IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RISPERIDONE - ORAL

(riss-PAIR-ih-doan)

COMMON BRAND NAME(S): Risperdal

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.

USES: Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, manic phase of bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and function in daily life.

This is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used in combination with other medication to treat depression.

This drug should only be used for the condition for which it was prescribed.

HOW TO USE: Take this medication by mouth exactly as prescribed. This drug may be taken with or without food. During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication.

If you are using the liquid form of this medication, measure your dose with a special measuring spoon or device. Do not use a household spoon because it may not provide the correct dose.

The dosage is based on your medical condition and response to therapy. Continue to take this medication as directed, even if you are feeling better and thinking more clearly.

Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop taking this drug without your doctor's approval.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Inform your doctor if your condition persists or worsens.

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.

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.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: sibutramine.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting risperidone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antidepressants (e.g., fluoxetine, paroxetine), high blood pressure medicine (e.g., beta-blockers such as propranolol, alpha-blockers such as doxazosin or prazosin), medications for Parkinson's disease (e.g., levodopa).

Many drugs besides risperidone may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), thioridazine, sparfloxacin, among others. Therefore, before using risperidone, report all medications you are currently using to your doctor or pharmacist.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: medicine for sleep (e.g., sedatives), tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include unusual drowsiness; fast heartbeat; fainting; unusual muscle movement or stiffness of the face, neck, or limbs; tremor; seizures; and loss of consciousness.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., fasting blood sugar-FBS, weight, blood pressure, blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: Try to take each dose at the scheduled time. If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

STORAGE: Store this medicine at room temperature away from light and moisture. Per the U.S. manufacturer, store the US product between 59 and 77 degrees F (15-25 degrees C). Per the Canadian manufacturer, store the Canadian product between 59 and 86 degrees F (15-30 degrees C). If you use the oral solution, do not allow it to freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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).

Information last revised February 2011 Copyright(c) 2011 First DataBank, Inc.

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