Risperidone (patient information)

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as risperidone have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment. Tell your doctor and pharmacist if you are taking furosemide (Lasix). If you experience any of the following symptoms, call your doctor immediately: slow or difficult speech, sudden dizziness or faintness, or weakness or numbness of an arm or leg.

Risperidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking risperidone. For more information visit the FDA website: http://www.fda.gov/cder

Why is this medication prescribed

Risperidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to treat episodes of mania (frenzied, abnormally excited, or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Risperidone is also used to treat behavior problems such as aggression and self-injury and sudden mood changes in teenagers and children 5-16 years of age who have autism (a condition that causes repetitive behavior, difficulty interacting with others, and problems with communication). Risperidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

How should this medicine be used

Risperidone comes as a tablet, a solution (liquid), and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once or twice a day with or without food. Take risperidone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take risperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Use the dropper provided to measure your dose of risperidone oral solution. You can take the oral solution with water, orange juice, coffee, or low-fat milk. Do not take the solution with tea or cola.

Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with or without liquid. Do not chew or crush the tablet.

Your doctor will probably start you on a low dose of risperidone and gradually increase your dose to allow your body to adjust to the medication.

Risperidone may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of risperidone. Continue to take risperidone even if you feel well. Do not stop taking risperidone without talking to your doctor. If you suddenly stop taking risperidone, your symptoms may return and your illness may become harder to treat.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking risperidone:

• tell your doctor and pharmacist if you are allergic to risperidone or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; carbamazepine (Tegretol); cimetidine (Tagamet); clozapine (Clozaril); dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip); levodopa (Dopar, Sinemet); medications for anxiety, high blood pressure, or seizures; other medications for mental illness; paroxetine (Paxil); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); quinidine (Quinaglute, Quinidex); ranitidine (Zantac); rifampin (Rifadin, Rimactane); sedatives; sleeping pills; tranquilizers; and valproic acid (Depakote, Depakene). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you use or have ever used street drugs or large amounts of alcohol or if you have ever overused prescription medications and if you have or have ever had Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); difficulty swallowing; breast cancer; angina (chest pain); irregular heartbeat; high or low blood pressure; heart failure; a heart attack; a stroke; seizures; or heart, kidney or liver disease; or if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking risperidone, call your doctor. Do not breastfeed while taking risperidone.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking risperidone.
• you should know that risperidone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking risperidone.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking risperidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking risperidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, upset stomach and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that risperidone may make it harder for your body to cool down when it gets very hot or warm up when it gets very cold. Tell your doctor if you plan to do vigorous exercise or be exposed to extremely high or low temperatures.
• you should know that risperidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking risperidone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Risperidone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• diarrhea
• constipation
• heartburn
• dry mouth
• increased appetite
• weight gain
• stomach pain
• anxiety
• agitation
• restlessness
• dreaming more than usual
• difficulty falling asleep or staying asleep
• decreased sexual interest or ability
• runny nose
• cough
• sore throat
• muscle or joint pain
• dry or discolored skin
• difficulty urinating

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately:

• fever
• muscle stiffness
• confusion
• fast or irregular pulse
• sweating
• unusual movements of your face or body that you cannot control
• faintness
• seizures
• slow movements or shuffling walk
• rash
• hives
• itching
• difficulty breathing or swallowing
• painful erection of the penis that lasts for hours

Risperidone may cause children to gain more weight than expected and for boys and male adolescents to have an increase in the size of their breasts. Talk to your doctor about the risks of giving this medication to your child.

Risperidone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• fast, pounding, or irregular heartbeat
• upset stomach
• blurred vision
• fainting
• dizziness
• seizures

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to risperidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Risperdal®
• Risperdal® M-TAB®