CLOPIXOL Film-coated tablet Ref.[8461] Active ingredients: Zuclopenthixol

Posology

Adults

The dosage range is 4-150 mg/day in divided doses. The usual initial dose is 20-30 mg/day (sometimes with higher dosage requirements in acute cases), increasing as necessary. The usual maintenance dose is 20-50 mg/day.

Maximum dosage per single dose is 40 mg.

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from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.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

Paediatic population

Clopixol is not indicated for use in children due to lack of clinical experience.

Patients with renal impairment

Clopixol can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage.

Patients with hepatic impairment

Use with caution in patients with liver disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised

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.

Clopixol Tablets are stable for 2 years. Each container has an expiry date.

Clopixol Tablets 2 mg: Store in the original container in order to protect from light.

Clopixol tablets 10 mg, 25 mg: This medicinal product does not require any special storage conditions.

Grey polypropylene container (with desiccant capsule for 2 mg strength)

or

Glass bottle

or

White HDPE container with LDPE twist-off cap including desiccant

Pack size: 100 tablets.

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