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Strattera Summary of Product Characteristics (SmPC)
There is limited clinical trial experience with atomoxetine overdose.
postmarketing, there have been reports of non-fatal acute and chronic
overdoses of atomoxetine alone. The most commonly reported symptoms
accompanying acute and chronic overdoses were gastrointestinal
symptoms, somnolence, dizziness, tremor and abnormal behaviour.
Hyperactivity and agitation have also been reported. Signs and
symptoms consistent with mild to moderate sympathetic nervous system
activation (e.g., tachycardia, blood pressure increased, mydriasis,
dry mouth) were also observed and reports of pruritus and rash have
been received. Most events were mild to moderate. In some cases of
overdose involving atomoxetine, seizures have been reported and very
rarely QT prolongation. There have also been reports of fatal, acute
overdoses involving a mixed ingestion of atomoxetine and at least one
is limited clinical trial experience with atomoxetine overdose.
airway should be established. Activated charcoal may be useful in
limiting absorption if the patient presents within 1 hour of
ingestion. Monitoring of cardiac and vital signs is recommended,
along with appropriate symptomatic and supportive measures. The
patient should be observed for a minimum of 6 hours. Because
atomoxetine is highly protein-bound, dialysis is not likely to be
useful in the treatment of overdose.
Summary of Product Characteristics
Date of Last Review:November 02, 2018
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