Anoro Ellipta

Anoro Ellipta Special Precautions

umeclidinium + vilanterol

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Asthma: Umeclidinium/vilanterol should not be used in patients with asthma since it has not been studied in this patient population.
Paradoxical bronchospasm: As with other inhalation therapies, administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be life-threatening. Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Not for acute use: Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Deterioration of disease: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the event of deterioration of COPD during treatment with umeclidinium/vilanterol, 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 and sympathomimetics, including umeclidinium/vilanterol. Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease.
Antimuscarinic activity: Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Hypokalaemia: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose. Caution should be exercised when umeclidinium/vilanterol is used with other medicinal products that also have the potential to cause hypokalaemia (see Interactions).
Hyperglycaemia: Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.
No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose. Upon initiation of treatment with umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients.
Coexisting conditions: Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
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: Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
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