Bevespi Aerosphere

Posology The recommended dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening). Patients should be advised not to take more than 2 inhalations twice daily. If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.

A double dose should not be taken to make up for a forgotten dose. 2). Renal impairment Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate renal impairment. 2). Hepatic impairment 3 Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate hepatic impairment.

2). Paediatric population There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD. Method of administration For inhalation use. Instructions for use On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity.

When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.

Note:

Patients should be instructed on the correct inhalation technique. It is important to instruct the patient to: • Carefully read the instructions for use in the package leaflet, which is packed together with each inhaler. • Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.

• Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, has been exposed to low temperatures, or has been dropped. To get adequate lung deposition of the active substances, actuation must be co-ordinated with inhalation.

Patients who find it difficult to co-ordinate actuation with inspiration of breath may use Bevespi Aerosphere with a spacer to ensure proper administration of the product. 2).

Summary of the safety profile The safety profile is characterised by anticholinergic and β2-adrenergic class effects related to the individual components of the combination. 3%). Tabulated list of adverse reactions The tabulated list of adverse reactions is based on clinical trials and post-approval experience with Bevespi Aerosphere as well as experience with the individual components and related products.

The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).

Table 1 Adverse reactions by frequency and system organ class (SOC) System Organ Class Preferred term Frequency Immune system disorders Hypersensitivity reactions including rash and pruritus Uncommon Metabolism and nutrition disorders Hyperglycaemia1 Uncommon Psychiatric disorders Anxiety Common Agitation Restlessness Insomnia Uncommon Nervous system disorders Headache1 Dizziness Common Tremor1 Uncommon Cardiac disorders Tachycardia Palpitations Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles) Uncommon Gastrointestinal disorders Dry mouth2, Nausea Common Musculoskeletal and connective tissue disorders Muscle spasms1 Common Renal and urinary Urinary tract infection Common 7 disorders Urinary retention2 Uncommon General disorders and administration site conditions Chest pain Common 1 Adverse reaction relates to formoterol 2 Adverse reaction relates to glycopyrronium Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

e. as a rescue therapy. Asthma Bevespi Aerosphere should not be used to treat asthma. Paradoxical bronchospasm As with other inhalation therapy, administration of this medicinal product may result in paradoxical bronchospasm, which can be life-threatening.

If paradoxical bronchospasm does occur, treatment with the medicinal product should be stopped and other treatments considered. g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium or formoterol.

Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Bevespi Aerosphere should be used with caution in patients with severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

5). Hypokalaemia β2-adrenergic agonists may produce significant hypokalaemia, which may increase the susceptibility to cardiac arrhythmias. The decrease in serum potassium is usually transient, not requiring supplementation. 5). Hyperglycaemia Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose.

8). 2). 2). These patients should be monitored for potential adverse reactions.

1.