Trimbow 87/5/9 Pressurised Metered Dose Inhaler (pMDI) & Trimbow 88/5/9 NEXThaler
Please refer to the Summary of Product Characteristics (SPC) before prescribing. Presentation: Each Trimbow 87/5/9 pMDI delivered dose contains 87micrograms (mcg) of beclometasone dipropionate (BDP), 5mcg of formoterol fumarate dihydrate (formoterol) and 9mcg of glycopyrronium. Each Trimbow 88/5/9 NEXThaler delivered dose contains 88 micrograms of BDP, 5 micrograms of formoterol and 9 micrograms of glycopyrronium These are both the equivalent to a metered dose of 100mcg BDP, 6mcg formoterol and 10mcg glycopyrronium. Indication: COPD: 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 on symptoms control and prevention of exacerbations see section 5.1 of the SPC). Asthma (Trimbow 87/5/9 pMDI only): Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. Dosage and administration: For inhalation in adult patients (≥18 years). COPD & Asthma: 2 inhalations twice daily. Maximum dose 2 inhalations twice daily. Trimbow pMDI can be used with the AeroChamber Plus® spacer device. Patients should be advised to take Trimbow every day even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief. When choosing the starting dose strength of Trimbow in asthma patients, the patients’ disease severity, their previous asthma therapy including the inhaled corticosteroid (ICS) dose as well as the patients’ current control of asthma symptoms and risk of future exacerbation should be considered. The aerosol particles of Trimbow are characterised by an extrafine particle size distribution. For BDP this results in a more potent effect than formulations of BDP with a non-extrafine particle size distribution (100mcg of BDP extrafine in Trimbow are equivalent to 250mcg of BDP in a non-extrafine formulation). Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Not for acute use in treatment of acute episodes of bronchospasm or to treat an acute disease exacerbation. Discontinue immediately if hypersensitivity or paradoxical bronchospasm occur. Deterioration of disease: Trimbow should not be stopped abruptly. Cardiovascular effects: Due to the presence of a long-acting beta2-agonist and a long-acting muscarinic antagonist, use with caution in patients with cardiac arrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, occlusive vascular diseases, arterial hypertension and aneurysm. Caution should also be used 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. Limited data in asthmatic patients with cardiovascular co-morbidities or risk-factors suggest that these patients are also at higher risk of adverse reactions like local fungal infections or dysphonia. Trimbow should not be administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias. Caution in patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia. Increase in pneumonia and pneumonia hospitalisation in COPD patients receiving ICS observed. Clinical features of pneumonia may overlap with symptoms of COPD exacerbations. Systemic effects of ICS may occur, particularly at high doses for long periods, but are less likely than with oral steroids. The daily dose of both Trimbow 87/5/9 & 88/5/9 correspond to a medium dose of ICS. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression and aggression. Patients on Trimbow should be reviewed regularly and the dose of ICS is reduced to the lowest dose at which effective control of asthma is maintained. Use with caution in patients with pulmonary tuberculosis or fungal/viral airway infections. Potentially serious hypokalaemia may result from beta2-agonist therapy (particular caution with severe disease). Formoterol may cause a rise in blood glucose levels. Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or urinary retention. Use in patients with severe hepatic or renal impairment should only be considered if benefit outweighs the risk. Consider referral of patients reporting blurred vision or visual disturbances to an ophthalmologist as causes may include cataract,
Fostair 100/6 and 200/6
Please refer to the full Summary of Product Characteristics (SPC) before prescribing.
Presentation: Each Fostair pressurised metered dose inhaler (pMDI) 100/6 dose contains 100 micrograms (mcg) of beclometasone dipropionate (BDP) and 6mcg of formoterol fumarate dihydrate (formoterol). Each Fostair pMDI 200/6 dose contains 200mcg of BDP and 6mcg of formoterol. Each Fostair NEXThaler 100/6 dry powder inhaler (DPI) dose contains 100mcg of BDP anhydrous and 6mcg of formoterol. Each Fostair NEXThaler 200/6 DPI dose contains 200mcg of BDP anhydrous and 6mcg of formoterol. Indications: Asthma: Regular treatment of asthma where use of an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination is appropriate: patients not adequately controlled on ICS and as needed short-acting beta2-agonist, or patients already adequately controlled on both ICS and LABA. COPD (Fostair 100/6 only): Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. Dosage and administration: For inhalation in adult patients (≥18 years). Asthma: Maintenance And Reliever Therapy (Fostair 100/6 only) can be taken as a regular maintenance treatment and as needed in response to asthma symptoms: 1 inhalation twice daily plus 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation is recommended. The maximum daily dose is 8 inhalations. Fostair 100/6 may also be used as maintenance therapy (with a separate short-acting bronchodilator as needed). Fostair 200/6 should be used as maintenance therapy only. Maintenance therapy: Fostair 100/6: 1–2 inhalations twice daily. Fostair 200/6: 2 inhalations twice daily. The maximum daily dose is 4 inhalations. Patients should receive the lowest dose that effectively controls their symptoms. COPD (Fostair 100/6 only): 2 inhalations twice daily. Fostair pMDI can be used with the AeroChamber Plus® spacer device. BDP in Fostair is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of BDP with a non-extrafine particle size distribution (100mcg of BDP extrafine in Fostair are equivalent to 250mcg of BDP in a non-extrafine formulation). When switching patients from previous treatments, it should be considered that the recommended total daily dose of BDP for Fostair is lower than that for non-extrafine BDP containing products and should be adjusted to the needs of the individual patient. However, patients who are transferred between Fostair NEXThaler and Fostair pMDI do not need dose adjustment. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Use with caution in patients with cardiac arrhythmias, aortic stenosis, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, severe heart failure, congestive heart failure, occlusive vascular diseases, arterial hypertension, severe arterial hypertension, aneurysm, thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia. Caution should also be used when treating patients with known or suspected prolongation of the QTc interval (QTc > 0.44 seconds). Formoterol itself may induce QTc prolongation. Potentially serious hypokalaemia may result from beta2-agonist therapy and may also be potentiated by concomitant treatments (e.g. xanthine derivatives, steroids and diuretics). Formoterol may cause a rise in blood glucose levels. Fostair should not be administered for at least 12 hours before the start of anaesthesia, if halogenated anaesthetics are planned as there is risk of arrhythmias. Use with caution in patients with pulmonary tuberculosis or fungal/viral airway infections. Increase in pneumonia and pneumonia hospitalisation in COPD patients receiving ICS. Clinical features of pneumonia may overlap with symptoms of COPD exacerbations. Fostair treatment should not be stopped abruptly. Medical attention should be sought if treatment ineffective. Treatment should not be initiated during exacerbations or acutely deteriorating asthma. Fostair treatment should be discontinued immediately if the patient experiences a paradoxical bronchospasm. Fostair is not intended for initial
Clenil Modulite 50, 100, 200, 250
Please refer to Summary of Product Characteristics (SPC) before prescribing.
Presentation: Each Clenil Modulite pressurised metered dose inhaler (pMDI) 50 dose contains 50 micrograms (mcg) of beclometasone dipropionate (BDP). Each Clenil Modulite pMDI 100 dose contains 100 mcg of BDP. Each Clenil Modulite pMDI 200 dose contains 200 mcg of BDP. Each Clenil Modulite 250 dose contains 250 mcg of BDP. Indications: Prophylactic management of mild, moderate, or severe asthma in adults or children. Dosage and administration: For inhalation use only. A Volumatic™ spacer device may be used by patients who have difficulty synchronising actuation with inspiration and must always be used when Clenil Modulite administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 mcg or greater and when administered to children and adolescents 15 years of age and under, whatever dose prescribed. Starting dose of inhaled BDP should be adjusted to severity of disease. Dose may then be adjusted until control achieved and then should be titrated to lowest dose at which effective control of asthma maintained. Total daily dosage should be administered as two to four divided doses. Adults: Clenil Modulite 50, 100 & 200: Usual starting dose is 200 mcg twice daily. In severe cases this may be increased to 600 to 800 mcg daily. Clenil Modulite 250: Usually 1000 mcg daily, which may be increased to 2000 mcg daily. Clenil Modulite 200 & 250 presentations not recommended for children. Children: Clenil Modulite 50 & 100: Usual starting dose 100 mcg twice daily. Depending on severity of asthma, daily dose may be increased up to 400 mcg. Contraindications: Hypersensitivity to active substances or to any excipients (HFA-134a, ethanol, glycerol). Warnings and Precautions: Active or quiescent pulmonary tuberculosis. Patients should have relief medication available for acute asthma symptoms. Severe asthma requires regular medical assessment as risk of severe attacks and even death. Patients must seek medical attention and have their condition assessed, should they find that they are using their relief medication more often than normal or if it appears less effective. Do not stop Clenil Modulite treatment abruptly. Systemic effects may occur particularly with high doses for prolonged periods. These include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density and more rarely psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Monitor growth of children on prolonged
Atimos Modulite 12mcg pressurised inhalation solution
Please refer to the full Summary of Product Characteristics (SPC) before prescribing.
Presentation: Each Atimos Modulite dose contains 12 micrograms of formoterol fumarate dihydrate. Indications: Asthma: Long-term symptomatic treatment of persistent, moderate to severe asthma in patients requiring regular bronchodilator therapy in combination with long-term anti-inflammatory therapy (inhaled and/or oral glucocorticoids). Glucocorticoid therapy should be continued on a regular basis. COPD: Relief of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease. Dosage and administration: Asthma: Adults, including the elderly, and adolescents aged 12 years and above: usually, one actuation twice daily (morning and evening). In severe cases, a maximum of two actuations twice daily can be used. Atimos is not intended to relieve acute asthma attacks. In the event of an acute attack, a short-acting beta2-agonist should be used. Atimos should not be used in children under 12 years. COPD: Adults aged 18 years and over: the usual dose is one actuation twice daily (morning and evening). If required, up to two additional inhalations may be used for relief of symptoms, up to a maximum total daily dose of 4 inhalations (48 micrograms/day). No more than 2 inhalations should be taken on any single occasion. Contraindications: Hypersensitivity to any of the components. Warnings and Precautions: Atimos should not be used (and is not sufficient) as the first treatment for asthma. Asthmatic patients, who require therapy with long-acting beta2-agonists, should also receive optimal maintenance anti-inflammatory therapy with corticosteroids. Patients must be advised to continue taking their anti-inflammatory therapy after the introduction of formoterol even when symptoms decrease. Should symptoms persist, or treatment with beta2-agonists needs to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the maintenance therapy. Patients should not be initiated on Atimos during an acute severe asthma exacerbation or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Atimos. Patients should continue treatment but should seek medical advice if asthma remains uncontrolled or worsens after initiation of Atimos. The lowest effective dose of Atimos should be used. The maximum daily dose should not be exceeded. Caution in third degree atrioventricular block, refractory diabetes mellitus, thyrotoxicosis, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure and occlusive vascular diseases, especially arteriosclerosis. Formoterol may induce prolongation of the QTc-interval. Caution should be observed when treating patients with prolongation of the QTc-interval e.g. congenital or drug-induced (QTc > 0.44 seconds) and in patients treated with drugs affecting the QTc-interval. Additional blood glucose monitoring is recommended initially in diabetic patients. Atimos should not be administered for at least 12 hours before the start of anaesthesia, if anaesthesia with halogenated anaesthetics is planned. Discontinue treatment immediately and start alternative therapy if patient experiences paradoxical bronchospasm. Potentially serious hypokalaemia may result from beta2-agonist therapy. The hypokalaemic effect may be