Consumer Information for: ABILIFY

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ABILIFY. Talk about any health conditions or problems you may have, including if you:

• have or have a family history of diabetes or high blood sugar. Your doctor should check your blood sugar before you start taking ABILIFY and during your treatment.
• have or have had blackouts or seizures (convulsions).
• have or have had high blood pressure.
• suffer from high blood pressure or have rapid heart-beat and a drop in blood pressure when getting up.
• have a history of:
• stroke
• mini-stroke
• high blood pressure

Medicines like ABILIFY can raise the risk of stroke/mini-stroke in elderly people who have dementia.

• have or have a family history of:
• heart problems
• a condition called “congenital long QT syndrome” or “acquired long QT syndrome”
• any problems with the way your heart beats
• heart disease
• are taking any medication that affects how your heart beats.
• are an elderly patient and suffer from dementia (loss of memory and other mental abilities).
• are at risk for developing blood clots. Risk factors include:
• having a family history of blood clots
• being over the age of 65
• smoking
• being overweight
• having a recent major surgery (such as hip or knee replacement)
• not being able to move due to air travel or other reasons
• taking oral birth control (“The Pill”)
• have or have had a low white blood cell count.
• have or have had involuntary, irregular muscle movements, especially in the face (tardive dyskinesia).
• drink alcoholic beverages or use recreational drugs
• have a history of drug abuse or addiction.
• have a history of gambling or impulse-control disorders (urge to gamble, spend money, eat or other urges).
• have a history of or are at risk of sleep apnea (a sleep disorder where your breathing is interrupted during sleep).
• have been told you are a “CYP2D6 poor metabolizer”.
• suffer from lactose intolerance or have one of the following rare hereditary diseases because lactose is a non-medicinal ingredient in ABILIFY:
• Galactose intolerance
• Glucose-galactose malabsorption
• are pregnant, think you are pregnant or plan to become pregnant. It is not known if ABILIFY may harm your unborn baby.
• are breastfeeding or plan to breastfeed. ABILIFY can pass into your milk and harm your baby. Talk to your healthcare professional about the best way to feed your baby if you take ABILIFY.

Other warnings you should know about:

Self-harm: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital right away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses. Ask them to read this leaflet. You might ask them to tell you if they:

• think your depression or mental illness is getting worse, or
• are worried about changes in your behaviour

Impulse Behaviours: The following behaviours may occur in some people who take ABILIFY:

• hypersexuality (uncontrollable and/or inappropriate sexual behaviour)
• an urge to gamble, spend money, binge eat, other urges or the development of new or increased urge

Tell your doctor right away if you or those close to you notice these behaviours.

Complex Sleep-Related Behaviours: While taking medicines such as ABILIFY, you may get out of bed while not being fully awake and do activities that you do not know you are doing, such as:

• sleep-walking
• eating

The next morning you may not remember that what you did during the night.

Effects in Newborns: In some cases, babies born to a mother taking ABILIFY during pregnancy have symptoms that are severe that require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. You should be ready to get emergency medical help for your newborn, if he/she:

• has trouble breathing
• is overly sleepy
• has muscle stiffness or floppy muscles (like a rag doll)
• is shaking or
• is having trouble feeding

Falls: The following symptoms have been reported with the use of antipsychotic drugs:

• feeling sleepy,
• a fall in blood pressure when you stand up from sitting or lying down,
• vision or speech problems

This can lead to falls that may cause fractures or other fall-related injuries. Certain medications, diseases or conditions can make this worse.

Severe Skin Reactions: In very rare cases, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with ABILIFY. Other skin reactions such as Stevens - Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP) that can be serious or life-threatening have been reported in very rare cases with atypical antipsychotics.

These skin reactions can spread to your mouth, lips, face, hands, trunk (torso), arms and legs. Talk to your healthcare professional right away if you experience:

• fever
• severe rash
• peeling skin
• swelling of the face
• swollen lymph glands
• flu-like feeling
• yellow skin or eyes
• shortness of breath
• swelling of the legs
• dry cough
• chest pain or discomfort
• feeling thirsty
• urinating less often, less urine or dark urine

Dehydration and Overheating: It is important not to become too hot or dehydrated while you are taking ABILIFY.

• Do not exercise too much
• In hot weather, stay inside in a cool place if possible
• Stay out of the sun
• Do not wear too much clothing or heavy clothing
• Drink plenty of water.

Neuroleptic Malignant Syndrome (NMS): NMS is potentially a life-threatening condition that has been reported with the use of antipsychotic drugs like ABILIFY. Symptoms include:

• severe muscle stiffness or inflexibility with high fever,
• rapid or irregular heartbeat,
• sweating,
• state of confusion or reduced consciousness

Weight Gain: Your doctor should check your body weight before starting ABILIFY. They should continue to monitor it for as long as you are being treated with ABILIFY.

Driving and Using Machines: You should avoid driving a car or using machinery until you know how ABILIFY affects you. Some people experience:

• a change (reduced) judgment, thinking and motor skills
• feeling sleepy
• feeling light-headed (especially when going from sitting to standing) and
• possible fainting

Blood Tests: Your doctor should do blood tests before starting treatment with ABILIFY and while you are taking it. These tests will monitor:

• blood sugar
• cholesterol
• triglycerides and
• white blood cell count.