Nozinan (Sanofi-Aventis Canada, 5 mg, 25 mg, 50 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Nozinan^® is used to treat symptoms of schizophrenias, psychoses, manic-depressive syndromes or for conditions associated with anxiety and tension.

Nozinan^® is also used to control pain, to intensify the effects of anesthetics, to control nausea and vomiting or for the management of insomnia.

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

What it does:

Nozinan^® helps to

• reduce and control psychotic symptoms,
• tranquilize,
• reduce anxiety,
• induce sleep,
• relieve pain,
• intensify the effects of anesthetics.

When it should not be used:

Do not use Nozinan^® if you:

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

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

• Are in an altered state of consciousness or coma, especially

  if this is caused by alcohol or drug

• Have liver disease
• Have a blood disorder

What the medicinal ingredient is:

Methotrimeprazine maleate for tablets

Methotrimeprazine hydrochloride for injection

What the nonmedicinal ingredients are:

Tablets: Non-medicinal ingredients: croscarmellose sodium, colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake,

dicalcium phosphate, FD&C Yellow #6 Aluminium Lake, magnesium stearate, microcrystalline cellulose, Opadry II White Y-22-7719, polyethylene glycol and talc.

Injectable: Non-medicinal ingredients: 0.1% ascorbic acid, 0.65% sodium chloride, 0.05% sodium sulfite and water for injection.

What dosage forms it comes in:

Tablets 5 mg, 25 mg, 50 mg.

Injectable 25 mg/mL

WARNINGS AND PRECAUTIONS

During the first few days of treatment, Nozinan^® 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 Nozinan^® does not affect you.

Tardive dyskinesia, neuroleptic malignant syndrome and cardiac disorders may occur in some patients taking Nozinan^® (See the section “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”).

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

• Have heart or blood vessel disease
• If you have a history of cerebrovascular disease including strokes or transient ischemic attacks (mini-strokes)

• Suffer from an enlarged prostate (Benign Prostatic

  Hyperplasia)

• Suffer from an increase pressure within the eyes (glaucoma)
• Have or have had seizure disorders (e.g. epilepsy)
• Plan to have surgery (or a procedure requiring anaesthetics)

• Are or are planning to become pregnant

• Are breast-feeding

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

Blood counts should also be done regularly, particularly during the first 2 or 3 months of treatment. During long-term therapy, periodic liver function tests should be done.

INTERACTIONS WITH THIS MEDICATION

Nozinan^®

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

The combination of Nozinan^® with some medicines can increase the quantity of the other medicine in your body and therefore the risk of having side effects. Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.

Nozinan^® can add to the effects of other drugs that cause drowsiness. Some examples of drugs that cause drowsiness are: ③ Drugs for allergies

• Drugs for sleep
• Drugs for pain
• Drugs for seizure
• Drugs for depression
• Drugs for mental illness

Nozinan^® may cause a false reading of some types of pregnancy tests. For further information, please consult your doctor or your pharmacist.

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 Nozinan^® 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

Low doses can be given to tranquilize, reduce anxiety, relieve pain or induce sleep: the initial dose is 6 to 25 mg a day, divided into 3 smaller doses taken with meals. Your doctor may increase your dose if needed. To induce sleep, a single night time dose of 10 to 25 mg is usually sufficient.

Higher doses can be given to reduce symptoms of psychoses or intense pain: the initial dose is 50 to 75 mg a day, divided into 2 or 3 smaller doses. Your doctor may increase your dose if needed.

Injection Dosage Form:

Injection in the muscle: Nozinan^® may be given as an injection in the muscle for the initial treatment of psychosis, to control severe pain or before or after a surgery.

Injection in the vein: Nozinan^® may be given as an injection in

the vein during surgery or labour. The Nozinan^® injection formulation is diluted with a glucose solution and injected slowly in a vein.

Children

The dose is based on the body weight. The dose should not exceed 40 mg a day for a child less than 12 years of age.

Injection Dosage Form:

Injection in the muscle: Nozinan^® may be given as an injection in the muscle. The dose is based on the body weight.

Injection in the vein: Nozinan^® may be given as an injection in the vein during surgery. The Nozinan^® injection formulation is diluted with a glucose solution and injected slowly in a vein. The dose is based on the body weight.

Overdose:

If you have taken too much Nozinan^®, immediately see your doctor or go to your nearest hospital emergency department. Show the doctor your bottle of tablets. Do this even if there are no signs of discomfort or poisoning. The signs if you have taken too much Nozinan^® may include drowsiness, spasm, shaking, seizure, low blood pressure, difficult breathing and coma.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

Side effects include:

• Drowsiness may appear early in treatment but usually disappears during the first weeks. If this effect persists, discuss this with your doctor. Your medication might have to be reduced.
• Dryness of the mouth.
• In older patients, constipation and difficulty in urinating.

Less common side effects include:

• Weight gain has been occasionally reported in patients during long-term treatment with high doses.
• Your skin may be more sensitive to sunlight.

1. a) Low blood pressure. At the start of treatment with high oral doses or following an injection, some people may have low blood pressure and feel dizzy, especially when getting up from a lying or sitting position.
2. b) Allergic Reactions: You may also develop an allergy to Nozinan^® for example skin rash, redness or itching. Consult your doctor immediately if you develop an allergy to Nozinan^®.
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 and jaundice.
4. d) Cardiac disorders: Uncommonly, Nozinan^® may cause the heartbeat to become faster or irregular. Check with your doctor immediately if you experience any of these side effects.
5. e)

   Extrapyramidal reactions are rare and usually appear only after long-term therapy at high doses. 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 immediately if you experience any of these side effects. Your medication might have to be reduced.

   1. 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.
   2. g) Tardive dyskinesia may occur in some patients on long-term therapy or after they stop using Nozinan^®. Signs of tardive dyskinesia include muscle twitching or uncontrolled movements of the mouth, tongue, face or jaw. In some patients, this side effect may not go away after they stop using Nozinan^®. Tell your doctor immediately if you experience any muscle twitching or abnormal body movements.

Uncommon side effects include:

• Severe intestine problems
• Painful erection.

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

HOW TO STORE IT

Nozinan^® should be stored at room temperature (15˚ to 30˚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: 1-866-234-2345

Toll-free fax: 1-866-678-6789

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: May 18, 2007