Brand name Trimbow

Form solution, inhalation

Active substance / Dosage

FORMOTEROL FUMARATE DIHYDRATE

GLYCOPYRROLATE BROMIDE

BECLOMETASONE DIPROPIONATE

Prescription type Restricted prescription – dispensable on hospital or specialist prescription

ATC code

R03AL09

Registration number 045489

Manufacturer CHIESI FARMACEUTICI S.P.A.

Table of Contents

Patient Information Leaflet: Information for the User
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised solution for
1. What Trimbow is and what it is used for
2. What you need to know before using Trimbow
3. How to use Trimbow
4. Possible side effects
5. How to store Trimbow
6. Package contents and other information
Package leaflet: Information for the user
Trimbow 172 micrograms/5 micrograms/9 micrograms pressurized solution for
1. What Trimbow is and what it is used for
2. What you need to know before using Trimbow
3. How to use Trimbow
4. Possible side effects
5. How to store Trimbow
6. Package contents and other information
Package leaflet: information for the user
Trimbow 88 micrograms/5 micrograms/9 micrograms inhalation powder
1. What Trimbow is and what it is used for
2. What you need to know before using Trimbow
3. How to use Trimbow
1. Open the pouch and remove the inhaler.
2. Inspect the inhaler.
3. Open the lid completely.
4. Before inhaling, breathe out as fully as possible without effort.
1. Lift the inhaler, bring it to your mouth and place your lips around the mouthpiece.
2. Take a strong, deep breath in through the mouth.
3. If another dose is needed, repeat steps C.1 to C.3.
4. Possible side effects
5. How to store Trimbow
6. Package contents and other information

Patient Information Leaflet: Information for the User

Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised solution for

inhalation
beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What Trimbow is and what it is used for
What you need to know before you use Trimbow
How to use Trimbow
Possible side effects
How to store Trimbow
Contents of the pack and other information

1. What Trimbow is and what it is used for

Trimbow is a medicine that helps you breathe and contains three active substances:

beclometasone dipropionate,
formoterol fumarate dihydrate,
glycopyrronium.

Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which exert an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They relax the muscles of the airways through different mechanisms, thereby dilating the airways and making breathing easier.
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 obstructive lung disease.
Trimbow is used for the regular treatment of:

chronic obstructive pulmonary disease (COPD) in adults,
asthma in adults.

Trimbow is able to reduce exacerbations (sudden worsening) of COPD and asthma symptoms.
COPD is a serious chronic disease characterised by obstruction of the airways and damage to the lung alveoli, resulting in difficulty breathing.
Asthma is a serious chronic disease in which the muscles surrounding the airways narrow (bronchoconstriction) and become swollen and irritated (inflammation). Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough.
You must use Trimbow every day, not only when you have breathing problems or other asthma symptoms, in order to ensure adequate asthma control. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.

2. What you need to know before using Trimbow

Do not use Trimbow
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
Trimbow is used as maintenance therapy for chronic obstructive pulmonary disease (COPD). Do not use this
medicine to treat an acute episode of breathlessness or wheezing.

If breathing worsens
If you experience a worsening of shortness of breath or wheezing (audible whistling during breathing) immediately after inhaling the medicine, stop using the Trimbow inhaler and use your "reliever" (rescue) inhaler with rapid action immediately. Contact your doctor right away; they will assess your symptoms and, if necessary, prescribe a different treatment.
See also section 4, “Possible side effects”.

If lung disease worsens
If your symptoms worsen or become difficult to control (e.g. if you need to use your "reliever" inhaler more frequently), or if your "reliever" inhaler fails to improve your symptoms, contact your doctor immediately. Your lung condition may be deteriorating, and your doctor may prescribe a different treatment.

Talk to your doctor or pharmacist before using Trimbow:

if you have heart problems, such as angina (chest pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries surrounding the heart (coronary heart disease), heart valve disease or any other heart abnormality, or if you suffer from a condition called obstructive hypertrophic cardiomyopathy (or HCM, a disease characterized by an abnormality of the heart muscle).
if you have heart rhythm disorders such as irregular heartbeat, rapid pulse or palpitations, or if your electrocardiogram (ECG) is abnormal.
if you have narrowed arteries (known as arteriosclerosis), high blood pressure, or an aneurysm (an abnormal dilation of 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 Trimbow with other lung medicines or diuretics (medicines to eliminate water from the body, used to treat heart conditions or high blood pressure) may cause a marked decrease in blood potassium levels. Therefore, your doctor may periodically check your blood potassium levels.
if you have any liver or kidney disease.
if you have diabetes. High doses of formoterol may increase blood glucose levels; therefore, you may need additional blood tests to monitor your blood sugar levels when starting this medicine and periodically during treatment.
if you have a tumour of the adrenal glands (called phaeochromocytoma).
if you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with Trimbow at least 12 hours before anaesthesia.
if you have or have had tuberculosis (TB) or a chest infection.
if you have a condition affecting the eyes called closed-angle glaucoma.
if you have difficulty urinating.
if you have a mouth or throat infection.

If any of these conditions apply to you, inform your doctor before using Trimbow.
If you have or have had any medical condition or allergy, or if you are unsure whether you can use
Trimbow, consult your doctor or pharmacist before using 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. hospitalization after an injury, severe injuries or before surgery), you may need a higher dose of this medicine. In such cases, 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 administer this medicine to children and adolescents under 18 years of age.

Other medicines and Trimbow
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also includes medicines similar to Trimbow used for your lung condition.

Some medicines may increase the effects of Trimbow, and your doctor may wish to monitor you closely if you are taking these medicines (including certain medicines for human immunodeficiency virus (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 prescribed a beta-blocker that does not interfere with breathing. Beta-blockers (including beta-blocker eye drops) may reduce or completely counteract the effects of formoterol. On the other hand, the use of other beta2-agonist medicines (which have an action similar to formoterol) may increase the effects of formoterol.

The use of Trimbow together with:

medicines used to treat
- heart rhythm disorders (quinidine, disopyramide, procainamide),
- allergic reactions (antihistamines),
- symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines may cause changes in the electrocardiogram (ECG). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).
medicines used to treat Parkinson’s disease (levodopa), to treat underactive thyroid gland (levotyroxine), medicines containing oxytocin (which cause uterine contractions), and alcohol, may increase the likelihood of cardiac side effects due to formoterol.
monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine, used to treat mental disorders, may increase blood pressure.
medicines used to treat heart conditions (digoxin), may reduce potassium levels in the blood. This may increase the likelihood of heart rhythm abnormalities.
other medicines used to treat chronic obstructive pulmonary disease (theophylline, aminophylline or corticosteroids) and diuretics, may reduce potassium levels in the blood.
certain anaesthetics, may increase the risk of heart rhythm abnormalities.
disulfiram, a medicine used to treat people with alcoholism (alcohol dependence), or metronidazole, an antibiotic used to treat infection, may cause side effects (e.g. nausea, vomiting, stomach upset) due to the small amount of alcohol present in Trimbow.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use Trimbow during pregnancy only if advised by your doctor. It is preferable to avoid using Trimbow during labour due to formoterol’s inhibitory effect on uterine contractions.
Do not use Trimbow while breastfeeding. You and your doctor must decide whether to discontinue breastfeeding or discontinue/abstain from treatment with Trimbow, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.

Driving and using machines
It is unlikely that Trimbow will affect your ability to drive or operate machinery.

Trimbow contains ethanol
Trimbow contains 8.856 mg of alcohol (ethanol) per actuation, equivalent to 17.712 mg per two-actuation dose. The amount in two actuations of this medicine is equivalent to that contained in less than 1 mL of wine or beer. The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Trimbow

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is two inhalations in the morning and two inhalations in the evening.
Do not use more medicine than prescribed by your doctor.
You must use Trimbow every day, even if you do not have asthma symptoms.
Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
If you feel the medicine is not working well enough, speak to your doctor.
If you have previously used a different inhaler containing beclometasone dipropionate, ask your
doctor for advice, as the effective dose of beclometasone dipropionate contained in Trimbow for the treatment
of your chronic obstructive pulmonary disease may be lower than that of other inhalers.
Route of administration
Trimbow is for inhalation use.
You must inhale the medicine through your mouth: this way, the medicine reaches directly into the
lungs.
This medicine is contained in a pressurised canister within a plastic inhaler
with a mouthpiece.
Trimbow is available in three different canisters:

a 60-dose canister
a 120-dose canister
a 180-dose canister.

If you have been prescribed a 60-dose or 120-dose canister
On the back of the inhaler there is a dose counter indicating the number of doses remaining. Each time
you press the pressurised canister, one dose of medicine is released, and the dose counter decreases by one unit. Be careful not to drop the inhaler, as this may cause the dose indicator to lose count.
If you have been prescribed a 180-dose canister
On the back of the inhaler there is a dose indicator showing the number of doses remaining. Each time
you press the pressurised canister, one dose of medicine is released, and the dose indicator rotates slightly. The number of remaining doses is displayed at intervals of 20. Be careful not to
drop the inhaler, as this may cause the dose indicator to lose count.
Checking the inhaler is working
Before using it for the first time, you must test the inhaler as described below to ensure it is working correctly.

Depending on the type of canister prescribed to you, check that the dose counter shows the number 61 or 121, and that the dose indicator shows the number 180.
Remove the protective cap from the mouthpiece.
Hold the inhaler upright, with the mouthpiece pointing downwards.
Point the mouthpiece away from yourself and firmly press down on the pressurised canister to release one dose.
Check the dose counter or dose indicator. If you are using the inhaler for the first time, the counter should display:

60 120 180

if using the 60-dose canister - if using the 120-dose canister - if using the 180-dose canister

Technical drawing of a medical device with a dose counter showing the number 09 on a small lateral digital display

Diagram showing a dose indicator on a medical device with an inset highlighting the number 180 in a box

Technical drawing of a medical device with a dose counter showing the number 120 enlarged in a lateral circle

How to use the inhaler
During inhalation, stand or sit upright.
IMPORTANT: do not perform steps 2 to 5 too quickly.

Sequence of five illustrated steps showing how to remove the cap, position the

Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt.
Breathe out as slowly and deeply as possible to empty your lungs.
Hold the inhaler upright, with the mouthpiece pointing downwards, and place the mouthpiece between your teeth without biting it. Close your lips around the mouthpiece, keeping your tongue below it.
Breathe in slowly and deeply through your mouth to fill your lungs with air (this inhalation should take about 4–5 seconds). Immediately after starting to inhale, firmly press down on the top of the pressurised canister to release one dose.
Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler.
Check that the dose counter (60/120 doses) has decreased by one unit, or that the dose indicator (180 doses) has rotated slightly.

To take the second dose, hold the inhaler upright for about half a minute, then repeat steps 2 to 5.
If you see a kind of "mist" escaping from the top of the inhaler or from the sides of your mouth, this means Trimbow is not reaching your lungs properly. Take another dose following the instructions from step 2.
After use, replace the protective cap.
To prevent a fungal infection in your mouth and throat, rinse your mouth or gargle with water (without swallowing) or brush your teeth each time you use the inhaler.
When to get a new inhaler
Replace the inhaler when the dose counter or dose indicator shows the number 20. Do not use the inhaler any longer once the dose counter or dose indicator shows 0, as the medicine remaining in the inhaler may be insufficient to deliver a complete dose.
If you have a weak grip, it may be 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 have difficulty using the inhaler while starting to inhale, you may use the AeroChamber Plus spacer. Ask your doctor or pharmacist for information about this device.
It is important to read the instruction leaflet provided with the AeroChamber Plus spacer and carefully follow the instructions for use and cleaning of the AeroChamber Plus spacer.
Cleaning the Trimbow inhaler
Clean the inhaler once a week.

Do not remove the pressurised canister from the inhaler and do not use water or other liquids to clean the inhaler.
Remove the protective cap from the mouthpiece by pulling it off the inhaler.
Wipe the inside and outside of the mouthpiece and inhaler with a clean, dry cloth or wipe.
Replace the protective cap on the mouthpiece.

If you use more Trimbow than you should
It is important that you take the dose as prescribed by your doctor. Do not take a higher dose than prescribed without consulting your doctor.
If you use more Trimbow than you should, side effects may occur, as described in section 4.
Inform your doctor if you have used more Trimbow than you should and if any of these symptoms occur. Your doctor may decide to carry out some blood tests.
If you forget to use Trimbow
Use it as soon as you remember. If it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the scheduled time. Do not double the dose.
If you stop using Trimbow
It is important to use Trimbow every day. Do not stop treatment with Trimbow and do not 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately after using Trimbow, there is a risk that shortness of breath and wheezing may worsen. This effect is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs, stop treatment with Trimbow immediately and use your "reliever" inhaler with fast action to treat shortness of breath and wheezing. Seek medical advice immediately.

Inform your doctor immediately:

if you experience any allergic reaction such as skin allergies, hives, skin itching, rash (may affect up to 1 in 100 people), skin redness, swelling of the skin or mucous membranes, particularly 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, seeing halos or coloured images, together with red eyes. These may be signs of an acute attack of closed-angle glaucoma (may affect up to 1 in 10,000 people).

Inform your doctor if any of the following symptoms occur during treatment with Trimbow, as they may be symptoms of a lung infection (may affect up to 1 in 10 people):

fever or chills
increased mucus production, change in mucus colour
increased coughing or worsening breathing difficulty.

The possible side effects are listed below in order of frequency.

Common (may affect up to 1 in 10 people)

sore throat
runny nose, nasal congestion, and sneezing
fungal infections of the mouth. These side effects can be prevented by rinsing the mouth or gargling with water, or by brushing your teeth immediately after inhalation
hoarseness
headache
urinary tract infection.

Uncommon (may affect up to 1 in 100 people)

influenza • sore throat irritation
sinusitis • nosebleeds
nasal itching, runny nose, or nasal • pharyngeal redness congestion • dry mouth
fungal infections of the throat or • diarrhoea oesophagus • difficulty swallowing
vaginal fungal infections • feeling unwell
restlessness • stomach disorders
tremor • stomach discomfort after meals
dizziness • burning sensation of the lips
altered or reduced sense of taste • dental caries
numbness • rash, urticaria, skin itching
ear inflammation • inflammation of the oral mucosa,
irregular heartbeat with or without ulcers
changes in electrocardiogram (ECG) • increased sweating
rapid heartbeat and disturbances • muscle cramps and muscle pain in heart rhythm • pain in arms or legs
palpitations (awareness of abnormal heartbeat) • pain in muscles, bones, or joints of the chest
facial flushing • fatigue
increased blood flow to certain • increased blood pressure body tissues • reduced levels of certain blood components: a type of white blood cells called granulocytes, potassium, or cortisol
asthma attack
cough and productive cough
increased 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 • bleeding from a blood vessel into surrounding tissues
loss of appetite
sleep disturbance (sleeping too little or too much)
sharp chest pain
sensation of missed heartbeat or extra heartbeats, slow heartbeat
worsening of asthma
dry throat
painful and frequent urination
difficulty and pain during urination
kidney inflammation.

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

low number of certain blood cells called platelets
breathlessness or shortness of breath
swelling of hands and feet
growth retardation in children and adolescents.

Not known (frequency cannot be estimated from the available data):

blurred vision

Long-term use of inhaled corticosteroids may, very rarely, cause systemic effects:

adrenal gland function problems (adrenal suppression)
reduced bone mineral density (thinning of the bones)
lens opacity (cataract).

Trimbow does not contain high doses of inhaled corticosteroid, but your doctor may wish to periodically monitor blood cortisol levels. The following side effects may also occur with long-term use of high-dose inhaled corticosteroids, but the frequency is not known (cannot be estimated from the available data):

depression
feelings of anxiety, nervousness, hyperexcitability, or irritability. These events are more likely in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Trimbow

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the box after
Exp. The expiry date refers to the last day of that month.
Do not freeze.
Do not expose to temperatures above 50°C.
Do not pierce the pressurised container.
Before dispensing:
Store in a refrigerator (2 °C–8 °C).
After dispensing (after receiving the medicine from the pharmacist):
60-dose pressurised container: store the inhaler at a temperature below 25°C for up to 2 months.
120-dose (from a single or multiple pack) and 180-dose pressurised containers: store the inhaler at a temperature below 25°C for up to 4 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Trimbow contains
The active substances are beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.
Each delivered dose (the dose that exits 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 by the metering 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 ingredients are anhydrous ethanol (see section 2), hydrochloric acid, propellant:
norflurane.
This medicine contains fluorinated greenhouse gases.
Each 60-dose inhaler contains 6.481 g of norflurane (HFC-134a), equivalent to 0.009 tonnes of CO₂
equivalent (global warming potential = 1430).
Each 120-dose inhaler contains 10.37 g of norflurane (HFC-134a), equivalent to 0.015 tonnes of CO₂
equivalent (global warming potential = 1430).
Each 180-dose inhaler contains 14.259 g of norflurane (HFC-134a), equivalent to 0.02 tonnes of CO₂
equivalent (global warming potential = 1430).

Description of the appearance of Trimbow and package contents
Trimbow is a pressurised solution for inhalation.
Trimbow is supplied in a pressurised container (aluminium-coated), with metering valve. The pressurised container is placed inside a plastic inhaler device. This includes a mouthpiece with a protective plastic cap and a dose counter (60- or 120-dose packs) or a dose indicator (180-dose packs).
Each pack contains one pressurised container delivering 60 doses, 120 doses or 180 doses.
Multiple packs are also available, containing 240 doses (2 pressurised containers with 120 doses each) or 360 doses (3 pressurised containers with 120 doses each).
Not all pack sizes may 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
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Wien
Austria

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919

България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Teл.: + 359 29201205 Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: + 420 261221745 Tel.: + 36-1-429 1060

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf: + 46 8 753 35 20 Tel: + 39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20

Ελλάδα Österreich
Chiesi Hellas AEBE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 6179763 Tel: + 43 1 4073919

España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: + 34 93 494 8000 Tel.: + 48 22 620 1421

France Portugal
Chiesi S.A.S. Tecnifar- Indústria Técnica Farmacêutica S.A.
Tél: + 33 1 47688899 Tel.: +351 210330700

Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: + 43 1 4073919 Tel: + 40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. Chiesi Slovenija d.o.o.
Tel: + 39 0521 2791 Tel: + 386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: + 421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Chiesi Farmaceutici S.p.A. Chiesi Pharma AB
Τηλ: + 39 0521 2791 Tel: +46 8 753 35 20

Latvija
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919

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

Package leaflet: Information for the user

Trimbow 172 micrograms/5 micrograms/9 micrograms pressurized solution for

inhalation
beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Trimbow is and what it is used for
What you need to know before using Trimbow
How to use Trimbow
Possible side effects
How to store Trimbow
Contents of the pack and other information

1. What Trimbow is and what it is used for

Trimbow is a medicine that helps you breathe and contains three active substances:

beclometasone dipropionate,
formoterol fumarate dihydrate,
glycopyrronium.

Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which exert an anti-inflammatory effect by reducing swelling and irritation in the lungs.
Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They relax the muscles of the airways through different mechanisms, thereby dilating the airways and making breathing easier.
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.
Trimbow is used for the regular treatment of asthma in adults.
Trimbow can reduce exacerbations (sudden worsening) of asthma symptoms.
Asthma is a serious chronic disease in which the muscles surrounding the airways constrict (bronchoconstriction) and become swollen and inflamed. Symptoms come and go, and include shortness of breath, wheezing, chest tightness and cough.
You must use Trimbow every day, not only when you have breathing problems or other asthma symptoms, in order to ensure adequate asthma control. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.

2. What you need to know before using Trimbow

Do not use Trimbow
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
Trimbow is used as maintenance therapy for chronic obstructive pulmonary disease (COPD). Do not use this
medicine to treat an acute episode of breathlessness or wheezing.

If your breathing worsens
If you experience worsening shortness of breath or wheezing (an audible whistling sound during breathing) immediately after inhaling the medicine, stop using the Trimbow inhaler and immediately use your "reliever" (rescue) inhaler with fast-acting action. Contact your doctor immediately; they will assess your symptoms and, if necessary, prescribe a different 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 need to use your "reliever" inhaler more frequently), or if your "reliever" inhaler fails to improve your symptoms, contact your doctor immediately. Your lung condition may be deteriorating, and your doctor may prescribe a different treatment.

Talk to your doctor or pharmacist before using Trimbow if:

you have heart problems such as angina (chest pain), recent heart attack (myocardial infarction), heart failure, narrowing of the arteries surrounding the heart (coronary heart disease), heart valve disease or any other heart abnormality, or if you have a condition called obstructive hypertrophic cardiomyopathy (or HCM, a disease characterized by abnormal heart muscle).
you have heart rhythm disorders such as irregular heartbeat, rapid pulse or palpitations, or if your electrocardiogram (ECG) is abnormal.
you have narrowing of the arteries (known as arteriosclerosis), high blood pressure, or an aneurysm (an abnormal bulging of a blood vessel wall).
you have an overactive thyroid gland.
you have low levels of potassium in your blood (hypokalaemia). The combination of Trimbow with other lung medicines or diuretics (medicines that remove water from the body, used to treat heart conditions or high blood pressure) may cause a marked decrease in blood potassium levels. Therefore, your doctor may periodically check your blood potassium levels.
you have any liver or kidney disease.
you have diabetes. High doses of formoterol may increase blood glucose levels; therefore, you may need additional blood tests to monitor your blood sugar levels when starting this medicine and periodically during treatment.
you have a tumour of the adrenal glands (called a phaeochromocytoma).
you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with Trimbow at least 12 hours before the procedure.
you currently have or have previously been treated for tuberculosis (TB) or have a chest infection.
you have a condition of the eyes called closed-angle glaucoma.
you have difficulty urinating.
you have a mouth or throat infection.

If any of these conditions apply to you, inform your doctor before using Trimbow.
If you have or have previously had any medical condition or allergy, or if you are unsure whether you can
use Trimbow, consult your doctor or pharmacist before using 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 event (e.g. hospitalization after an injury, severe trauma or before surgery), you may require a higher dose of this medicine. In such cases, your doctor may need to increase your corticosteroid dose to manage 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 medicine to children and adolescents under 18 years of age.

Other medicines and Trimbow
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines similar to Trimbow used for your lung condition.
Some medicines may increase the effects of Trimbow, and your doctor may want to monitor you closely if you are taking these (including certain medicines for human immunodeficiency virus (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 specifically prescribed a beta-blocker that does not interfere with breathing. Beta-blockers (including beta-blocker eye drops) may reduce or completely counteract the effects of formoterol. Conversely, the use of other beta2-agonist medicines (which have a similar action to formoterol) may increase the effects of formoterol.

The use of Trimbow together with:

medicines used to treat
- heart rhythm disorders (quinidine, disopyramide, procainamide),
- allergic reactions (antihistamines),
- symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbazid), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines may cause changes in the electrocardiogram (ECG). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).
medicines used to treat Parkinson’s disease (levodopa), to treat underactive thyroid gland (levothyroxine), medicines containing oxytocin (which cause uterine contractions), and alcohol may increase the likelihood of cardiac side effects due to formoterol.
monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine, used to treat mental disorders, may increase blood pressure.
medicines used to treat heart conditions (digoxin), may reduce potassium levels in the blood. This may increase the risk of heart rhythm abnormalities.
other medicines used to treat chronic obstructive pulmonary disease (theophylline, aminophylline or corticosteroids) and diuretics, may reduce potassium levels in the blood.
certain anaesthetics, may increase the risk of heart rhythm abnormalities.
disulfiram, a medicine used to treat alcoholism (alcohol dependence), or metronidazole, an antibiotic used to treat infection, may cause side effects (e.g. nausea, vomiting, stomach upset) due to the small amount of alcohol present in Trimbow.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use Trimbow during pregnancy only if advised by your doctor. It is preferable to avoid using Trimbow during labour due to formoterol’s inhibitory effect on uterine contractions.
Do not use Trimbow while breastfeeding. You and your doctor must decide whether to stop breastfeeding or to stop/abstain from treatment with Trimbow, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.

Driving and using machines
It is unlikely that Trimbow will affect your ability to drive or operate machinery.

Trimbow contains ethanol
Trimbow contains 8.856 mg of alcohol (ethanol) per actuation, equivalent to 17.712 mg for a two-actuation dose. The amount in two actuations of this medicine is equivalent to that contained in less than 1 mL of wine or beer. The small amount of alcohol in this medicine will not produce significant effects.