Canada - English - Health Canada
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DATE OF REVISION :
December 19, 2012
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.
As adjunctive medication in some psychotic patients, for the control of residual prevailing
hostility, impulsiveness and aggressiveness.
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.
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.
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
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
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
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
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
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.
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
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
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
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.
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
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
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
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
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
Very rare cases of
interval prolongation have been reported. There have been isolated reports
of sudden death, with possible causes of cardiac origin (see
), 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
: 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.
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
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.
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.
Protect from light. Store between 15 – 30°C.
IMPORTANT: PLEASE READ
Page 1 of 4
PART III: CONSUMER INFORMATION
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
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
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
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
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:
What the nonmedicinal ingredients are:
Capsules: calcium phosphate, croscarmellose sodium, FD&C
Blue No 1, FD&C Red No 3, gelatin, magnesium stearate and
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
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
You have heart disease, glaucoma or prostatic
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
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 initial doses are:
Adults: 5 to 20 mg in the morning and 10 to 40 mg in the
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.
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.
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
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
hives, swelling of
the face, lips,
tongue or throat,
may include high
stiff muscles, fast
drowsy or agitated
how and when you
Fast or irregular
Seizures or fits
(greater than 4
hours in duration)
erection of penis
twitches of the
body, face, eyes or
the neck and body
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Symptom / effect
Talk with your
getting up from a
lying or sitting
colour to skin and
eyes, dark urine
or fast breathing
New or worsening
inability to remain
glaucoma or other
swelling, pain and
redness in an arm
or leg that can be
warm to touch.
You may develop
sudden chest pain,
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
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form
and the adverse reaction reporting guidelines are
available on the MedEffect
Canada Web site at
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.
This document plus the full product monograph, prepared for
health professionals can be found at:
or by contacting the sponsor, Erfa Canada Inc. at:
This leaflet was prepared by Erfa Canada 2012 Inc.
Last revised: December 19, 2012.