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SPIOLTO RESPIMAT should not be used more frequently than once daily.
Asthma: SPIOLTO RESPIMAT should not be used in asthma. The efficacy and safety of SPIOLTO RESPIMAT in asthma have not been studied in this indication.
The long-term efficacy and safety of olodaterol in the treatment of asthma have not been studied. LABAs may increase the risk of asthma-related hospitalisations and death. Data from a large placebo-controlled study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABAs, including olodaterol, one of the active ingredients in SPIOLTO RESPIMAT.
Acute bronchospasm: SPIOLTO RESPIMAT is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Deterioration of disease and acute episodes: SPIOLTO RESPIMAT should not be initiated in patients with acutely deteriorating COPD. In this case, the patient's COPD management plan should direct the patient to seek medical advice immediately, and a re-evaluation of the patient and the COPD treatment regimen should be undertaken. Increasing the daily dosage of SPIOLTO RESPIMAT beyond the recommended dose is not appropriate.
Hypersensitivity: As with all medications, immediate hypersensitivity reactions may occur after administration of SPIOLTO RESPIMAT.
Paradoxical bronchospasm: As with other inhaled medicines SPIOLTO RESPIMAT may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs SPIOLTO RESPIMAT should be discontinued immediately and alternative therapy substituted.
Narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction: Consistent with the anticholinergic activity of tiotropium, SPIOLTO RESPIMAT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. In a meta-analysis of placebo-controlled trials, tiotropium was associated with a non-significant increase in the risk of urinary retention, and a significant increase in the risk of micturition difficulties.
Patients with renal impairment: Because tiotropium is a predominantly renally excreted drug, SPIOLTO RESPIMAT use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of <50 ml/min) (see Dosage & Administration).
Eye symptoms: Patients must be instructed in the correct administration of SPIOLTO RESPIMAT. Care must be taken not to allow the solution or mist to enter into the eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop specialist advice should be sought immediately.
Miotic eye drops are not considered to be effective treatment.
Systemic effects: SPIOLTO RESPIMAT contains a long acting beta2-adrenergic agonist. Long acting beta2-adrenergic agonists should be administered with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy and hypertension; in patients with convulsive disorders or thyrotoxicosis, in patients with known or suspected prolongation of the QT interval; and in patients who are unusually responsive to sympathomimetic amines.
Cardiovascular effects: Like other beta2-adrenergic agonists, olodaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur, treatment may need to be discontinued. In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave and ST segment depression, although the clinical significance of these observations is unknown.
Patients with a history of myocardial infarction during the previous year, unstable or life-threatening cardiac arrhythmia, hospitalised for heart failure during the previous year or with a diagnosis of paroxysmal tachycardia (>100 beats per minute) were excluded from the clinical trials. Therefore the experience in these patient groups is limited. SPIOLTO RESPIMAT should be used with caution in these patient groups.
Hypokalaemia: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see Interactions), which may increase the susceptibility to cardiac arrhythmias.
Hyperglycaemia: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
Others: SPIOLTO RESPIMAT should not be used in conjunction with any other medication containing LABAs or LAMAs (see Interactions). Patients who have been taking inhaled, short acting beta2-adrenergic agonists on a regular basis (e.g. four times a day) should be instructed to use them only for symptomatic relief of acute respiratory symptoms.
Benzalkonium chloride: This medicine contains 0.0011 mg benzalkonium chloride in each actuation.
Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if the patient has asthma. Patients with asthma are at an increased risk for these adverse events.
Driving and Using Machines: No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that dizziness and blurred vision have been reported with the use of SPIOLTO RESPIMAT. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience such symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
