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.

RISPERDAL® CONSTA® (risperidone) is indicated for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR INVEGA, RISPERDAL, AND RISPERDAL CONSTA

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone), RISPERDAL (risperidone), and RISPERDAL CONSTA (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, 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.

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, 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 INVEGA, RISPERDAL, 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. 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, RISPERDAL CONSTA, and similar medications can raise 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, RISPERDAL, or 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 may be reduced or it may go away over time.

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

INVEGA, RISPERDAL, and 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.

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, RISPERDAL, or RISPERDAL CONSTA. Caution should be exercised when administering to a nursing woman.

INVEGA, RISPERDAL, and RISPERDAL CONSTA 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, RISPERDAL, or RISPERDAL CONSTA. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on INVEGA, RISPERDAL, or RISPERDAL CONSTA.

The most common side effects that occurred with INVEGA 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.

The most common side effects that occurred with RISPERDAL CONSTA were anxiety, sleepiness, restlessness, tremors, muscle stiffness, dizziness, constipation, nausea, stomach upset, runny nose, dry mouth, rash, weight increase, and rapid heartbeat.

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