5%), which is a typical anticholinergic effect. In asthmatic patients, adverse reactions tend to cluster during the first 3 months following initiation of therapy and become less frequent with longer-term use (after 6 months of treatment).
Tabulated summary of adverse reactions Adverse reactions associated to beclometasone dipropionate/formoterol/glycopyrronium occurred during clinical studies and post-marketing experience as well as adverse reactions listed for the marketed individual components are provided below, listed by system organ class and frequency.
9 Frequencies are defined as: 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). 4) Frequency not known Glaucoma1, cataract1 Very rare Ear and labyrinth disorders Otosalpingitis1 Uncommon Cardiac disorders Atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia1, palpitations Uncommon Angina pectoris (stable1 and unstable), extrasystoles (ventricular1 and supraventricular), nodal rhythm, sinus bradycardia Rare Vascular disorders Hyperaemia1, flushing1, hypertension Uncommon Extravasation blood Rare Respiratory, thoracic and mediastinal disorders Dysphonia Common Asthmatic crisis1, cough, productive cough1, throat irritation, epistaxis1, pharyngeal erythema Uncommon Bronchospasm paradoxical1, exacerbation of asthma, oropharyngeal pain, pharyngeal inflammation, dry throat Rare Dyspnoea1 Very rare Gastrointestinal disorders Diarrhoea1, dry mouth, dysphagia1, nausea, dyspepsia1, burning sensation of the lips1, dental caries1, (aphthous) stomatitis Uncommon Skin and subcutaneous tissue disorders Rash1, urticaria, pruritus, hyperhidrosis1 Uncommon Angioedema1 Rare Musculoskeletal and connective tissue disorders Muscle spasms, myalgia, pain in extremity1, musculoskeletal chest pain1 Uncommon Growth retardation1 Very rare 10 MedDRA system organ class Adverse reaction Frequency Renal and urinary disorders Dysuria, urinary retention, nephritis1 Rare General disorders and administration site conditions Fatigue1 Uncommon Asthenia Rare Oedema peripheral1 Very rare Investigations C-reactive protein increased1, platelet count increased1, free fatty acids increased1, blood insulin increased1, blood ketone body increased1, cortisol decreased1 Uncommon Blood pressure increased1, blood pressure decreased1 Rare Bone density decreased1 Very rare 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Trydonis Among the observed adverse reactions the following are typically associated with: Beclometasone dipropionate Pneumonia, oral fungal infections, lower respiratory tract infection fungal, dysphonia, throat irritation, hyperglycaemia, psychiatric disorders, cortisol decreased, blurred vision.
Formoterol Hypokalaemia, hyperglycaemia, tremor, palpitations, muscle spasms, electrocardiogram QT prolonged, blood pressure increased, blood pressure decreased, atrial fibrillation, tachycardia, tachyarrhythmia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm.
Glycopyrronium Glaucoma, atrial fibrillation, tachycardia, palpitations, dry mouth, dental caries, dysuria, urinary retention, urinary tract infection. 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.