Trydonis

Posology The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. Special populations Elderly No dose adjustment is required in elderly patients (65 years of age and older). 73 m2) renal impairment.

2). 2). Paediatric population There is no relevant use of Trydonis in the paediatric population (under 18 years of age) for the indication of COPD. Method of administration For inhalation 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 (see “Instructions for use” below).

The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet. This medicinal product is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.

For the 120 actuation pressurised container, each time the patient presses the container a puff of the solution is released and the counter counts down by one. For the 180 actuation pressurised container, each time the patient presses the pressurised container a puff of the solution is released and the indicator rotates by a small amount; the number of puffs remaining is displayed in intervals of 20.

The patient should be advised not to drop the inhaler as this may cause the counter to count down. Instructions for use Priming the inhaler Before using the inhaler for the first time, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming).

Before priming the 120 or 180 actuation pressurised containers, the counter/indicator should read 121 or 180, respectively. After priming, the counter/indicator should read 120 or 180. Use of the inhaler The patient should stand or sit in an upright position when inhaling from the inhaler.

The steps below should be followed. IMPORTANT: steps 2 to 5 should not be performed too quickly: 1. The patient should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.

2. The patient should breathe out slowly and as deeply as comfortable, in order to empty the lungs. 3. The patient should hold the inhaler vertically with its body upwards and place the mouthpiece between the teeth without biting. The lips should then be placed around the mouthpiece, with the tongue flat under it.

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.

e. as a rescue therapy). Hypersensitivity Immediate hypersensitivity reactions have been reported after administration. 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.

5 Paradoxical bronchospasm Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator (reliever). Treatment should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Deterioration of disease It is recommended that treatment 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 or progressive deterioration in symptoms is potentially life-threatening and the patient should undergo urgent medical assessment. Cardiovascular effects Due to the presence of a long-acting beta2-agonist and a long-acting muscarinic antagonist, Trydonis should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heartbeat, including atrial fibrillation), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.

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.

1.