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|Risperidone Orally Disintegrating Tablets

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Risperidone Orally Disintegrating Tablets

Generic Name: Risperidone Orally Disintegrating Tablets (RISS-PURR-ih-dohn)
Brand Name: Risperdal M-Tabs

Risperidone Orally Disintegrating Tablets is an atypical antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Risperidone Orally Disintegrating Tablets is not approved to treat mental problems caused by dementia.

Risperidone Orally Disintegrating Tablets is used for:

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

Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets if:

you are allergic to any ingredient in Risperidone Orally Disintegrating Tablets

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

Before using Risperidone Orally Disintegrating Tablets:

Some medical conditions may interact with Risperidone Orally Disintegrating Tablets. 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 have phenylketonuria
if you will be exposed to extreme heat

Some MEDICINES MAY INTERACT with Risperidone Orally Disintegrating Tablets. 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 Orally Disintegrating Tablets may be decreased
Selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine, paroxetine) because actions and side effects of Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets
Clozapine because risk of side effects such as NMS may be increased
Dopamine receptor agonists (eg, pramipexole) or levodopa because effectiveness may be decreased by Risperidone Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets:

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

Take Risperidone Orally Disintegrating Tablets by mouth with or without food.
Do not remove the blister from the outer pouch until you are ready to take Risperidone Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Risperidone Orally Disintegrating Tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
Taking Risperidone Orally Disintegrating Tablets at the same time each day will help you remember to take it.
Continue to use Risperidone Orally Disintegrating Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Risperidone Orally Disintegrating Tablets, 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 Orally Disintegrating Tablets.

Important safety information:

Risperidone Orally Disintegrating Tablets may cause drowsiness, dizziness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Risperidone Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets; 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 Orally Disintegrating Tablets to work. Do not stop taking Risperidone Orally Disintegrating Tablets without checking with your doctor.
Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Risperidone Orally Disintegrating Tablets. 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 Orally Disintegrating Tablets 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 Orally Disintegrating Tablets 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 Orally Disintegrating Tablets.
Risperidone Orally Disintegrating Tablets may in rare instances increase your blood level of a certain hormone (prolactin). Symptoms may include unusual breast milk production, missed menstrual period, ordecreased sexual ability, decreased ability to produce sperm, or enlarged breasts. Contact your doctor immediately if you experience any of these symptoms.
Phenylketonuria patients - Risperidone Orally Disintegrating Tablets contains phenylalanine.
Risperidone Orally Disintegrating Tablets 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 use Risperidone Orally Disintegrating Tablets. 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 Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness on standing.
Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets while you are pregnant. Risperidone Orally Disintegrating Tablets is found in breast milk. Do not breast-feed while taking Risperidone Orally Disintegrating Tablets.

Possible side effects of Risperidone Orally Disintegrating Tablets:

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.

Seek medical attention right away if any of these SEVERE side effects occur:

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.

Proper storage of Risperidone Orally Disintegrating Tablets:

Store Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Risperidone Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
Risperidone Orally Disintegrating Tablets 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 Orally Disintegrating Tablets. 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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