt treatment with Trimbow 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 can cause side effects, although not everyone will experience them.

There is a risk of worsening breathing difficulty and immediate coughing immediately after using Trimbow, known as paradoxical bronchospasm (it can affect up to 1 in 1,000 people). If this occurs, you should interrupt treatment with Trimbow and use your quick-acting rescue inhaler to treat breathing difficulty and coughing. You should contact your doctor immediately.

Inform your doctor immediately

• if you experience allergic reactions such as skin rashes, itching, skin eruptions (it can affect up to 1 in 100 people), skin redness, skin swelling or mucous membrane swelling, especially on the eyes, face, lips, and throat (it can 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 (it can affect up to 1 in 10,000 people).

Inform your doctor if you notice any of the following symptoms during the use of Trimbow, as they may be due to a lung infection (it can 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(it can affect 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(it can affect up to 1 in 100 people)

Rare(it can affect up to 1 in 1,000 people)

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

• low platelet count
• sensation of choking or breathing difficulty
• swelling of the hands and feet
• delayed growth in children and adolescents

Frequency unknown(it cannot be estimated from available data)

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

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

Trimbow 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 (it 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 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 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 the pouch was opened 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 containers and medications that you no longer need. In this way,

you will help to protect the environment.

Trimbow Composition

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

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

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

The other components are: lactose monohydrate (see section2) and magnesium stearate.

Appearance of the product and contents of the package

Trimbow is a white to almost white powder for inhalation.

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

Each inhaler is packaged in a closed protective bag.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Responsible Person

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

Last update of the summary of product characteristics:December 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.