Auro-Aripiprazole: Uses, Side Effects and Dosage

Serious Warnings and Precautions

AURO-ARIPIPRAZOLE belongs to a group of medicines called atypical antipsychotics. These medicines have been linked to a higher rate of death when used in elderly patients with dementia (which is the loss of memory and other mental abilities).

AURO-ARIPIPRAZOLE is not to be used if you are elderly and have dementia.

What is AURO-ARIPIPRAZOLE used for?

AURO-ARIPIPRAZOLE is used for the treatment of schizophrenia in adults and in adolescents (15-17 years of age). Not all people with this disorder have the same symptoms. Some of the most common symptoms of schizophrenia may include:

• hallucinations (seeing, feeling, hearing or smelling things that are not there)
• delusions (believing things that are not true)
• paranoia (not trusting others or feeling very suspicious)
• avoiding family members and friends and wanting to be alone
• feeling depressed, anxious or tense

AURO-ARIPIPRAZOLE is not a cure, but it can help manage your symptoms and in adult patients may reduce the risk of relapse.

How does AURO-ARIPIPRAZOLE work?

Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain may be due to certain chemicals (dopamine and serotonin) in the brain being out of balance. These imbalances may cause some of the symptoms you may be experiencing. Exactly how AURO-ARIPIPRAZOLE works is unknown. However, it seems to correct the balance of these chemicals.

What are the ingredients in AURO-ARIPIPRAZOLE?

Medicinal ingredient: aripiprazole

Non-medicinal ingredients: Cellulose microcrystalline, Colloidal Anhydrous, Hydroxypropyl cellulose, Lactose monohydrate, Magnesium Stearate, Maize starch, Coloring agents (2 mg: Ferric oxide

(Sicovit yellow 10) and FD&C Blue No.2 lake/ Indigo Carmine aluminium Lake; 5 mg: FD&C Blue No.2 lake/ Indigo Carmine aluminium Lake; 15 mg: Ferric oxide (Sicovit yellow 10); 10 mg & 30 mg: Ferric oxide (Sicovit Red 30) and silica

AURO-ARIPIPRAZOLE comes in the following dosage forms:

Tablets; 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg.

Do not use AURO-ARIPIPRAZOLE if:

• You are allergic to aripiprazole or to any of the ingredients in AURO-ARIPIPRAZOLE (see list of Non- medicinal ingredients). AURO-ARIPIPRAZOLE contains lactose.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AURO-ARIPIPRAZOLE. 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 AURO-ARIPIPRAZOLE 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 AURO-ARIPIPRAZOLE 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 AURO-ARIPIPRAZOLE:

  • Galactose intolerance
  • Glucose-galactose malabsorption

• are pregnant, think you are pregnant or plan to become pregnant. It is not known if AURO-ARIPIPRAZOLE may harm your unborn baby.

• are breastfeeding or plan to breastfeed. AURO-ARIPIPRAZOLE 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 AURO-ARIPIPRAZOLE.

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 AURO-ARIPIPRAZOLE:

• 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 AURO-ARIPIPRAZOLE, 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 AURO-ARIPIPRAZOLE 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 AURO-ARIPIPRAZOLE. 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 AURO-ARIPIPRAZOLE.

• 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 AURO-ARIPIPRAZOLE. 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 AURO-ARIPIPRAZOLE. They should continue to monitor it for as long as you are being treated with AURO-ARIPIPRAZOLE.

Driving and Using Machines: You should avoid driving a car or using machinery until you know how AURO-ARIPIPRAZOLE 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 AURO-ARIPIPRAZOLE and while you are taking it. These tests will monitor:

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

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with AURO-ARIPIPRAZOLE:

• ketoconazole or itraconazole, used to treat fungal infections
• quinidine, used to treat abnormal heartbeats
• paroxetine or fluoxetine, used to treat depression
• carbamazepine, used to treat seizures
• medicines used to lower your blood pressure
• alcohol. The effects of alcohol can be made worse if you drink alcohol while taking AURO-ARIPIPRAZOLE. Do NOT drink alcohol while taking AURO-ARIPIPRAZOLE.

While on AURO-ARIPIPRAZOLE, only take other medicines if your doctor tells you to.

How to take AURO-ARIPIPRAZOLE:

• Take AURO-ARIPIPRAZOLE exactly as your healthcare professional tells you to take it.
• Your doctor has decided on the best dosage for you based on your individual situation, but may change your dose depending on how you respond.
• Even if you feel better, do NOT change your dose or stop taking AURO-ARIPIPRAZOLE without speaking to your healthcare professional.

• AURO-ARIPIPRAZOLE can be taken with or without food. Always take the tablet with water and swallow it whole.

• Try to take AURO-ARIPIPRAZOLE at the same time each day.

Usual dose:

Schizophrenia

Usual adult dose: 10 mg or 15 mg once a day. However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Usual adolescent (15 -17 years of age) dose: 10 mg once a day. At the start of treatment, your doctor will prescribe a lower daily dose (2 mg) and will increase the dose to 5 mg once a day after 2 days and to the target dose of 10 mg once a day after 2 additional days. Depending on how well you respond and tolerate the 10 mg dose, your doctor may prescribe a lower or higher dose, to a maximum of 30 mg once a day.

AURO-ARIPIPRAZOLE is NOT for use in children under the age of 15 years for the treatment of schizophrenia.

Overdose:

Missed Dose:

If you miss a dose, take the missed dose as soon as you remember. If most of the day has passed, wait until your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using AURO-ARIPIPRAZOLE?

These are not all the possible side effects you may feel when taking AURO-ARIPIPRAZOLE. If you experience any side effects not listed here, contact your healthcare professional.

You should tell the doctor if you notice any symptoms that worry you, even if you think it is not connected with the medicine. If any of these effects are severe, tell the doctor, nurse or pharmacist.

Side effects may include:

• insomnia
• changes in weight (gain or loss)
• feeling restless
• headache
• anxiety
• drowsiness
• diarrhea, nausea and vomiting
• constipation
• an urge to gamble, to spend money, to eat (binge eating) or other urges (development of a new or increased urge)
• hypersexuality (uncontrollable and/or inappropriate sexual behaviour of severity or duration that causes distress)
• shaking (tremors)
• abnormal movements
• dizziness
• sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
• sleep walking and eating while asleep (sleep-related eating disorders)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store AURO-ARIPIPRAZOLE at room temperature (15ºC - 30ºC). Do not use AURO-ARIPIPRAZOLE after the expiry date which is stated on the label or carton after EXP.

Keep out of the reach and sight of children.

If you want more information about AURO-ARIPIPRAZOLE:

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.

Last revised: March 17, 2022.