TRELEGY Ellipta: Available in two strengths for asthma in the easy-to-use Ellipta inhaler

TRELEGY Safety Information:

Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate and magnesium stearate) or patients with severe milk-protein allergy. Warnings & Precautions: Asthma: Should not be used to treat acute asthma symptoms or an acute exacerbation in COPD for which a short-acting bronchodilator is required. COPD: Should not be used to treat an acute exacerbation in COPD for which a short-acting bronchodilator is required. Patients should not stop therapy with Trelegy Ellipta, in asthma or COPD, without physician supervision since symptoms may recur after discontinuation. Discontinue Trelegy if paradoxical bronchospasm occurs and institute alternative therapy if necessary. Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists or sympathomimetics, use with caution in patients with unstable or life-threatening cardiovascular disease. Monitor patients with moderate to severe hepatic impairment for systemic corticosteroid-related adverse reactions and the 100/62.5/25 micrograms dose should be used. Systemic effects may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Possible systemic effects include HPA suppression, decrease in bone mineral density, cataract, glaucoma, central serous chorioretinopathy and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Use with caution in patients with urinary retention, narrow angle glaucoma, pulmonary tuberculosis or with chronic or untreated infections. hyperglycaemia and severe hepatic impairment. Consider risk factors for pneumonia in patients with COPD before prescribing, and re-evaluate treatment if pneumonia occurs.  Adverse Reactions: Very Common: Nasopharyngitis. Common: Urinary tract infection, sinusitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, dysphonia, constipation, pneumonia, bronchitis, rhinitis, influenza, candidiasis of mouth and throat, arthralgia, back pain, viral respiratory tract infection. Uncommon: dry mouth, dysgeusia, atrial fibrillation, supraventricular tachyarrythmia, tachycardia, fractures.

Version number: GDS12/IPI13a(SI)