1. NAME OF THE MEDICINAL PRODUCT
Fluanxol Tablet 0.5mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol 0.5 mg: Each tablet contains 0.5 mg flupentixol (as 0.5840 mg
Excipients with known effects:
Lactose monohydrate and Sucrose
For the full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
0.5 mg:Round, biconvex, ochre-yellow, sugar coated tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Depression involving anxiety, asthenia and lack of initiative.
Chronic neuroses with anxiety, depression, and inactivity.
Psychosomatic disorders with asthenic reactions.
Acute and situational anxiety and tension states in which a sedative/
hypnotic effect is not required and especially when the patient is
considered in danger of abusing minor tranquillizers.
4.2 Posology and method of administration
Initially 1 mg daily as a single morning dose or 0.5 mg twice daily.
After one week the dosage may be increased to 2 mg daily if there is
inadequate clinical response. Daily dosage of more than 2 mg should be in
divided doses up to a maximum of 3 mg.
Patients often respond to flupentixol within two or three days. If no effect
has been observed within one week of maximum dosage (3 mg daily) the drug
should be withdrawn.
Older patients should receive half the recommended dosages.
The initial dosage for older patient is 0.5 mg as a single morning dose.
After one week, if response is inadequate, dosage may be increased to 1 mg
Caution should be exercised in further increasing the dosage but occasional
patients may require up to a maximum of 1.5 mg a day which
should be given in divided doses.
Reduced renal function
Flupentixol has not been studied in renal impairment. Increased cerebral
sensitivity to antipsychotics has been noted in severe renal impairment.
Reduced liver function
Flupentixol has not been studied in hepatic impairment. It is extensively
metabolised by the liver and particular caution should be used in this
situation and serum level monitoring is advised.
Not recommended for children
Method of administration
The tablets are swallowed with water.
Hypersensitivity to the active substance or to any of the excipients listed
in section 6.1.
Circulatory collapse, depressed level of consciousness due to any cause
(e.g. intoxication with alcohol, barbiturates or opiates), coma.
4.4 Special warnings and precautions for use
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
Like other neuroleptics flupentixol should be used with caution in patients
with organic brain syndrome, convulsion and advanced hepatic
Not recommended for excitable or overactive patients in doses up to 25
mg/day since its activating effect may lead to exaggeration of these
characteristics. If previously the patient has been treated with
tranquillizers or neuroleptics with sedative effect, these should be
As described for other psychotropics flupentixol may modify insulin and
glucose responses calling for adjustment of the antidiabetic therapy in
Patients on long-term therapy, particularly on high doses, should be
monitored carefully and evaluated periodically to decide whether the
maintenance dosage can be lowered.
As with other drugs belonging to the therapeutic class of anti
psychotics, 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).
Depression is associated with an increased risk of suicidal thoughts,
self-harm and suicide (suicide-related events). This risk persists until
significant remission occurs. As improvement may not occur during the first
few weeks or more of treatment, patients should be closely monitored until
such improvement occurs. It is general clinical experience that the risk of
suicide may increase in the early stages of recovery.
Other psychiatric conditions for which flupentixol is prescribed can also be
associated with an increased risk of suicide-related events. In addition,
these conditions may be co-morbid with major depressive disorder. The same
precautions observed when treating patients with major depressive disorder
should therefore be observed when treating patients with other psychiatric
Patients with a history of suicide-related events, or those exhibiting a
significant degree of suicidal ideation prior to commencement of treatment
are known to be at greater risk of suicidal thoughts or suicide attempts,
and should receive careful monitoring during treatment. A meta-analysis of
placebo-controlled clinical trials of antidepressant drugs in adult patients
with psychiatric disorders showed an increased risk of suicidal behaviour
with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should
accompany drug therapy especially in early treatment and following dose
changes. Patients (and caregivers of patients) should be alerted about the
need to monitor for any clinical worsening, suicidal behaviour or thoughts
and unusual changes in behaviour and to seek medical advice immediately if
these symptoms present.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic
drugs. Since patients treated with antipsychotics often present with
acquired risk factors for VTE, all possible risk factors for VTE should be
identified before and during treatment with flupentixol and preventive
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.
Increased Mortality in older people with Dementia
Data from two large observational studies showed that older people with
dementia who are treated with antipsychotics are at a small increased risk
of death compared with those who are not treated. There are insufficient
data to give a firm estimate of the precise magnitude of the risk and the
cause of the increased risk is not known.
Flupentixol is not licensed for the treatment of dementia-related
The tablets contain lactose monohydrate. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not receive this medicine. The
tablets also contain sucrose. Patients with rare hereditary problems of
fructose intolerance, glacose-galactose malabsorption or sucrase-isomaltase
insufficiency should not take this medicine.