Seebri Breezhaler Special Precautions

Not for acute use: SEEBRI BREEZHALER is a once-daily long-term maintenance treatment and is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Hypersensitivity: Immediate hypersensitivity reactions have been reported after administration of SEEBRI BREEZHALER. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria, or skin rash, SEEBRI BREEZHALER should be discontinued immediately and alternative therapy instituted.
Paradoxical bronchospasm: As with other inhalation therapy, administration of SEEBRI BREEZHALER may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, SEEBRI BREEZHALER should be discontinued immediately and alternative therapy instituted.
Anticholinergic effect: Like other anticholinergic drugs, SEEBRI BREEZHALER should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Patients should be advised about signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using SEEBRI BREEZHALER and to contact their doctor immediately should any of these signs or symptoms develop.
Patients with severe renal impairment: A moderate mean increase in total system exposure (AUC_last) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease.
For patients with severe renal impairment (estimated glomeruiar filtration rate below 30 mL/min/1.73 m²) including those with end-stage renal disease requiring dialysis, SEEBRI BREEZHALER should be used only if the expected benefit outweighs the potential risk (see Pharmacology under Actions). These patients should be monitored closely for potential adverse drug reactions.
Patients with a history of cardiovascular disease: Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms for males or >470 ms for females) were excluded from the clinical trials, and therefore the experience in these patient groups is limited. SEEBRI BREEZHALER should be used with caution in these patient groups.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.