Duaklir Genuair · 4.8 Undesirable effects · 1

HOS-096996 · has-adverse-reaction-information · PDF-Seite 5

The presentation of the safety profile is based on the experience with Duaklir Genuair and the individual components. Summary of the safety profile The safety experience with Duaklir Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience. Adverse reactions associated with Duaklir Genuair were similar to those of the individual components. As Duaklir Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Duaklir Genuair. The most frequently reported adverse reactions with Duaklir Genuair were nasopharyngitis (7.9%) and headache (6.8%). Tabulated summary of adverse reactions The Duaklir Genuair clinical development programme was conducted in patients with moderate or severe COPD. A total of 1222 patients were treated with Duaklir Genuair 340 micrograms /12 micrograms. The frequencies assigned to the adverse reactions are based on crude incidence rates observed with Duaklir Genuair 340 micrograms /12 micrograms in the pooled analysis of randomised, placebo-controlled Phase III clinical studies of at least six months duration, or on experience with individual components or on post-marketing study results. The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). System organ class Preferred term Frequency 5  Nasopharyngitis Urinary tract infection Infectious and infestations Common Sinusitis Tooth abscess Hypersensitivity Rare Immune system disorders Angioedema Not known Anaphylactic reaction Metabolism and nutrition Hypokalaemia Uncommon disorders Hyperglycaemia Uncommon Insomnia

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HOS-096992 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances or to the excipient listed in section 6.1.

HOS-096991 · has-indication-information · PDF-Seite 2

Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

HOS-096994 · has-interaction-information · PDF-Seite 4

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. 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 (see section 4.4). β-adrenergic blockers β-adrenergic blockers may weaken or antagonise the effect of β2-adrenergic agonists. If β-adrenergic 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. 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 (see section 5.2).

HOS-096995 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no data available on the use of Duaklir Genuair in pregnant women. 4 Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium and adverse effects in reproduction studies with formoterol at very high systemic exposure levels (see section 5.3). Duaklir Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks. Breast-feeding It is unknown whether aclidinium (and/or its metabolites) or formoterol are excreted in human milk. As studies in rats have shown excretion of small amounts of aclidinium (and/or its metabolites) and formoterol into 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. Fertility Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium and formoterol (see section 5.3). Nevertheless, it is considered unlikely that Duaklir Genuair administered at the recommended dose will affect fertility in humans.

HOS-096993 · has-warning-information · PDF-Seite 3

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 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). Cardiac arrhythmias, including atrial fibrillation and paroxysmal tachycardia were seen after the administration of Duaklir Genuair (see section 4.8). Therefore, Duaklir Genuair should be used with caution in patients with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias. 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 3 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. L

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