When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to lurasidone, or if you are using certain medications such as ketoconazole (Nizoral®) or rifampin (Rifadin®, Rimactane®). Make sure your doctor knows what medications you are taking and if you start a new medicine. This medicine should not be used in elderly patients who have a mental illness called dementia-related psychosis.

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.
• It is best to take this medicine with food or milk.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses.

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

• Make sure your doctor knows if you are also using diltiazem (Cardizem®). Make sure your doctor knows all of the medications you are taking (including over-the-counter medicines). Your doctor should be notified if you start taking any new medication.
• 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:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, blood or bone marrow problems, prolactin-dependent breast cancer, diabetes, trouble with swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, a low amount of blood, heart rhythm problems, or a history of a heart attack or stroke. Also, tell your doctor if you have had thoughts of hurting yourself or others.
• Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
• Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: lip smacking or puckering; puffing of the cheeks; rapid, worm-like movements of the tongue; uncontrolled chewing movements; or other uncontrolled movements of the arms and legs.
• This medicine may cause an increase in your blood sugar. If you have diabetes, you may need to check your blood sugar more often. Check with your doctor right away if you have increased thirst or increased urination, or if you have any questions.
• This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
• This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.
• This medicine should not be used to treat mental disorders in elderly patients who have dementia. Using this medicine to treat this condition could increase the risk for serious side effects, including death. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease or dementia).
• Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
• This medicine may make you dizzy, drowsy, have trouble with thinking, or have trouble with controlling body movements. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert, well-coordinated, or able to think well.
• This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.
• This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies. If you or your caregiver notice any of these side effects, tell your doctor right away.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for unwanted effects.

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
• Chest pain.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Increased thirst, hunger, or urination.
• Lightheadedness, dizziness, or fainting.
• Mood or behavioral changes, or thoughts of hurting yourself or others.
• Neck muscle spasm, throat tightness, difficulty with swallowing or breathing, or sticking out of the tongue.
• Seizures.
• Twitching or muscle movements you cannot control (often in your face, tongue, or jaw).

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

• Anxiety or restlessness.
• Diarrhea, nausea, vomiting, or upset stomach.
• Sleepiness or unusual drowsiness.
• Tiredness.
• Trouble sleeping.
• 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