Cariprazine oral capsules

What is this medicine?

CARIPRAZINE (car i PRA zeen) is an antipsychotic. It is used to treat schizophrenia or bipolar disorder. Bipolar disorder is also known as manic-depression.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You may take it with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• fever or chills, sore throat

• inability to keep still

• problems with balance, talking, walking

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of neuroleptic malignant syndrome such as confusion; fast or irregular heartbeat; high fever; increased sweating; stiff muscles

• sudden numbness or weakness of the face, arm, or leg

• suicidal thoughts or other mood changes

• trouble swallowing

• uncontrollable movements of the arms, face, head, mouth, neck, or upper body

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• drowsiness

• nausea, vomiting

• upset stomach

• weight gain

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• metoclopramide

This medicine may also interact with the following medications:

• carbamazepine

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for sleep

• itraconazole

• ketoconazole

• medicines for blood pressure

• rifampin

• St John's wort

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dementia

• diabetes

• difficulty swallowing

• heart disease

• history of breast cancer

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low blood pressure

• Parkinson's disease

• seizures

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to cariprazine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Ask your doctor or health care professional for advice.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. The effects of this medicine on an unborn child are not known. A registry is available to monitor pregnancy outcomes in pregnant women exposed to this medicine or similar medicines. Talk to your health care professional or pharmacist for more information.