Dizziness and Disturbance in Gait and Coordination   
Eslicarbazepine acetate causes dose-related increases in adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, ataxia, vertigo, balance disorder, gait disturbance, nystagmus, and abnormal coordination) [see Adverse Reactions ( 6.1)] . In controlled adult adjunctive epilepsy trials, these events were reported in 26% and 38% of patients randomized to receive eslicarbazepine acetate at doses of 800 mg and 1,200 mg/day, respectively, compared to 12% of placebo-treated patients. Events related to dizziness and disturbance in gait and coordination were more often serious in eslicarbazepine acetate-treated patients than in placebo-treated patients (2% vs. 0%), and more often led to study withdrawal in eslicarbazepine acetate-treated patients than in placebo-treated patients (9% vs. 0.7%). There was an increased risk of these adverse reactions during the titration period (compared to the maintenance period) and there also may be an increased risk of these adverse reactions in patients 60 years of age and older compared to younger adults. Nausea and vomiting also occurred with these events. Adverse reactions related to dizziness and disturbance in gait and coordination were also observed in adult monotherapy trials and pediatric trials.   
The incidence of dizziness was greater with the concomitant use of eslicarbazepine acetate and carbamazepine compared to the use of eslicarbazepine acetate without carbamazepine in adult and pediatric trials. Therefore, consider dosage modifications of both eslicarbazepine acetate and carbamazepine if these drugs are used concomitantly [see Dosage and Administration ( 2.3)] .   
Somnolence and Fatigue   
Eslicarbazepine acetate causes dose-dependent increases in somnolence and fatigue-related adverse reactions (fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy). In the controlled adult adjunctive epilepsy trials, these events were reported in 13% of placebo patients, 16% of patients randomized to receive 800 mg/day eslicarbazepine acetate, and 28% of patients randomized to receive 1,200 mg/day eslicarbazepine acetate. Somnolence and fatigue-related events were serious in 0.3% of eslicarbazepine acetate-treated patients (and 0 placebo patients) and led to discontinuation in 3% of eslicarbazepine acetate-treated patients (and 0.7% of placebo-treated patients). Somnolence and fatigue-related reactions were also observed in adult monotherapy trials and in pediatric trials.   
Cognitive Dysfunction   
Eslicarbazepine acetate causes dose-dependent increases in cognitive dysfunction-related events in adults (memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation). In the controlled adult adjunctive epilepsy trials, these events were reported in 1% of placebo patients, 4% of patients randomized to receive 800 mg/day eslicarbazepine acetate, and 7% of patients randomized to receive 1,200 mg/day eslicarbazepine acetate. Cognitive dysfunction-related events were serious in 0.2% of eslicarbazepine acetate-treated patients (and 0.2% of placebo patients) and led to discontinuation in 1% of eslicarbazepine acetate-treated patients (and 0.5% of placebo-treated patients). Cognitive dysfunction events were also observed in adult monotherapy trials.   
Visual Changes   
Eslicarbazepine acetate causes dose-dependent increases in events related to visual changes including diplopia, blurred vision, and impaired vision. In the controlled adult adjunctive epilepsy trials, these events were reported in 16% of patients randomized to receive eslicarbazepine acetate compared to 6% of placebo patients. Eye events were serious in 0.7% of eslicarbazepine acetate-treated patients (and 0 placebo patients) and led to discontinuation in 4% of eslicarbazepine acetate-treated patients (and 0.2% of placebo-treated patients). There was an increased risk of these adverse reactions during the titration period (compared to the maintenance period) and also in patients 60 years of age and older (compared to younger adults). The incidence of diplopia was greater with the concomitant use of eslicarbazepine acetate and carbamazepine compared to the use of eslicarbazepine acetate without carbamazepine (up to 16% vs. 6%, respectively) [see Dosage and Administration ( 2.3)] . Similar adverse reactions related to visual changes were also observed in adult monotherapy trials and in pediatric trials.   
Hazardous Activities   
Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of eslicarbazepine acetate is known.