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Riarify (Previously CHF is a brand name for Beclomethasone (also known as Beclometasone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects…
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. Special populations Elderly No dosage 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 Riarify 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 60 and 120 actuation pressurised containers, 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).
Other brands of Beclomethasone in European Union.
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Before priming the 60, 120 or 180 actuation pressurised containers, the counter/indicator should read 61, 121 or 180, respectively. After priming, the counter/indicator should read 60, 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.
4. At the same time, the patient should breathe in slowly and deeply through the mouth until the lungs are full of air (this should take approximately 4 – 5 seconds). Immediately after starting to breathe in, the patient should firmly press down on the top of the pressurised container to release one puff.
5. The patient should then hold the breath for as long as comfortably possible, then remove the inhaler from the mouth and breathe out slowly. The patient should not breathe out into the inhaler. Medicinal product no longer authorised 4 6.
The patient should then check the dose counter or dose indicator to ensure it has moved accordingly. To inhale the second puff, the patient should keep the inhaler in a vertical position for approximately 30 seconds and repeat steps 2 to 6.
If mist appears after the inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2. After use, the patient should close the inhaler with the protective mouthpiece cap and check the dose counter or dose indicator.
4). When to get a new inhaler The patient should be advised to get a new inhaler when the dose counter or indicator shows the number 20. He/she should stop using the inhaler when the counter or indicator shows 0 as any puffs left in the device may not be enough to release a full actuation.
Additional instructions for specific groups of patients For patients with weak hands it may be easier to hold the inhaler with both hands. Therefore, the index fingers should be placed on the top of the pressurised container and both thumbs on the base of the inhaler.
Patients who find it difficult to synchronise aerosol actuation with inspiration of breath may use the AeroChamber Plus spacer device, properly cleaned as described in the relevant leaflet. They should be advised by their doctor or pharmacist about the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled active substance to the lungs.
This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation. 2). Cleaning For the regular cleaning of the inhaler, patients should remove weekly the cap […]
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).
Medicinal product no longer authorised 9 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.
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 Medicinal product no longer authorised 10 MedDRA system organ class Adverse reaction Frequency 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 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 Riarify 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.
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.
Medicinal product no longer authorised 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, Riarify 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.
Patients diagnosed with the described cardiovascular conditions were excluded from clinical studies with Riarify. If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Riarify is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
Caution is also required when treating patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia. Pneumonia in patients with COPD An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. The daily dose of Riarify corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include:
Cushing's syndrome, Cushingoid features, adrenal suppression, growth Medicinal product no longer authorised 6 retardation, decrease in bone mineral density and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Therefore, it is important that the patient is reviewed regularly. Riarify should be administered with caution in patients with active or quiescent pulmonary tuberculosis and in patients with fungal and viral infections in the airways.
Hypokalaemia Potentially serious hypokalaemia may result from beta2-agonist therapy. This has the potential to produce adverse cardiovascular effects. Particular caution is advised in severe disease as this effect may be potentiated by hypoxia.
5). Caution is also recommended when a number of reliever bronchodilators are used. It is recommended that serum potassium levels are monitored in such situations. Hyperglycaemia The inhalation of formoterol may cause a rise in blood glucose levels.
Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes. Anticholinergic effect Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or urinary retention.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Riarify and to contact their doctor immediately should any of these signs or symptoms develop. 5). Patients with severe renal impairment In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if […]
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.