Approved for the maintenance treatment of Bipolar I Disorder.

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^®

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL^® CONSTA^® (risperidone) is 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 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 used 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 taking 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.

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.

For more information about RISPERDAL^® CONSTA^® , please read the Important Product Information.