Consumer Information for: TEVA-CHLORPROMAZINE

What the medication is used for

TEVA-CHLORPROMAZINE belongs to a group of medicines known as antipsychotics and antiemetics.

Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

What it does

TEVA-CHLORPROMAZINE 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 TEVA-CHLORPROMAZINE works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

When it should not be used

You should not use TEVA-CHLORPROMAZINE if you have:

An allergy to chlorpromazine hydrochloride to any of its ingredients or to phenothiazines
A medical condition known as pheochromocytoma (a tumor of the adrenal gland)
A severe heart or blood disorder
Had brain damage
Liver disease
A blood cell disorder such as anemia, low white blood cell counts, or low platelets
Drowsiness, slow breathing, weak pulse
Decreased alertness caused by taking certain medications or drinking alcohol
A scheduled anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)
Coma
Bone marrow that is not producing a normal number of blood cells

What the medicinal ingredient is

chlorpromazine hydrochloride

What the non-medicinal ingredients are

Colloidal silicon dioxide, hypromellose, maltodextrin, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol/macrogol, pregelatinized starch, sodium lauryl sulfate, titanium dioxide, triacetin

What dosage form it comes in

Film Coated Tablets; 25mg, 50mg and 100mg

Warnings and precautions

Serious Warnings and Precautions

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

BEFORE you use TEVA-CHLORPROMAZINE talk to your doctor or pharmacist if:

You have heart disease, glaucoma or prostatic hypertrophy
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 are addicted to alcohol. You should not take TEVA-CHLORPROMAZINE if you are under the effects of alcohol.
You are pregnant. TEVA-CHLORPROMAZINE 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 lung disease or breathing problems.
You have high or low blood pressure.
You have an abnormal number of blood cells.

TEVA-CHLORPROMAZINE 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 TEVA-CHLORPROMAZINE 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 TEVA-CHLORPROMAZINE are cautioned:

Against exposure to extreme heat
Protect your skin with clothing and sunscreen with a sun protection factor (SFP) of at least 30 before going into the sun.
Side effects may occur if TEVA-CHLORPROMAZINE is stopped suddenly after taking high doses of up to 1000 mg. Do not stop without your doctor’s approval.
That drugs such as TEVA-CHLORPROMAZINE 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 TEVA-CHLORPROMAZINE.

Interactions with this medication

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

Tell your doctor about all your prescription and over-the-counter 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 TEVA-CHLORPROMAZINE, 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 TEVA-CHLORPROMAZINE if you have drowsiness caused by other medications.

Drugs that may interact with TEVA-CHLORPROMAZINE include:
anti-anxiety agents, antidepressants, muscle relaxants, anti-seizure 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.

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 TEVA-CHLORPROMAZINE.

Proper use of this medication

Usual Dose

For management of psychotic disorders:
Adults: Initially, 25 to 75 mg daily in 2 to 4 divided doses or one single dose of 75 mg at bedtime. The dose may be increased by your doctor. Do not exceed 1000 mg per day.

For prevention and treatment of nausea and vomiting:
Adults: 12.5 to 25 mg every 4 to 6 hours as a starting dose. The dose may be increased by your doctor. The maximum recommended daily dose is 150 mg.

During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication. Some symptoms may begin to improve within about two weeks, but significant improvement can take several weeks.

Your doctor will decide which dose is best for you,; take the medication exactly as prescribed by your doctor:

Do not take this medication less often or decrease your dose without consulting your doctor.
Do not stop taking this drug suddenly without your doctor's approval as side effects may occur.
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.

How to take TEVA-CHLORPROMAZINE:

TEVA-CHLORPROMAZINE tablets must be swallowed whole and should not be chewed, dissolved or crushed, since chlorpromazine could be released too fast. The 25 mg, 50 mg and 100 mg tablets have a score line to facilitate halving, if directed by your doctor. The half tablets should also be swallowed intact.
Take the tablets with a full glass of water.
The tablets should be taken at the same time each day.

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 agitation, and confusion, drowsiness, dizziness, muscle stiffness or twitching, dry mouth, increased salivation, trouble swallowing, weakness, loss of balance or coordination, blurred vision and fainting.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your 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, TEVA-CHLORPROMAZINE 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: dry eyes, urinary incontinence, 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, sweating.

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

Your doctor should check your body weight before starting TEVA-CHLORPROMAZINE and continue to monitor it for as long as you are being treated. Your doctor should take blood tests before starting TEVA-CHLORPROMAZINE. They will 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, nurse, or pharmacist only if severe	Talk with your doctor, nurse, or pharmacist in all cases	Stop taking drug and seek immediate emergency medical attention
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.			✔
Seizures or fits			✔
Long-lasting (greater than 4 hours in duration) and painful erection of penis			✔
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.		✔
Tardive Dyskinesia: uncontrollable movements or twitches of the body, face, eyes or tongue, stretching the neck and body		✔
Fast or irregular heartbeat		✔
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 colour 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 TEVA-CHLORPROMAZINE, contact your doctor or pharmacist.

How to store

Store between 15 and 25°C.

Keep this and all medications out of the reach and sight of children.

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 three 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 MedEffect^TM 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

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English
1-877-777-9117 (French)
or druginfo@tevacanada.com

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9

Last revised: December 11, 2012

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