Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use


Asthma
Duaklir Genuair should not be used in asthma; clinical studies of Duaklir Genuair in asthma have not been conducted.


Paradoxical bronchospasm
In clinical studies, paradoxical bronchospasm was not observed with Duaklir Genuair at its recommended dose. However, paradoxical bronchospasm has been observed with other inhalation therapies. If this occurs, medicinal product should be stopped, and other treatment will be considered.
Not for acute use
Duaklir Genuair is not indicated for the treatment of acute episodes of bronchospasm.


Cardiovascular effects
Patients with a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, QTc (Bazett's method) above 470 msec, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association” were excluded from the clinical studies, therefore Duaklir Genuair should be used with caution in these patients' groups.
β2-adrenergic agonists may produce increases in pulse rate and blood pressure, electrocardiogram (ECG) changes such as T wave flattening, ST segment depression and prolongation of the QTc-interval in some patients. In case such effects occur, treatment may need to be discontinued. Long-acting β2-adrenergic agonists should be used with caution in patients with history of or known prolongation of the QTc-interval or treated with medicinal products affecting the QTc interval (see section 4.5).


Systemic effects
Duaklir Genuair should be used with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma.
Metabolic effects of hyperglycaemia and hypokalaemia may be observed with high doses of β2-adrenergic agonists. In Phase III clinical studies, the frequency of notable increases in blood glucose with Duaklir Genuair was low (0.1%) and similar to placebo. Hypokalaemia is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5). Hypokalaemia increases susceptibility to cardiac arrhythmias.
Due to its anticholinergic activity, Duaklir Genuair should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely). Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.



Lactose content

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product 

Effects on Driving

4.7 Effects on ability to drive and use machines
Duaklir Genuair has no or negligible influence on the ability to drive and use machines. The occurrence of blurred vision or dizziness may influence the ability to drive or to use machines.