NEULEPTIL CAPSULE

Canada - English - Health Canada

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Active ingredient:
PERICIAZINE
Available from:
ERFA CANADA 2012 INC
ATC code:
N05AC01
INN (International Name):
PERICIAZINE
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
PERICIAZINE 10MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PHENOTHIAZINES
Product summary:
Active ingredient group (AIG) number: 0106194001; AHFS: 28:16.08.24
Authorization status:
APPROVED
Authorization number:
01926772
Authorization date:
2000-10-17

Documents in other languages

PRESCRIBING INFORMATION

PRODUCT MONOGRAPH

NEULEPTIL

Periciazine

Psychotropic Agent

8250 Décarie Blvd, suite 110

Montréal, QC

Canada, H4P 2P5

Control number 160701

DATE OF REVISION :

December 19, 2012

Neuleptil®

®:Aventis Pharma

Periciazine

Psychotropic Agent

ACTION

Periciazine is a phenothiazine of the piperidine group. It has been shown to reduce pathologic

arousal and affective tension in some psychotic patients, while the symptoms of abnormal mental

integration are relatively unaffected.

It is a sedative phenothiazine with weak antipsychotic properties. It also has adrenolytic,

anticholinergic metabolic and endocrine effects, and an action on the extrapyramidal system.

Like other phenothiazines, it is presumed to act principally in the subcortical areas, by producing

what has been described as a central adrenergic blockade.

INDICATIONS

As adjunctive medication in some psychotic patients, for the control of residual prevailing

hostility, impulsiveness and aggressiveness.

CONTRAINDICATIONS

Circulatory collapse, altered states of consciousness or comatose states, particularly when they

are due to intoxication with central depressant drugs such as alcohol, hypnotics, analgesics,

narcotics, etc. It should also not be administered in association with spinal or regional anesthesia.

Periciazine is contraindicated in patients with a history of blood dyscrasias, liver disease or

hypersensitivity related to other phenothiazines.

WARNINGS

Geriatrics and Debilitated Patients: Particular care should be exercised when periciazine is given

to elderly or debilitated patients as some appear to be unduly sensitive to the effects of the drug.

Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with

antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled

trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs,

revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in

placebo-treated patients. Over the course of a typical 10- week controlled trial, the rate of death

in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death in clinical trials with atypical antipsychotics were varied, most of

the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious

(e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic

drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to

which the findings of increased mortality in observational studies may be attributed to the

antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

Hematologic:

Venous Thromboembolism

Venous thromboembolism (VTE), including fatal pulmonary embolism, has been reported with

antipsychotic drugs, including NEULEPTIL, in case reports and/or observational studies. When

prescribing NEULEPTIL all potential risk factors for VTE should be identified and preventive

measures undertaken.

Risk of Stroke: In randomized clinical trials versus placebo performed in a population of elderly

patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of

the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not

known. An increase in the risk with other antipsychotic drugs or other populations of patients

cannot be excluded. NEULEPTIL should be used with caution in patients with stroke risk

factors.

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

Occupational Hazards: Because drowsiness, slowing of reaction time or impaired judgment may

occur, patients should generally not operate a motor vehicle or engage in dangerous activities

while under the action of the drug.

Patients who have demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice)

with a phenothiazine should not be re-exposed to any phenothiazine unless, in the judgment of

the physician, the potential benefits of treatment outweigh the possible hazards.

It should not be used in patients with convulsive disorders that are not receiving appropriate

anticonvulsive medication.

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. Periciazine 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 periciazine 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.

Cases of venous thromboembolism, sometimes fatal, have been reported with antipsychotic

drugs. Therefore, NEULEPTIL should be used with caution in patients with risk factors for

thromboembolism. (See also

ADVERSE REACTIONS

Pregnant Women:

Non-teratogenic effects: Neonates exposed to antipsychotic drugs including NEULEPTIL during

the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms

following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor,

somnolence, various degrees of respiratory disorders ranging from tachypnoea to respiratory

distress and bradycardia. Although these events occurred most often when other drugs such as

psychotropic or antimuscarinic drugs were coadministered, they may also occur with

antipsychotic use alone. Signs related to atropinic properties of phenothiazines such as

meconium ileus, delayed meconium passage, abdominal bloating, tachycardia and feeding

disorder in neonates can also occur. These complications have varied in severity; while in some

cases symptoms have been self-limited, in other cases neonates have required intensive care unit

support and prolonged hospitalization. Appropriate monitoring and treatment of neonates born to

mothers receiving NEULEPTIL are recommended.

Since the safety of NEULEPTIL during pregnancy has not been established, NEULEPTIL

should not be used during pregnancy or in women of child bearing potential unless the expected

benefits to the mother markedly outweigh the potential risks to the fetus.

PRECAUTIONS

Periciazine may potentiate the action of other drugs; caution should therefore be exercised when

it is prescribed with other phenothiazine derivatives or CNS depressants such as barbiturates,

analgesics, narcotics or antihistamines, and the usual doses of these compounds should be

reduced by at least half while the new treatment is being gradually introduced. Patients should

also be advised against ingesting alcohol while under treatment.

Therapy should be initiated at low doses and caution used in patients with arteriosclerosis,

cardiovascular disease, or other conditions where sudden hypotension is undesirable. Careful

adjustments of dosage may be necessary if other drugs likely to cause postural hypotension are

being administered concurrently. If hypotension should occur and a pressor agent is required,

norepinephrine or phenylephrine may be used. Epinephrine should

not

be used since it may

further lower blood pressure.

Because of its anticholinergic action, periciazine should be used with great caution in patients

with glaucoma or prostatic hypertrophy. Paralytic ileus has occurred in patients, particularly in

the elderly, taking one or more drugs with anticholinergic action for extended periods. In such

patients caution should be observed if constipation develops.

Retinal changes and abnormal skin pigmentation have been observed with phenothiazines and

may occur after prolonged therapy. Discontinue therapy if these changes are observed.

It is generally advisable to perform periodic liver function tests during prolonged medication

with periciazine. Periodic blood counts should also be performed, particularly during the first 2

or 3 months of therapy and patients should be observed for any signs or symptoms suggestive of

blood dyscrasia.

To lessen the likelihood of adverse reactions related to drug accumulation, patients on long-term

therapy, particularly on high doses, should be evaluated periodically to decide whether the

maintenance dosage could be lowered or drug therapy discontinued. Sudden onset of severe CNS

or vasomotor symptoms should be kept in mind.

Rare cases of priapism have been reported with antipsychotic use, such as NEULEPTIL. This

adverse reaction, as with other psychotropic drugs, did not appear to be dose-dependent and did

not correlate with the duration of treatment.

Endocrine and Metabolism: Hyperglycaemia or intolerance to glucose has been reported in

patients treated with NEULEPTIL. Diabetic ketoacidosis (DKA) has occurred in patients with no

reported history of hyperglycemia. Patients should have baseline and periodic monitoring of

blood glucose and body weight.

Patients with an established diagnosis of diabetes mellitus or with risk factors for the

development of diabetes who are started on NEULEPTIL, should get appropriate glycaemic

monitoring during treatment. (See also

ADVERSE REACTIONS

Hyperprolactinemia: Long-standing hyperprolactinemia when associated with hypogonadism

may lead to decreased bone mineral density in both female and male subjects.

Blood disorders: Neutropenia, granulocytopenia and agranulocytosis have been reported during

antipsychotic use. Therefore, it is recommended that patients have their complete blood count

(CBC) tested prior to starting NEULEPTIL and then periodically throughout treatment.

ADVERSE REACTIONS

Drowsiness, hypotension and extrapyramidal symptoms are the more frequently reported adverse

reactions. Autonomic and psychomotor effects are usually observed at the beginning of treatment

and frequently resolve while therapy is being continued or subside upon adjustment of dosage.

Extrapyramidal reactions usually occur somewhat later and are mainly observed with higher

dosages.

Adverse reactions with different phenothiazines vary in type, frequency, and mechanism of

occurrence, i.e., some are dose-related, while others involve individual patient sensitivity. Some

adverse reactions may be more likely to occur, or occur with greater intensity in patients with

special medical problem e.g., patients with mitral insufficiency or pheochromocytoma have

experienced severe hypotension following recommended doses of certain phenothiazines.

Not all of the following adverse reactions have been observed with every phenothiazine

derivative, but they have been reported with one or more and should be borne in mind when

drugs of this class are administered:

Behavioral: Drowsiness and impaired psychomotor activity are the most frequent initial

untoward reactions but tend to subside within 1 to 3 weeks. Small initial doses will test tolerance

to the drug. If a toxic-confusional state appears the medication should be stopped immediately.

Paradoxical effects, such as agitation, insomnia, inversion of sleep, increased aggressiveness and

activation of psychotic symptoms, have been occasionally observed.

Autonomic Nervous System: Postural hypotension and acute hypotensive crisis have been

observed, particularly in the elderly, and occur more often at the beginning of treatment or when

initial high dosages are used. These reactions may be avoided by testing the patient's tolerance

with initial low doses. ECG changes and cardiac arrhythmias, including AV block paroxysmal

tachycardia, and ventricular fibrillation, although not reported with periciazine, have been

observed with some phenothiazines.

Predominant anticholinergic effects or sympathetic depression may be responsible for the

following adverse reactions: tachycardia, blurred vision, aggravation of glaucoma, dry mouth

(sometimes with oral infections and dental caries), nausea, vomiting, constipation, fecal

impactation, paralytic ileus, perspiration, diarrhea, and nasal congestion. Changes in body

temperature and hyperglycemia have been known to occur with phenothiazines.

CNS: The extrapyramidal reactions include:

Parkinsonism, dystonic reactions and akathisia.

Parkinsonism occurs more frequently in patients receiving high doses and can usually be

controlled by reducing the dose or temporarily discontinuing medication and, when necessary, by

administering an antiparkinson drug. The dystonic reactions consist mainly of protrusion of the

tongue, hyperextension of the neck and trunk, contraction of muscles of the neck and face,

oculogyric crises, myolonic twitches and carpopedal spasm. Dystonic reactions are usually not

dose-related but may be quite dramatic and require urgent treatment. Dystonic reactions have

been reported with periciazine.

Tardive persistent dyskinesia resistant to treatment has been reported in connection with

phenothiazine drugs (for detailed description see

WARNINGS

EEG changes, disturbed temperature regulation and seizures have also been reported. Periciazine

is generally well tolerated by epileptics maintained on anticonvulsive therapy. However,

epileptic attacks have been reported and it has not been established that periciazine effectively

controls arousal or affective tension in these patients.

Allergic or Toxic Reactions: Agranulocytosis and other blood dyscrasias are among the more

serious adverse reactions to phenothiazines. They may occur suddenly or follow a fall in blood

count, usually during the first 2 or 3 months of treatment. Cholestatic jaundice and liver injury,

mainly of cholestatic or mixed type, are very rarely reported in patients treated with periciazine.

Priapism has been very rarely reported in patients treated with periciazine.

Skin reactions, photosensitivity, asthma, laryngeal edema, angioneurotic edema, hyperpyrexia

and other allergic reactions may also occur. Abnormal pigmentation, including comeal and lens

deposits have been observed, usually when high doses of phenothiazines are given for prolonged

periods.

Metabolic and Endocrine: Endocrine effects from phenothiazines such as delayed ovulation,

menstrual irregularities, lactation, gynecomastia, changes in libido, inhibition of ejaculation,

false positive pregnancy tests, weight gain and edemas, have been known to occur. Voracious

appetite and weight gain have been reported in some patients on periciazine therapy. Intolerance

to glucose, hyperglycemia have been reported (see

PRECAUTIONS

Miscellaneous: Unexpected sudden deaths, hypostatic pneumonia, and potentiation of other

drugs have occurred during phenothiazine therapy. In some unexpected deaths, myocardial

lesions have been observed. Previous brain damage or seizures may also be predisposing factors;

high doses should be avoided in known seizure patients. Several patients have shown sudden

exacerbations of psychotic behavior patterns shortly before death. Autopsy findings have also

revealed acute fulminating pneumonia or pneumonitis and aspiration of gastric contents. The

physician should therefore be alerted to the possible development of "silent pneumonias".

Cases of venous thromboembolism, including cases of pulmonary embolism, sometimes fatal,

and cases of deep vein thrombosis have been reported with antipsychotic drugs (see also

WARNINGS

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

), as well as cases of

unexplained sudden death, in patients receiving neuroleptic phenothiazines.

Patients should be advised of the risk of severe constipation during NEULEPTIL treatment, and

that they should tell their doctor if constipation occurs or worsens, as they may need laxatives.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Symptoms: In milder cases of phenothiazine overdosage the patient may be agitated, delirious

and confused. Frequently he is lethargic or in a comatose state. Twitching dystonic movements

or convulsions may be present and hypotension, cardiovascular collapse, arrhythmias and

hypothermia might be observed.

Treatment: When indicated, gastric lavage can remove significant amounts of the drug. Careful

supportive management is required until the patient is well out of drug-induced CNS depression.

Shock, arrhythmia, respiratory failure and hypothermia are the main management problems.

When a pressor agent is required, norepinephrine or phenylephrine may be used.

For management of a suspected drug overdose, contact your regional Poison Control Center.

DOSAGE AND ADMINISTRATION

Adults: 5 to 20 mg in the morning and 10 to 40 mg in the evening. For maintenance therapy, the

dosage should be reduced to the minimum effective dose. Lower doses of 2.5 to 15 mg in the

morning, and 5 to 30 mg in the evening have been suggested.

For elderly patients the initial total daily dosage should be in the order of 5 mg and increased

gradually as tolerated, until an adequate response is obtained. A daily dosage of more than 30 mg

will rarely be needed.

Children and adolescents (5 years of age and over): 2.5 to 10 mg in the morning and 5 to

30 mg in the evening. These dosages approximate a daily dosage range of 1 to 3 mg/year of age.

In general, for both children and adults, the lower doses should not be exceeded initially.

Subsequently, dosage may be gradually increased until the most effective level is reached.

Caution is required when these dosages are exceeded.

Troublesome initial drowsiness has often been observed following periciazine administration.

This may be obviated by giving the drug twice daily and reserving the major portion of the daily

dosage for the evening.

Periciazine is not recommended in children under 5 years of age, since limited clinical

experience is available.

AVAILABILITY OF DOSAGE FORMS

Capsules

: Each light blue cap and white body opaque capsule, with black radial impression

‘’ERFA’’ on the cap and 5mg on the body contains: periciazine 5 mg. Nonmedicinal ingredients:

calcium phosphate, croscarmellose sodium, FD&C Blue No 1, FD&C Red No 3, gelatin,

magnesium stearate and titanium oxide. Tartrazine-free. Bottles of 100.

10

mg: Each light blue cap and white body opaque capsule, with black radial impression

‘’ERFA’’ on the cap and 10mg on the body contains: periciazine 10 mg. Nonmedicinal

ingredients: calcium phosphate, croscarmellose sodium, FD&C Blue No 1,

FD&C Red No 3, gelatin, magnesium stearate and titanium oxide. Tartrazine-free. Bottles of

100.

20

mg: Each capsule, with light blue cap and white body, with black radial impression ‘’ERFA’’

on the cap and 20 mg on the body opaque capsule contains: periciazine 20 mg Nonmedicinal

ingredients: calcium phosphate, croscarmellose sodium, FD&C Blue No 1, FD&C Red No 3,

gelatin, magnesium stearate and titanium oxide. Tartrazine-free. Bottles of 100.

Oral Drops:

Each mL of liquid contains: periciazine 10 mg. Nonmedicinal ingredients: alcohol,

ascorbic acid, caramel, glycerin, peppermint oil, purified water, sucrose and tartaric acid.

Energy: 4.3 kJ (1.0 kcal)/mL. Tartrazine-free. Bottles of 100 mL with calibrated dropper.

Storage condition:

Protect from light. Store between 15 – 30°C.

IMPORTANT: PLEASE READ

Page 1 of 4

PART III: CONSUMER INFORMATION

Neuleptil

(Periciazine)

This leaflet is part III of a three-part "Product Monograph"

published when Neuleptil was approved for sale in Canada and

is designed specifically for Consumers. This leaflet is a

summary and will not tell you everything about Neuleptil.

Contact your doctor or pharmacist if you have any questions

about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Neuleptil belongs to a group of medicines called

“phenothiazines”. It is used to control prevailing hostility,

impulsiveness and aggressiveness when used with other

medicines.

What it does:

Neuleptil 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 Neuleptil works is

unknown. However, it seems to readjust the balance of

dopamine and serotonin.

When it should not be used:

You should not use Neuleptil if you have:

An allergy to periciazine, 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

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

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:

Periciazine

What the nonmedicinal ingredients are:

Capsules: calcium phosphate, croscarmellose sodium, FD&C

Blue No 1, FD&C Red No 3, gelatin, magnesium stearate and

titanium oxide.

Oral drops: alcohol, ascorbic acid, caramel, glycerin,

peppermint oil, purified water, sucrose and tartaric acid.

What dosage forms it comes in:

Capsules: 5mg, 10mg, 20mg

oral drops:

10 mg/ml.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which

NEULEPTIL belongs, when used in the elderly patients

with dementia, have been associated with an increased

rate of death. NEULEPTIL is not indicated in elderly

patients with dementia.

BEFORE you use Neuleptil talk to your doctor or pharmacist

if:

You have heart disease, glaucoma or prostatic

hypertrophy

You are addicted to alcohol. You should not take

Neuleptil if you are under the effects of alcohol.

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 pregnant. Neuleptil 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,

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.

Neuleptil 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 Neuleptil 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 Neuleptil are cautioned:

Against exposure to extreme heat

That drugs such as Neuleptil 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

IMPORTANT: PLEASE READ

Page 2 of 4

Neuleptil.

INTERACTIONS WITH THIS MEDICATION

Neuleptil can add to the effects of alcohol. You should avoid

consuming alcoholic beverages while on Neuleptil 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 Neuleptil, 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 Neuleptil if you have drowsiness caused

by other medications.

Drugs that may interact with Neuleptil 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 Neuleptil.

PROPER USE OF THIS MEDICATION

Take this medication by mouth 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:

Usual initial doses are:

Adults: 5 to 20 mg in the morning and 10 to 40 mg in the

evening

Older adults: At first, 5 mg a day. Your doctor may increase

your dose if needed. However, the dose is not usually more

than 30 mg a day

Children 5 years of age and older: 2.5 to 10 mg taken in the

morning, and 5 to 30 mg taken in the evening.

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, Neuleptil 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, 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

Neuleptil and continue to monitor it for as long as you are being

treated.

Your doctor should take blood tests before starting Neuleptil.

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.

IMPORTANT: PLEASE READ

Page 3 of 4

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Unknown

Allergic

Reaction:

rash,

hives, swelling of

the face, lips,

tongue or throat,

difficulty

swallowing or

breathing

Neuroleptic

Malignant

Syndrome:

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.

Fast or irregular

heartbeat

Seizures or fits

Long-lasting

(greater than 4

hours in duration)

and painful

erection of penis

Tardive

Dyskinesia

uncontrollable

movements or

twitches of the

body, face, eyes or

tongue, stretching

the neck and body

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Low Blood

Pressure:

feeling

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:

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.

IMPORTANT: PLEASE READ

Page 4 of 4

This is not a complete list of side effects. For any unexpected

effects while taking Neuleptil, contact your doctor or pharmacist.

HOW TO STORE IT

Store this medication at room temperature between 15 and 30 oC

away from heat and light. Do not store in the bathroom.

Keep this and

all medications out of the reach and sight of children.

REPORTING SUSPECTED 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, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form

and the adverse reaction reporting guidelines are

available on the MedEffect

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 at:

http://www.ECI2012.net

or by contacting the sponsor, Erfa Canada Inc. at:

1-800-922-3133

This leaflet was prepared by Erfa Canada 2012 Inc.

Last revised: December 19, 2012.

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