Incruse Ellipta Special Precautions

Asthma: INCRUSE should not be used in patients with asthma since it has not been studied in this patient population.
Paradoxical bronchospasm: Administration of INCRUSE may produce paradoxical bronchospasm that may be life-threatening. Treatment should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Deterioration of disease: INCRUSE 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 INCRUSE, 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 INCRUSE. In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, INCRUSE should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
Antimuscarinic activity: Consistent with its antimuscarinic activity, INCRUSE 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, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on ability to drive and use machines: INCRUSE has no or negligible influence on the ability to drive and use machines.