Consumer Information for: PIMOZIDE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Pimozide is used to control the symptoms of chronic schizophrenia where the main manifestations do not include excitement, agitation or hyperactivity.

What it does

Pimozide is an antipsychotic medication which affects chemicals in the brain that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how Pimozide works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

When it should not be used

Pimozide should not be used to manage mania or acute schizophrenia.

You should not use Pimozide if you:

  • Have an allergy to pimozide, to any of the ingredients in Pimozide or components of the container, or to phenothiazines
  • Have a medical condition known as pheochromocytoma (a tumor of the adrenal gland)
  • Have a severe heart disorder or a family history of heart disorders such as long QT syndrome, Torsade de Pointes or arrhythmia
  • Have a severe blood vessel or blood disorder
  • Have severe kidney problems
  • Have had brain damage
  • Have liver disease
  • Have a blood cell disorder such as anemia, low white blood cell counts, low platelets
  • Have drowsiness, slow breathing, weak pulse
  • Have decreased alertness caused by taking certain medications or drinking alcohol
  • Are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)
  • Have Parkinson’s syndrome
  • Have a depressive disorder
  • You are under treatment of tics
  • You have family history of irregular heartbeats
  • Have central nervous system depression or comatose states
  • Are being treated with the following drugs:
    1. CYP 3A4-inhibiting drugs such as antifungal drugs (e.g.micronazole, ketonazole), antiviral (e.g. Saquinavir, Ritonavir), macrolide antibiotics (e.g. Clarithromycin and erythromycin) and nefazodone.
    2. CYP 2D6-inhibiting drugs such as quinidine
    3. Selective Serotonin Reuptake Inhibitor antidepressants such as sertraline, paroxetine, citalopram and escitalopram.
What the medicinal ingredient is

Pimozide.

What the non-medicinal ingredients are

Anhydrous Lactose, Croscarmellose Sodium, Magnesium Stearate

4 mg Tablets: contains additional D & C Yellow #10 Aluminium Lake 14-18%, Indigotine AL Lake 12-14% (Blue #2).

What dosage form it comes in

Tablets, 2 mg and 4 mg

Warnings and precautions

Serious Warnings and Precautions

Studies with various medicines of the group to which pimozide belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death. Pimozide is not indicated in elderly patients with dementia.

BEFORE you use Pimozide talk to your doctor or pharmacist if:

  • You have a history of problems with the heart and/or blood vessels
  • You are prone to low blood pressure (hypotension)
  • You have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives ("The Pill")
  • You have glaucoma or prostatic hypertrophy
  • You are addicted to alcohol. You should not take Pimozide if you are under the effects of alcohol
  • You are pregnant. Pimozide should not be used during pregnancy unless your doctor considers the benefits to you markedly outweigh the potential risks to the fetus
  • You are taking barbiturates, painkillers, narcotics or, antihistamines or other drugs that make you drowsy
  • You have any allergies to this drug or its ingredients
  • You have or ever had a blackout or seizure
  • You are breast feeding
  • You have a history of breast cancer

Pimozide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, especially during the first few days of therapy. You should be cautious when performing potentially hazardous tasks.

Effects on Newborns:
In some cases, babies born to a mother taking Pimozide during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.

People who take Pimozide are cautioned:

  • Against exposure to extreme heat
  • That drugs such as Pimozide increase the toxicity of certain types of insecticides ("organophosphorous" insecticides) including insecticides for agriculture (farming), treating animals (flea and tick control) and for treating pests around the house and garden. Be cautious if you must use these products while taking Pimozide.
Interactions with this medication

Pimozide can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on Pimozide therapy.

Because substances in grapefruit juice may interact with Pimozide, you should avoid grapefruit juice when taking Pimozide.

Tell your doctor about all your prescription and over-thecounter medications, vitamins, minerals, herbal products (such as St. John’s Wort), and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Before using Pimozide, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxants, and medicine for seizures, depression, or anxiety). You should not take Pimozide if you have drowsiness caused by other medications.

Some MEDICINES MAY INTERACT with Pimozide. Tell your health care provider if you are taking: Anti-anxiety agents, antidepressants, muscle relaxants, antiseizure medicine, high blood pressure medicine, cabergoline, metrizamide, guanethidine, guanadrel, grepafloxacin, sparfloxacin, lithium, cisapride, atropine-like drugs, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, drowsiness-causing antihistamines (e.g., diphenhydramine), other drugs that may make you drowsy, levodopa, antimicrobial and antiviral medications (such as azole antimycotics, antiviral protease inhibitors, macrolide antibiotics and analogues, quinolone antibiotics, pentamidine, antimalarials (i.e. quinine), amphotericin B), antiarrhythmics, antipsychotics, domperidone, 5-HT3 antagonists, tacrolimus, beta-2-adrenoceptor agonists, diuretics, laxatives and enemas and high dose corticosteroids.

Many cough-and-cold products contain ingredients that may add a drowsiness effect. Before using cough-and-cold medications, ask your doctor or pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

This list is not complete and there may be other drugs that can interact with Pimozide.

Proper use of this medication

Take this medication by mouth exactly as prescribed. During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication. Do not take this medication more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop taking this drug suddenly without your doctor's approval.

Your doctor will decide which dose is best for you.

Adult usual Dose

Pimozide is usually taken once daily in the morning. Follow your doctor’s instructions.

Take Pimozide tablets with a full glass of water.

Pimozide is not recommended for use in patients under 18 years of age or in patients 65 years of age or older.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Overdose symptoms may include irregular heartbeat, low blood pressure, agitation, and confusion, drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, and fainting

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for the next dose wait until then to take the medicine and skip the missed dose. Do not double your dose to make up the missed dose.

Side effects and what to do about them

Like other medications, Pimozide may cause some side effects. These side effects may be minor and temporary. However, some may be serious and need medical attention.

Side effects may include: sweating, urinary incontinence, severe constipation, dizziness, drowsiness, dry mouth, nasal congestion, nausea and vomiting, headache, menstrual changes, change in libido, swelling of the breasts and milk production in both men and women, weight changes and blurred vision.

If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting Pimozide and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting Pimozide to monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency assistance
Unknown
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Neuroleptic Malignant Syndrome: any group of symptoms which may include high fever, sweating, stiff muscles, fast heartbeat, fast breathing and feeling confused, drowsy or agitated     ✔
Extrapyramidal Symptoms: muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want     ✔
Fast or irregular heartbeat   ✔  
Seizures or fits     ✔
Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations   ✔  
Long-lasting (greater than 4 hours in duration) and painful erection of penis     ✔
Tardive Dyskinesia: uncontrollable movements or twitches of the body, face, eyes or tongue, stretching the neck and body   ✔  
Low Blood Pressure: feeling of lightheadedness or fainting especially when getting up from a lying or sitting position   ✔  
High Blood Pressure: headaches, vision disorders, nausea and vomiting   ✔  
Decreased sweating   ✔  
Jaundice: yellow color to skin and eyes, dark urine   ✔  
Respiratory Infection: fever, flu-like symptoms, coughing, difficult or fast breathing   ✔  
New or worsening Constipation   ✔  
Akathisia: a feeling of restlessness, inability to remain motionless   ✔  
Vision Changes: blurred vision, glaucoma or other eye disorder   ✔  
Increased Blood Sugar: frequent urination, thirst and hunger ✔    

This is not a complete list of side effects. For any unexpected effects while taking PIMOZIDE, contact your doctor or pharmacist.
How to store

Store Pimozide tablets at room temperature (15⁰C-30⁰C) in well-closed containers.

Do not use after the expiry date shown on the bottle.

Keep this medication and all medications out of the reach and sight

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701E
                     Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, AA Pharma Inc. at:

1-877-998-9097

This leaflet was prepared by AA Pharma Inc., Vaughan, Ontario, L4K 4N7.

Date of Revision: March 11, 2014

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