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|Risperidone Tablets

Risperidone

Risperidone is used for:

Treating schizophrenia or bipolar mania. It may also be used for other conditions as determined by your doctor.

Risperidone is an antipsychotic. It is not fully understood how it works. It may alter the balance of certain chemicals in the brain, which are responsible for thinking and behavior. It can improve concentration and self-control in severely mentally ill (psychotic or schizophrenic) patients.

Do NOT use Risperidone if:

• you are allergic to any ingredient in Risperidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Risperidone:

Some medical conditions may interact with Risperidone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems (eg, history of heart attack or ischemia, heart failure, irregular heartbeat), problems with the blood vessels in your brain (eg, history of stroke), or high or low blood pressure, or if you are dehydrated or have a low level of fluid in your body
• if you have Alzheimer disease or other dementia, trouble swallowing, breast cancer, Parkinson disease, kidney or liver problems, or a history of neuroleptic malignant syndrome (NMS) or suicidal thoughts or attempts
• if you have diabetes or a family history of diabetes, or if you are very overweight
• if you will be exposed to extreme heat

Some MEDICINES MAY INTERACT with Risperidone. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbamazepine, phenobarbital, phenytoin, or rifampin because effectiveness of Risperidone may be decreased
• Selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine, paroxetine) because actions and side effects of Risperidone may be increased
• Furosemide because the risk of serious side effects may be increased
• Blood pressure medicines because the risk of low blood pressure may be increased
• Valproic acid because actions and side effects may be increased by Risperidone
• Clozapine because the risk of side effects such as NMS may be increased
• Dopamine receptor agonists (eg, pramipexole) or levodopa because effectiveness may be decreased by Risperidone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Risperidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Risperidone:

Use Risperidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Risperidone by mouth with or without food.
• Taking Risperidone at the same time each day will help you remember to take it.
• Continue to take Risperidone even if you feel well. Do not miss any doses.
• If you miss a dose of Risperidone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Risperidone.

Important safety information:

• Risperidone may cause drowsiness, dizziness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Risperidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Risperidone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Risperidone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• It may take several days to weeks for Risperidone to work. Do not stop taking Risperidone without checking with your doctor.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Risperidone. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Some patients who take Risperidone may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Risperidone in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Risperidone.
• Risperidone may, in rare instances, increase your blood level of a certain hormone (prolactin). Symptoms may include unusual breast milk production, missed menstrual period, or decreased sexual ability, decreased ability to produce sperm, or enlarged breasts. Contact your doctor immediately if you experience any of these symptoms.
• Risperidone may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• LAB TESTS, including fasting blood sugar levels, may be performed while you take Risperidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Risperidone with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness on standing.
• Risperidone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Risperidone while you are pregnant. Risperidone is found in breast milk. Do not breast-feed while taking Risperidone.

Possible side effects of Risperidone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Agitation; anxiety; constipation; coughing; diarrhea; difficulty concentrating; dizziness; drowsiness; dry skin; fatigue; headache; increased dreams; increased salivation; indigestion; joint pain; nausea; nervousness; runny nose; sleeplessness; stomach pain; toothache; vomiting; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; altered mental abilities, including lack of response to your surroundings; change in urination; chest pain; confusion; decreased sexual ability or desire; difficulty swallowing; enlarged breasts; fainting; fast or irregular heartbeat; fever; increased thirst; loss of coordination; mental/mood changes; missed menstrual period; muscle rigidness or stiffness; numbness in the face, arms, or legs; one-sided weakness; prolonged painful erection; seizures; severe dizziness; slurred speech; sudden severe headache; thoughts of suicide; unusual breast milk production; unusual or uncontrolled muscle movements; unusual sweating; vision changes; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include fainting; loss of consciousness; rapid pulse; seizures; severe drowsiness; unusual muscle movement or rigidity of the face, limbs, or neck.

Store Risperidone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Risperidone out of the reach of children and away from pets.

General information:

• If you have any questions about Risperidone, please talk with your doctor, pharmacist, or other health care provider.
• Risperidone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Risperidone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.