umeclidinium bromide

HOS-216610 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reactions are nasopharyngitis (6%) and upper respiratory tract infection (5%). Tabulated list of adverse reactions The safety profile of umeclidinium was evaluated in patients with COPD who received doses of 55 micrograms or greater for up to one year. This includes patients who received the recommended dose of 55 micrograms once daily. The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed from efficacy studies, the long-term safety study (which involved patients who received umeclidinium), post-marketing studies and spontaneous reporting. 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 Adverse reactions Frequency Infections and Nasopharyngitis Common infestations Upper respiratory tract infection Common Urinary tract infection Common Sinusitis Common Pharyngitis Uncommon Immune system Hypersensitivity reactions including: disorders Rash, urticaria and pruritus Uncommon Anaphylaxis Rare Nervous system Headache Common disorders Dysgeusia Uncommon Dizziness Not known Eye disorders Eye pain Rare Glaucoma Not known Vision blurred Not known Intraocular pressure increased Not known Cardiac disorders Tachycardia

Auszug; vollständigen Abschnitt im Original lesen.

HOS-216606 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

HOS-216605 · has-indication-information · PDF-Seite 2

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

HOS-216608 · has-interaction-information · PDF-Seite 4

Clinically significant interactions mediated by umeclidinium at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing. 4  Other antimuscarinics Co-administration of umeclidinium with other long acting muscarinic antagonists or medicinal products containing this active substance has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions. Metabolic and transporter based interactions Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of umeclidinium were assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose. An approximately 1.3-fold increase in umeclidinium AUC was observed at an 8-fold higher dose with no effect on umeclidinium Cmax. Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium is co- administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in CYP2D6 activity (poor metabolisers). Umeclidinium is a substrate of P-glycoprotein (P-gp) transporter. The effect of the moderate P- gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers. No effect of verapamil was observed on umeclidinium Cmax. An approximately 1.4-fold increase in umeclidinium AUC was observed. Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium is co-administered with P-gp inhibitors. Other medicinal products for COPD Although no formal in vivo interaction studies have been performed, inhaled umeclidinium has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.

HOS-216609 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of umeclidinium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Umeclidinium should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus. Breast-feeding It is unknown whether umeclidinium is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue Incruse Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 5  Fertility There are no data on the effects of umeclidinium on human fertility. Animal studies indicate no effects of umeclidinium on fertility.

HOS-216607 · has-warning-information · PDF-Seite 4

Asthma Umeclidinium should not be used in patients with asthma since it has not been studied in this patient population. Paradoxical bronchospasm Administration of umeclidinium may produce paradoxical bronchospasm that may be life- threatening. If paradoxical bronchospasm occurs treatment should be discontinued immediately and alternative therapy instituted if necessary. Deterioration of disease Umeclidinium is intended for the maintenance treatment of COPD. It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the event of deterioration of COPD during treatment with umeclidinium, a re- evaluation of the patient and of the COPD treatment regimen should be undertaken. Cardiovascular effects Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium (see section 4.8). Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, umeclidinium should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias. Antimuscarinic activity Due to its antimuscarinic activity, umeclidinium should be used with caution in patients with urinary retention or with narrow-angle glaucoma. Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.