Please discuss your symptoms with your healthcare professional. Your healthcare professional will review your symptoms and may consult the established guidelines, which are available in the Diagnostic and Statistical Manual of Mental Disorders, where applicable.

INVEGA^® (paliperidone) extended-release tablets are indicated for the treatment of schizophrenia in adults and adolescents (12-17 years of age). The efficacy of INVEGA^® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (12-17 years of age), as well as one maintenance trial in adults.

INVEGA^® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressant therapy in adults. The efficacy of INVEGA^® in schizoaffective disorder was established in two 6-week trials in adults.

INVEGA^® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA^® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.

Neuroleptic Malignant Syndrome (NMS) is a rare but serious side effect that could be fatal and has been reported with INVEGA^® and similar medicines. Call your doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.

Tardive Dyskinesia (TD) is a rare but serious and sometimes permanent side effect reported with INVEGA^® and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received. This condition can also develop after a short period of treatment at low doses, but this is less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped.

One risk of INVEGA^® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

• High blood sugar and diabetes have been reported with INVEGA^® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
• Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.
• Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA^®.

Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.

INVEGA^® and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.

INVEGA^® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects, including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

INVEGA^® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.

INVEGA^® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA^®, be careful driving a car, operating machines, or doing things that require you to be alert.

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

INVEGA^® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

Do not drink alcohol while you are taking INVEGA^®.

The most common side effects that occurred with INVEGA^® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes) and fast heartbeat, and in adolescents were: drowsiness, abnormal muscle movement (including restlessness, tremor shaking, involuntary muscle contractions, stiff muscles making your movements jerky, fast heartbeat, anxiety (nervousness), and in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor [shaking], shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

If you have any questions about INVEGA^® or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

© Janssen Pharmaceuticals, Inc. 2013. All rights reserved.

This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.

This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

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