| Central nervous system In common with all neuroleptics, extrapyramidal symptoms may occur, e.g. tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia, oculogyric crisis and laryngeal dystonia.Anti-Parkinson agents should only be given as required; they should not be prescribed routinely as a preventive measure.As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or after drug discontinuation. The syndrome is mainly characterised by rhythmical involuntary movements of the tongue, face, mouth or jaw. The manifestations may be permanent in some patients. Anquil should be given in the minimal effective dose for the minimum possible time.The syndrome may be masked when the treatment is reinstituted, when the dosage is increased or when a switch is made to a different antipsychotic drug. Treatment should be discontinued as soon as possible.The potential seriousness and unpredictability of tardive dyskinesia and the fact that it has occasionally been reported to occur when neuroleptic antipsychotic drugs have been prescribed for relatively short periods in low dosage means that the prescribing of such agents requires especially careful assessment of risks versus benefit. Tardive dyskinesia can be precipitated or aggravated by anti-Parkinson drugs. Tardive dyskinesia may occur after abrupt drug withdrawal.It has been reported that fine vermicular movements of the tongue may be an early sign of tardive dyskinesia and that the full syndrome may not develop if the medication is stopped at that time. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all neuroleptic drugs should be considered.As with other neuroleptics, rare cases of neuroleptic malignant syndrome, an idiosyncratic response characterised by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness, coma and elevated CPK levels, have been reported. Signs of autonomic dysfunction such as tachycardia, labile arterial pressure and sweating may precede the onset of hyperthermia, acting as early warning signs. Antipsychotic treatment should be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.Anquil, even in low dosage in susceptible (especially non-psychotic) individuals, may cause unpleasant subjective feelings of being mentally dulled or slowed down, dizziness, headache, or paradoxical effects of excitement, agitation or insomnia.Depression and seizures have been reported rarely. A causal relationship with Anquil has not been unequivocally established.Confusional or agitated states have been reported rarely.Gastro-intestinal system Nausea, vomiting, loss of appetite, constipation and dyspepsia have been reported.Endocrinological system Hormonal effects of antipsychotic neuroleptic drugs include hyper-prolactinaemia, which may cause galactorrhoea, gynaecomastia and oligo- or amenorrhoea.Cardiovascular system Dose-related hypotension is uncommon but can occur, particularly in the elderly who are more susceptible to the sedative and hypotensive effects. Benign tachycardia has occasionally been reported.As with other neuroleptics QT prolongation, ventricular arrhythmias (including ventricular fibrillation and rarely ventricular tachycardia), Torsades de Pointes and cardiac arrest may occur. In rare cases this may lead to sudden “unexplained” death. Treatment of undesirable cardiac effects includes withdrawal of the causal agent, and correction of hypoxia, electrolyte abnormalities and acid base disturbances.Other adverse reactions Jaundice or transient abnormalities of liver function in the absence of jaundice have been reported. The following effects have been reported rarely: oedema, skin rashes or hypersensitivity reactions such as exanthema and pruritus. Blood dyscrasias, including granulocytopenia, have been reported occasionally. Weight changes may occur. Isolated cases of salivation and body temperature dysregulation have been reported. | |