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  • Anoro Ellipta 55/22 mcg
    / GSK

    Active Ingredient *
    Umeclidinium 55 mcg
    Vilanterol 22 mcg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Inhalation Powder

    30 Doses

    partial basket chart 74085 9815

    Related information


    Adults: The recommended dose is one inhalation of 55/22 mcg once daily. This drug should be administered once daily at the same time of the day each day to maintain bronchodilation. The maximum dose is one inhalation of 55/22 mcg once daily.
    Special populations: Elderly patients, No dosage adjustment is required in patients over 65 years.
    Renal impairment: No dosage adjustment is required in patients with renal impairment.
    Hepatic impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment. The use of this product has not been studied in patients with severe hepatic impairment and should be used with caution.
    Paediatric population: There is no relevant use of this product in the paediatric population (under 18 years of age) in the indication for COPD.
    For method of administration: See prescribing information for full details.


    Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). This drug is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.


    Hypersensitivity to the active substances or to any of the excipients.

    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 hypokalaemiaHyperglycaemia 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.
    See prescribing information for full details.

    Side Effects

    Urinary tract infection, Sinusitis, Nasopharyngitis, Pharyngitis, Upper respiratory tract, Infection, Headache, Cough, Oropharyngeal pain.
    See prescribing information for full details.

    Drug interactions

    Beta-adrenergic blockers: Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol. Concurrent use of either non-selective or selective beta-adrenergic blockers should be avoided unless there are compelling reasons for their use.
    Metabolic and transporter based interactions: Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4). Concomitant administration of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the metabolism of, and increase the systemic exposure to, vilanterol.
    Other antimuscarinics and sympathomimetics: Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions.
    Hypokalaemia: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution.
    Other medicinal products for COPD: Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
    See prescribing information for full details.

    Pregnancy and Lactation

    Pregnancy: There are no data from the use of umeclidinium/vilanterol in pregnant women. See prescribing information for full details.
    Lactation: It is unknown whether umeclidinium or vilanterol are excreted in human milk.
    See prescribing information for full details.


    An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components’ actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia). If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

    Important notes

    Lactose: Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
    Storage: Do not store above 30°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use. Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use. Use within 6 weeks after opening the tray. Do not open the tray until ready to inhale.

    Glaxo Operations UK Ltd