Janssen-Cilag Ltd

Section 4.3
In common with several other neuroleptics, pimozide has been reported to prolong the QT interval.  It is, therefore, contra-indicated in patients with a pre-existing congenital prolongation of QT, or with a history or family history of this syndrome, and in patients with a history of cardiac arrhythmias and a history of Torsades de pointes. Orap should not be used in the case of acquired long QT interval, such as that associated with the concomitant use of drugs known to prolong the QT interval (see section 4.5 Interactions), known uncorrected hypokalaemia or hypomagnesaemia, or clinically significant cardiac disorders (eg recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products) or clinically significant bradycardia.

Section 4.4
Please also refer to Drug Interactions section.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Orap is not licensed for the treatment of dementia-related behavioural disturbances.

Cardiac monitoring (See also Section 4.3)

There have been very rare reports of QT prolongation, ventricular arrhythmias, and Torsade de Pointes in patients without risk factors for QT prolongation administered therapeutic doses of pimozide, and in the setting of overdose. Ventricular tachycardia and ventricular fibrillation (in some cases with fatal outcomes) have also been reported, in addition to very rare reports of sudden death and cardiac arrest.

As with other neuroleptics, cases of sudden unexpected death have been reported with pimozide at recommended doses and in the setting of overdose. An ECG should be performed prior to initiation of treatment with pimozide, as well as periodically during treatment. If repolarization changes (prolongation of QT interval, T-wave changes or U-wave development) appear or arrhythmias develop, the need for treatment with pimozide in these patients should be reviewed. They should be closely monitored and their dose of pimozide should be reduced or the drug discontinued. If QT or QTc exceeds 500 msec, pimozide should be discontinued.

As with other neuroleptics, caution is advised in patients with cardiovascular diseases, patients with a family history of QT prolongation.Hypotension may very rarely occur.

Electrolyte disturbances should also be considered a risk factor (see Section 4.3 Contraindications and Section 4.5 Interaction with other medicinal products and other forms of interaction) and periodic electrolyte monitoring is recommended.

Drugs which may cause electrolyte disturbances are not recommended in patients receiving long-term pimozide (please also refer to Section 4.5) the Drug Interactions section.)

Section 4.8
Addition of Hyponatraemia and Weight increased to the Section 4.8 table. Pruritus and Rash moved from Not Known to Uncommon