MEDICATION GUIDE

Aripiprazole (air-eh-PIP-rah-zole) Orally Disintegrating Tablets, USP

What is the most important information I should know about aripiprazole orally disintegrating tablets?
(For other side effects, also see “What are the possible side effects of aripiprazole orally disintegrating tablets?”).
Serious side effects may happen when you take aripiprazole orally disintegrating tablets, including:

• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole orally disintegrating tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole orally disintegrating tablets are not approved for the treatment of patients with dementia-related psychosis.
• Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

What are aripiprazole orally disintegrating tablets?

• Aripiprazole orally disintegrating tablets are a prescription medicine used to treat:
• Schizophrenia

It is not known if aripiprazole orally disintegrating tablets are safe or effective in children:

• under 13 years of age with schizophrenia
• under 10 years of age with bipolar I disorder

Do not take aripiprazole orally disintegrating tablets if you are allergic to aripiprazole or any of the ingredients in aripiprazole orally disintegrating tablets. See the end of this Medication Guide for a complete list of ingredients in aripiprazole orally disintegrating tablets.

Before taking aripiprazole orally disintegrating tablets, tell your healthcare provider about all your medical conditions, including if you have or had:

• diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start aripiprazole orally disintegrating tablets and also during therapy.
• seizures (convulsions).
• low or high blood pressure.
• heart problems or stroke.
• pregnancy or plans to become pregnant. It is not known if aripiprazole orally disintegrating tablets will harm your unborn baby.
• If you become pregnant while receiving aripiprazole orally disintegrating tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/ pregnancy registry/breast-feeding or plans to breast-feed. Aripiprazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive aripiprazole orally disintegrating tablets.
• low white blood cell count.
• phenylketonuria. Aripiprazole orally disintegrating tablets contain phenylalanine.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Aripiprazole orally disintegrating tablets and other medicines may affect each other causing possible serious side effects. Aripiprazole orally disintegrating tablets may affect the way other medicines work, and other medicines may affect how aripiprazole orally disintegrating tablets work.

Your healthcare provider can tell you if it is safe to take aripiprazole orally disintegrating tablets with your other medicines. Do not start or stop any medicines while taking aripiprazole orally disintegrating tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take aripiprazole orally disintegrating tablets?• Take aripiprazole orally disintegrating tablets exactly as your healthcare provider tells you to take them. Do not change the dose or stop taking aripiprazole orally disintegrating tablets yourself.

• Aripiprazole orally disintegrating tablets can be taken with or without food.
•  If you miss a dose of aripiprazole orally disintegrating tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of aripiprazole orally disintegrating tablets at the same time.
• If you have been prescribed aripiprazole orally disintegrating tablets, take it as follows:
• Do not open the bottle until ready to take the aripiprazole orally disintegrating tablet.
•  Immediately upon opening the bottle, using dry hands, remove the tablet and place the entire aripiprazole orally disintegrating tablet on the tongue.
•  Tablet disintegration occurs rapidly in saliva. It is recommended that aripiprazole orally disintegrating tablet be taken without liquid. However, if needed, it can be taken with liquid.
• Do not attempt to split aripiprazole orally disintegrating tablet.
• If you take too much aripiprazole, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking aripiprazole orally disintegrating tablets?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how aripiprazole orally disintegrating tablets affect you. Aripiprazole orally disintegrating tablets may make you drowsy.
• Avoid getting over-heated or dehydrated.
• Do not over-exercise.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun. Do not wear too much or heavy clothing.
• Drink plenty of water.

What are the possible side effects of aripiprazole orally disintegrating tablets?
Aripiprazole orally disintegrating tablets may cause serious side effects, including:

• See “What is the most important information I should know about aripiprazole orally disintegrating tablets?”
• Stroke in elderly people (cerebrovascular problems) that can lead to death
• Neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
• Uncontrolled body movements (tardive dyskinesia). Aripiprazole orally disintegrating tablets may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving aripiprazole orally disintegrating tablets. Tardive dyskinesia may also start after you stop receiving aripiprazole orally disintegrating tablets.
• Problems with your metabolism such as:
• High blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who take aripiprazole orally disintegrating tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start aripiprazole orally disintegrating tablets and during your treatment.

Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole orally disintegrating tablets:

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity
• Increased fat levels (cholesterol and triglycerides) in your blood.
• Weight gain. You and your healthcare provider should check your weight regularly.
• Unusual urges. Some people taking aripiprazole have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges.
  If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• Orthostatic hypotension (decreased blood pressure). Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position.
• Falls. Aripiprazole orally disintegrating tablets may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
• Low white blood cell count
• Seizures (convulsions)
• Problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot. It is important for you to drink water to avoid dehydration. See “What should I avoid while receiving aripiprazole orally disintegrating tablets?”
• Difficulty swallowing that can cause food or liquid to get into your lungs.

The most common side effects of aripiprazole orally disintegrating tablets in adults include:

• nausea
• vomiting
• constipation
• headache
• blurred vision
• upper respiratory illness
• dizziness
• anxiety
• insomnia
• restlessness
• inner sense of restlessness/need to move (akathisia)

The most common side effects of aripiprazole orally disintegrating tablets in children include:

• feeling sleepy
• headache
• vomiting
• fatigue
• increased or decreased appetite
• increased saliva or drooling
• insomnia
• nausea
• stuffy nose
• weight gain
• uncontrolled movement such as restlessness, tremor
• muscle stiffness

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store aripiprazole orally disintegrating tablets?

• Store at 20° to 25°C (68° to 77°F); excursions permitted within 15° to 30°C (59° to 86°F).

Keep aripiprazole orally disintegrating tablets and all medicines out of the reach of children.

General information about the safe and effective use of aripiprazole orally disintegrating tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole orally disintegrating tablets for a condition for which they were not prescribed. Do not give aripiprazole orally disintegrating tablets to other people, even if they have the same symptoms you have. They may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole orally disintegrating tablets that was written for healthcare professionals.

What are the ingredients in aripiprazole orally disintegrating tablets?
Active ingredient: Aripiprazole, USP
Inactive ingredients: acesulfame potassium, aspartame (which contains phenylalanine), cream vanilla, crospovidone, croscarmellose sodium, mannitol, magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and ferric oxide red.

Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

For more information about aripiprazole orally disintegrating tablets, call Orchid at 866-562-4590.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:
OrchidPharma, Inc.
Princeton, NJ 08540 USA

Manufactured by:

Orchid Healthcare
(A Division of Orchid Pharma Ltd.)
Irungattukottai - 602 117, India

Revised: 2/2021
948026731