Trixeo Aerosphere

Posology The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening). 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 This medicinal product can be used at the recommended dose in patients with mild to moderate renal impairment. 2). 3 Hepatic impairment This medicinal product can be used at the recommended dose in patients with mild to moderate hepatic impairment.

2). Paediatric population There is no relevant use of this medicinal product in children and adolescents (under 18 years of age) for the indication of COPD. Method of administration For inhalation use. Instructions for use To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique.

The patient should be advised to read the package leaflet carefully and follow the instructions for use as given in the leaflet. It is important to instruct the patients to: • Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.

For best results the inhaler should be at room temperature before use. • Prime the inhaler by shaking it well 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, after weekly washing or if it has been dropped.

• Rinse their mouth out with water after inhaling the dose to minimise the risk of oropharyngeal thrush. Do not swallow. On actuation of Trixeo Aerosphere, a volume of the suspension is expelled from the pressurised container. 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.

Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product. 2).

Summary of the safety profile The safety profile is characterised by corticosteroid, anticholinergic and β2-adrenergic class effects related to the individual components of the combination. 7%). Tabulated list of adverse reactions The tabulated list of adverse reactions is based on the experience with this medicinal product in clinical trials and experience with the individual components.

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).

g. 4) Not known Cardiac disorders Palpitations Common Angina pectoris Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles) Tachycardia Uncommon Respiratory, thoracic and mediastinal disorders Dysphonia Cough Common Bronchospasm Throat irritation Uncommon Gastrointestinal disorders Nausea Common Dry mouth Uncommon Skin and subcutaneous tissue disorders Bruising Uncommon Musculoskeletal and connective tissue disorders Muscle spasms Common Renal and urinary disorders Urinary retention Uncommon 9 System Organ Class Preferred term Frequency General disorders and administration site conditions Chest pain Uncommon Description of selected adverse reactions Pneumonia KRONOS was a 24-week study in a total of 1,896 patients with moderate to very severe COPD (mean post-bronchodilator screening FEV1 50% of predicted, standard deviation [SD] 14%), 26% of whom had experienced a COPD exacerbation in the year prior to study entry.

3% (4 patients) for open-labelled formoterol fumarate dihydrate/budesonide Turbuhaler (FOR/BUD) TBH 6/200 micrograms (n=318). ETHOS was a 52-week study in a total of 8,529 patients (in the safety population) with moderate to very severe COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 43% of predicted, SD 10%).

e. as a rescue therapy. Paradoxical bronchospasm Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.

Treatment with this medicinal product should be discontinued immediately if paradoxical bronchospasm occurs. The patient should be assessed, and alternative therapy instituted if necessary. 4 Deterioration of disease It is recommended that treatment with this medicinal product should not be stopped abruptly.

If patients find the treatment ineffective, they should continue treatment, but medical attention must be sought. Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy.

Sudden and progressive deterioration in the symptoms of COPD is potentially life-threatening and the patient should undergo urgent medical assessment. g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol.

This medicinal product should be used with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias, and severe heart failure.

Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc >450 milliseconds for males, or >470 milliseconds for females), either congenital or induced by medicinal products.

Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.

1.