Leaflet: information for the user

Trimbow 172micrograms/5micrograms/9micrograms solution for inhalation in pressurized container

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 others 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.

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

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

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

Formoterol and glycopyrronio 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.

The regular treatment with these three active principles helps to alleviate and prevent symptoms such as difficulty breathing, wheezing, and cough in adult patients with chronic obstructive pulmonary disease.

Trimbow is used for the regular treatment of asthma in adults.

Trimbow may reduce exacerbations (attacks) of asthma symptoms. Asthma is a serious and chronic disease in which the muscles surrounding the airways contract (bronchoconstriction) and swell and become inflamed. Symptoms appear and disappear and include shortness of breath, wheezing, chest tightness, and cough.

You must use Trimbow every day and not just when you have breathing problems or other asthma symptoms. This will ensure that the medication controls your asthma properly. Do not use this medication to relieve a sudden crisis of difficulty breathing or wheezing.

No use Trimbow

If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium or any of the other components of this medicine (listed in section6).

Warnings and precautions

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

If your breathing worsens

If you experience a worsening of difficulty breathing or wheezing immediately after inhaling the medicine, stop treatment with the Trimbow inhaler and use your rescue inhaler immediately. You should contact your doctor as soon as possible. Your doctor will assess 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, see your doctor immediately. It may be that your COPD is 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 abnormality, or if you have a condition called hypertrophic obstructive cardiomyopathy (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 a narrowing of the arteries (also known as arteriosclerosis), 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 Trimbow with certain other medicines for the lungs or medicines such as diuretics (medicines that make the body lose water to treat heart disease or high blood pressure) may cause a significant drop in potassium levels in the blood. Your doctor may want to measure your potassium levels in the 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 some additional blood tests to determine your blood sugar levels when you start taking this medicine and from time to time during treatment.

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

• If you are to be given an anesthetic. Depending on the type of anesthetic, you may need to stop treatment with Trimbow at least 12hours before the anesthetic.

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

• If you have a problem with your eyes 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 or 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 you experience a stressful situation (e.g., if you are taken to hospital after an accident, have a serious injury, or before surgery), you may need more medicine. 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 medicine to children and adolescents under 18years.

Other medicines and Trimbow

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

Some medicines may increase the effects of Trimbow, so your doctor will make close checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Do not use this medicine 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.

Using Trimbow with:

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

• medicines to treat Parkinson's disease (levodopa), medicines to treat an underactive thyroid gland (levotiroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol may increase the likelihood of formoterol having 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 to treat heart disease (digoxin) may cause a drop in potassium levels in the blood.This may increase the risk of abnormal heart rhythms.

• other medicines 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 medicine used to treat people with alcoholism (problems with alcohol) or metronidazole, an antibiotic 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 Trimbow.

Pregnancy and breastfeeding

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

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

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

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 doses in the morning and two doses at night.

Do not use more than the amount indicated by your doctor.

You must use Trimbow every day, even if your asthma is not giving you problems.

Do not use this medication to relieve a sudden crisis of difficulty breathing or wheezing.

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

If you have been using another inhaler that contained beclomethasone dipropionate previously, consult your doctor, as the effective dose of beclomethasone 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 must 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.

Trimbow is available in two package sizes:

•a package that provides 60doses

•a package that provides 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 be reduced.

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

How to use the inhaler

Stand up or sit upright to perform the inhalation.

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. 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 pointing downwards and place the mouthpiece between the teeth without biting it. Then, place the lips around the mouthpiece, with the tongue flat underneath it.
4. Breathe in slowly and deeply through the mouth to fill the lungs with air (this should take about 4-5 seconds). Just after starting to inhale, press the container firmly 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 that the dose counter has decreased by one unit.

To take the second dose, hold the inhaler straight for about half a minute and then repeat steps 2 to 5.

If some of the gas escapes through the top of the inhaler or through the corner of the lips, it means that Trimbow 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 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 acquire a new inhaler

You must acquire a replacement when the counter shows the number20. Stop using the inhaler when the counter shows 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 that you read the prospectus provided with the AeroChamber Plus device and follow its instructions for use and cleaning carefully.

Cleaning the Trimbow 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 inside and outside of the mouthpiece and the inhaler with a clean and dry cloth or paper towel.

4.Put the protective cap back on the mouthpiece.

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 adverse effects described in section 4 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 are feeling 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 Trimbow, known as paradoxical bronchospasm (which can affect up to 1 in 1,000 people). If this occurs, you should interrupt treatment with Trimbow and use your rescue inhaler quickly 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, itching, skin rash (which can affect up to 1 in 100 people), skin redness, skin swelling or mucous membrane swelling, especially on the eyes, face, lips, and throat (which 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 (which 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 (which 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(which can 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(which can affect up to 1 in 100 people)

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

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

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

Frequency not known(cannot be estimated from available data)

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)

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 (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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: 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 the 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.

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 172 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopronio (in the form of 11 micrograms of bromide of glycopronio).

Each measured dose (the dose that comes out of the valve) contains 200 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopronio (in the form of 12.5 micrograms of bromide of glycopronio).

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 6.471 g of norflurano (HFC-134a) corresponding to 0.009 tonnes of CO2 equivalent (global warming potential PCG = 1430).

Each inhaler of 120 puffs contains 10.354 g of norflurano (HFC-134a) corresponding to 0.015 tonnes of CO2 equivalent (global warming potential PCG = 1430).

Appearance of the product and contents of the pack

Trimbow is a pressurized solution for inhalation.

Trimbow is presented in a pressurized container (aluminium-coated) with a dosing valve. The pressurized container is inserted in a plastic inhaler. This incorporates a mouthpiece with a plastic protective cap and a dose counter (containers with 60 and 120 doses).

Each container contains a pressurized container that provides 60 doses or 120 doses. In addition, there are multiple-container packs containing 240 doses (2 pressurized containers with 120 doses each) or 360 doses (3 pressurized containers with 120 doses each).

Only some container 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

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.