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FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
Date:8/22/2007

ncontinence, saliva increased, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.

A rare but serious side effect that has been reported with this kind of medicine, including RISPERDAL(R), is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.

You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your health care professional.

Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL(R). Some people may need regular blood sugar testing.

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

You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors and muscle stiffness. Some people taking RISPERDAL(R) have these side effects. If you have these symptoms, talk to your health care professional.

Some medications may interact with RISPERDAL(R). Avoid alcohol while on RISPERDAL(R).

Inform your health care professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL(R). Do not breastfeed if you are taking RISPERDAL(R).

RISPERDAL(R) may affect your driving ability, therefore, do not drive or operate machines before talking to your health care professional.

RISPERDAL(R) may affect alertness and motor skills; use caution until the effect of
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SOURCE Janssen, L.P.
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