Beclometasone / Formoterol

VERBATIM §4.2 — A. Maintenance therapy: 'Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times. Dose recommendations for adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations.' B. Maintenance and reliever therapy: 'Patients take their daily maintenance dose of this medicinal product and in addition take this medicinal product as needed in response to asthma symptoms… The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations.' COPD: 'Dose recommendations for adults 18 years and above: Two inhalations twice daily.' || NOT FOR INITIAL MANAGEMENT — §4.2: 'This medicinal product is not intended for the initial management of asthma.' §4.4: 'Patients should not be initiated on beclometasone dipropionate/formoterol during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.' || EXTRAFINE POTENCY — §4.2 verbatim: 'Beclometasone dipropionate in this medicinal product is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of beclometasone dipropionate with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in this medicinal product are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation). Therefore, the total daily dose of beclometasone dipropionate administered in this medicinal product should be lower than the total daily dose of beclometasone dipropionate administered in a non-extrafine beclometasone dipropionate formulation.' || SELECTION OF REGIMEN — §4.2: maintenance and reliever therapy 'should especially be considered for patients with: not fully controlled asthma and in need of reliever medication; asthma exacerbations in the past requiring medical intervention'. 'Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of this medicinal product as-needed inhalations.' 'Patients requiring frequent use of rescue inhalations daily should be strongly recommended to seek medical advice.' || TITRATION — §4.2: 'The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.' If an individual patient needs a combination of doses other than those available in the combination inhaler, appropriate doses of beta-2-agonists and/or corticosteroids by individual inhalers should be prescribed. || PAEDIATRIC — §4.2 verbatim: 'Dose recommendations for children and adolescents under 18 years: The safety and efficacy of beclometasone dipropionate/formoterol in children and adolescents under 18 years of age have not been established. Data available with beclometasone dipropionate/formoterol in children between 5 and 11 years of age and adolescents between 12 and 17 years of age are described in section 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.' paedDose is therefore null. || ELDERLY — §4.2: 'There is no need to adjust the dose in elderly patients.' || ADMINISTRATION — before first use, or if the inhaler has not been used for 14 days or more, release one actuation into the air; after that first test the counter should read 120 (120-dose presentation). Get a new inhaler when the counter shows 20 and stop using it at 0. 'Patients should rinse their mouth or gargle with water or brush the teeth after inhaling.' 'To inhale a further puff, patients should keep the inhaler in a vertical position for about half a minute and repeat steps 2 to 5.' || ANAESTHESIA — §4.4: 'If anaesthesia with halogenated anaesthetics is planned, it should be ensured that this medicinal product is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.' || DO NOT STOP ABRUPTLY — §4.4: 'It is recommended that treatment with this medicinal product should not be stopped abruptly.' 'Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.' || The 200/6 strength is not covered by this bundle. || TRUNCATION: §4.4 was cut mid-sentence at 'Serious asthma-related adverse events and exacerbations may occur […]' and §4.8 at 'C-reactive protein increased, platelet count increased, free […]'; §4.5 interactions and §4.9 overdose were not retrieved. Read those sections on the eMC before prescribing.