Brexpiprazole oral tablets

What is this medicine?

BREXPIPRAZOLE (brex PIP ray zole) is an antipsychotic. It is used to treat schizophrenia. This medicine is also used in combination with antidepressants to treat major depressive disorder.

How should I use this medicine?

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

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 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

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• problems with balance, talking, walking

• restlessness or need to keep moving

• 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.

• suicidal thoughts or other mood changes

• trouble swallowing

• uncontrollable and excessive urges (examples: gambling, binge eating, shopping, having sex)

• uncontrollable head, mouth, neck, arm, or leg movements

• 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

• drowsiness

• headache

• stomach upset

• weight gain

What may interact with this medicine?

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

• aripiprazole

• metoclopramide

This medicine may also interact with the following medications:

• clarithromycin

• certain medicines for blood pressure

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole

• duloxetine

• fluoxetine

• paroxetine

• quinidine

• 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). 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

• high cholesterol or high levels of triglycerides in the blood

• history of stroke

• kidney disease

• liver disease

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

• 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 brexpiprazole, 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 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.

There have been reports of uncontrollable and strong urges to gamble, binge eat, shop, and have sex while taking this medicine. If you experience any of these or other uncontrollable and strong urges while taking this medicine, you should report it to your health care provider as soon as possible.

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.