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摘要

Eklira? Genuair? 322 micrograms inhalation powder. Please consult the Summary of ProductCharacteristics (SPC) for the full prescribing information. Presentation: Inhalation powder in a whiteinhaler with an integral dose indicator and a green dosage button. Each delivered dose contains 375μg aclidinium bromide equivalent to 322 μg of aclidinium. Also, contains lactose. Use: Maintenancebronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonarydisease (COPD). Dosage: For inhalation use. Recommended dose is one inhalation of 322 microgramsaclidinium twice daily. Patients should be instructed on how to administer the product correctly asthe Genuair inhaler may work differently from inhalers used previously. It is important to instruct thepatients to read the Instructions for Use in the pack. No dose adjustments are required for elderlypatients, or those with renal or hepatic impairment. No relevant use in children and adolescents.Contraindications: Hypersensitivity to aclidinium bromide or to any of the excipients. Warningsand Precautions: Stop use if paradoxical bronchospasm occurs and consider other treatments.Do not use for the relief of acute episodes of bronchospasm. Use with caution in patients withmyocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia withinthe previous 3 months, or hospitalisation within the previous 12 months for heart failure functionalclasses III and IV. Dry mouth, observed with anticholinergic treatment, may be associated with dentalcaries in the long term. Use with caution in patients with symptomatic prostatic hyperplasia orbladder-neck obstruction or with narrow-angle glaucoma. Do not use in patients with rare hereditaryproblems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.Interactions: Do not administer with other anticholinergic-containing medicinal products. No otherinteractions expected. Please consult the SPC for more details. Fertility, pregnancy and lactation:No data on use in pregnancy. Risk to newborns/infants cannot be excluded. Consider risk-benefitbefore using during lactation. Unlikely to affect fertility at the recommended dose. Side-effects:Common (1-10%): Sinusitis, nasopharyngitis, headache, cough, diarrhoea, nausea. Uncommon(0.1- 1%): Dizziness, blurred vision, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash,pruritus, urinary retention. Rare (0.01-0.1%): hypersensitivity. Not known: angioedema, anaphylacticreaction. Pack sizes: Carton containing 1 inhaler with 60 unit doses. Legal category: POM MarketingAuthorisation Number: EU/1/12/778/002 Marketing Authorisation holder: AstraZeneca AB, SE15185 S?dert?lje, Sweden. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt,Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924. Further information is available onrequest to A. Menarini Pharmaceuticals Ireland Ltd. or may be found in the SPC. Last updated: May2018.