Formoterol Easyhaler inhalation powder 120 doses

Formoterol Easyhaler inhalation powder is indicated for:

Composition

Active ingredient: formoterol;

1 dose that comes out of the mouthpiece contains 12 mcg of formoterol fumarate dihydrate;

Excipients: lactose monohydrate.

Contraindication

Hypersensitivity to formoterol fumarate or lactose monohydrate (contains small amounts of milk proteins). Hypersensitivity to other β2-adrenergic stimulants.

Tachyarrhythmia, third-degree atrioventricular block, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, thyrotoxicosis.

Patients with suspected or known QT prolongation (QTc> 0.44 sec).

Method of application

Method of administration - inhalation.

Adults (including elderly patients) and children from 12 years of age.

Bronchial asthma. Regular maintenance therapy: 1 inhalation (12 mcg) 2 times a day. In case of severe diseases, this dosage regimen may be increased to 2 inhalations (24 mcg) 2 times a day.

The maximum daily dose is 4 inhalations (48 mg) per day.

Chronic obstructive pulmonary disease. Regular maintenance therapy: 1 inhalation (12 mcg) 2 times a day.

The maximum daily dose is 2 inhalations (1 inhalation 2 times a day).

Application features

Pregnant women

Treatment with formoterol should only be considered if necessary to control asthma and if there is no other safe alternative, taking into account that the expected benefit to the mother outweighs the risk to the fetus.

Children

Children under 6 years of age should not be prescribed Formoterol Easyhaler, as experience with the drug in this group of patients is insufficient.

Drivers

If dizziness, tremors, or seizures occur during treatment, you should not drive or operate complex machinery.

Overdose

Symptoms: There is limited clinical experience with the treatment of overdose. Overdose is likely to be accompanied by symptoms commonly seen with β2-agonist overdose: tremor, headache, palpitations. In isolated cases, symptoms such as tachycardia, hyperglycemia, hypokalemia, QTc prolongation, arrhythmia, nausea and vomiting have been reported.

Treatment: Supportive and symptomatic treatment is indicated. Hospitalization is required in severe cases.

Cardioselective beta-blockers may be considered, but with caution, as beta-blockers may cause bronchospasm. Serum potassium should be monitored.

Side effects

The most common side effects reported with β2-agonist treatment, such as tremor and palpitations, are mostly mild and disappear within a few days of treatment.

Interaction

Concomitant use with macrolides requires caution, as their effect on the cardiovascular system may be enhanced.

Concomitant use of other sympathomimetic agents, such as other <> β2-agonists or ephedrine, may potentiate both the desired and unwanted effects of Formoterol Easyhaler. Therefore, dose titration may be necessary.

Storage conditions

Store in original packaging before first use.

After opening the package, store at a temperature not exceeding 30 °C in a place protected from moisture.

Shelf life - 2 years.