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INVEGA: PATIENT COUNSELING INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe Invega (Paliperidone).

Orthostatic Hypotension

Patients should be advised that there is risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose.

Interference with Cognitive and Motor Performance

As Paliperidone (Invega) has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Invega therapy does not affect them adversely.

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Invega (Paliperidone).

Nursing

Caution should be exercised when Paliperidone (Invega) is administered to a nursing woman. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone.

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions.

Alcohol

Patients should be advised to avoid alcohol while taking Invega (Paliperidone).

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration.

Administration

Patients should be informed that Paliperidone (Invega) should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug 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 something that looks like a tablet in their stool.

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