LIFEROL 6 MCG Roztwór ciśnieniowy do inhalacji

Treść ulotki

1. LIFEROL 6 mcg/dose pressurized solution for inhalation
   1. What is LIFEROL and what is it used for
   2. What you need to know before taking LIFEROL
   3. How to take LIFEROL
   4. Possible side effects
   5. How to store LIFEROL
   6. Package Contents and Other Information
2. LIFEROL 12 mcg/dose pressurized solution for inhalation
   1. What is LIFEROL and what is it used for
   2. What you need to know before taking LIFEROL
   3. How to take LIFEROL
   4. Possible side effects
   5. How to store LIFEROL
   6. Package Contents and Other Information

LIFEROL 6 mcg/dose pressurized solution for inhalation

Formoterol fumarate

Read this leaflet carefully before taking 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 others, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is LIFEROL and what is it used for

LIFEROL is a medicine for inhalation and releases its active ingredient directly into the
lungs. LIFEROL is used for the treatment and prevention of symptoms such as cough, shortness of breath or
difficulty breathing, which occur in patients with obstructive bronchopneumopathies such as asthma or
chronic bronchitis, with or without emphysema. Its active ingredient, formoterol fumarate, belongs to a
group of medicines called bronchodilators which help to breathe better as they relax the spasms in the
muscles of the airways of the lungs.
LIFEROL can also be used for the treatment and prevention of symptoms due to bronchospasm
such as shortness of breath, difficulty breathing, caused by allergy, exertion or cold.
Since the drug has a very prolonged action over time (up to 12 hours), a maintenance therapy of two daily
administrations is able to control those bronchospastic forms frequently found in chronic
bronchopneumopathies, both during the day and at night.

2. What you need to know before taking LIFEROL

Do not take LIFEROL:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other drugs with similar chemical structures;
• if you are pregnant or if you are breastfeeding;
• in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking LIFEROL if:

• you have serious heart problems, especially if you have recently had a heart attack or have heart or blood vessel disease or have severe heart muscle weakness (heart failure);
• you have irregular heartbeat such as increased heart rate, heart valve defects or abnormal electrocardiogram or any other heart disease (such as third-degree atrioventricular block, idiopathic hypertrophic subaortic stenosis, obstructive hypertrophic cardiomyopathy, ischemic heart disease or severe heart failure);
• you have an abnormal widening of the blood vessel wall (aneurysm);
• you suffer from high blood pressure (severe hypertension);
• you have high blood sugar levels (diabetes mellitus);
• you have low potassium levels in your blood (hypokalemia);
• your thyroid gland is very active (severe hyperthyroidism);
• you have an enlargement of the prostate gland (prostatic hypertrophy);
• you have increased pressure in the eye with possible worsening of vision (glaucoma);
• you have tumors of the adrenal medulla (pheochromocytoma).

Other medicines and LIFEROL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine, because some medicines can interfere with the action of LIFEROL. This is
particularly important if you are taking medicines:

• for the treatment of irregular heartbeats (antiarrhythmics such as quinidine, disopyramide, procainamide);
• sympathomimetics such as β agonists or ephedrine (used for the treatment of nasal congestion);
• called beta-blockers used to treat heart disease or glaucoma (increased pressure inside the eye), such as tablets or eye drops;
• that have an adrenergic action, used for example to treat low blood pressure;
• for the treatment of depression symptoms: monoamine oxidase inhibitors or tricyclic antidepressants;
• for the treatment of allergic reactions (such as antihistamines such as terfenadine, astemizole, mizolastine);
• for the treatment of bronchial asthma (for example theophylline, aminophylline or steroids);
• used to increase urine production (diuretics such as thiazides and loop diuretics);
• called anticholinergics used for example in urinary incontinence or against muscle spasms;
• such as erythromycin, a medicine used against infections;
• such as digitalis;
• you are going to undergo any surgical operation and receive halogenated anesthetics.

Other special warnings
LIFEROL should not be used (and is not sufficient) as a first treatment for asthma.
Although LIFEROL can be prescribed as additional therapy when inhaled corticosteroids do not
provide adequate control of asthma symptoms, patients should not start therapy with LIFEROL
during a severe acute exacerbation of asthma, or if they have a significant worsening or
an asthma that is acutely worsening.
If your doctor has prescribed steroid therapy for your breathing problems, it is very
important that you continue to use these medicines regularly. Do not stop using them or change
the dose when you start using LIFEROL.

Paradoxical bronchospasm
As with other inhaled therapies, the possibility of paradoxical bronchospasm should be kept in mind.
In these cases, therapy should be discontinued immediately and another
therapy should be instituted.
It is recommended to strictly adhere to the recommended dosage to avoid the onset of serious
side effects, especially of a cardiovascular nature.
V.7.0_2025_02
Because LIFEROL contains a small amount of alcohol, it is particularly important that you inform your
doctor if you are taking:

• disulfiram (used in alcoholism);
• metronidazole (used in infections).

Pregnancy and breastfeeding
Do not use LIFEROL if you are pregnant or if you are breastfeeding. If you suspect or are planning
a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
LIFEROL can cause tremors or agitation. Make sure you do not suffer from these side effects before
driving vehicles or using machinery.

LIFEROL contains ethanol
This medicine contains 7 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.40 mg/kg
per dose, for 4 actuations in adults and equivalent to 1.39 mg/kg per dose for 4 actuations in children.
The amount in 4 actuations of this medicine is equivalent to less than 1 ml of beer or wine.
The small amount of alcohol in this medicine will not produce significant effects.

For those who engage in sports:

• the use of the drug without therapeutic necessity constitutes doping and may still result in positive anti-doping tests;

3. How to take LIFEROL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The dose of LIFEROL to be taken depends on the reason why you are taking this medicine.

If you are taking LIFEROL for asthma or chronic bronchitis
The doctor will establish the correct dose based on the severity of your condition; take regularly only the
prescribed dose.
The usual dose for ADULTSand CHILDREN over 6 years of ageis 2-4 inhalations, every 12 hours
(2 times a day). For more severe patients, the doctor may prescribe 2-4 additional inhalations per day.

If you are taking LIFEROL to prevent bronchospasm caused by allergy, exertion or
cold
The usual dose for ADULTSand CHILDREN over 6 years of ageis 2 inhalations 15 minutes before
the triggering event (e.g. before exertion or before exposure to a known allergen, or to
cold).
For more severe patients, it is possible to take 4 inhalations.

Method of administration
LIFEROL is a pressurized solution. Take LIFEROL by inhalation, through the mouth; inhale
deeply to ensure the entry of the drug into the lungs.
To use this medicine correctly, consult the section “Instructions for use of your inhaler” at
V.7.0_2025_02

If you take more LIFEROL than you should, side effects such as lowering or raising of
blood pressure, changes in heart rate or electrocardiogram, sensation of heart in
throat, headache, tremors, drowsiness, feeling and state of unwellness, nausea and vomiting, changes in
some blood parameters (hyperglycemia, hypokalemia) may occur. If you take more LIFEROL than you should,
immediately inform your doctor or go to the nearest hospital, as appropriate measures may need to be
taken.

If you forget to take LIFEROL,take the dose as soon as you remember. If it is almost time to take
the next dose, do not take the forgotten dose, just take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking LIFEROL
Do not stop or reduce the dose of LIFEROL or any other medicine you are using to improve
your breathing just because you feel better and without talking to your doctor. It is very important that
you use this medicine regularly.

Do not increase the dose ofLIFEROLwithout consulting your doctor. If you do not notice improvements or your asthma
seems to worsen or you have more shortness of breath than usual, immediately inform your doctor. In such
cases, the doctor will assess the possibility of changing your therapy, for example by changing the dose or
prescribing you other medicines.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
side effects.

Stop taking LIFEROLand consult your doctor immediately ifyou experience the following symptoms
associated with severe allergic reactions: itching, more or less sudden appearance of skin lesions such as,
for example, color changes in patches or widespread (rash, urticaria), swelling of the face, eyes, lips, throat with difficulty breathing (angioedema) and bronchospasm. These
side effects are rare.
As with other inhaled medications, immediately after taking the dose, shortness of breath, cough, shortness of breath and wheezing ( paradoxical bronchospasm) may occur. If this should happen:

• stop taking LIFEROL immediately;
• contact your doctor.This side effect is uncommon.

Inform your doctor if you notice the following during therapy with LIFEROL:

Common side effects(may affect up to 1 in 10 people)

• headache, tremors;
• feeling of heart racing (palpitation);
• worsening of asthma (in children aged between 6 and 12 years), cough and feeling of breathlessness (dyspnea).

Uncommon side effects(may affect up to 1 in 100 people)

• agitation, anxiety, restlessness, sleep disturbances;
• dizziness;
• increased heart rate (tachycardia);
• difficulty breathing (bronchospasm and paradoxical bronchospasm), throat irritation; V.7.0_2025_02
• cramps and muscle pain.

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

• decreased potassium in the blood (hypokalaemia);
• irregular heartbeat (e.g., atrial fibrillation, supraventricular tachycardia and extrasystoles);
• nausea.

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

• increased blood sugar (hyperglycemia);
• altered taste;
• swelling of the legs (peripheral edema), chest pain (angina pectoris), altered electrocardiogram (prolongation of the QTc interval);
• altered blood pressure.

Side effects with unknown frequency(frequency cannot be estimated based on available data
data)

• redness and swelling of the eyes;
• fatigue;
• increased levels of insulin, free fatty acids, glycerol and ketone bodies in the blood.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store LIFEROL

Keep this medicine out of the sight and reach of children.
Do not puncture the pressurized container, and do not bring it, even if empty, near sources of heat.
Do not freeze it and do not expose it to direct sunlight.
The closed medicine should be stored at a temperature between 2  C and 8  C for a period of validity
of up to 15 months. Once opened, store at a temperature not exceeding 30  C for a maximum of 3
months.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date
refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine in 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 LIFEROL contains

• The active ingredient is formoterol fumarate. Each actuation contains: 6 micrograms of formoterol fumarate.

V.7.0_2025_02

• The other ingredients are: anhydrous ethanol, 1N hydrochloric acid, HFC 134a (norflurane).
• This medicine contains fluorinated greenhouse gases. Each inhaler with 100 actuations contains 7.143 g of norflurane (HFC-134a) which corresponds to 0.010 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Each inhaler with 120 actuations contains 8.163 g of norflurane (HFC-134a) which corresponds
to 0.012 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Description of the appearance of LIFEROL and package contents
This medicine is a pressurized solution for inhalation, available in a container under
pressure with a standard metering valve. LIFEROL is sufficient for 100 or 120 actuations.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Master Pharma S.r.l., Via G. Chiesi 1, Parma.
Manufacturer
Chiesi Farmaceutici S.p.A., Via S. Leonardo 96, 43122 Parma - Italy
V.7.0_2025_02

INSTRUCTIONS FOR USING YOUR INHALER
LIFEROL is easy to use. Before use, read the following instructions carefully, which tell you what
to do and what to pay attention to. If necessary, ask your doctor for more detailed explanations.
Successful treatment depends on correct use of the inhaler.
Inhaler function test: before using the inhaler for the first time, or if you have not used
the inhaler for three or more days, remove the protective cap from the mouthpiece by pressing it gently
on the sides and perform a test actuation to make sure your inhaler is working correctly.

Opening the package
When you open the box, the actuator is closed with the protective cap.

Taking a dose of LIFEROL
Figure 1-2 Remove the protective cap.
Hold the actuator between your thumb and index finger, with the mouthpiece at the bottom.
Figure 3 a-b Perform a complete exhalation (3a) and then place the mouthpiece between
your closed lips (3b).
Figure 4 a-b-c Inhale slowly and deeply through your mouth only and press
simultaneously with your index finger on the actuator once. After
inhalation, hold your breath for as long as possible. Once you have completed the
prescribed number of inhalations, close the mouthpiece with the protective
cap.
If the medicine is being taken by a child, inhalations must be carried out under the supervision
of an adult. It is useful to close the nostrils during inhalation.

Cleaning
The mouthpiece must always be kept clean. For cleaning, remove the pressurized container and
rinse the mouthpiece with lukewarm water.

V.7.0_2025_02

LIFEROL 12 mcg/dose pressurized solution for inhalation

Formoterol fumarate

Read this leaflet carefully before you start to take 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is LIFEROL and what is it used for

LIFEROL is a medicine for inhalation and releases its active ingredient directly into the
lungs. LIFEROL is used for the treatment and prevention of symptoms such as cough, shortness of breath or
difficulty breathing, which occur in patients with obstructive bronchopneumopathies such as asthma or
chronic bronchitis, with or without emphysema. Its active ingredient, formoterol fumarate, belongs to a
group of medicines called bronchodilators that help you breathe better because they relax the spasms in the
muscles of the airways of the lungs.
LIFEROL can also be used for the treatment and prevention of symptoms due to bronchospasm
such as shortness of breath, difficulty breathing, caused by allergy, exertion or cold.
Since the drug has a very prolonged action over time (up to 12 hours), a maintenance therapy of two
daily administrations is able to control those bronchospastic forms frequently found in chronic
bronchopneumopathies, both during the day and at night.

2. What you need to know before taking LIFEROL

Do not take LIFEROL:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other drugs with similar chemical structures;
• if you are pregnant or if you are breastfeeding;
• in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking LIFEROL if:

• you have serious heart problems, especially if you have recently had a heart attack or have heart or blood vessel disease or have severe heart muscle weakness (heart failure); V.7.0_2025_02
• you have irregular heartbeat such as increased heart rate, heart valve defects or changes in the electrocardiogram or any other heart disease (such as third-degree atrioventricular block, idiopathic hypertrophic subaortic stenosis, obstructive hypertrophic cardiomyopathy, ischemic heart disease or severe heart failure);;
• you have an abnormal widening of the blood vessel wall (aneurysm);
• you suffer from high blood pressure (severe hypertension);
• you have high blood sugar levels (diabetes mellitus);
• you have low potassium levels in your blood (hypokalaemia);
• your thyroid gland is very active (severe hyperthyroidism);
• you have an enlarged prostate (prostatic hypertrophy);
• you have increased pressure in the eye with possible worsening of vision (glaucoma);
• you have tumors of the adrenal medulla (pheochromocytoma).;

Other medicines and LIFEROL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, because some medicines can interfere with the action of LIFEROL. This is particularly important if you are taking medicines:

• for the treatment of heart rhythm disturbances (antiarrhythmics such as quinidine, disopyramide, procainamide);
• sympathomimetics such as β agonists or ephedrine (used for the treatment of nasal congestion);
• called beta-blockers used to treat heart disease or glaucoma (increased pressure inside the eye), such as tablets or eye drops;
• that have an adrenergic action, used for example to treat low blood pressure;
• for the treatment of depression symptoms: monoamine oxidase inhibitors or tricyclic antidepressants;
• for the treatment of allergic reactions (such as antihistamines such as terfenadine, astemizole, mizolastine);
• for the treatment of bronchial asthma (for example theophylline, aminophylline or steroids);
• used to increase urine production (diuretics such as thiazides and loop diuretics);
• called anticholinergics used for example in urinary incontinence or against muscle spasms;
• such as erythromycin, a medicine used against infections;
• such as digitalis;
• you are going to have any surgical operation and receive halogenated anesthetics.

Other special warnings
LIFEROL should not be used (and is not sufficient) as a first-line treatment for asthma.
Although LIFEROL can be prescribed as additional therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not start therapy with LIFEROL during a severe acute episode of asthma exacerbation, or if they have a significant worsening or an acutely worsening asthma.
If your doctor has prescribed steroid therapy for your breathing problems, it is very important that you continue to use these medications regularly. Do not stop using them or change the dose when you start using LIFEROL.

Paradoxical bronchospasm
As with other inhaled therapies, the possibility of paradoxical bronchospasm should be kept in mind. In these cases, therapy should be immediately discontinued and another therapy should be instituted.
It is recommended to strictly adhere to the recommended dosage to avoid the onset of serious side effects, especially of a cardiovascular nature.
V.7.0_2025_02
Because LIFEROL contains a small amount of alcohol, it is particularly important that you inform your doctor if you are taking:

• disulfiram (used in alcoholism);
• metronidazole (used in infections).

Pregnancy and breastfeeding
Do not use LIFEROL if you are pregnant or if you are breastfeeding. If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
LIFEROL can cause tremors or agitation. Make sure you do not suffer from these side effects before driving vehicles or using machinery.

LIFEROL contains ethanol
This medicine contains 8.9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.25 mg/kg per dose, for 2 actuations in adults and equivalent to 0.89 mg/kg per dose for 2 actuations in children.
The amount in 2 actuations of this medicine is equivalent to less than 1 ml of beer or wine.
The small amount of alcohol in this medicine will not produce significant effects.

For those who play sports:

• the use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test;

3. How to take LIFEROL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The dose of LIFEROL to be taken depends on the reason why you are taking this medicine.

If you are taking LIFEROL for asthma or chronic bronchitis
The doctor will establish the correct dose based on the severity of your condition; take regularly only the
prescribed dose.
The usual dose for ADULTSand CHILDREN over 6 years of ageis 1-2 inhalations, every 12 hours
(2 times a day). For more severe patients, the doctor may prescribe 1-2 additional inhalations per day.

If you are taking LIFEROL to prevent bronchospasm caused by allergy, exertion or
cold
The usual dose for ADULTSand CHILDREN over 6 years of ageis 1 inhalation 15 minutes before
the triggering event (e.g. before exertion or before exposure to a known allergen, or to the
cold).
For more severe patients, it is possible to take 2 inhalations.

Method of administration
LIFEROL is a pressurized solution. Take LIFEROL by inhalation, through the mouth; inhale
deeply to ensure the entry of the drug into the lungs.
To use this medicine correctly, consult the section “Instructions for use of your inhaler” at
V.7.0_2025_02

If you take more LIFEROL than you should, low or high blood pressure, heart rhythm or
electrocardiogram changes, a feeling of a lump in your throat, headache, tremors, drowsiness, feeling and
state of unwellness, nausea and vomiting, changes in
some blood parameters (hyperglycemia, hypokalemia) may occur. If you take more LIFEROL than you should,
immediately inform your doctor or go to the nearest hospital, as appropriate measures may be needed
to be implemented.

If you forget to take LIFEROL,take the dose as soon as you remember. If it is almost time to take
the next dose, do not take the forgotten dose, just take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking LIFEROL
Do not stop or reduce the dose of LIFEROL or any other medicine you are using to improve
your breathing just because you feel better and without talking to your doctor. It is very important that
you use this medicine regularly.

Do not increase the dose ofLIFEROLwithout consulting your doctor. If you do not notice any improvement or your asthma
seems to be getting worse or you have more shortness of breath than usual, immediately inform your doctor. In such
cases, the doctor will assess the possibility of modifying your therapy, for example by changing the dose or
prescribing you other medicines.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
side effects.

Stop taking LIFEROLand consult your doctor immediately ifyou experience the following symptoms
associated with serious allergic reactions: itching, more or less sudden appearance of skin lesions such as,
for example, color changes in patches or widespread (rash, urticaria), swelling of the face, eyes, lips, throat with difficulty breathing (angioedema) and bronchospasm. These
side effects are rare.
As with other inhaled medications, immediately after taking the dose, shortness of breath, cough, shortness of breath and wheezing (paradoxical bronchospasm) may occur. If this should happen:

• stop taking LIFEROL immediately;
• contact your doctor.This side effect is uncommon.

Inform your doctor if you notice the following during therapy with LIFEROL:

Common side effects(may affect up to 1 in 10 people)

• headache, tremors;
• feeling of heart racing (palpitation);
• worsening of asthma (in children aged between 6 and 12 years), cough and feeling of breathlessness (dyspnea).

Uncommon side effects(may affect up to 1 in 100 people)

• agitation, anxiety, restlessness, sleep disturbances;
• dizziness;
• increased heart rate (tachycardia);
• difficulty breathing (bronchospasm and paradoxical bronchospasm), throat irritation; V.7.0_2025_02
• cramps and muscle pain.

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

• decreased potassium in the blood (hypokalaemia);
• irregular heartbeat (e.g., atrial fibrillation, supraventricular tachycardia and extrasystoles);
• nausea.

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

• increased blood sugar (hyperglycemia);
• altered taste;
• swelling of the legs (peripheral edema), chest pain (angina pectoris), altered electrocardiogram (prolongation of the QTc interval);
• altered blood pressure.

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• redness and swelling of the eyes;
• fatigue;
• increased levels of insulin, free fatty acids, glycerol and ketone bodies in the blood.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store LIFEROL

Keep this medicine out of the sight and reach of children.
Do not puncture the pressurized container, and do not bring it, even if empty, near sources of heat.
Do not freeze it and do not expose it to direct sunlight.
The closed medicine should be stored at a temperature between 2  C and 8  C for a period of validity
of up to 15 months. Once opened, store at a temperature not exceeding 30  C for a maximum of 3
months.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine in 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 LIFEROL contains

• The active ingredient is formoterol fumarate. Each actuation contains: 12 micrograms of formoterol fumarate.

V.7.0_2025_02

• The other ingredients are: anhydrous ethanol, 1N hydrochloric acid, HFC 134a (norflurane).
• This medicine contains fluorinated greenhouse gases. Each 100-actuation inhaler contains 9.087 g of norflurane (HFC-134a) which corresponds to 0.013 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Each 120-actuation inhaler contains 10.384 g of norflurane (HFC-134a) which corresponds
to 0.015 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Description of the appearance of LIFEROL and package contents
This medicine is a pressurized solution for inhalation, available in a container under
pressure with a standard metering valve. LIFEROL is sufficient for 100 or 120 actuations.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Master Pharma S.r.l., Via G. Chiesi 1, Parma.
Manufacturer
Chiesi Farmaceutici S.p.A., Via S. Leonardo 96, 43122 Parma - Italy
V.7.0_2025_02

INSTRUCTIONS FOR USING YOUR INHALER
LIFEROL is easy to use. Before use, read the following instructions carefully, which tell you what
to do and what to pay attention to.
Positive treatment outcome depends on correct use of the inhaler.
Inhaler function test: before using the inhaler for the first time, or if you have not used
the inhaler for three or more days, remove the protective cap from the mouthpiece by pressing it gently
on the sides and perform a test actuation into the air to ensure that your inhaler is working correctly.

Opening the package
When you open the box, the actuator is closed with the protective cap.

Taking a dose of LIFEROL
Figure 1-2 Remove the protective cap.
Hold the actuator between thumb and index finger, with the mouthpiece at the bottom.
Figure 3 a-b Perform a complete exhalation (3a) and then place the mouthpiece between
your closed lips (3b).
Figure 4 a-b-c Inhale slowly and deeply through your mouth only and press
simultaneously with your index finger on the actuator once. After
completing the inhalation, hold your breath for as long as possible. Once the
prescribed number of inhalations is completed, close the mouthpiece with the
protective cap.
If the medicine is being taken by a child, the inhalations must be performed under the supervision
of an adult. It is helpful to close the nostrils during inhalation.

Cleaning
The mouthpiece should always be kept clean. For cleaning, remove the pressurized container and
rinse the mouthpiece with lukewarm water.

V.7.0_2025_02