INVEGA^® SUSTENNA™ (paliperidone palmitate) is used for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR INVEGA^® SUSTENNA™

INVEGA® SUSTENNA™ is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® SUSTENNA™ 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® SUSTENNA™ and similar medicines. Call the 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® SUSTENNA™ 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® SUSTENNA™ 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).

High blood sugar and diabetes have been reported with INVEGA® SUSTENNA™ 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.

Weight gain has been observed with INVEGA® SUSTENNA™ and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.

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® SUSTENNA™ 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® SUSTENNA™ 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.

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

INVEGA® SUSTENNA™ can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA® SUSTENNA™, 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.

Some medications interact with INVEGA® SUSTENNA™ Please inform your healthcare professional of any medications or supplements that you are taking.

INVEGA® SUSTENNA™ 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.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA® SUSTENNA™.

Do not drink alcohol while you are taking INVEGA® SUSTENNA™.

In a study of people taking INVEGA® SUSTENNA™, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes.

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® SUSTENNA™ or your therapy, talk with your doctor.

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RISPERDAL® CONSTA® (risperidone) is used for the treatment of schizophrenia and for the longer-term treatment of Bipolar I Disorder.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL® CONSTA®

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® CONSTA® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the 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 overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDAL® CONSTA® and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL® CONSTA®. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERDAL® CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDAL® CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect can be reduced or it may go away over time.

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDAL® CONSTA®.

RISPERDAL® CONSTA® may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL® CONSTA® 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.

Painful, long lasting erections have been reported with the use of RISPERDAL® CONSTA®. Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL® CONSTA®. Caution should be exercised when administering RISPERDAL® CONSTA® to a nursing woman.

RISPERDAL® CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL® CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL® CONSTA®.

In a study of people taking RISPERDAL® CONSTA®, the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In a study of people taking RISPERDAL® CONSTA®, the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and tremors (when used with lithium or valproate).

If you have any questions about RISPERDAL® CONSTA® or your therapy, talk with your doctor.

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INVEGA® (paliperidone) extended-release tablets are used for the treatment of schizophrenia.

RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder; the treatment of schizophrenia; and the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

IMPORTANT SAFETY INFORMATION FOR INVEGA® AND RISPERDAL®

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA® (paliperidone) and RISPERDAL® (risperidone) are not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with INVEGA®, RISPERDAL®, and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

One risk of INVEGA® is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with INVEGA®. Please inform your healthcare professional of any medications or supplements that you are taking.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA®, RISPERDAL®, and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the 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 overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with INVEGA®, RISPERDAL®, and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

INVEGA®, RISPERDAL®, and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.

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 taking INVEGA® or RISPERDAL® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced or it may go away over time.

Problems with the blood have been reported with INVEGA®, RISPERDAL®, and similar medications. Depending upon condition your doctor may choose to monitor your blood as you start therapy with these medications.

INVEGA® and RISPERDAL® may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

INVEGA® and RISPERDAL® 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.

Painful, long lasting erections have been reported with the use of INVEGA®, RISPERDAL®, and similar medications. Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking INVEGA® or RISPERDAL®. Caution should be exercised when administering to a nursing woman.

INVEGA® and RISPERDAL® may affect alertness and motor skills; use caution until this effect is known.

INVEGA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when 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.

Some medications interact with INVEGA® or RISPERDAL®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking INVEGA® or RISPERDAL®.

In a study of people taking INVEGA®, the most common side effects in the treatment of schizophrenia were restlessness and extra pyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).

The most common adverse reactions observed in all clinical trials with RISPERDAL® occurring at a rate of at least 10% were somnolence, increased appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, increased saliva, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.