ATIMOS 6 MCG Roztwór ciśnieniowy do inhalacji

Treść ulotki

1. ATIMOS 6 mcg/dose pressurized solution for inhalation
   1. What is ATIMOS and what is it used for
   2. What you need to know before you take ATIMOS
   3. How to take ATIMOS
   4. Possible side effects
   5. How to store ATIMOS
   6. Contents of the pack and other information
2. ATIMOS 12 mcg/delivery pressurized solution for inhalation
   1. What is ATIMOS and what is it used for
   2. What you need to know before taking ATIMOS
   3. How to take ATIMOS
   4. Possible side effects
   5. How to store ATIMOS
   6. Contents of the pack and other information

ATIMOS 6 mcg/dose pressurized solution for inhalation

Formoterol fumarate

Read this leaflet carefully before you start to take 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 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 ATIMOS is and what it is used for
• 2. What you need to know before you take ATIMOS
• 3. How to take ATIMOS
• 4. Possible side effects
• 5. How to store ATIMOS
• 6. Contents of the pack and other information

1. What is ATIMOS and what is it used for

ATIMOS is a medicine for inhalation and releases its active ingredient directly into the lungs. ATIMOS is used for the treatment and prevention of symptoms such as cough, shortness of breath or wheezing and shortness of breath, 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.
ATIMOS can also be used for the treatment and prevention of symptoms due to bronchospasm such as shortness of breath, wheezing and shortness of breath, 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 you take ATIMOS

Do not take ATIMOS:

• 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 chemically similar;
• 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 ATIMOS if:

• you have serious heart problems, especially if you have recently had a heart attack or have heart vessel disease or have a severe weakness of the heart muscle (heart failure);
• 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);

atrioventricular block of third degree, idiopathic hypertrophic subaortic stenosis, obstructive hypertrophic cardiomyopathy
obstruction, 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 the 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 ATIMOS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, because some medicines can interfere with the action of ATIMOS. 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 (e.g. 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 drug used against infections;
• such as digitalis;
• you are going to undergo any surgical operation and receive halogenated anesthetics.

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

Paradoxical bronchospasm
As with other inhalation therapies, the possibility of paradoxical bronchospasm should be considered.
In these cases, therapy should be immediately discontinued and another
therapy should be established.
It is recommended to strictly adhere to the recommended dosage to avoid the onset of serious
side effects, especially of a cardiovascular nature.
Since ATIMOS 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 ATIMOS 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
ATIMOS can cause tremors or agitation. Make sure you do not suffer from these side effects before
driving vehicles or using machinery.

ATIMOS contains ethanol
This medicine contains 7 mg of alcohol (ethanol) per 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 play sports:

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

3. How to take ATIMOS

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

If you are taking ATIMOS 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 ATIMOS 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 the
cold). For more severe patients, it is possible to take 4 inhalations.

Method of administration
ATIMOS is a pressurized solution. Take ATIMOS 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 the

If you take more ATIMOS 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 discomfort, nausea and vomiting, changes in
some blood parameters (hyperglycemia, hypokalemia) may occur. If you take more ATIMOS than you should,
immediately inform your doctor or go to the nearest hospital, as appropriate measures may be necessary
to be implemented.

If you forget to take ATIMOS,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 ATIMOS
Do not stop or reduce the dose of ATIMOS 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 ofATIMOSwithout 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 modifying your therapy, for example by changing the dose or
prescribing 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 ATIMOSand 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 ATIMOS immediately;
• contact your doctor.This side effect is uncommon.

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

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

• headache, tremors;
• feeling of heart racing (palpitations);
• 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;
• cramps and muscle pain.

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

• decreased potassium in the blood (hypokalemia);
• 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 ATIMOS

Keep this medicine out of the sight and reach of children.
Do not pierce 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 its 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. Contents of the pack and other information

What ATIMOS contains

• The active ingredient is formoterol fumarate. Each actuation contains: 6 micrograms of formoterol fumarate.
• 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 ATIMOS and contents of the pack
This medicine is a pressurized solution for inhalation, available in a container under
pressure with a standard metering valve. ATIMOS is sufficient for 100 or 120 inhalations.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, Parma.
Manufacturer
Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 – Parma, Italy

INSTRUCTIONS FOR USING YOUR INHALER
ATIMOS 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.
Positive treatment outcomes depend 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 ensure your inhaler is working correctly.

Opening the pack
When you open the box, the metering valve is closed with the protective cap.

Taking a dose of ATIMOS
Figure 1-2 Remove the protective cap.
Hold the metering valve between thumb and forefinger, 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 metering valve once. Once completed
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 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 container under pressure and
rinse the mouthpiece with lukewarm water.

ATIMOS 12 mcg/delivery 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 ATIMOS is and what it is used for
• 2. What you need to know before you take ATIMOS
• 3. How to take ATIMOS
• 4. Possible side effects
• 5. How to store ATIMOS
• 6. Contents of the pack and other information

1. What is ATIMOS and what is it used for

ATIMOS is a medicine for inhalation and releases its active substance directly into the lungs. ATIMOS is used for the treatment and prevention of symptoms such as cough, shortness of breath or wheezing and shortness of breath, which occur in patients with obstructive bronchopneumopathies such as asthma or chronic bronchitis with or without emphysema. Its active substance, formoterol fumarate, belongs to a group of medicines called bronchodilators that help you breathe better because they relax spasms in the muscles of the airways of the lungs.
ATIMOS can also be used for the treatment and prevention of symptoms due to bronchospasm such as shortness of breath, wheezing and shortness of breath, 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 ATIMOS

Do not take ATIMOS:

• 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 chemically similar;
• 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 ATIMOS 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);

atrioventricular block of third degree, idiopathic hypertrophic subaortic stenosis, obstructive hypertrophic cardiomyopathy
obstruction, 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 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 ATIMOS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, because some medicines can interfere with the action of ATIMOS. This is
particularly important if you are taking medicines:

• for the treatment of irregular heartbeat (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 (e.g. 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 drug used against infections;
• such as digitalis;
• you are going to undergo any surgical operation and receive halogenated anesthetics.

Other special warnings
ATIMOS should not be used (and is not sufficient) as a first-line treatment for asthma.
Although ATIMOS can be prescribed as add-on therapy when inhaled corticosteroids do not
provide adequate control of asthma symptoms, patients should not start therapy with
ATIMOS during a severe acute exacerbation of asthma, 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 ATIMOS.

Paradoxical bronchospasm
As with other inhaled therapies, the possibility of paradoxical bronchospasm should be kept in mind.
In these cases, therapy should be stopped 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.
Since ATIMOS 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 ATIMOS 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
ATIMOS can cause tremors or agitation. Make sure you do not suffer from these side effects before
driving vehicles or using machinery.

ATIMOS 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 ATIMOS

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

If you are taking ATIMOS 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
(twice a day). For more severe patients, the doctor may prescribe 1-2 additional inhalations per day.

If you are taking ATIMOS 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
ATIMOS is a pressurized solution. Take ATIMOS 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 the

If you take more ATIMOS than you should, low or high blood pressure, changes in heart rate or
electrocardiogram, a feeling of a lump in your throat, headache, tremors, drowsiness, feeling and state of
illness, nausea and vomiting, changes in some blood parameters (hyperglycemia, hypokalemia) may occur. If you take more ATIMOS 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 ATIMOS,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 ATIMOS
Do not stop or reduce the dose of ATIMOS or any other medicine you are using to improve
your breathing just because you feel better without talking to your doctor. It is very important that
you use this medicine regularly.

Do not increase the dose ofATIMOSwithout consulting your doctor. If you do not notice improvements 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 everybody gets them.
side effects.

Stop taking ATIMOSand 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 medicines, immediately after taking the dose, shortness of breath, cough, shortness of breath and wheezing (paradoxical bronchospasm) may occur. If this should happen:

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

Tell your doctor if you notice the following during therapy with ATIMOS:

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

• headache, tremors;
• feeling of heart racing (palpitations);
• worsening of asthma (in children aged between 6 and 12 years), cough and feeling of shortness of breath (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;
• 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 get any side effects, even those not listed in this leaflet, tell 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 ATIMOS

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 its 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. Contents of the pack and other information

What ATIMOS contains

• The active ingredient is formoterol fumarate. Each actuation contains: 12 micrograms of formoterol fumarate.
• The other ingredients are: anhydrous ethanol, 1N hydrochloric acid, HFC 134a (norflurane).
• This medicine contains fluorinated greenhouse gases. Each inhaler with 100 actuations contains 9.087 g of norflurane (HFC-134a) which corresponds to 0.013 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Each inhaler with 120 actuations 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 ATIMOS and contents of the pack
This medicine is a pressurized solution for inhalation, available in a container under
pressure with a standard metering valve. ATIMOS is sufficient for 100 or 120 inhalations.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Chiesi Farmaceutici S.p.A., Via Palermo 26/A, Parma.
Manufacturer
Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 – Parma, Italy

INSTRUCTIONS FOR USING YOUR INHALER
ATIMOS 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 to ensure that your inhaler is working correctly.

Opening the pack
When you open the box, the metering valve is closed with the protective cap.

Taking a dose of ATIMOS
Figure 1-2 Remove the protective cap.
Hold the metering valve between thumb and forefinger, 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 metering valve once. After
completing the 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 taken by a child, the inhalations must be performed 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 container under pressure and
rinse the mouthpiece with lukewarm water.