NOZINAN TAB 50MG TABLET

Canada - English - Health Canada

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Active ingredient:
METHOTRIMEPRAZINE (METHOTRIMEPRAZINE MALEATE)
Available from:
SANOFI-AVENTIS CANADA INC
ATC code:
N05AA02
INN (International Name):
LEVOMEPROMAZINE
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
METHOTRIMEPRAZINE (METHOTRIMEPRAZINE MALEATE) 50MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
PHENOTHIAZINES
Product summary:
Active ingredient group (AIG) number: 0134080003; AHFS: 28:16.08.24
Authorization status:
APPROVED
Authorization number:
01927671
Authorization date:
2006-05-11

Documents in other languages

PRODUCT MONOGRAPH

NOZINAN

®

Methotrimeprazine Maleate Tablets

5, 25, 50 mg methotrimeprazine as methotrimeprazine maleate

Methotrimeprazine Hydrochloride Injection

25 mg/mL methrorimeprazine as methotrimeprazine hydrochloride

Neuroleptic

sanofi-aventis Canada Inc.

Date of Revision:

2150 St. Elzear Blvd. West

May 18, 2007

Laval, Quebec H7L 4A8

Submission Control No.: 111761

s-a Version 4.0 dated

Page 2 of 15

P

RODUCT

M

ONOGRAPH

N

AME OF

D

RUG

NOZINAN

Methotrimeprazine Maleate Tablets

Methotrimeprazine Hydrochloride Injection

T

HERAPEUTIC

C

LASSIFICATION

Neuroleptic

A

CTION AND

C

LINICAL

P

HARMACOLOGY

Nozinan possesses antipsychotic, tranquilizing, anxiolytic, sedative and analgesic properties and

it is also a potent potentiator of anesthetics.

I

NDICATIONS AND

C

LINICAL

U

SE

Psychotic disturbances: acute and chronic schizophrenias, senile psychoses, manic-depressive

syndromes.

Conditions associated with anxiety and tension: autonomic disturbances, personality disturbances,

emotional troubles secondary to such physical conditions as resistant pruritus, etc.

Nozinan is also employed:

As an analgesic: In pain due to cancer, zona, trigeminal neuralgia and neurocostal

neuralgia and in phantom limb pains and muscular discomforts.

As a potentiator of anesthetics: In general anesthesia where it can be used as both a pre-

and post-operative sedative and analgesic.

As an antiemetic: For the treatment of nausea and vomiting of central origin.

As a sedative: For the management of insomnia.

C

ONTRAINDICATIONS

In cases of coma or CNS depression due to alcohol, hypnotics, analgesics or narcotics.

It is also contraindicated in patients with blood dyscrasia, hepatic troubles or a sensitivity to

phenothiazines.

Page 3 of 15

W

ARNINGS

Occupational Hazards

: Nozinan can reduce psychomotor activity especially during the first few

days of treatment. Patients should therefore be cautioned not to drive a motor vehicle or to

participate in activities requiring total mental alertness.

As with other neuroleptics, very rare cases of QT interval prolongation have been reported with

Nozinan. Neuroleptic phenothiazines may potentiate QT interval prolongation, which increases

the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is

potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of

bradycardia, hypokalemia, and congenital or acquired (i.e., drug induced) QT prolongation. If the

clinical situation permits, medical and laboratory evaluations should be performed to rule out

possible risk factors before initiating treatment with a neuroleptic agent and as deemed necessary

during treatment (See also ADVERSE REACTIONS and DRUG INTERACTIONS).

Tardive Dyskinesia

: As with all antipsychotic agents, tardive dyskinesia may appear in some

patients on long-term therapy or after drug discontinuation. The syndrome is mainly characterized

by rhythmical involuntary movements of the tongue, face, mouth or jaw. The manifestations may

be permanent in some patients. The syndrome may be masked when treatment is reinstituted,

when the dosage is increased or when a switch is made to a different antipsychotic drug. Nozinan

should be prescribed in a manner that is most likely to minimize the risk of tardive dyskinesia.

The lowest effective dose and the shortest duration of treatment should be used, and treatment

should be discontinued at the earliest opportunity, or if a satisfactory response cannot be obtained.

If the signs and symptoms of tardive dyskinesia appear during treatment, discontinuation of

Nozinan should be considered.

Neuroleptic Malignant Syndrome

: Neuroleptic malignant syndrome (NMS) may occur in patients

receiving antipsychotic drugs. NMS is characterized by hyperthermia, muscle rigidity, altered

consciousness, and signs of autonomic instability including irregular blood pressure, tachycardia,

cardiac arrhythmias and diaphoresis. Additional signs may include elevated serum creatine

kinase, myoglobinuria (rhabdomyolysis), acute renal failure and leukocytosis. Hyperthermia is

often an early sign of this syndrome. Antipsychotic treatment should be withdrawn immediately

and appropriate supportive therapy and careful monitoring instituted.

Elderly patients

with

dementia

treated

with

certain

atypical

antipsychotic drugs

increased risk of Cerebrovascular Adverse Events (CVAEs) such as stroke and transient ischemic

attacks, as well as death, compared to placebo. The mechanism of this increased risk is not

known. As an increase in the risk with other antipsychotic drugs cannot be excluded, Nozinan

should be used with caution in the elderly with dementia.

Pregnancy:

The drug should be used with caution in pregnant women, particularly during the first

trimester, unless the benefit to the patient outweighs any possible risk to the fetus.

Page 4 of 15

P

RECAUTIONS

In high oral or parenteral doses, orthostatic hypotension may be encountered at the start of

treatment. Patients whose treatment is started by the parenteral route should be kept in bed during

the first few days.

Nozinan

therapy

should

initiated

doses

patients

with

arteriosclerosis

cardiovascular problems.

Because of its anticholinergic effects, Nozinan must be administered with caution in patients with

glaucoma or prostatic hypertrophy.

During long-term therapy, periodic liver function tests should be performed. In addition, blood

counts should be conducted regularly, particularly during the first 2 or 3 months of treatment, and

physicians should watch for any signs of blood dyscrasia.

Nozinan does not alter EEG activity. Nevertheless, since phenothiazines can lower the threshold

of cortical excitation, it is advisable to administer an appropriate anticonvulsant medication to

epileptic patients receiving Nozinan therapy.

Drug Interactions

Nozinan potentiates the action of other phenothiazines and CNS depressants (barbiturates,

analgesics, narcotics and antihistaminics). The usual doses of these agents should be reduced by

half if they are to be given concomitantly with Nozinan until the dosage of the latter has been

established.

Nozinan and its non-hydroxylated metabolites are reported to be inhibitors of cytochrome P450

2D6. Coadministration of Nozinan and drugs primarily metabolized by the cytochrome P450 2D6

enzyme system may result in increased plasma concentrations of these drugs.

Neuroleptic

phenothiazines

potentiate

interval

prolongation.

prolongation

exacerbated, in particular, in the presence of bradycardia, hypokalemia, and congenital or

acquired (i.e., drug induced) QT prolongation (See also WARNINGS AND PRECAUTIONS).

Drug-Laboratory Interactions

False positive or negative pregnancy tests have occurred in patients receiving phenothiazine

therapy.

Page 5 of 15

A

DVERSE

R

EACTIONS

May be classified as follows:

CNS: Drowsiness may appear early in treatment but will gradually disappear during the first

weeks or with an adjustment in the dosage.

Extrapyramidal effects are rare and usually appear only after prolonged therapy at high doses.

These reactions may be corrected either by reducing the dose of Nozinan or by administering an

antiparkinsonian agent.

Autonomic Nervous System: Dryness of the mouth and, in older patients occasional urinary

retention, constipation and tachycardia.

Cardiovascular: Orthostatic hypotension may be encountered at the start of treatment by the

parenteral route or with high oral doses. Very rare cases of QT interval prolongation have been

reported. There have been isolated reports of sudden death, with possible causes of cardiac origin

(see WARNINGS and DRUG INTERACTIONS), as well as cases of unexplained sudden death,

in patients receiving neuroleptic phenothiazines.

Blood: Rare instances of agranulocytosis have been reported.

Endocrine: Weight gain has been occasionally reported in patients during prolonged treatment

with high doses.

Gastrointestinal: Rare cases of cholostatic jaundice without liver damage have been observed.

Necrotizing enterocolitis, which can be fatal, has been very rarely reported in patients treated with

Nozinan.

Skin Reactions: Skin reactions due to photosensitivity or allergies are extremely rare.

Urogenital System: Priapism has been very rarely reported.

S

YMPTOMS AND

T

REATMENT OF

O

VERDOSAGE

Symptoms:

Symptoms of acute intoxication may include: simple CNS depression, spasms, tremor

or tonic and clonic convulsions, coma accompanied by hypotension and respiratory depression.

Treatment:

There is no specific antidote. After gastric lavage, treatment is symptomatic. Centrally

acting emetics are ineffective because of the anti-emetic action of Nozinan.

Hypotension: A 5% glucose solution may be administered. If a hypertensive agent is required,

norepinephrine

phenylephrine

used,

epinephrine,

which

aggravate

hypotension.

Respiratory depression: Oxygen by inhalation or controlled respiration after tracheal intubation.

Respiratory infection: Wide spectrum antibiotics.

Page 6 of 15

Extrapyramidal reactions: An antiparkinsonian agent or chloral hydrate, however the latter must

be used with caution because of its depressant effect on respiration.

Any CNS stimulant should be used with caution.

D

OSAGE AND

A

DMINISTRATION

Dosage must be adjusted according to the indication and individual needs of the patient. If

sedation during the day is too pronounced, lower doses may be given during the day and higher

doses at night.

Adults

Oral:

Minor conditions in which Nozinan may be given in low doses as a tranquilizer, anxiolytic,

analgesic or sedative: begin treatment with 6 to 25 mg/day in 3 divided doses at mealtimes.

Increase the dosage until the optimum level has been reached. As a sedative, a single night time

dose of 10 to 25 mg is usually sufficient.

Severe conditions: Such as psychoses or intense pain in which Nozinan is employed at higher

doses: Begin treatment with 50 to 75 mg/day divided into 2 or 3 daily doses; increase the dosage

until the desired effect is obtained. In certain psychotics, doses may reach 1 g or more/day. If it is

necessary to start therapy with higher doses, i.e., 100 to 200 mg/day, administer the drug in

divided daily doses and keep the patient in bed for the first few days.

Parenteral

I.M.: To be used primarily for the initial treatment of psychoses for certain severe pain as a

premedication or for the treatment of postoperative pain. In psychoses and pain, doses vary from

75 to 100 mg given as 3 or 4 deep i.m. injections in a large muscle. When given as a

premedication or post-operative analgesic, the average dose varies from 10 to 25 mg every

8 hours, which is equivalent to 20 to 40 mg given orally. The last dose during premedication,

given 1 hour before surgery, can be 25 to 50 mg i.m.

I.V.: To be used primarily as an infusion during surgery or labour. The dose may range from 10

to 25 mg in 500 mL of a 5% glucose solution administered at a rate of 20 to 40 drops/minute. If

Nozinan is administered with a barbiturate or narcotic, the doses of the latter must be reduced by

at least one-half.

Children

Oral

The initial dose has been established at 1/4 mg/kg daily given in 2 or 3 divided doses. This

dosage may be increased gradually until an effective level is reached which should not surpass 40

mg/day for a child less than 12 years of age.

Page 7 of 15

Parenteral

I.M.: A dose of 1/16 to 1/8 mg/kg/day in one or divided among several injections. Oral

medication should be substituted as soon as possible.

I.V.: In anesthesia, 1/16 mg/kg in 250 mL of a 5% glucose solution may be administered as a

slow infusion (20 to 40 drops per minute) during surgery.

P

HARMACEUTICAL

I

NFORMATION

Drug substance

Proper name :

Methotrimeprazine hydrochloride

Chemical name :

2-methoxy-N,N,

-trimethyl-10H-phenothiazine-10-propamine

hydrochloride

Structural formula :

HCl

Molecular formula :

Molecular weight :

364.9

Physical form :

White to very slightly yellow, slightly hygroscopic powder

Solubility :

Freely soluble in water and in alcohol, practically insoluble in ether

Melting point :

142˚C and 162˚C

Drug substance

Proper name :

Methotrimeprazine maleate

Chemical name :

2-methoxy-N,N,

-trimethyl-10H-phenothiazine-10-propamine maleate

Structural formula :

C

Molecular formula :

Molecular weight :

444.5

Page 8 of 15

Physical form :

White to very slightly yellow crystalline powder

Solubility :

Slightly soluble in water and in alcohol, practically insoluble in ether,

sparingly soluble in dichloromethane

Melting point :

186˚C

pH :

3.5 to 5.5

Composition

Injectable

: Each mL contains: methotrimeprazine base 25 mg (as the hydrochloride). Non-

medicinal ingredients: 0.1% ascorbic acid, 0.65% sodium chloride, 0.05% sodium sulfite and

water for injection.

Tablets:

Each yellow tablet contains: methotrimeprazine base 5, 25 or 50 mg (as the maleate).

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.

Stability and storage recommendation

Nozinan (methotrimeprazine hydrochloride) injectable and Nozinan (methotrimeprazine maleate)

tablets should be stored at 15

to 30˚C. Protect from light.

A

VAILABILITY OF

D

OSAGE

F

ORMS

Nozinan (methotrimeprazine base) 25 mg/mL (as hydrochloride) injectable is available in amber

glass ampoules of 1 mL in boxes of 10 ampoules.

Nozinan (methotrimeprazine base) 5, 25 and 50 mg (as maleate) tablets are available in white

HDPE bottles of 100 and 500 tablets.

P

HARMACOLOGY

Nozinan possesses strong sedative properties. It potentiates ether and hexobarbital anesthesia as

well as morphine analgesia. It also exerts a potent anti-apomorphine effect, a hypothermic action

3 times more potent than that of chlorpromazine and strong antispasmodic and anti-histaminic

effects.

Nozinan is capable of reversing epinephrine-induced hypertension but has practically no effect

against norepinephrine and acetylcholine. It readily protects rats against traumatic shock and

produces deep local anesthesia following parasciatic injections.

T

OXICOLOGY

In mice the LD

of Nozinan is 70 mg/kg i.v., 250 mg/kg s.c., 344 mg/kg i.p. and 380 mg/kg p.o.

Signs of acute toxicity consist of CNS depression interrupted by periods of convulsions and

uncoordinated movements.

Page 9 of 15

In the rat, a daily dose of 5 or 10 mg/kg p.o. for 4 consecutive weeks did not produce any

digestive troubles or weight loss. During the first days of treatment, a state of depression

appeared, which was most pronounced on the third or fourth day and then almost completed

disappeared. Laboratory and function tests indicated no renal, hepatic or blood anomalies.

Microscopic visceral examinations revealed no toxic lesions.

In the dog, a daily dose of 2.5 or 5 mg/kg p.o. for 4 consecutive weeks did not affect weight

stability but animals appeared lethargic. Some relaxation of the nictitating membrane and a

transient reduction of blood pressure were observed. During treatment, the leucocyte count and

blood

coagulation

remained

normal.

Anatomopathological

examination

visceral

parenchyma of sacrificed animals confirmed that all organs remain normal.

Page 10 of 15

R

EFERENCES

Capron M, Lafitte B, Benedit M, Camard CN, Nicolas F, Beligon C, et al. Necrotizing colitis

in a 29-year-old man under high-dose neuroleptics. Reanimation Urgences 1999;8(8):701-4.

Cubeddu LX. QT prolongation and fatal arrhythmias: a review of clinical implications and

effects of drugs. American Journal of Therapeutics 2003;10(6):452-7.

Courvoisier S, Ducrot R, Fournel J, Julou L. Propriétés pharmacodynamiques générales de la

lévomépromazine (7044 R.P.). C.R. Soc Biologie 1957;151(7):1378-82.

Divry P, Boron J, Collard J. La lévomépromazine dans les cures de sommeil potentialisées et

les cures neuroleptiques. Acta Neurol Psych Belgica 1959;59(3):325-36.

Fekete Z. Control of pruritus with levomepromazine. Appl Therap 1963;5(4):333-4.

Fenichel RR, Malik M, Antzelevitch C, Sanguinetti M, Roden DM, Priori SG, et al. Drug-

induced torsades de pointes and implications for drug development. J Cardiovasc Electr

2004;15(4):475-95.

Filloux MC, Marechal K, Bagheri H, Morales J, Nouvel A, Laurencin G. Phenothiazine-

induced

acute

colitis:

positive

rechallenge

case

report.

Clin

Neuropharmacol

1999;22(4):244-5.

Flamant J. Utilisation à faibles doses d'un nouveau neuroleptique (lévomépromazine, 7044

R.P.) dans le traitement des dystonies neuro-végétatives. L'Hôpital 1960;March H.S.

Gram LF, Hansen MG, Sindrup SH, Brösen K, Poulsen JH, Aaes-Jörgensen T, et al.

Citalopram: interaction studies with levomepromazine, imipramine and lithium. Ther Drug

Monitoring 1993;15:18-24.

Hals

Dahl

Effect

levomepromazine

metabolites

debrisoquine

hydroxylation in the rat. Pharmacology & Toxicology 1994;75:255-60.

Huot JM, Kristof AC. Lévomépromazine (Nozinan) - a new neuroleptic agent for treatment

of senile patients. CMAJ 1959;81:546-8.

Kenbubpha K, Silpakit C. Association between antipsychotics and sudden death in psychotic

in-patients. International Medical Journal 2002;9(1):27-31.

Lambert PA, Beaujard M, Achaintre A, Broussolle P, Perrin J, Berthier C, et al

.

Essais

thérapeutiques d'un nouveau dérivé de la phénothiazine, la lévomépromazine ou 7044 R.P.

Ann Medico-Psychol 1957;115(2):291-6.

Larrey D, Lainey E, Blanc P, Diaz D, David R, Biaggi A. Acute colitis associated with

prolonged administration of neuroleptics. J Clin Gastroenterol 1992;14(1):64-7.

Levy L, Ban T. Phenothiazine drugs and the general practitioner. CMAJ 1962;86:415-7.

Mehtonen OP, Aranko K, Malkonen L, Vapaatalo H. A survey of sudden death associated

with the use of antipsycgotic or antidepressant drugs: 49 cases in Finland. Acta Psychiatr

Scand 1991;84:58-64.

Page 11 of 15

Muller D. The treatment of restless psychotics with methotrimeprazine (Veractil). J Ment Sci

1961;107(449):783-6.

Panaccio V. La lévomépromazine dans le traitement des dermatoses prurigineuses. Union

Med Canada 1964;93(3):317-9.

Paradis B. La lévomépromazine en anesthésie. Anesthésie-Analgésie 1959;16(1):185-93.

Paradis B, Lamontagne A, Gagne-Desrosiers R, Lamarche Y. Association Nozinan-fluothane

en anesthésie. Laval Medical 1959;28(3):337-44.

Payne P, Veringer D. Levomepromazine in the treatment of neuroleptic resistant psychotics. J

Ment Sci 1960;106:1429-31.

Ray WA, Meredith S, Thapa PB, Meador KG, Hall K, Mur

r

ay KT. Antipsychotics and the

risk of sudden cardiac death. Arch Gen Psychiat 2001;58(12):1161-7.

Reilly JG, Ayis SA, Ferrier IN, Jones SJ, Thomas SHL. Thioridazine and sudden unexplained

death in psychiatric in-patients. Brit J Psychiat 2002;180:515-22.

Sakurai T, Nishizono M, Nothohara N, Kitahara N. The treatment of schizophrenia with large

doses of levomepromazine. Clin Psychiat 1963;4(10):741-54.

Sarwer-Foner GJ, Hajnsek F, Groszman M, Grauer H, Koranyi EK. Clinical investigation of

levomepromazine

(Nozinan)

open

psychiatric

settings.

Services

Canada

1961;17(11):798-817.

Sigwald J, Bouttier D, Caille F. Le traitement du zona et des algies zostériennes. Étude des

résultats obtenus avec la lévomépromazine. Thérapie 1959;14(5):818-24.

Sigwald J, Bouttier D, Solignac J. Essai de traitement de la névralgie essentielle du trijumeau

par la lévomépromazine. Rev Neurol 1958;99(5):580-1.

Sigwald J, Bouttier D, Solignac J, Dumezil. L'action antialgique des phénothiazines. I- Le

traitement

lévomépromazine

algies

intenses

irréductibles.

Thérapie

1959;14(6):978-84.

Simard-Savoie S, Bloomfield S, Bernier J, Tetreault L. Evaluation clinique des propriétés

analgésiques de la lévomépromazine, de la morphine et du placebo sur la douleur chronique.

Union Med Canada 1964;93(1):61-7.

Syvälathi EKG, Lindberg R, Kallio J, De Vocht M. Inhibitory effects of neuroleptics on

debrisoquine oxidation in man. Brit J Clin Pharmacol 1986;22:89-92.

Taylor DM. Antipsychotics and QT prolongation. Acta Psychiat Scand 2003;107(2):85-95.

Taylor

Doku

methotrimeprazine

after

oral

surgery.

Dental

1967;22:141-3.

Zeltser D, Justo D, Halkin A, Prokhorov V, Heller K, Viskin S. Torsade de pointes due to

noncardiac

drugs:

most

patients

have

easily

identifiable

risk

factors.

Medicine

2003;82(4):282-90.

IMPORTANT: PLEASE READ

Page 12 of 15

CONSUMER INFORMATION

Pr

NOZINAN

®

Methotrimeprazine Maleate Tablets

Methotrimeprazine Hydrochloride Injection

This

leaflet

is

designed specifically for

Consumers.

This

leaflet is a summary and will not tell you everything about

Nozinan

®

. Contact your doctor or pharmacist if you have

any questions about the drug.

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

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.

IMPORTANT: PLEASE READ

Page 13 of 15

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:

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.

IMPORTANT: PLEASE READ

Page 14 of 15

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND

WHAT TO DO ABOUT THEM

Talk with your

doctor or

pharmacist

Symptom / effect

Only if

severe

In all

cases

Stop

taking

drug and

call your

doctor or

pharmacist

Common

Low blood

pressure

a)

Uncommon

Allergic reactions

b)

See text

below

Blood disorders

c)

Cardiac

disorders

d)

Extrapyramidal

reactions

e)

Liver disorders

c)

Lung disorders

c)

Neuroleptic

malignant

syndrome

f)

Tardive

dyskinesia

g)

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.

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

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.

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.

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.

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.

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.

IMPORTANT: PLEASE READ

Page 15 of 15

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

This leaflet was prepared by sanofi-aventis Canada Inc.

Last revised: May 18, 2007

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