ABILIFY- aripiprazole tablet 
Bryant Ranch Prepack

----------

MEDICATION GUIDE

ABILIFY® (a BIL ĭ fī)

Generic name: aripiprazole

Read this Medication Guide before you start taking ABILIFY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ABILIFY?

(For other side effects, also see “What are the possible side effects of ABILIFY?”)

Serious side effects may happen when you take ABILIFY, including:

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:

What else do I need to know about antidepressant medicines?

What is ABILIFY?

ABILIFY is a prescription medicine used to treat:

The symptoms of schizophrenia include:

The symptoms of bipolar I disorder include:

The symptoms of major depressive disorder (MDD) include:

The symptoms of irritability associated with autistic disorder include:

The symptoms of agitation associated with schizophrenia or bipolar disorder include:

What should I tell my healthcare provider before taking ABILIFY?

Before taking ABILIFY, tell your healthcare provider if you have or had:

Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works.

Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY 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 ABILIFY?

If you take too much ABILIFY, 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 ABILIFY?

What are the possible side effects of ABILIFY?

Serious side effects have been reported with ABILIFY including:

Also see “What is the most important information I should know about ABILIFY?” at the beginning of this Medication Guide.

Common side effects with ABILIFY in adults include:

• nausea• inner sense of restlessness/need to move (akathisia)
• vomiting• anxiety
• constipation• insomnia
• headache• restlessness
• dizziness

Common side effects with ABILIFY in children include:

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

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist.

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 ABILIFY?

Keep ABILIFY and all medicines out of the reach of children.

General information about ABILIFY

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals. For more information about ABILIFY visit www.abilify.com.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets: cornstarch, hydroxypropyl, cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

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

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

1239550B2 03US12L-0104C Rev February 2012

© 2012, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan

Revised: 01/2013
 
Bryant Ranch Prepack