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Efficacy and safety

Efficacy of Incruse Ellipta 1

For a detailed overview of the efficacy for Incruse please refer to the Summary of Product Characteristics.

Safety of Incruse Ellipta 1

Common adverse events (≥1/100 to <1/10) Nasopharyngitis, upper respiratory tract infection, headache, urinary tract infection, sinusitis, tachycardia and cough
Uncommon (≥1/1,000 to <1/100) Pharyngitis, dysgeusia, atrial fibrillation, supraventricular tachycardia, rhythm idioventricular, supraventricular extrasystoles, rash, dry mouth, constipation Hypersensitivity reactions including: Rash, urticaria and pruritus.
Rare (≥1/10,000 to <1/1,000) Eye pain
Not Known Urinary retention and Dusuria


Contraindications

Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate).

Special warnings and precautions for use

Incruse Ellipta should not be used in patients with asthma. Treatment with Incruse Ellipta should be discontinued in the event of paradoxical bronchospasm and alternative therapy initiated if necessary. Cardiovascular effects may be seen after the administration of muscarinic receptor antagonists, therefore Incruse Ellipta should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias. Incruse Ellipta should be used with caution in patients with urinary retention or narrow angle glaucoma. No dosage adjustment is required in renal or mild to moderate hepatic impairment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose‐galactose malabsorption should not take this medicinal product.

Acute Symptoms

Incruse Ellipta is not indicated for acute episodes of bronchospasm. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.

Fertility, pregnancy and breast‐feeding

No available human in vivo data. Balance risks against benefits.

Interactions of Incruse Ellipta with other medicinal products

Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists or medicinal products containing this active substance has not been studied and therefore, is not recommended.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Incruse and Ellipta are registered trademarks of the GlaxoSmithKline Group of Companies.