Abbreviated Prescribing Information: Brimica Genuair 340 micrograms/12 micrograms inhalation powder.
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Presentation: Inhalation powder in a white inhaler with an integral dose indicator and an orange dosage button. Each delivered dose contains 396 μg aclidinium bromide (equivalent to 340 μg of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. Also, contains lactose.Use: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).Dosage: Recommended dose is one inhalation of 340 µg/12 µg twice daily. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers used previously. It is important to instruct the patients to read the Instructions for Use in the pack. No dose adjustments are required for elderly patients, or those with renal or hepatic impairment. No relevant use in children and adolescents.Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Do not use in asthma. 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 with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias. (elderly patients, coronary artery disease, heart failure, hypertension, known arrhythmic substrate, abnormal potassium, magnesium or calcium levels, thyroid disease, obstructive sleep apnoea, diabetes mellitus, excessive alcohol or caffeine intake, use of drugs with proarrhythmic effects). Discontinue if increases in pulse rate, blood pressure or changes in ECG occur. Use with caution in patients with a history of or known prolongation of the QTc interval or treated with products affecting the QTc interval. Use with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma. Hypokalaemia may occur, is usually transient and supplementation not needed. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment. Use with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Dry mouth, observed with anticholinergic treatment, may be associated with dental caries in the long term. Do not use in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.Interactions: Do not administer with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products. Caution in use with methylxanthine derivatives, steroids, non-potassium-sparing diuretics, β-adrenergic blockers or medicinal products known to prolong the QTc interval. Please consult the SPC for more details. Fertility, Pregnancy and lactation: o data on use in pregnancy. Consider risk-benefit before using during lactation. Unlikely to affect fertility at the recommended dose.Side-effects: Common (1-10%): Nasopharyngitis, urinary tract infection, sinusitis tooth abscess, insomnia, anxiety, headache, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, myalgia, muscle spasms, peripheral oedema, increased blood creatine phosphokinase. Uncommon (0.1- 1%): Hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, tachycardia, electrocardiogram QTc prolonged, palpitations, angina pectoris, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention, increased blood pressure. Rare (0.01-0.1%): Hypersensitivity, bronchospasm, including paradoxical. Not known: anaphylactic reaction, angioedema.Pack size: Carton containing 1 inhaler with 60 unit doses.Legal category: POM.
Marketing Authorisation Number: EU/1/14/963/001.  Marketing Authorisation Holder: Covis Pharma Europe B.V. Gustav Mahlerplein 2, 1082MA, Amsterdam, The Netherlands.Marketed by: A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924.
Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd or may be found in the SmPC.
Last updated: February 2025