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General Warnings: SPIOLTO RESPIMAT re-usable should not be used more frequently than once daily.
Asthma: SPIOLTO RESPIMAT re-usable should not be used in asthma. The efficacy and safety of SPIOLTO RESPIMAT re-usable in asthma have not been studied.
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.
Acute bronchospasm: SPIOLTO RESPIMAT re-usable 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 re-usable.
Paradoxical bronchospasm: As with other inhaled medicines SPIOLTO RESPIMAT re-usable may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs SPIOLTO RESPIMAT re-usable 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 re-usable 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 bromide increases with decreased renal function in patients with moderate to severe renal impairment (creatinine clearance ≤50 ml/min), SPIOLTO RESPIMAT re-usable 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 should be cautioned to avoid getting the spray into their eyes. They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema. Should any combination of these eye symptoms develop, patients should stop using SPIOLTO RESPIMAT re-usable and consult a specialist immediately.
Dental caries: Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with dental caries.
Systemic effects: SPIOLTO RESPIMAT re-usable 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, hospitalized 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 re-usable 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, hypokalemia 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.
SPIOLTO RESPIMAT re-usable should not be used in conjunction with any other medication containing long-acting beta2-adrenergic agonists or long-acting muscarinic antagonists. 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. Patients with asthma are at an increased risk for these adverse events.
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 re-usable. 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.
