Janssen: RISPERDAL® (risperidone)

RISPERDAL -- Autism

RISPERDAL® (risperidone) is the first medication approved to treat irritability associated with autistic disorder including symptoms of aggression, tantrums, self-injury and quickly changing moods in children and adolescents ages 5 - 16 years. Autism is a developmental disorder characterized by impairments in communication and social interaction, repetitive movements or behaviors and, sometimes, by severe irritability, agitation, aggression, hyperactivity, temper tantrums and self-injurious behavior.

The FDA first approved RISPERDAL in 1993 as a treatment for schizophrenia for adults, and it currently is the most widely prescribed medication for the treatment of schizophrenia in its class. RISPERDAL is approved for treatment of schizophrenia in more than 100 countries. The FDA approved RISPERDAL for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in 2003. And on October6, 2006, the U.S. Food and Drug Administration (FDA) approved RISPERDAL to treat irritability associated wtih autism in children and adolescents. RISPERDAL is the most-studied medication of its class in children.

RISPERDAL is marketed by Janssen, L.P. and is available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tablets. RISPERDAL is also available as an oral disintegrating tablet (RISPERDAL® M-Tab™) in 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg doses. It is also available as an oral solution in 1.0 mg/mL.

To learn more about other aspects of mental health visit www.mentalwellness.com.

For more information, refer to the full U.S. Prescribing Information including the Boxed Warning for RISPERDAL or visit www.risperdalautism.com.

Information about Bipolar Mania

Information about 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 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. RISPERDAL (risperidone) and RISPERDAL CONSTA (risperidone) are not approved for the treatment of patients with dementia-related psychosis.

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 with RISPERDAL CONSTA were sleepiness, restlessness, tremors and muscle stiffness, stomach upset, constipation, dry mouth, feeling tired, and weight increase.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with 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.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with 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.

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.

RISPERDAL, 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. The connection between prolactin levels and side effects is unknown.

High blood sugar and diabetes have been reported with 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.

Some people taking 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.

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.

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

Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL or RISPERDAL CONSTA. Do not breast-feed if you are taking RISPERDAL or RISPERDAL CONSTA.

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

RISPERDAL and RISPERDAL CONSTA may affect alertness and motor skills; use caution until the effect of RISPERDAL or RISPERDAL CONSTA is known.

01RS2004

For more information, read the full US Prescribing Information including the Boxed Warning for RISPERDAL and RISPERDAL CONSTA.