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 cariprazine.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• 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 can affect how cariprazine works. Tell your doctor if you are using any of the following:
  
  • Carbamazepine, itraconazole, ketoconazole, rifampin

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, high cholesterol, trouble swallowing, or a history of seizures. Tell your doctor if you have heart or blood vessel problems, including low blood pressure, heart failure, heart rhythm problems, or a history of heart attack or stroke.
• This medicine may cause the following problems:
  
  • High blood sugar levels
  • Low blood cell counts, which can increase your risk of infection
  • Neuroleptic malignant syndrome (can be life-threatening)
  • Tardive dyskinesia (trouble controlling movements), which may become permanent
• This medicine may make you dizzy, drowsy, or lightheaded, especially when you first use it or when the dose is changed. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly.
• This medicine may cause you to become overheated. Drink plenty of water during hot weather or when exercising.
• 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
• Fever, chills, cough, sore throat, body aches
• Increased hunger or thirst, frequent urination
• Jerky muscle movements that you cannot control (often in your face, tongue, or jaw), problems with balance or walking
• Lightheadedness, dizziness, drowsiness
• Seizures, tremors
• Sweating, confusion, uneven heartbeat, muscle stiffness

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

• Constipation, nausea, vomiting, stomach pain
• Headache
• 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