Undesirable effects reported in clinical studies or from post-marketing experience are listed as follows by system organ class and frequency. For clinical trials, the frequency is defined as follows: Very common (>10%); common (>1-10%); uncommon (>0.1-1%); rare (0.01-0.1%); very rare (<0.01%), including isolated reports. Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.
General Disorders and Administration Site Conditions: Very Common: Asthenia.
Nervous System Disorders: Very Common: Somnolence. Common: Amnesia, ataxia, convulsion, dizziness, headache, tremor.
Psychiatric Disorders: Common: Depression, emotional lability, hostility, insomnia, nervousness. Post-Marketing Experience: Abnormal behaviour, aggression, anger, anxiety, confusion, hallucination, irritability, psychotic disorder.
Gastrointestinal Disorders: Common: Diarrhoea, dyspepsia, nausea.
Metabolism and Nutrition Disorders: Common: Anorexia.
Ear and Labyrinth Disorders: Common: Vertigo.
Eye Disorders: Common: Diplopia.
Injury, Poisoning and Procedural Complications: Common: Accidental injury.
Skin and Subcutaneous Tissue Disorders: Common: Rash.
Blood and Lymphatic System Disorders: Post-Marketing Experience: Leukopenia, neutropenia, pancytopenia, thrombocytopenia.
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