FLUANXOL Film-coated tablet Ref.[27514] Active ingredients: Flupentixol

Posology

Adults

The standard initial dosage is 1 mg as a single morning dose. After one week the dose may be increased to 2 mg 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 daily.

Older patients

Older patients should receive half the recommended dosages. The standard initial dosage is 0.5 mg as a single morning dose. After one week, if response is inadequate, dosage may be increased to 1 mg once a day.

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.

Children

Flupentixol is not recommended for use in children due to lack of clinical experience.

Patients with reduced renal function

Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4).

atients with reduced hepatic 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 (see section 4.4).

Patients often respond within 2-3 days. If no effect has been observed within one week at maximum dosage the drug should be withdrawn.

Method of administration

The tablets are swallowed with water.

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.
• gastric lavage should be considered.

3 years.

This medicinal product does not require any special storage conditions.

PVC/PE/PVdC/Aluminium blister, pack with an outer carton; 60 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.