General Warnings: SPIOLTO RESPIMAT should not be used more frequently than once daily. SPIOLTO RESPIMAT should not be used in asthma. The efficacy and safety of SPIOLTO RESPIMAT in asthma have not been studied.
Acute bronchospasm: SPIOLTO RESPIMAT is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
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.
Patients with renal impairment: As plasma concentration of tiotropium increases with decreased renal function in patients with moderate to severe renal impairment (creatinine clearance ≤50 ml/min) Spiolto Respimat should be used only if the expected benefit outweighs the potential risk. There is no long term experience in patients with severe renal impairment (see Pharmacology: Pharmacokinetics under Actions).
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.
Cardiovascular 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.
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.
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 (please refer to Interactions), which may increase the susceptibility to cardiac arrhythmias.
Hyperglycaemia: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
Anaesthesia: Caution needs to be taken in case of a planned operation with halogenated hydrocarbon anaesthetics due to an increased susceptibility to the adverse cardiac effects of beta agonist bronchodilators.
Spiolto Respimat should not be used in conjunction with any other medications containing long-acting beta2-adrenergic agonists.
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.
Effects on ability to drive and use 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.