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 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.
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, read the Important Product Information by clicking here.
01CS09130
