Invega 3 mg, 6mg, 9mg, 12mg prolonged-release tablets

4.8       Undesirable effects

Undesirable effects noted with risperidone formulations

Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperidone products and can be expected to occur with INVEGA.

Psychiatric disorders: sleep-related eating disorder

Nervous system disorders: cerebrovascular disorder

Eye disorders: floppy iris syndrome (intraoperative)

Respiratory, thoracic and mediastinal disorders: rales

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis

Change to section 2 - interactions with other medicines, food or drink Change to section 4 - possible side effects. Change local representtaive in Ireland.

Addition of information regarding concomitant use with psychostimulants (Section 4.4 and 4.5). Addition of a new side-effect catatonia categorised as ‘rare’ (Section 4.8).  

Addition of information regarding concomitant use with psychostimulants (Section 4.4 and 4.5). Addition of a new side-effect catatonia categorised as ‘rare’ (Section 4.8).  

Section 4.4. – addition of sodium content statement

Section 4.8 – addition of ADRs: somnambulism and sleep related eating disorder

4.2       Posology and method of administration

Renal impairment

For patients with moderate to severe renal impairment (creatinine clearance ³ 10 to < 50 ml/min), the recommended initial dose of INVEGA is 1.5 mg 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment. As INVEGA has not been studied in patients with creatinine clearance below 10 ml/min, use is not recommended in such patients.

4.9       Overdose

In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in association with overdose. In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.

Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents. Gastric lavage (after intubation if the patient is unconscious) and a Administration of activated charcoal together with a laxative should be considered. In case of severe extrapyramidal symptoms, anticholinergic agents should be administered. Close supervision and monitoring should continue until the patient recovers.

4.2       Posology and method of administration

Renal impairment

For patients with moderate to severe renal impairment (creatinine clearance ³ 10 to < 50 ml/min), the recommended initial dose of INVEGA is 1.5 mg 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment. As INVEGA has not been studied in patients with creatinine clearance below 10 ml/min, use is not recommended in such patients.

4.9       Overdose

In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in association with overdose. In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.

Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents. Gastric lavage (after intubation if the patient is unconscious) and a Administration of activated charcoal together with a laxative should be considered. In case of severe extrapyramidal symptoms, anticholinergic agents should be administered. Close supervision and monitoring should continue until the patient recovers.