When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to iloperidone.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Call your doctor for instructions if you must stop taking the medicine for more than 3 days.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods affect how iloperidone works. Tell your doctor if you are using any of the following:
  
  • Medicine to treat heart rhythm problems, including amiodarone, procainamide, quinidine, sotalol
  • Blood pressure medicine
  • Chlorpromazine, thioridazine
  • Gatifloxacin, moxifloxacin, clarithromycin
  • Methadone
  • Pentamidine
  • Ketoconazole, itraconazole
  • Fluoxetine, paroxetine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, diabetes, low blood pressure, heart failure, heart rhythm problems, breast cancer, high cholesterol, or trouble swallowing. Tell your doctor if you have a history of stroke, heart attack, or seizures.
• This medicine may cause the following problems:
  
  • Heart rhythm problems
  • High blood sugar levels
  • Neuroleptic malignant syndrome (a nerve disorder that can be life-threatening)
  • Tardive dyskinesia (muscle movement you cannot control)
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• This medicine may cause you to overheat. Drink plenty of water during hot weather or when exercising. Avoid hot tubs and saunas.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, and body aches
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness
• Increased hunger or thirst, urinating more often than usual
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Mood or behavior changes, or thoughts of hurting yourself or others
• Seizure

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Sleepiness
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088