Spiolto Respimat Reusable Special Precautions

General Warnings: SPIOLTO RESPIMAT Reusable should not be used more frequently than once daily.
Asthma: SPIOLTO RESPIMAT Reusable should not be used in asthma. The efficacy and safety of SPIOLTO RESPIMAT Reusable in asthma have not been studied.
Acute bronchospasm: SPIOLTO RESPIMAT Reusable 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 Reusable.
Paradoxical bronchospasm: As with other inhaled medicines SPIOLTO RESPIMAT Reusable may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs SPIOLTO RESPIMAT Reusable 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 Reusable should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder- neck obstruction.
Patients with renal impairment: Because tiotropium is a predominantly renally excreted drug, SPIOLTO RESPIMAT Reusable 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 Reusable. 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 Reusable 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.
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. SPIOLTO RESPIMAT Reusable should not be used in conjunction with any other medication 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.
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 Reusable. 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.