Section 4.4 Special warnings and precautions for use
Addition of:
As described for other psychotropics flupentixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.
An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.
Flupentixol should be used with caution in patients with risk factors for stroke.
As with other drugs belonging to the therapeutic class of antipsychotics, flupentixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in susceptible individuals (with hypokalemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.
Concomitant treatment with other antipsychotics should be avoided (see section 4.5).
The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation, and opiate and alcohol abuse are over-represented among fatal cases.
Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful.Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drug.
Blood dyscrasias, including thrombocytopenia, have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.
The tablets also contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Removal of:
Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of thioxanthenes and similar drugs. The emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.
Please refer to Section 4.8 of the SPC on Abrupt discontinuation
Section 4.9 Overdose
Amended to:
Overdosage may cause somnolence, or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper-or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.
Treatment is symptomatic and supportive, with measures aimed at supporting the respiratory and cardiovascular systems. The following specific measures may be employed if required.
- anticholinergic antiparkinson drugs if extrapyramidal symptoms occur.
- sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions.
- noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given.
- ingestion of activated charcoal and gastric lavage should be considered.
Section 6.3 Shelf life
This has been reduced from 3 years to:
Fluanxol tablets are stable for 2 years. The box is labelled with an expiry date.
Section 6.4 Special precautions for storage
Storage temperature has been reduced from 30oC to:
Do not store above 25°C.