RISPIDE Film-coated tablet Ref.[115330] Active ingredients: Risperidone

Posology

Schizophrenia

Switching from other antipsychotics to RISPIDE

When medically appropriate, gradual discontinuation of the previous treatment, while RISPIDE therapy is initiated, is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate RISPIDE therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medications should be re-evaluated periodically.

Adults

RISPIDE may be given once or twice daily.

Patients should start with RISPIDE 2 mg/day. The dosage may be increased on the second day to 4 mg/day. From then on, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses of between 4 mg/day and 8 mg/day. Doses above 6 mg/day (when administered twice daily) are associated with more extrapyramidal symptoms and other adverse effects and are not recommended. In some patients, particularly with first episode acute psychosis, a slower titration phase and a lower starting and maintenance dose may be appropriate. Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause an increased incidence of side effects such as extrapyramidal symptoms. Dosages above 10 mg/day should only be considered if the benefits outweigh the risk. The maximum total daily dose is 16 mg/day.

A benzodiazepine may be added to RISPIDE if additional sedation is required.

Special populations

Renal and liver impairment

Caution should be exercised with these groups of patients, as clinical experience is lacking in these patient populations. It is recommended to halve both the starting dose and the subsequent dose increments.

Elderly patients

A starting dose of 0,5 mg twice daily is recommended. This dosage can be individually adjusted with 0,5 mg twice daily increments to 1 to 2 mg twice daily.

Paediatric population

RISPIDE should not be used in children under 15 years, as efficacy and safety in children under the age of 15 years have not been demonstrated in schizophrenia.

Behavioural disturbances in adult patients with dementia

A starting dose of 0,25 mg twice daily is recommended. This dosage can be individually adjusted by increments of 0,25 mg twice daily, not more frequently than every other day, if needed. The optimum dose is 0,5 mg twice daily, for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.

Once patients have reached their target dose, a once-daily dosing regimen can be considered. The continued use of RISPIDE must be evaluated and justified on an ongoing basis.

Conduct and other disruptive behaviour disorders in children 5–12 years of age

Subjects <50 kg

A starting dose of 0,01 mg/kg once daily is recommended. This dosage can be individually adjusted by increments of 0,01 mg/kg once daily not more frequently than every other day, if needed. The recommended maintenance dose is 0,02 to 0,04 mg/kg once daily. The mean dose is 0,03 mg/kg once daily.

The continued use of RISPIDE must be evaluated and justified on an ongoing basis.

Experience is lacking in children aged less than 5 years (see section 4.5).

Method of administration

Oral use. Can be taken with or without food.

Reported signs and symptoms have been those resulting from an exaggeration of RISPIDE's known pharmacological effects. Symptoms of acute overdosage include drowsiness, sedation, hypotension, tachycardia and extrapyramidal symptoms. In overdose, cases of QT prolongation have been reported.

In the case of acute overdosage, the possibility of multiple medicine ingestion should be considered.

Treatment

Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Administration of activated charcoal together with a laxative should be considered. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible dysrhythmias.

Since there is no known antidote if accidental poisoning or overdosage is suspected, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.

36 months.

Store in the original packaging (in the carton) at or below 25°C.

Packs of 30 tablets packed in opaque white PVC/PE/PVDC/Aluminium blisters in a cardboard carton.

Not all strengths are necessarily marketed.

No special requirements.