|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Atimos||inhalation aerosol, solution; 12 μg / metered dose (1 metered dose contains 12 μg formoterol fumarate dihydrate, which corresponds to the dose delivered 10.1 μg); 120 doses||Chiesi||120.15||
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
An inhalation drug with bronchodilator, facilitating the free flow of air in the airways. Used in diseases with bronchospasm.
The active substance is formoterol, a medicine from the sympathomimetic group. Sympathomimetics work by stimulating a specific type of receptors, called adrenergic receptors. Adrenergic receptors are found on the surface of nerve, muscle or glandular cells. Under physiological conditions, they are stimulated by adrenaline or noradrenaline, released after the activation of the sympathetic (sympathetic) nervous system. Inhaled formoterol causes stimulation of beta 2 adrenergic receptors found in bronchial smooth muscle. Due to this mechanism of action, formoterol is considered to be beta2-agonists. Inhalation is intended to allow the drug to reach the place of action in the airways quickly and directly, and to minimize systemic side effects. Stimulation of beta 2 receptors in the bronchi leads to muscle relaxation and bronchodilation, which facilitates the free flow of air into the lungs. The ventilation of the lungs improves and the patient experiences significant relief or complete resolution of breathlessness caused by the contraction of the muscles of the respiratory tract. The effect of formoterol occurs quickly, after 1-3 minutes after administration of the drug and persists for 12 hours or longer (long-acting drug).
The preparation is indicated in:
• long-term symptomatic treatment of moderate to severe, chronic asthma in patients requiring regular use of bronchodilators in combination with long-term inhalation of inhaled and / or oral glucocorticosteroids
• relieving symptoms of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD).
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
Do not use the preparation in children under 12 years of age.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
It is not suitable for people who start treatment for asthma and should not be used as a first line treatment. The preparation is intended for people whose disease is chronic and requires regular use of the preparation. The product is not intended for the relief of acute asthma attacks.
In asthma maintenance treatment, long-acting bronchodilators should only be used in combination with anti-inflammatory drugs, i.e. inhaled or oral corticosteroid s.
The preparation may be added to previously used corticosteroids, which may additionally help to relieve the symptoms of the disease.
The preparation does not replace inhalation or oral corticosteroids. When starting treatment with the preparation, corticosteroids should not be discontinued. Remember, if you experience improvement, you can not interrupt or modify your current dose of anti-inflammatories (corticosteroids), unless your doctor tells you otherwise.
Important! If the symptoms persist or if the dose of bronchodilator should be increased, a doctor should be consulted. This indicates a worsening of the course of asthma and increases the risk of acute seizure. Your doctor will assess your condition and verify your further treatment. It can, for example, increase the dose of inhaled corticosteroids or introduce oral corticosteroids for treatment.
Do not start treatment with the product during exacerbation of asthma, worsening its symptoms or if the patient gets worse during the exacerbation.
If the symptoms of asthma intensify during use (this may be manifested by the severity of wheezing in the airways, chest tightness) or the symptoms are not properly controlled, do not interrupt the treatment, but consult a physician.
If the control of asthma symptoms is sufficient, your doctor may advise you to gradually reduce your dose. During the period of reducing the dose should remain under the special doctor's supervision. Your doctor will advise you to use the lowest effective dose.
Remember that the sudden and rapidly progressing worsening of asthma symptoms is a potentially life-threatening condition and requires immediate medical consultation!
Do not increase single doses or total daily dose due to the risk of side effects, especially on the part of the cardiovascular system.
Before using the preparation, consult a doctor if you suspect or have been diagnosed with:
• overactive thyroid gland
• aneurysm or other cardiovascular diseases (including hypertension, arrhythmia, especially in the third degree atrioventricular block, hypertrophic cardiomyopathy with narrowing of the outflow tract, idiopathic subvalvular aortic stenosis, ischemic heart disease, severe heart failure , atherosclerosis prolonged QTc interval in the ECG record)
• you take drugs that prolong the QTc interval on the ECG
• reduced Glucose tolerance
• diabetes (formoterol may cause an increase in blood glucose and blood glucose should be monitored more often).
Patients with the above-mentioned comorbidities should remain under careful medical supervision.
Rarely, in some people, after taking a dose of inhalation medication used for bronchodilation, there may occur, contrary to the intended effect, a violent bronchospasm (the so-called paradoxical bronchospasm). It manifests itself in the severity of wheezing immediately after taking the drug. The contraction may be so intense that it may be life-threatening. In this case, you should immediately discontinue the use of the preparation and use a different, quick-acting inhaling bronchodilator and seek medical help.
You should know that the use of this preparation as well as the use of other medicines in this group (other beta2 adrenergic stimulant sympathomimetics) may lead to a decrease in serum potassium (hypokalaemia) which may be dangerous to your health. Hypokalemia may cause cardiac arrhythmia, which may be additionally aggravated by tissue hypoxia as a result of dyspnoea. You should exercise extreme caution, especially if you use additional diuretics (used for example in the treatment of hypertension) or you are suffering from severe asthma treated with xanthine derivatives (eg theophylline) or corticosteroids, because in this situation hypokalemia may increase. Ask your doctor whether you should regularly monitor your blood potassium levels and how often you should undergo these tests.
If an operation under general anesthesia is planned using halogenated anesthetics, formoterol should not be used for at least 12 hours before the start of anesthesia.
Important information about the use of the preparation
One inhalation dose contains 12 μg of the active substance (formoterol) and is administered during a single inhalation. The delivered dose depends on properly conducted inhalation. Therefore, it is very important to properly master the inhalation technique. Inhalation of the drug allows its rapid access directly to the airways, that is to the place of its operation.
• To always buy your prescription in time and buy a new one before you use up the previous one.
• Always carry a inhaler with a fast-acting bronchodilator.
• Keep the inhaler clean. To prevent the inhaler from being blocked 1-2 times a week, you should clean it. Remove the metal container from the inside of the inhaler and remove the protective cap from the mouthpiece. Do not put a metal container in the water. Rinse the inside of the inhaler under running warm water, shake off the remaining water and dry thoroughly. Do not use any heat sources for this purpose. Improper drying of the inside of the inhaler may cause the inhaler to become blocked. Insert the metal container back into the inhaler and place the protective cap on the mouthpiece.
Does this preparation affect the ability to drive vehicles?
There was no effect on the ability to drive and use machines / machines.
Use the product as directed by your doctor. The product is intended for inhalation use only. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.
Adults and adolescents over 12 years of age: 1 inhalation dose (12 μg) twice a day, morning and evening (ie 24 μg daily). In severe cases, a maximum of 2 inhalation doses (24 μg) twice a day, morning and evening (ie 48 μg daily). The maximum daily dose is 4 inhalation doses, or 48 μg per day in divided doses. Do not use more than 2 sprays at a time.
Do not use the preparation in children under 12 years of age.
There is no need to adjust the dosage in the elderly and in patients with impaired renal or hepatic function.
Chronic obstructive pulmonary disease (COPD):
Adults after 18 years of age: usually 1 inhalation dose (12 μg) twice a day, morning and evening (ie 24 μg / day). If necessary, additional doses may be taken to relieve symptoms so that the total daily dose is not greater than 4 inhalation doses. The maximum daily dose is 4 inhalation doses, or 48 μg per day in divided doses. Do not use more than 2 sprays at a time.
Do not use the preparation in children and adolescents up to 18 years of age.
Instructions for use of the preparation
The product is an inhaled aerosol and is intended for inhalation through the mouth. The aerosol is contained in a metal container under pressure placed in a plastic cover provided with a mouthpiece. Before the first use and whenever the inhaler has not been used for more than 3 days, one spray into the air (press the inhaler once and release one spray dose with the outlet of the mouthpiece directed into the air). To take a dose always follow the instructions below:
• remove the protective cap from the mouthpiece of the inhaler; check that the mouthpiece inside and outside is clean and free from contaminants that could accidentally be sucked into the respiratory tract during inhalation
• grasp the inhaler between the thumb and forefinger
• keep the inhaler in an upright position with the base pointing up
• do a calm, deep exhale
• place the mouthpiece in your mouth and squeeze your mouth around the mouthpiece
• press the bottom of the inhaler (the dose will be released) while making a deep, calm breath through the mouth; it is very important to properly synchronize the inhalation and the moment of release of the dose of the drug, so immediately after starting to inhale, press the bottom of the inhaler and continue to calm deep breath
• hold your breath for a few seconds (important!), Remove the mouthpiece and exhale
• if you should take another dose, wait about half a minute and repeat the steps described above
• after use, secure the mouthpiece with the protective cap.
The first few inhalations are best done in front of the mirror. If you notice that a mist is coming out of the inhaler or from the Corn ers of the mouth, it means that the preparation has not been properly taken and inhalation should be repeated. If you have trouble using the inhaler, consult a doctor or nurse. Some people may find it easier to hold the inhaler in both hands. In this case, the index fingers of both hands should be placed on the bottom of the container and the thumbs below the mouthpiece.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that you consult a physician before taking any medicine during pregnancy or breastfeeding and explain beyond any doubt the potential risks and benefits of using the medicine. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.
There are no adequate data on the safety of the preparation in pregnant women. If there is a need to control asthma, the use of the preparation during pregnancy is only allowed if the doctor deems it absolutely necessary and if in the opinion of the physician the expected benefits clearly outweigh the possible risks. Only a doctor can assess the benefit / risk ratio in your case!
Do not use the product during breast-feeding.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
In combination therapy with formoterol, cardiac glycosides (eg Digoxin ) or other drugs that prolong the ECG QT interval, such as some anti-arrhythmic drugs (eg quinidine, disopyramide, procainamide), antihistamines (such as terfenadine), should not be used. astemizole, mizolastine), Erythromycin , phenothiazine and tricyclic antidepressants. Parallel use of the above drugs with formoterol increases the risk of ventricular arrhythmias.
Parallel application of the preparation and other sympathomimetics (eg other beta 2 adrenergic stimulants, ephedrine, phenylephrine, pseudoephedrine, epinephrine) may increase the side-effects of formoterol; if necessary, the doctor will adjust the dosage.
Xanthine derivatives (eg theophylline), diuretics (used, e.g., for the treatment of hypertension, such as Furosemide ), laxatives and corticosteroids may enhance the hypokalemiem action of the preparation. Hypokalemia can lead to arrhythmias. Check with your doctor whether in your situation you should regularly check the concentration of potassium in your blood and how often you should undergo this test.
Theophylline may increase the side effects associated with the use of the preparation, including arrhythmias. Levodopa, levothyroxine, oxytocin or alcohol may increase the risk of cardiovascular side effects.
Patients taking tricyclic antidepressants or MAO inhibitors (eg moclobemide, selegiline) should be cautious, due to the risk of serious side effects (arrhythmias, increased blood pressure).
During general anesthesia with halogenated inhalants, patients treated with formoterol are at increased risk of arrhythmias; you should ensure that formoterol has not been used for at least 12 hours before the start of anesthesia.
Anticholinergics may increase the bronchodilating effect of formoterol.
Interactions of formoterol and other drugs acting on adrenergic receptors may have a detrimental effect on the cardiovascular system. Beta-adrenergic blockers (beta-blockers used, e.g., for the treatment of hypertension or cardiac dysfunctions), also in the form of eye drops, inhibit the effects of formoterol and should not be used in parallel with the preparation.
Drugs in this group as formoterol (beta2 mimetics) may increase blood glucose levels, which may require dose adjustment of antidiabetic drugs; please consult your doctor.
Like all medicines, Atimos can also cause side effects, although it will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Frequently or uncommonly possible: muscle tremors, spasms and muscle aches, palpitations, increased heart rate (tachycardia), headaches, dizziness, nausea, taste disturbances, excessive sweating, anxiety (especially motor), agitation, disorder sleep, irritation of the throat and mouth, cough. Rare: cardiac arrhythmias (atrial fibrillation, sUPRA ventricular tachycardia, extra spasms), angina pectoris, changes in blood pressure, decreases in potassium in the blood (hypokalaemia), nephritis, hypersensitivity reactions, angioneurotic edema (swelling of the lips, tongue, throat that may impede breathing ), bronchospasm, urticaria. The preparation, like other inhaled medicines, can rarely cause sudden and severe bronchospasm (so-called paradoxical bronchospasm) that causes difficulty in breathing. In the event of paradoxical bronchoconstriction, stop using the product immediately, use another quick-acting inhaler bronchodilator and seek medical attention. Very rare: behavioral disorders, hallucinations, agitation, thrombocytopenia, increased blood glucose (hyperglycemia), prolonged ECG QT interval, dyspnoea, asthma exacerbation and peripheral edema. When using formoterol and other beta2 mimetics, the concentration of free fatty acids, glycerol and ketones in the blood may increase.
Foradil (inhalation powder in hard capsules)
Foramed (powder for inhalation in capsules)
Forastmin (inhalation powder in hard capsules)
Formoterol Easyhaler (powder for inhalation)
Oxis Turbuhaler (powder for inhalation)
Oxodil PPH (powder for inhalation in hard capsules)
Zafiron (powder for inhalation in capsules)