ATIMOS 12 mcg/measured dose Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Atimos, 12 micrograms/dose, inhalation aerosol, solution
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Atimos and what is it used for
4. Important information before using Atimos
   1. When not to use Atimos:
   2. Warnings and precautions
   3. Before starting to use Atimos, discuss it with your doctor or pharmacist. You should always inform your doctor if you:
   4. Atimos and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Atimos contains ethanol
5. How to use Atimos
   1. Recommended dose in asthma:
   2. This medicine is not intended for use in children with asthma under 12 years of age.
   3. Recommended dose in chronic obstructive pulmonary disease (COPD):
   4. This medicine is not intended for use in patients with COPD under 18 years of age.
   5. Using a higher dose of Atimos than recommended
   6. Missing a dose of Atimos
   7. Instructions for use
   8. If a "mist" appears over the top opening of the mouthpiece or from the side of the mouth, it means that Atimos has not been taken correctly and will not reach the lungs. Take another dose of the medicine, following the instructions exactly, starting from step 2.
   9. Cleaning the inhaler
6. Possible side effects
   1. If breathing difficulties or wheezing worsen after inhaling the medicine, you should
   2. Reporting side effects
7. How to store Atimos
8. Contents of the packaging and other information
   1. What Atimos contains:
   2. What Atimos looks like and what the pack contains:
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: 01/2025

Leaflet accompanying the packaging: information for the user

Atimos, 12 micrograms/dose, inhalation aerosol, solution

Formoterol fumarate dihydrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Atimos and what is it used for
• 2. Important information before using Atimos
• 3. How to use Atimos
• 4. Possible side effects
• 5. How to store Atimos
• 6. Contents of the packaging and other information

1. What is Atimos and what is it used for

Atimos is an inhalation medicine whose active substance reaches the lungs directly, where it works. It is used to treat symptoms (wheezing and shortness of breath) of moderate or severe asthma. The active substance of the medicine, formoterol fumarate, belongs to a group of bronchodilator medicines. They facilitate breathing by relaxing the airway muscles. Regular use of Atimos together with steroids (inhalation or oral) helps prevent breathing difficulties in the long term. Atimos can also be used to relieve symptoms such as coughing, wheezing, and shortness of breath in patients with chronic obstructive pulmonary disease (COPD) who require long-term treatment with bronchodilators.

2. Important information before using Atimos

When not to use Atimos:

• if the patient is allergic to formoterol or any other component of this medicine (listed in section 6).
• in asthma attacks, as it is ineffective. In such cases, a fast-acting inhalation bronchodilator should be used, which should always be carried with you.

Warnings and precautions

Before starting to use Atimos, discuss it with your doctor or pharmacist. You should always inform your doctor if you:

• have severe heart disease, especially if you have recently had a heart attack, if you have coronary heart disease or significant heart failure (congestive heart failure),
• have heart rhythm disorders, such as rapid heart rate, heart valve defects, or abnormal electrocardiogram, as well as other heart diseases,
• have hypertrophic obstructive cardiomyopathy, especially aortic stenosis, or abnormal blood vessel dilation,
• have high blood pressure,
• have high blood sugar levels (diabetes),
• have low potassium levels in the blood,
• have hyperthyroidism,
• have a pheochromocytoma that produces adrenaline and noradrenaline,
• are scheduled for general anesthesia using halogenated anesthetics.

Atimos and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking, or have recently taken, as well as those that are available without a prescription. Some medicines may affect the action of Atimos. These include medicines:

• used to treat irregular heartbeat (e.g., quinidine, disopyramide, procainamide),
• used to treat heart diseases (e.g., digitalis glycosides),
• used to treat nasal congestion (e.g., ephedrine),
• beta-adrenergic receptor blockers used in heart diseases or glaucoma (increased eye pressure) in the form of tablets or eye drops,
• containing erythromycin (used to treat infections),
• used to treat symptoms of depression: monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid) or tricyclic antidepressants (e.g., amitriptyline and imipramine),
• used to treat severe mental disorders (e.g., chlorpromazine and trifluperazine),
• used to treat allergic reactions (such as antihistamines, e.g., terfenadine, astemizole, mizolastine),
• used to treat asthma (e.g., theophylline, aminophylline, or steroids),
• used to increase urine production (such as diuretics),
• used to treat Parkinson's disease (e.g., levodopa),
• containing oxytocin, which induces uterine contractions,
• used to treat hypothyroidism (e.g., thyroxine).

Concomitant use of anticholinergic medicines (such as tiotropium or ipratropium bromide) with Atimos may help to further expand the airways. Your doctor may also prescribe inhaled corticosteroids, which are used to treat breathing disorders. It is very important to use them regularly. After starting to use Atimos, do not stopthe recommended steroid treatment or change its dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Atimos can be used during pregnancy only if it is absolutely necessary.

Driving and using machines

It is unlikely that Atimos will affect your ability to drive or use machines.

Atimos contains ethanol

This medicine contains small amounts of ethanol (alcohol): 8.9 mg of alcohol (ethanol) per inhalation, which is equivalent to 0.25 mg/kg body weight per dose when using two inhalations in adults, and equivalent to 0.44 mg/kg body weight per dose when using two inhalations in adolescents. The amount of alcohol in two inhalations of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Atimos

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.

Recommended dose in asthma:

The dose of Atimos depends on the type of asthma and the severity of its symptoms. Your doctor will adjust the dose individually for each patient. It is essential to take Atimos regularly in the prescribed doses. The usual dose for adults, including the elderly, and adolescents over 12 years of age, is: 1 aerosol dose in the morning and 1 aerosol dose in the evening. This means taking a total of 2 aerosol doses (24 micrograms) of Atimos per day. In severe asthma, your doctor may recommend 4 aerosol doses per day (48 micrograms): 2 aerosol doses in the morning and 2 aerosol doses in the evening. The maximum daily doseis 4 aerosol doses (48 micrograms) of Atimos, and you should not exceedthe recommended daily dose.

This medicine is not intended for use in children with asthma under 12 years of age.

Recommended dose in chronic obstructive pulmonary disease (COPD):

The usual dose for adults (over 18 years of age), including the elderly, is: 1 aerosol dose in the morning and 1 aerosol dose in the evening. This means taking a total of 2 aerosol doses (24 micrograms) of Atimos per day. In severe COPD, your doctor may recommend 4 aerosol doses per day (48 micrograms), i.e., 2 aerosol doses in the morning and 2 aerosol doses in the evening. The maximum daily doseis 4 aerosol doses (48 micrograms) of Atimos, and you should not exceedthe recommended daily dose. Do not use more than 2 aerosol doses at the same time.

This medicine is not intended for use in patients with COPD under 18 years of age.

Atimos should not be used in asthma attacks.In such cases, use a fast-acting inhalation bronchodilator that has been prescribed by your doctor. Always carry this medicine with you.

Using a higher dose of Atimos than recommended

You may experience rapid heartbeat and weakness. You may also experience headache, tremors, nausea, and vomiting, or drowsiness. Consult your doctor as soon as possible.

Missing a dose of Atimos

If you miss a dose of Atimos, take the missed dose as soon as possible. When it is time for your next dose, do not take the missed dose, but take only one dose at the usual, scheduled time. Do not take a double dose.Do not stop using Atimos or reduce its dosewithout consulting your doctor. Also, do not stop the recommended treatment with other medicines intended to facilitate breathing without consulting your doctor, even if you feel better. It is essential to use these medicines regularly. Do not increasethe dose of Atimos without consulting your doctor first. If you experience shortness of breath or wheezing while using Atimos, continue to use Atimos and consult your doctor as soon as possible, as additional treatment may be necessary. After controlling the asthma symptoms, your doctor may consider gradually reducing the dose of Atimos.

Instructions for use

It is essential to know how to use the inhaler correctly. Your doctor, nurse, or pharmacist should show you how to use the inhaler correctly. Follow the instructions carefully to know how, when, and how muchof the medicine to take. The instructions for using the inhaler are at the end of the patient leaflet. If you have any doubts or problems with using the inhaler, consult your doctor, nurse, or pharmacist. Test the inhaler's proper functioning.Before using the inhaler for the first time or if the inhaler has not been used for 3 days or more, perform one inhalation into the air to ensure the inhaler is working correctly. When using the inhaler, stand or sit upright.

• 1. Remove the protective cap from the mouthpiece and hold the inhaler between your thumb and index finger, as shown in figure 1.
• 2. Exhale as deeply as possible.
• 3. Hold the canister upright with the stem pointing upwards and then place the mouthpiece in your mouth and seal it with your lips.
• 4. Take a deep breath in through your mouth, simultaneously pressing the canister to release the dose of medicine.
• 5. Hold your breath for as long as possible without difficulty, then remove the inhaler from your mouth.
• 6. If you need to take another dose, keep the inhaler upright and wait about half a minute, then repeat steps 2 to 5.
• 7. After use, replace the protective cap on the mouthpiece to protect it from dust and dirt. Press it firmly and snap it into place.

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2
3
4
5-6
7
IMPORTANT: Steps 2, 3, 4, and 5 should be performed slowly.
It is essential to take slow, deep breaths when using the inhaler.

If a "mist" appears over the top opening of the mouthpiece or from the side of the mouth, it means that Atimos has not been taken correctly and will not reach the lungs. Take another dose of the medicine, following the instructions exactly, starting from step 2.

People with weak grip will find it easier to hold the inhaler with both hands. Place both index fingers on the canister and your thumbs below the mouthpiece. If you have any difficulties with using the inhaler, consult your doctor, nurse, or pharmacist.

Cleaning the inhaler

To ensure the inhaler works correctly, it is essential to clean it at least once or twice a week. To do this:

• remove the metal canister from the plastic inhaler casing and remove the protective cap from the mouthpiece;
• rinsing the plastic casing and protective cap with warm water;
• do not put the metal canister in water;
• let it dry in a warm place; avoid excessive heat;
• replace the protective cap on the mouthpiece and the canister in the casing.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atimos can cause side effects, although not everyone gets them. Possible side effects are listed below by frequency of occurrence. If you have any doubts about the side effects listed below, consult your doctor.

If breathing difficulties or wheezing worsen after inhaling the medicine, you should

stop using Atimosand inform your doctor immediately. These symptoms are caused by airway constriction, but they occur rarely. Common(occurring in 1 in 10 people): irregular heartbeat and palpitations, cough, tremors, headache. Uncommon(occurring in less than 1 in 100 people): muscle spasms, muscle pain, nausea, excitement, restlessness, especially motor, sleep disturbances, dizziness, taste disturbances, throat irritation, rapid heartbeat, arrhythmias with accelerated heart rate, low potassium levels in the blood, increased blood sugar levels, increased insulin levels, free fatty acids, glycerol, and ketone bodies in the blood, excessive sweating. Rare(occurring in less than 1 in 1,000 people): additional heartbeats caused by premature ventricular contraction, feeling of pressure in the chest, increased or decreased blood pressure, wheezing occurring immediately after inhaling the medicine, sudden drop in blood pressure, kidney inflammation, allergic reactions, such as skin itching, skin rash, bronchospasm, hives, skin and mucous membrane swelling lasting for several days. Very rare(occurring in less than 1 in 10,000 people): worsening of asthma, breathing difficulties, swelling around the wrists and ankles, irregular heartbeat, decreased platelet count, hyperactivity, inappropriate behavior, hallucinations. The severity of some side effects, such as tremors, nausea, abnormal taste or taste disturbances, throat irritation, excessive sweating, restlessness, especially motor, headache, dizziness, and muscle spasms, may decrease within one to two weeks of uninterrupted asthma treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Atimos

• Keep the medicine out of sight and reach of children.
• Do not use the medicine for more than three months from the date of issue from the pharmacy. Never use the medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the month stated.
• Do not store above 30°C.
• If the inhaler becomes cold, remove the metal canister from the plastic casing and warm it in your hands for a few minutes before use. Neveruse other methods to heat the canister.
• Caution.The canister contains a pressurized liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atimos contains:

The active substance of Atimos is formoterol fumarate dihydrate. One dose contains 12 micrograms of formoterol fumarate dihydrate, which corresponds to a delivered dose containing 10.1 micrograms. The other ingredients are: hydrochloric acid, ethanol, and norflurane (HFC 134a). This medicine contains fluorinated greenhouse gases. Each inhaler delivering 50 doses contains 5.842 g of norflurane (HFC 134a), which corresponds to 0.008 tons of CO2 equivalent (GWP = 1430). Each inhaler delivering 100 doses contains 9.087 g of norflurane (HFC 134a), which corresponds to 0.013 tons of CO2 equivalent (GWP = 1430). Each inhaler delivering 120 doses contains 10.384 g of norflurane (HFC 134a), which corresponds to 0.015 tons of CO2 equivalent (GWP = 1430).

What Atimos looks like and what the pack contains:

Atimos is a solution in the form of an inhalation aerosol, placed in a pressurized aluminum canister with a metering valve, actuator, and protective cap. Each pack contains 1 inhaler, which delivers 50, 100, or 120 doses. Not all pack sizes may be marketed.

Marketing authorization holder:

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy

Manufacturer:

Chiesi Farmaceutici S.p.A, Via S. Leonardo 96, 43122 Parma, Italy Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria For further information, contact the local representative of the marketing authorization holder: Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw tel.: (22) 620 14 21, fax: (22) 652 37 79, e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 01/2025