DEPIXOL Film-coated tablet Ref.[8628] Active ingredients: Flupentixol

Posology

Adults

1-3 tablets twice daily to a maximum of 18 mg (6 tablets) per day. It is recommended that commencement of treatment and increase in dosage should be carried out under close supervision. As with all antipsychotic drugs, the dose of Depixol should be titrated to the needs of each patient.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

Older patients

In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older patients.

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).

Patients 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).

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.
• ingestion of activated charcoal and gastric lavage should be considered.

3 years.

This medicinal product does not require any special storage conditions.

White, High Density Polyethylene (HDPE) tablet container with a child-resistant closure and tamper-evident seal; 100 tablets.

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