PARNIDO PROLONGED-RELEASE TABLETS 6MG [SIN16782P]

Product Info

PARNIDO PROLONGED-RELEASE TABLETS 6MG

[SIN16782P]

4.1 Therapeutic indications

Parnido is indicated for the treatment of schizophrenia.

Parnido is indicated for the acute treatment of schizoaffective disorder as monotherapy and as an adjunct to antidepressants and/or mood stabilizers.

4.2 Posology and method of administration

Posology

Schizophrenia (adults)
The recommended dose of Parnido for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days.

Schizoaffective disorder (adults)
The recommended dose of Parnido for the treatment of schizoaffective disorder in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. A general trend for greater effects was seen with higher doses.This trend must be weighed against dose-related increase in adverse reactions. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 4 days. The maximum recommended dose is 12 mg/day.

Switching to other antipsychotic medicinal products
There are no systematically collected data to specifically address switching patients from Parnido to other antipsychotic medicinal products. Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.

Elderly
Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/min) are the same as for adults with normal renal function. However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Renal impairment below). Parnido should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. As paliperidone has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.

Renal impairment
For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 ml/min), the recommended initial dose is 3 mg once daily. The dose may be increased to 6 mg once daily based on clinical response and tolerability.

For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 ml/min), the recommended initial dose of paliperidone is 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment. As paliperidone has not been studied in patients with creatinine clearance below 10 ml/min, use is not recommended in such patients.

Paediatric population
Safety and effectiveness of Parnido in patients < 18 years of age have not been studied. There is no experience in children.

Other special populations
No dose adjustment for Parnido is recommended based on gender, race, or smoking status. (For pregnant women and breast-feeding mothers, see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Method of administration
Parnido is for oral administration. It must be swallowed whole with liquid, and must not be chewed, divided, or crushed. The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.

The administration of Parnido should be standardised in relation to food intake (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The patient should be instructed to always take Parnido in the fasting state or always take it together with breakfast and not to alternate between administration in the fasting state or in the fed state.

4.3 Contraindications

Hypersensitivity to the active substance, risperidone, or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.