Vraylar (Cariprazine Hydrochloride )

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

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.

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.

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.

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

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.

Visit your doctor or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of this medicine. Notify your doctor or health care professional if your symptoms get worse, if you have new symptoms, if you are having an unusual effect from this medicine, or if you feel out of control, very discouraged or think you might harm yourself or others. 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 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.

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 -changes in emotions or moods -confusion -difficulty swallowing -feeling faint or lightheaded, falls -fever or chills, sore throat -inability to control muscle movements in the face, mouth, hands, arms, or legs -increased hunger or thirst -increased urination -missed or irregular menstrual periods -problems with balance, talking, walking -redness, blistering, peeling or loosening of the skin, including inside the mouth -seizures -stiff muscles -suicidal thoughts or other mood changes -unusually weak or tired Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -constipation -dizziness -drowsiness -nausea, vomiting -restlessness -upset stomach -weight gain

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.

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.

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.