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RISPERIDONE DISINTEGRATING TABLET-ORAL (cont.)

PRECAUTIONS: Before taking risperidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, low blood pressure, seizures, difficulty swallowing (especially in patients with dementia or Alzheimer's disease), stroke (cerebrovascular disease), dehydration, breast cancer. (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 (including heart failure, heart attack or ischemia, arrhythmias), high blood cholesterol/triglyceride levels, high blood pressure, obesity. 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.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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