Anoro▼Ellipta (/vilanterol [as trifenatate]) Prescribing information (Please consult the full Summary of Product Characteristics (SmPC) before prescribing)

Anoro Ellipta 55/22mcg (umeclidinium with other medicinal products: Avoid β- bromide/vilanterol [as trifenatate]) inhalation blockers. Caution is advised when co- powder. Each single inhalation provides a administering with strong CYP3A4 inhibitors (e.g. delivered dose (the dose leaving the mouthpiece) ketoconazole, clarithromycin, itraconazole, of 55 micrograms umeclidinium (equivalent to 65 ritonavir, telithromycin). Co-administration with micrograms of umeclidinium bromide) and 22 other long-acting muscarinic antagonists, long- micrograms of vilanterol (as trifenatate). acting β2- agonists or products Indications: Maintenance containing either of these is not recommended. treatment to relieve symptoms in adult patients Caution if using concomitantly with with chronic obstructive pulmonary disease methylxanthine derivatives, steroids or non- (COPD). Dosage and administration: Inhalation potassium-sparing diuretics as they may only. One inhalation once daily. Administer at the potentiate possible hypokalaemic effect of β2- same time of day each day. Inhaler contains pre- adrenergic agonists. Fertility, pregnancy, and dispensed doses and is ready to use. breast-feeding: No data in pregnant woman or Contraindications: Hypersensitivity to the active human fertility. Animal studies (at exposures not substances or to any of the excipients (lactose clinically relevant) have shown reproductive monohydrate and magnesium stearate). toxicity. Should only use in pregnancy if expected Precautions: Should not be used in patients with benefit to the mother justifies potential risk to . Treatment should be immediately fetus. Unknown whether excreted in breast milk; discontinued in the event of paradoxical risk to newborns cannot be excluded; balance bronchospasm and alternative therapy initiated if risks for child against benefits for mother. Side necessary. Cardiovascular effects (eg effects: Common (≥1/100 to <1/10): urinary tract arrhythmias) may be seen after administration of infection, sinusitis, nasopharyngitis, pharyngitis, muscarinic receptor antagonists and upper respiratory tract infection, headache, sympathomimetics. Use with caution in patients cough, oropharyngeal pain, constipation and dry with severe cardiovascular disease; urinary mouth. Other less frequent side effects include: retention; narrow angle glaucoma; convulsive cardiac arrhythmias, hypersensitivity reactions disorders; thyrotoxicosis; severe hepatic (including rash, anaphylaxis, angioedema, impairment and in patients who are unusually urticaria), glaucoma, paradoxical bronchospasm, responsive to β2-adrenergic agonists. Caution urinary retention, bladder outlet obstruction, with other medicines which can cause dizziness and tremor. See SmPC for other hypokalaemia. More closely monitor plasma adverse reactions. Legal category: POM. glucose in diabetic patients upon initiation of Presentation and Basic NHS cost: Anoro Anoro. No dosage adjustment is required in the Ellipta. 1 inhaler x 30 doses. Anoro Ellipta elderly; renal or mild to moderate hepatic 55/22mcg - £32.50. Marketing authorisation impairment. Do not use in patients with rare (MA) no. 55/22mcg 1x30 doses hereditary problems of galactose intolerance, [EU/1/14/898/002]; MA holder: GlaxoSmithKline total lactase deficiency or glucose-galactose (Ireland) Limited,12 Riverwalk, Citywest malabsorption. Acute symptoms: Not indicated Business Campus, Dublin 24, Ireland Last date for acute episodes of bronchospasm. Patients of revision: September 2020. Anoro-PI-3768. should seek medical advice if short-acting Anoro and Ellipta are registered trademarks of inhaled bronchodilator use increases and re- the GlaxoSmithKline group of companies. All evaluation of the patient and COPD treatment rights reserved. Anoro was developed in regimen should be undertaken. Interactions collaboration with Innoviva Inc.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.