Consumer Information for: PMS-PROCHLORPERAZINE TAB 5MG

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

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Prochlorperazine belongs to a group of medicines called “phenothiazines”. It is used for the management of the symptoms of psychotic disorders such as excessive anxiety, tension, confusion, delusions, and agitation.
It also can be used to control nausea and vomiting.

Prochlorperazine Mesylate Injection BP

Prochlorperazine belongs to a group of medicines called “phenothiazines”. It is used for the management of the symptoms of psychotic disorders such as excessive anxiety, tension, confusion, delusions, and agitation. It also can be used to control nausea and vomiting.

What it does

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

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

Prochlorperazine Mesylate Injection BP

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

When it should not be used

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

You should not use pms-PROCHLORPERAZINE if you have:

  • An allergy to prochlorperazine, 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 vessel disorder
  • Severe kidney problems
  • Has 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
  • You are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)

Prochlorperazine Mesylate Injection BP

You should not use pms-PROCHLORPERAZINE if you have:

  • An allergy to prochlorperazine, 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 vessel disorder
  • Severe kidney problems
  • Has 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
  • You are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)
What the medicinal ingredient is

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Prochlorperazine

Prochlorperazine Mesylate Injection BP

Prochlorperazine (as prochlorperazine mesylate)

Also contains the non medicinal ingredient: sodium sulfite

What the non-medicinal ingredients are

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Tablets: colloidal silicon dioxide, croscarmellose sodium, D&C yellow # 10 Aluminum Lake, FD&C yellow # 6 lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol.
Suppositories: wecobee.

What dosage form it comes in

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Tablet: 5 mg and 10 mg
Suppository: 10 mg

Prochlorperazine Mesylate Injection BP

Injection: 5 mg/mL

Warnings and precautions

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Serious Warnings and Precautions

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

Before you use pms-PROCHLORPERAZINE talk to your doctor or pharmacist if:

  • 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 heart disease, glaucoma or prostatic hypertrophy
  • You are addicted to alcohol. You should not take pms- PROCHLORPERAZINE if you are under the effects of alcohol.
  • You are pregnant. pms-PROCHLORPERAZINE should not be used during pregnancy unless your doctor considers the benefits to you markedly outweighs 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 breastfeeding.

pms-PROCHLORPERAZINE 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 pms- PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE are cautioned:

  • Against exposure to extreme heat
  • That drugs such as pms-PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE.

Prochlorperazine Mesylate Injection BP

Serious Warnings and Precautions

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

Before you use pms-PROCHLORPERAZINE talk to your doctor or pharmacist if:

  • 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 heart disease, glaucoma or prostatic hypertrophy
  • You are addicted to alcohol. You should not take pms- PROCHLORPERAZINE if you are under the effects of alcohol.
  • You are pregnant. pms-PROCHLORPERAZINE should not be used during pregnancy unless your doctor considers the benefits to you markedly outweighs 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 breastfeeding.

pms-PROCHLORPERAZINE 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 pms- PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE are cautioned:

  • Against exposure to extreme heat
  • That drugs such as pms-PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE.
Interactions with this medication

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

pms-PROCHLORPERAZINE can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on pms- PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE, 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 pms-PROCHLORPERAZINE if you have drowsiness caused by other medications.

Drugs that may interact with pms-PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE.

Prochlorperazine Mesylate Injection BP

pms-PROCHLORPERAZINE can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on pms- PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE, 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 pms-PROCHLORPERAZINE if you have drowsiness caused by other medications.

Drugs that may interact with pms-PROCHLORPERAZINE 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 pms-PROCHLORPERAZINE.

Proper use of this medication

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Take this medication 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 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.

Usual dose

For treatment of psychiatric illness:
Usual initial adult dose: 10 mg three or four times daily. Doses vary according to individual condition, should be increased gradually by your doctor until your condition is under control.

For treatment of nausea and vomiting:
Usual adult dose: 5 mg to 10 mg, three or four times daily. In mild cases a single dose of 5 to 10 mg may be used.

Children's doses: usually based on weight, and given in divided doses. Not for children under 2 years of age or body weight less than 9 kg.

Your dosage may be increased or decreased by your doctor depending on your response to the treatment.

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, 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 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.

Prochlorperazine Mesylate Injection BP

Take this medication 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 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.

Usual dose

Your doctor will decide which dose is best for you.

Your dosage may be increased or decreased by your doctor depending on your response to the treatment.

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, 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 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, pms-PROCHLORPERAZINE 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, dizziness, drowsiness, dry mouth, nasal congestion, skin changes, insomnia, depression, agitation, anxiety, restlessness, excitement and bizarre dreams, decreased appetite, swelling of the hands and/or feet, 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 pms- PROCHLORPERAZINE and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting pms- PROCHLORPERAZINE. 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 or pharmacist Only if severe Talk with your doctor 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 spasm, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want.     ✔
Fast or irregular heartbeat   ✔  
Seizures or fits     ✔
Long-lasting (greater than 4 hours in duration) and painful erection of the 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 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 ✔    
Uncommon
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.   ✔  

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

Prochlorperazine Maleate Tablets USP and Prochlorperazine Suppositories USP

Store between 15°C and 30°C.
Protect unwrapped suppository from light.
Do not use after the expiry date shown on the bottle/boxes.
Keep this and all medications out of the reach and sight of children.

Prochlorperazine Mesylate Injection BP

Store between 15°C and 30°C. Protect from light.
Discard if marked discoloration.
Do not use after the expiry date shown on the boxes.
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 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 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

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

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Pharmascience Inc. at, 1-888-550-6060.

This leaflet was prepared by
        Pharmascience Inc.
        Montreal Quebec
        H4P 2T4

Last revised: December 20, 2012

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