Atimos

Package leaflet: Information for the patient

ATIMOS 6 mcg/dose pressurised inhalation solution

Formoterol fumarate
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using ATIMOS
3. How to use ATIMOS
4. Possible side effects
5. How to store ATIMOS
6. Contents of the pack and other information

1. What ATIMOS is and what it is used for

ATIMOS is an inhaled medicine that delivers its active substance directly into the lungs. ATIMOS is used for the treatment and prevention of symptoms such as cough, breathlessness, wheezing and shortness of breath occurring in patients with obstructive pulmonary diseases 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 you breathe better by relaxing spasms in the muscles of the airways in the lungs.

ATIMOS may also be used for the treatment and prevention of symptoms due to bronchospasm, such as breathlessness, wheezing and shortness of breath, caused by allergy, exertion or cold.

Since the drug has a prolonged duration of action (up to 12 hours), a maintenance therapy of two daily administrations is able to control the bronchospastic conditions frequently observed in chronic obstructive pulmonary diseases, 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 substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines chemically similar to this one;
• if you are pregnant or 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 recently had a heart attack, have heart vessel diseases, or have severe weakness of the heart muscle (heart failure);
• you have heart rhythm disorders such as increased heart rate, heart valve defects, electrocardiogram abnormalities, 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 enlargement 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 overactive (severe hyperthyroidism);
• you have an enlarged prostate (prostatic hypertrophy);
• you have increased eye pressure 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 may interfere with the action of ATIMOS. This is particularly important if you are taking medicines:

• for heart rhythm disorders (antiarrhythmics such as quinidine, disopyramide, procainamide);
• sympathomimetics such as β-agonists or ephedrine (used to treat nasal congestion);
• called beta-blockers used to treat heart conditions or glaucoma (increased pressure inside the eye), such as tablets or eye drops;
• that have adrenergic activity, used, for example, to treat low blood pressure;
• for treating symptoms of depression: monoamine oxidase inhibitors or tricyclic antidepressants;
• for treating allergic reactions (such as antihistamines like terfenadine, astemizole, mizolastine);
• for treating 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, for urinary incontinence or against muscle spasms;
• such as erythromycin, a medicine used for infections;
• such as digitalis;
• if you are scheduled for any surgical procedure and will receive halogenated anesthetics.

Other special warnings
ATIMOS must not be used (and is not sufficient) as first-line treatment for asthma.
Although ATIMOS may be prescribed as an add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients must not start ATIMOS therapy during a severe acute asthma exacerbation, or if they have significant worsening or acutely deteriorating asthma.
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 taking them or change the dose when starting ATIMOS.
Paradoxical bronchospasm
As with other inhaled therapies, the possibility of paradoxical bronchospasm should be considered. In such cases, treatment must be immediately discontinued and alternative therapy initiated.
It is recommended to strictly follow the recommended dosage to avoid the occurrence of serious adverse effects, particularly of a cardiovascular nature.
Since ATIMOS contains a small amount of alcohol, it is especially important that you inform your doctor if you are taking:

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

Pregnancy and breastfeeding
Do not use ATIMOS if you are pregnant or breastfeeding. If you suspect you may be pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
ATIMOS may cause tremors or nervousness. Make sure you do not experience these side effects before driving or operating machinery.
ATIMOS contains ethanol
This medicine contains 7 mg of alcohol (ethanol) per dose, equivalent to 0.40 mg/kg per dose for 4 doses in adults and 1.39 mg/kg per dose for 4 doses in children.
The amount in 4 doses 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 engaged in sports:

• using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test;

3. How to take ATIMOS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dose of ATIMOS you should take depends on the reason for which you are taking this medicine.

If you are taking ATIMOS for asthma or chronic bronchitis
Your doctor will determine the correct dose based on the severity of your condition; take regularly only the prescribed dose.
The usual dose for ADULTS and CHILDREN over 6 years of age is 2–4 inhalations every 12 hours (twice daily). For more severe patients, your doctor may prescribe up to 2–4 additional inhalations per day.

If you are taking ATIMOS to prevent bronchospasm caused by allergy, exertion, or cold
The usual dose for ADULTS and CHILDREN over 6 years of age is 2 inhalations 15 minutes before the triggering event (e.g., before physical exertion, before exposure to a known allergen, or to cold). For more severe patients, 4 inhalations may be taken.

Method of administration
ATIMOS is a pressurized solution. Take ATIMOS by inhalation through the mouth; inhale deeply to ensure the medicine reaches into the lungs.
For correct use of this medicine, refer to the section “Instructions for use of your inhaler” at the end of this leaflet.

If you take more ATIMOS than you should, you may experience lowering or raising of blood pressure, changes in heart rhythm or electrocardiogram, sensation of pounding heartbeat, headache, tremors, drowsiness, feeling unwell, nausea and vomiting, and changes in certain blood parameters (hyperglycemia, hypokalemia). If you take more ATIMOS than prescribed, inform your doctor immediately or go to the nearest hospital, as appropriate measures may be required.

If you forget to take ATIMOS, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose; take only the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with ATIMOS
Do not stop or reduce the dose of ATIMOS or of any other medicine you are using for breathing improvement 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 of ATIMOS without consulting your doctor. If you do not notice improvement, or if your asthma seems to worsen, or if you experience increased breathlessness or shortness of breath, inform your doctor immediately. In such cases, your doctor will assess whether your treatment needs to be changed, for example by adjusting the dose or prescribing other medicines.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Following the instructions contained in this leaflet reduces the risk of side effects.
Stop taking ATIMOS and contact your doctor immediately if you experience the following symptoms
indicating a severe allergic reaction: itching, sudden appearance of skin lesions such as discoloured spots or widespread rash (rash, urticaria), swelling of the face, eyes, lips, throat, accompanied by breathing difficulties (angioedema), or bronchospasm. These side effects are rare.

As with other inhaled medicines, immediately after taking the dose, shortness of breath, cough, short and wheezing breathing ( paradoxical bronchospasm ) may occur. If this happens:

• stop taking ATIMOS immediately ;
• contact your doctor. This side effect is not uncommon.

Inform your doctor if, during treatment with ATIMOS, you notice the following:
Common side effects (may affect up to 1 in 10 people)

• headache (cephalalgia), tremors;
• sensation of heart pounding (palpitations);
• worsening of asthma (in children aged 6 to 12 years), cough, and breathlessness (dyspnea).

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

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

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

• decreased potassium levels in the blood (hypokalaemia);
• heart rhythm disturbances (e.g.: atrial fibrillation, supraventricular tachycardia, extrasystoles);
• nausea.

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

• increased blood sugar levels (hyperglycaemia);
• taste disturbances;
• swelling in the legs (peripheral oedema), chest pain (angina pectoris), changes in electrocardiogram (prolongation of QTc interval);
• changes in blood pressure.

Side effects with unknown frequency (frequency cannot be estimated from the 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 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 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.
The pressurised container must not be pierced, must not be exposed, even when empty, to heat sources,
must not be frozen, and must not be exposed to direct sunlight.
The unopened medicine should be stored at a temperature between 2 °C and 8 °C for a maximum of 15
months. After opening, store at a temperature not exceeding 30 °C and use within 3 months.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to
the last day of that month. This date applies to the product in intact packaging and correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What ATIMOS contains

• The active substance is formoterol fumarate. Each dose contains: 6 micrograms of formoterol fumarate.
• The other components are: anhydrous ethanol, hydrochloric acid 1N, HFC 134a (norflurane).
• This medicinal product contains fluorinated greenhouse gases. Each 100-dose inhaler contains 7.143 g of norflurane (HFC-134a), equivalent to 0.010 tonnes of carbon dioxide (global warming potential GWP = 1430).

Each 120-dose inhaler contains 8.163 g of norflurane (HFC-134a), equivalent to
0.012 tonnes of carbon dioxide (global warming potential GWP = 1430).
Description of the appearance of ATIMOS and contents of the pack
This medicinal product is a pressurized solution for inhalation, available in a pressurized container fitted with a standard actuator. ATIMOS provides sufficient medication for 100 or 120 inhalations.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 USE OF YOUR INHALER

ATIMOS is easy to use. Before using it, carefully read the following instructions, which indicate what
to do and what to pay attention to. If necessary, consult your doctor for more detailed explanations.
The success of 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 mouthpiece cap by gently pressing the sides and
release one puff into the air to make sure your inhaler is working properly.
Opening the package
When you open the box, the actuator is closed with the protective cap.
Taking a dose of ATIMOS
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), then place the mouthpiece between your
lips, sealed tightly (3b).
Figure 4 a-b-c Inhale slowly and deeply through the mouth only, while pressing once
on the actuator with the index finger. After completing the inhalation, hold your breath as long as possible. After completing the prescribed number of inhalations, close the mouthpiece with the protective cap.
If the medicine is taken by a child, inhalations must be performed under adult supervision. It may be helpful to close the nostrils during inhalation.

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

Patient information leaflet

ATIMOS 12 mcg/dose pressurized solution for inhalation

Formoterol fumarate
Please read 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, consult 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 using ATIMOS
3. How to use ATIMOS
4. Possible side effects
5. How to store ATIMOS
6. Contents of the pack and other information

1. What ATIMOS is and what it is used for

ATIMOS is an inhaled medicine that delivers its active ingredient directly into the lungs. ATIMOS is used for the treatment and prevention of symptoms such as cough, shortness of breath, wheezing and breathlessness occurring in patients with obstructive pulmonary diseases 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 you breathe better by relaxing spasms in the muscles of the airways of the lungs.
ATIMOS may also be used for the treatment and prevention of symptoms due to bronchospasm, such as shortness of breath, wheezing and breathlessness, caused by allergy, exertion or cold.
Since the drug has a prolonged duration of action (up to 12 hours), a maintenance therapy consisting of two daily administrations can control the bronchospastic conditions frequently encountered in chronic obstructive pulmonary diseases, both during the day and at night.

2. What you should know before taking ATIMOS

Do not take ATIMOS:

• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines chemically similar to this one;
• if you are pregnant or 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 recently had a heart attack, have heart vessel disease, or have severe weakness of the heart muscle (heart failure);
• you have an irregular heart rhythm such as increased heart rate, heart valve defects, electrocardiogram abnormalities, 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 the blood (hypokalaemia);
• your thyroid gland is overactive (severe hyperthyroidism);
• you have an enlarged prostate (prostatic hypertrophy);
• you have increased eye pressure with possible worsening of vision (glaucoma);
• you have tumours of the adrenal medulla (phaeochromocytoma).

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 may interfere with the action of ATIMOS. This is particularly important if you are taking medicines:

• for heart rhythm disorders (antiarrhythmics such as quinidine, disopyramide, procainamide);
• sympathomimetics such as β-agonists or ephedrine (used to treat nasal congestion);
• called beta-blockers, used to treat heart conditions or glaucoma (increased pressure inside the eye), such as tablets or eye drops;
• with adrenergic action, used, for example, to treat low blood pressure;
• for depression symptoms: monoamine oxidase inhibitors or tricyclic antidepressants;
• for allergic reactions (e.g. antihistamines such as terfenadine, astemizole, mizolastine);
• for 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, for urinary incontinence or muscle spasms;
• such as erythromycin, a medicine used for infections;
• such as digitalis;
• if you are scheduled for any surgical procedure and will receive halogenated anaesthetics.

Other special warnings
ATIMOS must not be used (and is not sufficient) as initial treatment for asthma.
Although ATIMOS may be prescribed as an additional therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients must not start ATIMOS therapy during a severe acute asthma exacerbation, or if they have significant worsening or acutely deteriorating asthma.
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 or change the dose when starting ATIMOS.
Paradoxical bronchospasm
As with other inhaled therapies, paradoxical bronchospasm may occur. In such cases, treatment must be immediately discontinued and alternative therapy initiated.
Strict adherence to the recommended dosage is advised to avoid the occurrence of serious adverse effects, particularly 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 for infections).

Pregnancy and breastfeeding
Do not use ATIMOS if you are pregnant or breastfeeding. If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
ATIMOS may cause tremors or agitation. Make sure you do not experience these side effects before driving or operating machinery.
ATIMOS contains ethanol
This medicine contains 8.9 mg of alcohol (ethanol) per dose, equivalent to 0.25 mg/kg per dose for 2 actuations in adults and 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 engaged in sports:

• using the drug without therapeutic need constitutes doping and may lead to a positive anti-doping test;

3. How to take ATIMOS

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dose of ATIMOS you should take depends on the reason you are taking this medicine.

If you are taking ATIMOS for asthma or chronic bronchitis
Your doctor will determine the correct dose based on the severity of your condition; take regularly only the prescribed dose.
The usual dose for ADULTS and CHILDREN over 6 years of age is 1–2 inhalations every 12 hours (twice daily). For more severe patients, your doctor may prescribe an additional 1–2 inhalations per day.

If you are taking ATIMOS to prevent bronchospasm caused by allergy, exertion, or cold
The usual dose for ADULTS and CHILDREN over 6 years of age is 1 inhalation 15 minutes before the triggering event (e.g. before physical exertion, exposure to a known allergen, or cold air). For more severe patients, 2 inhalations may be taken.

Method of administration
ATIMOS is a pressurized solution. Administer ATIMOS by inhalation through the mouth; inhale deeply to ensure the medicine reaches into the lungs.
For correct use of this medicine, refer to the section “Instructions for use of your inhaler” at the end of this leaflet.

If you take more ATIMOS than you should
Symptoms such as low or high blood pressure, changes in heart rhythm or electrocardiogram, sensation of pounding heartbeat, headache, tremors, drowsiness, feeling unwell, nausea and vomiting, and changes in certain blood parameters (hyperglycemia, hypokalemia) may occur. If you take more ATIMOS than recommended, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.

If you forget to take ATIMOS, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose; take only the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with ATIMOS
Do not stop or reduce the dose of ATIMOS or of any other medicine you are using for breathing problems 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 of ATIMOS without consulting your doctor. If you do not notice improvement, or if your asthma seems to worsen, or if you experience increased breathlessness or shortness of breath, inform your doctor immediately. In such cases, your doctor will assess whether your treatment needs to be changed, for example by adjusting the dose or prescribing additional medicines.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Following the instructions contained in this leaflet reduces the risk of side effects.
Stop taking ATIMOS and contact your doctor immediately if you experience the following symptoms
indicative of severe allergic reactions: itching, sudden or gradual appearance of skin lesions such as
discoloration in spots or widespread (rash, urticaria), swelling of the face, eyes, lips, throat with breathing
difficulties (angioedema), and bronchospasm. These side effects are rare.

As with other inhaled medicines, immediately after taking a dose, shortness of breath, cough, and
wheezing ( paradoxical bronchospasm ) may occur. If this happens:

• stop taking ATIMOS immediately ;
• contact your doctor. This side effect is not uncommon.

Inform your doctor if, during treatment with ATIMOS, you notice the following:
Common side effects (may affect up to 1 in 10 people)

• headache (cephalalgia), tremor;
• sensation of heart pounding (palpitations);
• worsening of asthma (in children aged 6 to 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;
• muscle cramps and muscle pain.

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

• decreased potassium levels in the blood (hypokalaemia);
• changes in heart rhythm (e.g., atrial fibrillation, supraventricular tachycardia, extrasystoles);
• nausea.

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

• increased blood sugar levels (hyperglycaemia);
• taste disturbances;
• swelling in the legs (peripheral oedema), chest pain (angina pectoris), changes in electrocardiogram (prolongation of QTc interval);
• changes in blood pressure.

Side effects with unknown frequency (frequency cannot be estimated from 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 effect, including those not listed in this leaflet, please contact your doctor or
pharmacist. You may also report side effects directly via 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.
The pressurised container must not be pierced, and even if empty, must not be exposed to heat sources,
must not be frozen, and must not be exposed to direct sunlight.
The unopened medicine should be stored at a temperature between 2 °C and 8 °C for up to 15 months.
Once opened, store at a temperature not exceeding 30 °C and use within a maximum of 3 months.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What ATIMOS Contains

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

Each 120-dose inhaler contains 10.384 g of norflurane (HFC-134a), equivalent to
0.015 tonnes of CO2 (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 pressurized container with a standard actuator. ATIMOS provides sufficient medication for 100 or 120 inhalations.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 USE OF YOUR INHALER

ATIMOS is easy to use. Before using it, carefully read the following instructions, which indicate what
to do and what to pay attention to.
The success of your treatment depends on correct use of the inhaler.
Function test of the inhaler: before using the inhaler for the first time, or if you have not used
the inhaler for three or more days, remove the mouthpiece cap by gently pressing the sides and
release one puff into the air to make sure your inhaler is working properly.
Opening the package
When you open the box, the inhaler is closed with the mouthpiece cap.
Taking a dose of ATIMOS
Figure 1-2 Remove the mouthpiece cap.
Hold the inhaler between your thumb and index finger, with the mouthpiece at the bottom.
Figure 3 a-b Breathe out fully (3a), then place the mouthpiece between your lips, sealing your lips firmly around it (3b).
Figure 4 a-b-c Breathe in slowly and deeply through your mouth, while at the same time pressing once on the inhaler with your index finger. After completing the inhalation, hold your breath as long as possible. After completing the prescribed number of inhalations, close the mouthpiece with the mouthpiece cap.
If the medicine is taken by a child, inhalations must be performed under adult supervision. It may be helpful 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.