Lumateperone Oral Capsule (LUMATEPERONE - ORAL)

Instructions

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Avoid grapefruit and grapefruit juice while on this medicine.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Avoid becoming overheated during exercise or other activities. Try to stay cool in hot weather.

Family should check on the patient often. Call the doctor if patient becomes more depressed, has thoughts of suicide, or shows changes in behavior.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not take St. John's wort while on this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness or drowsiness
• dry mouth
• lightheadedness
• nausea

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• agitated feeling or trouble sleeping
• anger or hostile feelings
• change in behavior
• confusion
• fast or irregular heart beats
• unusual strong urges - such as increased need to shop, gamble, or have sex
• irritability
• signs of kidney damage (such as change in urine color or bubbly urine)
• uncontrollable movement of face, tongue, arms or legs
• muscle pain or weakness
• tight or rigid muscles
• talking quickly
• suicidal thoughts
• excessive or unusual sweating
• excessive thirst
• unusual or unexplained tiredness or weakness
• increased urinary frequency
• waking up at night to urinate
• dark urine
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.