Generic Name: RISPERIDONE - ORAL
Pronounced: (riss-PAIR-ih-doan)

Risperdal Oral Warning

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure) when this medication is used in elderly patients with dementia. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with your doctor.

If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

Risperdal Oral Side Effects

Dizziness, drowsiness, fatigue, nausea, constipation, runny nose, increased appetite, weight gain, nervousness, acne, dry skin, difficulty concentrating, decreased sexual ability/desire or difficulty sleeping may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur:

• severe dizziness
• fast/pounding/irregular heartbeat
• mental/mood changes
• fever
• muscle stiffness/spasms/twitching
• sweating
• uncontrolled muscle movements (e.g., tongue and facial muscles)
• drooling
• difficulty swallowing
• seizures
• frequent falls
• signs of infection (such as fever, persistent sore throat)

Seek immediate medical attention if any of these unlikely but serious side effects occur:

• chest pain
• fainting
• weakness on one side of the body
• numbness in the face/arms/legs
• sudden vision changes
• slurred speech
• confusion
• breast lumps
• change in amount of urine

This medication may in rare instances increase your blood level of a certain hormone (prolactin). In females, an increase in prolactin levels may result in unwanted breast milk, the end of menstruation or difficulty becoming pregnant. In males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

This drug may infrequently make your blood sugar level rise, therefore causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Risperdal Oral Precautions

Before taking risperidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• kidney disease
• low blood pressure
• seizures
• Parkinson's disease
• memory problems (dementia)
• difficulty swallowing (especially in patients with dementia or Alzheimer's disease)
• strokes (cerebrovascular disease)
• dehydration
• breast cancer
• low white blood cell count

(See also Side Effects section.) Also tell your doctor or pharmacist if either you or a family member has a history of the following:

• diabetes
• heart disease (e.g., heart attacks or ischemia, arrhythmias)
• high blood cholesterol/triglyceride levels
• high blood pressure
• obesity

Risperidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using risperidone, tell your doctor or pharmacist if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using risperidone safely.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication can reduce sweating. Heatstroke may occur if you become overheated during exercise or other physical activity or in hot weather. Drink plenty of liquids to avoid the risk of heatstroke.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the lowering of blood pressure.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug is excreted into breast milk. Breast-feeding is not recommended while using this drug.

Risperdal Oral Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

---

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.