Eklira Genuair

HOS-155197 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The most frequently reported adverse reactions with Eklira Genuair were headache (6.6%) and nasopharyngitis (5.5%). Tabulated summary of adverse reactions The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Eklira Genuair) observed with Eklira Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials or on post-marketing study results. A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Eklira Genuair up to 36 months did not identify other adverse reactions. 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 the available data). System organ class Preferred term Frequency Infections and infestations Sinusitis Common Nasopharyngitis Common Immune system disorders Hypersensitivity Rare Angioedema Not known Anaphylactic reaction Not known 4  Nervous system disorders Headache Common Dizziness Uncommon Eye disorders Blurred vision Uncommon Cardiac disorders Cardiac arrhythmias, Uncommon including atrial fibrillation and paroxysmal tachycardia Tachycardia Uncommon Palpitations Uncommon Respiratory, thoracic and Cough Common mediastinal disorders Dysphonia Uncommon Gastrointestinal disorders Diarrhoea Common Nausea Common Dry mouth Uncommon

Auszug; vollständigen Abschnitt im Original lesen.

HOS-155193 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.

HOS-155192 · has-indication-information · PDF-Seite 2

Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).

HOS-155195 · has-interaction-information · PDF-Seite 3

Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended. Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions. 3 In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of P-glycoprotein (P-gp), or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).

HOS-155196 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no data available on the use of aclidinium bromide in pregnant women. Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3). Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks. Breast-feeding It is unknown whether aclidinium bromide/metabolites are excreted in human milk. Animal studies have shown excretion of small amounts of aclidinium bromide/metabolites into milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eklira Genuair therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3). It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.

HOS-155194 · has-warning-information · PDF-Seite 3

Paradoxical bronchospasm: Administration of Eklira Genuair may cause paradoxical bronchospasm. If this occurs, treatment with Eklira Genuair should be stopped and other treatments considered. Deterioration of disease: Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy. In the event of a change in COPD intensity while the patient is being treated with aclidinium bromide so that the patient considers additional rescue medication is required, a re-evaluation of the patient and the patients’ treatment regimen should be conducted. Cardiovascular effects: Cardiac arrhythmias, including atrial fibrillation and paroxysmal tachycardia were seen after the administration of Eklira Genuair (see section 4.8). Therefore, Eklira Genuair should be used with caution in patients with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias. Experience in patients with cardiovascular comorbidities in clinical trials is limited (see section 5.1). These conditions may be affected by the anticholinergic mechanism of action. Anticholinergic activity: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries. Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely). Excipients: This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.