urred vision were reported in controlled clinical studies, particularly during titration (see section 4.8). It is recommended that patients are advised about the risk of such adverse reactions at treatment initiation and following each titration step, and that they are advised not to drive or operate machinery until they have established how Trobalt affects them.
As there is individual variation in response to all antiepileptic drug therapy, it is recommended that prescribers discuss with patients the specific issues of epilepsy and driving.
4.8 Undesirable effects
In pooled safety data from three multicentre, randomised, double-blind, placebo-controlled studies, adverse reactions were generally mild to moderate in intensity, and were most commonly reported in the first 8 weeks of treatment. There was an apparent dose-relationship for dizziness, somnolence, confusional state, aphasia, coordination abnormal, tremor, balance disorder, memory impairment, gait disturbance, blurred vision and constipation.
Adverse reactions that were most frequently reported to lead to discontinuation were dizziness, somnolence, fatigue and confusional state.
The following convention has been used for the classification of adverse reactions:
Very common:
1/10
Common:
1/100 to <1/10
Uncommon:
1/1,000 to <1/100
Rare:
1/10,000 to <1/1,000
Very rare:
<1/10,000.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Class
Very common
Common
Uncommon
Metabolism and nutrition disorders
Weight increased
Increased appetite
Psychiatric disorders
Confusional state
Psychotic disorders
Hallucinations
Disorientation
Anxiety
Nervous system disorders
Dizziness
Somnolence1
Amnesia1
Aphasia
Coordination abnormal1
Vertigo1
Paraesthesia
Tremor1
Balance disorder1
Memory impairment1
Dysphasia
Dysarthria
Disturbance in attention
Gait disturbance1
Myoclonus
Hypokinesia
Eye disorders
Diplopia
Blurred vision
Gastrointestinal disorders
Nausea
Constipation
Dyspepsia
Dry mouth
Dysphagia
Hepatobiliary disorders
Increased liver function tests
Skin and subcutaneous disorders
Skin rash
Hyperhidrosis
Renal and urinary disorders
Dysuria
Urinary hesitation
Haematuria
Chromaturia
Urinary retention
Nephrolithiasis
General disorders and administrative site conditions
Fatigue
Asthenia
Malaise
Peripheral oedema
1 Data from elderly patients indicates that they may be more likely to experience certain central nervous system events.
Description of selected adverse reactions
Adverse reactions related to voiding dysfunction, including urinary retention, were reported in 5% of retigabine-treated patients in the pooled safety dataset (see section 4.4). The majority of even
