Expiration date: 07/2025

Clinico-pharmacological group

(Bronchodilators - beta2-agonists)

Release form, composition and packaging

Capsule powder inhalations hard gelatin, size ?3, with a transparent colourless cap and body, marked with the company logo under a black strip on the lid and the inscription "IDL 150" in black ink above the black stripe, the contents of capsules - white or almost white powder.

Terms and conditions storage

The drug should be stored in a dry, inaccessible for children place at temperature not exceeding 30°C. shelf Life - 2 years. The drug is not use after expiration date.

Testimony

— long-term treatment of bronchial obstruction in patients with COPD.

Contraindications

— the age 18 years (effectiveness and safety have not been established),

— pregnancy,

— breastfeeding,

— hypersensitivity to indacaterol or any component of the drug.

With caution should appoint drug patients with concomitant cardiovascular disorders (ischemic heart disease, acute myocardial infarction, arrhythmia, hypertension), convulsive disorders, thyrotoxicosis, diabetes mellitus, and patients with a history of inadequate response to the action of agonists ?2-adrenergic receptors.

Special instructions

Hypersensitivity reactions

On the background of drug Onbrez Breezhaler was was a reaction of immediate hypersensitivity. If there are signs indicating the development of allergic reactions (in particular, difficulty in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash), the drug should be stopped and to find alternative therapy.

Bronchial asthma

In the absence of data on prolonged use of indacaterol in patients with bronchial asthma, the drug should not be used in these patients.

Paradoxical bronchospasm

As with any other inhalation therapy, the drug may cause paradoxical bronchospasm, which threaten the patient's life. In case of paradoxical bronchospasm drug treatment should be immediately discontinued and assigned to alternative therapy.

Worsening of the underlying disease

Do not use this drug for relief of acute bronchospasm, i.e. not to be used as emergency therapy. In case of deterioration of the course of COPD on the background of drug treatment, it is necessary to re-assess the patient's condition and review the treatment of the disease.

Effect on the cardiovascular system

In some patients, the drug Onbrez Breezhaler, like other agonists ?2-adrenergic receptors, can affect the cardiovascular system (increase heart rate, blood pressure). In the event of adverse effects may require discontinuation of drug therapy. In addition, the application of agonists ?2-adrenergic receptors may include the following electrocardiographic changes: flattening of the T wave, prolongation of the QT interval and depression of ST segment (however, the clinical significance of these changes is not established).

In applying the drug in clinical trials (at the recommended therapeutic doses) significant lengthening of the QT interval compared to placebo was observed.

Hypokalemia

Some patients at application of agonists ?2-adrenergic receptors may be significant hypokalemia, leading to the development of the undesirable phenomena from cardiovascular system. The decrease in potassium concentration in serum is usually transient and requires no correction. In patients with severe COPD, hypokalemia may be exacerbated by hypoxia and concomitant therapy, which in turn may increase the likelihood of developing arrhythmias.

Hyperglycemia

Inhalation of high doses of agonists ?2-adrenergic receptors may increase the level of glucose in the blood plasma. In applying the drug in patients with diabetes should regularly monitor glucose concentration in blood plasma. In clinical studies, patients receiving the drug (at recommended doses), there was an increase in the incidence of clinically significant hyperglycemia by an average of 1-2% compared to placebo. The efficacy and safety of the drug in patients with uncompensated diabetes has not been studied.

Effects on ability to drive vehicles and management mechanisms

Data on the impact of the drug on the ability to drive vehicles and operate machinery no.