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There is limited information on overdosing with SPIOLTO RESPIMAT. SPIOLTO RESPIMAT has been studied up to 5 microgram/10 microgram (tiotropium/olodaterol) in COPD patients and up to 10 microgram/40 microgram (tiotropium/olodaterol) in healthy subjects; no clinically relevant effects were observed. An overdose could lead to exaggerated anti-muscarinic effects of tiotropium and/or exaggerated β2 agonists effects of olodaterol.
Symptoms: Overdose of anticholinergic tiotropium: High doses of tiotropium may lead to anticholinergic signs and symptoms.
However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide in healthy volunteers. Additionally, no relevant adverse events, beyond dry mouth/throat and dry nasal mucosa were observed following 14-day dosing of up to 40 microgram tiotropium inhalation solution in healthy volunteers with the exception of pronounced reduction in salivary flow from day 7 onwards.
Overdose of β2-agonist olodaterol: An overdose of olodaterol is likely to lead to exaggerated effects typical of beta2-adrenergic agonists, i.e. myocardial ischemia, hypertension or hypotension, tachycardia, arrhythmias, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia and metabolic acidosis.
Treatment of overdose: Treatment with SPIOLTO RESPIMAT should be discontinued. Supportive and symptomatic treatment is indicated. Serious cases should be hospitalized. Use of cardioselective beta-blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm.
