Presentation and Status in Health Basket
1 X 60/dose
The recommended dose is one inhalation of Duaklir Genuair 340 micrograms /12 micrograms twice daily.
If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.
Elderly: No dose adjustments are required in elderly patients.
Renal impairment: No dose adjustments are required in patients with renal impairment.
Hepatic impairment: No dose adjustments are required in patients with hepatic impairment.
Paediatric population: There is no relevant use of Duaklir Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Method of administration: For inhalation use.
Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers the patients may have used previously. It is important to instruct the patients to read the instructions for use in the Package Leaflet, which is packed together with each inhaler.
Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Hypersensitivity to the active substances or to the excipients.
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.
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. 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.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The most frequently reported adverse reactions with Duaklir Genuair were nasopharyngitis (7.9%) and headache (6.8%).
See prescribing information for full details.
COPD medicinal products: Co-administration of Duaklir Genuair with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended.
Although no formal in vivo drug interaction studies have been performed with Duaklir Genuair, it has been used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Metabolic interactions: In vitro studies have shown that aclidinium or its metabolites at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases. Formoterol does not inhibit the CYP450
enzymes at therapeutically relevant concentrations.
Hypokalaemic treatment: Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of β2-adrenergic agonists, therefore caution is advised in their concomitant use.
β-adrenergic blockers: β -adrenergic blockers may weaken or antagonise the effect of β2-adrenergic agonists. If βadrenergic blockers are required (including eye drops), cardioselective beta-adrenergic blockers are preferred, although they should also be administered with caution.
Other pharmacodynamic interactions: Duaklir Genuair should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval such as monoamine oxidase inhibitors, tricyclic antidepressants, antihistamines or macrolides because the action of formoterol, a component of Duaklir Genuair, on the cardiovascular system may be potentiated by these medicinal products.
Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Pregnancy and Lactation
Pregnancy: There are no data available on the use of Duaklir Genuair in pregnant women. Duaklir Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Lactation: It is unknown whether aclidinium (and/or its metabolites) or formoterol are excreted in human milk. The use of Duaklir Genuair by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
See prescribing information for full details.
There is limited evidence on the management of overdose with Duaklir Genuair. High doses of Duaklir Genuair may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and hypertension.
DUAKLIR Genuair should be discontinued in case of overdose. Supportive and symptomatic treatment is indicated.
Shelf life: The expiry date of the product is indicated on the packaging materials. To be used within 60 days of opening the pouch.
Storage: Store below 30°C. Keep the Genuair inhaler protected inside the sealed pouch until the administration period starts.