Foradil capsules with powder for inhalation 12mkg / dose, No. 60 + inhaler

prevention and treatment of bronchospasm in patients with bronchial asthma as an adjunct to therapy with inhaled GCS;

prevention of bronchospasm caused by exercise, cold air or inhalation of allergens, as an adjunct to therapy with inhaled corticosteroids;

prevention and treatment of violations of bronchial patency in patients with COPD, in the presence of both reversible and irreversible bronchial obstruction, chronic bronchitis and pulmonary emphysema.

Inhalation

Designed for inhalation use in adults and children 5 years of age and older. The drug is not intended for oral administration.

The dose of the drug is selected individually, depending on the needs of the patient. The smallest dose that provides a therapeutic effect should be used. When achieving control of the symptoms of bronchial asthma against the background of therapy with Foradil, it is necessary to consider the possibility of a gradual reduction in the dose of the drug. Dose reduction is carried out under regular medical supervision of the patient's condition.

The drug is a powder for inhalation, which should be used only with the help of a special device - an aerolizer - which is included in the package.

Adults

In bronchial asthma, the dose of the drug for regular maintenance therapy is 12-24 mcg (contents of 1-2 caps.) 2 times a day.

The drug Foradil should be used only as an adjunct therapy to inhaled corticosteroids.

Do not exceed the maximum recommended dose of the drug for adults (48 mcg / day). Considering that the maximum daily dose of Foradil is 48 mcg, if necessary, you can additionally apply 12-24 mcg / day to relieve the symptoms of bronchial asthma.

If the need to use additional doses of the drug ceases to be episodic (for example, it becomes more often than 2 days a week), the patient should be advised to consult a doctor for a review of therapy, because this may indicate a worsening of the course of bronchial asthma.

Against the background of an exacerbation of bronchial asthma, you should not start treatment with Foradil or change the dosage. The drug Foradil should not be used to relieve acute attacks of bronchial asthma.

In order to prevent bronchospasm caused by physical activity or the inevitable exposure to a known allergen, 12 ?g of the drug should be inhaled 15 minutes before the expected contact with the allergen or before the load (contents of 1 capsule).

Patients with a history of severe bronchospasm may require inhalation of the contents of 2 caps for prophylaxis. (24 mcg).

In COPD, the dose of the drug for regular maintenance therapy is 12-24 mcg (contents of 1-2 caps.) 2 times a day.

Children 5 years and older

The maximum recommended dose of the drug is 24 ?g / day.

In bronchial asthma, the dose of the drug for regular maintenance therapy is 12 mcg 2 times a day. The drug Foradil should be used only as an adjunct therapy to inhaled corticosteroids.

In children from 5 to 12 years old, the use of combined preparations containing inhaled corticosteroids and a long-acting beta2-adrenergic receptor agonist is recommended, with the exception of cases when they need to be used separately.

In order to prevent bronchospasm caused by physical activity or the inevitable exposure to a known allergen, 12 ?g of the drug should be inhaled 15 minutes before the expected contact with the allergen or before the load (contents of 1 capsule).

Inhalation instructions

In order to ensure the correct use of the drug, the doctor or other healthcare professional must show the patient how to use the inhaler; explain to the patient that powder capsules for inhalation should be used only with the help of an aerolizer; warn the patient that the capsules are for inhalation use only and are not intended to be swallowed.

Children should use the drug under adult supervision.

It is important for the patient to understand that due to the destruction of the gelatin capsule, small pieces of gelatin can be inhaled into the mouth or throat. In order to minimize this phenomenon, do not pierce the capsule more than 1 time. Remove the capsule from the blister pack immediately before use (see 'Instructions for use of the aerolizer'). There are isolated reports of accidental swallowing of capsules of the drug by patients. Most of these cases are not associated with the development of adverse events. The healthcare professional must explain to the patient how to use the drug correctly, especially if after inhalation the patient does not have an improvement in breathing.

Elderly patients (over 65 years old). There are no data in favor of the need to use the drug in a different dose in patients over 65 years old compared to younger patients.

Instructions for use of the aerolizer

1. It is necessary to remove the cap from the aerolizer.

2. Hold the aerolizer firmly by the base and turn the mouthpiece in the direction of the arrow.

3. Place the capsule in the cell at the base of the aerolizer (it is in the shape of a capsule). It must be remembered that the capsule must be removed from the blister pack immediately before inhalation.

4. By turning the mouthpiece, close the aerolizer.

5. Holding the aerolizer in a strictly vertical position, press the blue buttons on the sides of the aerolizer 1 time to the end. Then let them go.

Note. At this point, if the capsule is pierced, it may break down, allowing small pieces of gelatin to enter the mouth or throat. Since gelatin is edible, it won't do any harm. In order for the capsule not to collapse completely, the following requirements should be met: do not pierce the capsule more than 1 time; follow the storage rules; remove the capsule from the blister just before inhalation.

6. It is necessary to make a full exhalation.

7. Take the mouthpiece in your mouth and tilt your head back slightly. Grasp the mouthpiece tightly with your lips and take a quick, even, deepest breath. There should be a characteristic rattling sound created by rotating the capsule and spraying the powder. If there is no characteristic sound, then you should open the aerolizer and see what happened to the capsule. She may be stuck in a cell. In this case, carefully remove the capsule. Under no circumstances should you try to release the capsule by repeatedly pressing the buttons on the sides of the aerolizer.

8. If a characteristic sound occurs during inhalation, you must hold your breath as long as possible. At the same time, remove the mouthpiece from your mouth. Then exhale. Open the aerolizer and see if there is any powder left in the capsule. If powder remains in the capsule, repeat steps 6Ц8.

9. After the end of the inhalation procedure, it is necessary to open the aerolizer, take out the empty capsule, close the mouthpiece and aerolizer with a cap.

Aerolizer Care: To remove powder residues, wipe the mouthpiece and cell with a dry cloth. You can also use a soft brush.

active substance: formoterol fumarate

hypersensitivity to any component of the drug;

children under 5 years of age;

lactation.

Carefully:

Observance of special caution when using the drug Foradil (especially in terms of dose reduction) and careful observation of patients is required in the presence of the following concomitant diseases:

coronary heart disease;

heart rhythm and conduction disorders, especially AV block III degree;

severe heart failure;

idiopathic subvalvular aortic stenosis;

hypertrophic obstructive cardiomyopathy;

thyrotoxicosis;

known or suspected prolongation of the QT interval (corrected QT> 0.44 sec);

diabetes mellitus (given the hyperglycemic effect inherent in beta2-adrenergic agonists, including Foradil, additional regular monitoring of blood glucose concentration is recommended).

pharmachologic effect

Beta agonist. Acts primarily on? 2-adrenergic receptors. It has a bronchodilator effect, relieves and prevents bronchospasm. Inhibits the release of histamine, leukotrienes and prostaglandin D2 from mast cells, basophils and sensitized cells of the bronchoalveolar tree.

Indications of the active substances of the drug

Prevention and treatment of bronchospasm in patients with obstructive bronchitis, bronchial asthma.

Dosage regimen

Applied by inhalation. The dose depends on the dosage form used and the age of the patient.

Side effect

Possibly: headache, nausea, dry mouth, tremors.

Rarely: muscle cramps, myalgia, tachycardia, dizziness, agitation, anxiety, sleep disturbances, nervousness, increased bronchospasm.

In some cases: hypersensitivity reactions (severe arterial hypotension, urticaria, angioedema, pruritus, exanthema), peripheral edema, change in taste.

Contraindications for use

Hypersensitivity to formoterol or other beta-adrenergic agonists, children under 5 years of age.

Application during pregnancy and lactation

During pregnancy and lactation, formoterol is used with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects for the fetus or child.

Application in children

Contraindicated in children under 5 years of age.

special instructions

Special care and careful observation is required if it is necessary to use formoterol in patients with the following concomitant diseases: IHD; heart rhythm and conduction disorders, especially AV block III degree; severe heart failure; idiopathic subvalvular aortic stenosis; hypertrophic obstructive cardiomyopathy; thyrotoxicosis; known or suspected prolongation of the QT interval (QT corrected> 0.44 sec).

Use with caution in patients with diabetes mellitus, uterine myoma.

Influence on the ability to drive vehicles and use mechanisms

Tremor or anxiety that occurs during treatment with beta-adrenostimulants can affect the patient's ability to drive, therefore, when using formoterol, it is not recommended to engage in potentially hazardous activities that require increased attention, rapid psychomotor reactions.

Drug interactions

You should not combine formoterol with adrenomimetics, MAO inhibitors, tricyclic antidepressants (the risk of side effects from the cardiovascular system increases).

With the simultaneous use of xanthine derivatives, GCS, diuretics increase the likelihood of hypokalemic action of the drug.

With the simultaneous use of quinidine, disopyramide, procainamide, phenothiazines, antihistamines, tricyclic antidepressants increase the risk of ventricular arrhythmias.

Beta-blockers (including in the form of eye drops) partially or completely block the action of formoterol.