Abbreviated Prescribing Information
Breztri

Presentation: Aerosphere pressurised inhalation, suspension budesonide 160μg/glycopyrronium 7.2μg/formoterol fumarate dihydrate 5μg per inhalation. Indications: As a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. Dosage: Two inhalations twice daily (two inhalations in the morning and two inhalations in the evening). Contraindications: Hypersensitivity to the active substances, norflurane, 1,2-distearoyl-sn-glycero-3-phosphocholine, calcium chloride. Precautions: Not for acute use. Should be discontinued immediately if paradoxical bronchospasm occurs. It is recommended that treatment should not be stopped abruptly. Caution in patients with clinically significant uncontrolled and severe cardiovascular disease. Potential systemic effects of inhaled corticosteroid. Particular care is needed in patients transferring from oral steroids. Increase in the incidence of pneumonia in patients with COPD. Risk in visual disturbance, hypokalaemia, hyperglycaemia. Used with caution in patients with thyrotoxicosis, symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma, severe renal impairment and severe hepatic impairment. Co-administration with other anticholinergic is not recommended. No or limited data on pregnancy, breast-feeding & fertility. Interactions: Strong CYP3A inhibitors, itraconazole, cimetidine, not recommended other anticholinergic and/or long-acting β2-adrenergic agonist. Other beta-adrenergic, xanthine derivatives, steroids and non-potassium sparing diuretics, β-adrenergic blockers, quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazines. L-dopa, L-thyroxine, oxytocin and alcohol.
Undesirable effects: Pneumonia, headache, urinary tract infection, oral candidiasis, hyperglycaemia, anxiety, insomnia, palpitations, dysphonia, cough, nausea, muscle spasms. Full local prescribing information is available upon request. API.HK.BRE.1022

HK-10000 19/02/2024