Stemetil: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Stemetil^® is used to treat symptoms of psychotic disorders such as agitation, confusion, delusion, tension and anxiety.

Stemetil^® is also used for the control of nausea and vomiting.

Ask your doctor if you have any questions about why Stemetil^® has been prescribed to you.

What it does:

Stemetil^® helps to:

• reduce and control psychotic symptoms
• control nausea and vomiting
• induce sleep

When it should not be used:

Do not use Stemetil^® if you:

• Are allergic to Stemetil^®, to phenothiazines (a type of

  antipsychotic) or to any of the ingredients in the product (see the section “What the non-medicinal ingredients are”)

• Have a sudden blood circulation failure or are in an altered

  state of consciousness or coma, especially if these were caused by alcohol or drugs

• Suffer from severe depression
• Have liver disease
• Have a blood disorder
• Have kidney problems

• Have pheochromocytoma (a tumour of the adrenal gland)

  • Have severe heart or blood vessel disorders
  • Have or have had brain damage
  • Are taking high doses of drugs that cause you to sleep

Stemetil^® is not indicated for use in children undergoing a surgery.

What the medicinal ingredient is:

Suppositories: Prochlorperazine

Injection: Prochlorperazine

What the nonmedicinal ingredients are:

Suppositories: hydrogenated vegetable glycerides

Injection: Sodium chloride, sodium citrate, sodium sulphite anhydrous and water for injection.

What dosage forms it comes in:

Suppositories 10 mg

Injection: 10 mg/2 mL prochlorperazine as prochlorperazine mesylate

WARNINGS AND PRECAUTIONS

At the beginning of treatment, Stemetil^® may cause some people to become drowsy or less alert. You should not drive a car, operate machinery or participate in activities requiring alertness until you are sure Stemetil^® does not affect you.

You should use extra care not to be exposed to extreme heat or some type of insecticides. Check with your doctor or pharmacist.

Children seem to be more susceptible than adult to some side effects. Stemetil^® should not be used in children under 2 years old unless the doctor decides that Stemetil^® is needed.

The incidence of adverse reactions may be greater in patients over 55 years of age. The lowest effective dose should be used to reduce the risk of having adverse reactions.

If you experience severe constipation and you are elderly, please consult your doctor as soon as possible.

Tardive dyskinesia, neuroleptic malignant syndrome cardiac, eye, skin and respiratory problems may occur in some patients taking Stemetil^® (see the section “SIDE EFFECTS AND WHAT TO

DO ABOUT THEM”).

Before using Stemetil^®, tell your doctor if you:

• Have heart or blood vessel disease
• Have cerebrovascular (blood vessels of the brain) disorder
• Have constipation or intestinal blockage
• Have or have had a brain tumour or brain damage

• Suffer from an enlarged prostate (Benign Prostatic

  Hypertrophy)

• Suffer from an increase pressure within the eyes

  (glaucoma)

• Have or have had seizure disorders (e.g. epilepsy or have

  members of your family with seizure disorders)

• Have or have had breast cancer

• Plan to have surgery (or a procedure requiring

  anaesthetics)

• Are or are planning to become pregnant

• Are breast-feeding

During long-term treatment, blood, liver, and kidney tests should be done at regular intervals.

INTERACTIONS WITH THIS MEDICATION

Stemetil ^®

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

Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.

Stemetil ^® can add to the effects of other drugs that cause drowsiness. Some examples of drugs that can cause drowsiness are:

• Drugs for allergies
• Drugs for insomnia
• Drugs for pain
• Drugs for seizure
• Drugs for depression

• Drugs for mental illness

  Stemetil ^® may cause a false pregnancy test result. Please check with your doctor if this happens.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor has decided the best dose for you based on your individual situation and needs. It is important to take Stemetil^® the way your doctor told you. Your doctor may increase or decrease your dose depending on your response.

You may experience side effects if the drug is stopped suddenly. Contact your physician before stopping your drug.

Adults

Rectal route: To control nausea, vomiting or anxiety, the usual dose is 5 to 10 mg, 3 or 4 times daily; in mild cases, a single dose of 5 to 10 mg is often adequate.

Injection in the muscle: Total daily dose rarely exceeds 40 mg, except in severe cases.

Injection in the vein: Stemetil^® may be given as an injection in the vein during and after surgery. The Stemetil^® injection formulation is diluted in a solution and injected slowly in a vein. Total daily dose rarely exceeds 30 mg.

Children

Stemetil^® should not be given to children under 2 years of age or 9 kg of body weight. Occasionally, the children may react to the drug with signs of restlessness and excitement; if this occurs, treatment should be stopped.

Injection in the muscle

Stemetil^® may be given as an injection in the muscle to control severe nausea and vomiting or in psychiatry. The dose is based on the body weight

Overdose:

If you have taken too much Stemetil^®, immediately see your doctor or go to your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. The signs if you have taken too much Stemetil^® may vary from drowsiness to coma. Agitation and restlessness may also occur. Other possible reactions include confusion, drowsiness, fever, low blood pressure, dry mouth and intestinal obstruction.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Stemetil®, like any medication, may cause some side effects. Discuss with your doctor if you do experience side effects.

Side effects include:

• Agitation, anxiety, bizarre dreams, dizziness, excitement,

  restlessness.

• Appetite changes, constipation, dizziness, dryness of the

  mouth, headache, increased thirst, nasal congestion, nausea, vomiting, sweating, urinary incontinence, weight changes.

• Changes in libido, impotence, increase of the breast size in

  men, lactation, menstrual irregularities, peripheral oedema (swelling of the legs, ankles, and feet).

• Your skin may be more sensitive to sunlight

Side effects that might need a reduction in your dose are:

• Drowsiness, fatigue, insomnia, sad mood, sleep

  disturbances.

Uncommon Allergic

Reactions^b) √

Blood disorders^c) √

Cardiac disorders^d)

√

Eye disorders^e) √

Liver disorders^c)

√

Lung disorders^c) √

1. a) Extrapyramidal reactions. The signs and symptoms of extrapyramidal reactions include tremor, muscle stiffness, body spasm, impairment of voluntary movement, upward eye rolling, exaggeration of reflexes or drooling. Tell your doctor if you experience any of these side effects. Your medication might have to be reduced.
2. b)

   Allergic Reactions:: You may develop an allergy to Stemetil^® for example skin rash, redness or itching. Consult your doctor immediately if you develop an allergy to Stemetil^®

   .

3. c) Blood, liver and lung disorders have been associated with this class of drug. It is important that you tell your doctor at once about any unexplained symptom you might experience. Examples of this are soreness of the mouth, gums or throat or any symptoms of upper respiratory infection, unexplained fever, itching, flu-like symptoms, coughing, abdominal pain, jaundice.
4. d) Cardiac disorders: Low blood pressure and fainting have been reported. Uncommonly, Stemetil^® may cause the heartbeat to become faster or irregular. Check immediately with your doctor if these side effects occur.
5. e) Eye disorders: Blurred vision has been observed. Other eye disorders are reported, specifically after long-term administration. Consult you doctor if you experience any vision problems.
6. f) Neuroleptic malignant syndrome:Another possible serious unwanted effect is the neuroleptic malignant syndrome. Signs and symptoms of the neuroleptic malignant syndrome include severe muscle stiffness, increased sweating, fever, fast or irregular heartbeat, high or low blood pressure, difficult or fast breathing and confusion. If any of the above side effects occur, consult your doctor immediately.
7. g) Tardive dyskinesia may occur in some patients on long-term therapy or after they stop using Stemetil^®. Signs of tardive dyskinesia include muscle twitching or uncontrolled movements of the mouth, tongue, face or jaw (e.g., protrusion of tongue,

puffing of cheeks, puckering of mouth, chewing movements). Sometimes, these may be accompanied by involuntary movements of the extremities. In some patients, this side effect may not go away after they stop using Stemetil^®. These effects are rare and usually appear only after long-term therapy at high doses. Elderly patients may be at higher risk. Tell your doctor immediately if you experience any muscle twitching or abnormal body movements.

This is not a complete list of side effects. For any unexpected effects while taking Stemetil^®, contact your doctor or pharmacist.

HOW TO STORE IT

Stemetil^® suppositories and injection should be stored at room temperature between 15°C and 25°C.

Protect from exposure to light.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

Your physician, nurse and pharmacist are always your best source of information about your condition and treatment. If you have additional questions or concerns, be sure to ask them.

This document plus the full product monograph is available upon request to the sponsor, sanofi-aventis Canada Inc., 2150 St Elzear Blvd. West , Laval , Quebec H7L 4A8, at: 1-800-265-7927

Last revised: October 13, 2006