Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Not for acute use
Seebri Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial 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, treatment should be discontinued immediately and alternative therapy instituted.

SEE API FEB22 V2                                                                    REF EU SmPC Nov2021 Paradoxical bronchospasm
In clinical studies with Seebri Breezhaler, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.

Anticholinergic effect
Seebri Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.

Patients should be informed about the 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 systemic exposure (AUClast) 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. In patients with severe renal impairment (estimated glomerular 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 section 5.2).
These patients should be monitored closely for potential adverse 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, total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.

Effects on Driving

4.7 Effects on ability to drive and use machines
Glycopyrronium has no or negligible influence on the ability to drive and use machines.