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CARIPRAZINE (car i PRA zeen) treats schizophrenia and bipolar disorder. It may also be used with antidepressant medication to treat depression. It works by balancing the levels of dopamine and serotonin in your brain, substances that help regulate mood, behaviors, and thoughts. It belongs to a group of medications called antipsychotics. Antipsychotic medications can be used to treat several kinds of mental health conditions.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed to children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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 medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

This medication may cause harm and death if taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome
• Infection—fever, chills, cough, or sore throat
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Pain or trouble swallowing
• Seizures
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Thoughts of suicide or self-harm, worsening mood, feelings of depression
• Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS)

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

• Constipation
• Dizziness
• Drowsiness
• Nausea
• Trouble sleeping
• Upset stomach
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

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

• Dehydration
• Dementia
• Diabetes
• Have had a heart attack or stroke
• Have, have had, or someone in your family has suicidal thoughts, plans, or attempt
• Heart disease
• High cholesterol
• High or low blood pressure
• Kidney disease
• Liver disease
• Low white blood cell levels
• Parkinson disease
• Seizures
• Trouble swallowing
• An unusual or allergic reaction to cariprazine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Metoclopramide

This medication may also interact with the following:

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Grapefruit and foods or drinks that contain grapefruit
• Medications for blood pressure
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Some antihistamines
• Some medications for depression, such as amitriptyline or trazodone
• Some medications for seizures, such as phenobarbital or primidone
• St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.

This medication may worsen depression and cause thoughts of suicide. This can happen at any time but is more common after first starting treatment and after a change in dose. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide. They can help you.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.

This medication may make it hard for your body to regulate its temperature so that you feel warm. Do not exercise too much. Stay indoors during hot weather. Do not wear too much or heavy clothing. Stay out of the sun. Do not wear too much or heavy clothing. Make sure you stay hydrated. Drink water often. Eat fruits and veggies that have a high water content. Drink more water when it is hot or you are active.

Talk to your care team if you may be pregnant. There are benefits and risks to taking medications during pregnancy. Your care team can help you find the option that works for you.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia.

This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.