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RISPERDAL
RISPERIDONE DISINTEGRATING TABLET - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

RISPERIDONE DISINTEGRATING TABLET - ORAL

(riss-PAIR-ih-doan)

COMMON BRAND NAME(S): Risperdal M-Tab

Uses

This medication is used to treat schizophrenia. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters). Risperidone has not been shown to be safe or effective in the elderly for the treatment of delusions/hallucinations (psychosis) due to dementia.

How To Use

Take this medication by mouth exactly as prescribed by your doctor, usually once or twice daily. It may be taken with or without food. This medication comes in a blister pack. Do not remove the tablet from the packaging until you are ready to take a dose. Tear apart the package at the perforation. Bend the corner of the package where directed and peel back the foil to show the tablet. Do not try to push the tablet through the foil, this can damage the tablet. Remove the tablet from the foil package with dry hands and place it on your tongue immediately. Do not split or chew the tablet. The tablet will melt on your tongue in a few seconds. After the tablet has melted on the tongue, it can be swallowed with or without water or other liquid. When you begin taking this medication your dose may be increased gradually as tolerated. The dosage is based on your medical condition and response to therapy. It may take several weeks to notice the full benefit of this drug. Continue to take it everyday as directed, even if you are feeling better and thinking more clearly.

Side Effects

Dizziness, drowsiness, fatigue, nausea, constipation, runny nose, 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. Tell your doctor immediately if any of these serious side effects occur: fainting, rapid/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. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, one-sided weakness, numbness in the face/arms/legs, sudden vision changes, slurred speech, confusion. 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 (sometimes fatal) conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination, or vision changes. If you already have diabetes, be sure to check your blood sugar level regularly. Males: In the unlikely event you have a painful, prolonged erection, stop using this drug and seek immediate medical attention or permanent problems could occur. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart disease (including heart failure, history of heart attack or ischemia, arrhythmias), low blood pressure, seizures, difficulty swallowing (especially in patients with dementia or Alzheimer's disease), stroke (cerebrovascular disease), dehydration, breast cancer, diabetes, any allergies (especially drug allergies). This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. This medication contains aspartame. If you have phenylketonuria (PKU) or any other condition where you must restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine. 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 when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Breast-feeding is not recommended while using this drug.

Drug Interactions

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: high blood pressure medicine (e.g., beta-blockers such as propranolol, "water pills" or diuretics such as furosemide or hydrochlorothiazide, alpha-blockers such as doxazosin or prazosin), antidepressants (e.g., fluoxetine, paroxetine), medications for Parkinson's disease (e.g., levodopa). Tell your doctor of any other medicines which may affect the heart rhythm (QTc prolongation in the EKG) including dofetilide, pimozide, quinidine, sotalol, procainamide, thioridazine, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolongating drugs you may be using in order to minimize this effect. Tell your doctor of any 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 (carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Check all labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask you pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include unusual drowsiness; fast heartbeat; unusual muscle movements or stiffness of the face, neck, or limbs; seizure; or loss of consciousness.

Notes

Do not share this medication with others. Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store this medicine at room temperature. 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). Do not store in the bathroom. Keep all medicines away from children and pets.

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).