TEVA-LENOLTEC NO. 4 TABLET

Canada - English - Health Canada

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Active ingredient:
ACETAMINOPHEN; CODEINE PHOSPHATE
Available from:
TEVA CANADA LIMITED
ATC code:
N02AJ06
INN (International Name):
CODEINE AND PARACETAMOL
Dosage:
300MG; 60MG
Pharmaceutical form:
TABLET
Composition:
ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 60MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0211376001; AHFS: 28:08.08
Authorization status:
APPROVED
Authorization number:
00621463
Authorization date:
2018-10-05

Documents in other languages

TEVA-LENOLTEC No. 4

Product Monograph

Page 1 of 35

PRODUCT MONOGRAPH

INCLUDING PATIENT MEDICATION INFORMATION

N

TEVA-LENOLTEC No. 4

Acetaminophen and codeine phosphate tablets

300 mg acetaminophen and 60 mg codeine phosphate

Analgesic-Antipyretic

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

www.tevacanada.com

Submission Control No.: 206206

Date of Revision:

October 4, 2018

TEVA-LENOLTEC No. 4

Product Monograph

Page 2 of 35

TABLE OF CONTENTS

PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3

SUMMARY

PRODUCT

INFORMATION ..................................................................................... 3

INDICATIONS

CLINICAL

USE ........................................................................................... 3

CONTRAINDICATIONS ................................................................................................................ 3

WARNINGS

PRECAUTIONS ............................................................................................... 4

ADVERSE

REACTIONS .............................................................................................................. 13

DRUG

INTERACTIONS ............................................................................................................... 15

DOSAGE

ADMINISTRATION ........................................................................................... 16

OVERDOSAGE ............................................................................................................................. 19

ACTION

CLINICAL

PHARMACOLOGY .......................................................................... 21

STORAGE

STABILITY ....................................................................................................... 23

SPECIAL

HANDLING

INSTRUCTIONS .................................................................................... 23

DOSAGE

FORMS,

COMPOSITION

PACKAGING ........................................................... 23

PART II: SCIENTIFIC INFORMATION .................................................................................... 24

PHARMACEUTICAL

INFORMATION ...................................................................................... 24

REFERENCES ............................................................................................................................... 25

PATIENT MEDICATION INFORMATION ............................................................................... 26

TEVA-LENOLTEC No. 4

Product Monograph

Page 3 of 35

N

TEVA-LENOLTEC No. 4

Acetaminophen and codeine phosphate tablets

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of

Administration

Dosage Form / Strength

Nonmedicinal Ingredients

Oral

Tablets

300 mg acetaminophen and

60 mg codeine phosphate

Croscarmellose Sodium, Magnesium Stearate,

Microcrystalline Cellulose, and Silica

Colloidal Anhydrous.

INDICATIONS AND CLINICAL USE

Adults

TEVA-LENOLTEC No. 4 (acetaminophen and codeine phosphate) is indicated for the short-term

relief of moderate to severe pain.

Geriatrics (> 65 years of age)

In general, dose selection for an elderly patient should be cautious, usually starting at the low end

of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac

function, concomitant disease or other drug therapy.

Pediatrics (< 18 years of age)

There are limited safety and efficacy studies with acetaminophen and codeine in the

pediatric

population. Therefore, the use of TEVA-LENOLTEC No. 4 is not recommended

patients over 12 and under 18 years of age.

Regardless of clinical setting, the use of codeine, including TEVA-LENOLTEC No. 4 is

contraindicated in patients below the age of 12 years due to increased safety concerns (see

CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS, Special Populations,

Pediatrics).

CONTRAINDICATIONS

Patients who are hypersensitive to the active substance acetaminophen and codeine

phosphate or other opioid analgesics or to any ingredient in the formulation. For a complete

listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the

Product Monograph.

TEVA-LENOLTEC No. 4

Product Monograph

Page 4 of 35

Patients with known or suspected mechanical gastrointestinal obstruction (e.g., bowel

obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any

type).

Patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).

Patients with mild pain that can be managed with other pain medications.

Patients with acute or severe bronchial asthma, chronic obstructive airway, or status

asthmaticus.

Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and

cor pulmonale.

Patients with acute alcoholism, delirium tremens, and convulsive disorders.

Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and

head injury.

Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).

Women who are nursing or during labour and delivery (see Serious Warnings and

Precautions and WARNINGS AND PRECAUTIONS, Special Populations,

Labour, Delivery and Nursing Women).

Pediatric patients (<18 years of age) who have undergone tonsillectomy and/or

adenoidectomy for obstructive sleep apnoea syndrome.

Patients with severe hepatic or renal impairment (see WARNINGS AND PRECAUTIONS,

Special Populations, Hepatic Impairment and Renal Impairment).

CYP2D6 ultra-rapid metabolizers who convert codeine into its active metabolite more

rapidly and completely than other people (see WARNINGS AND PRECAUTIONS, Risk

of Death in Ultra-Rapid Metabolizers of Codeine; SYMPTOMS AND TREATMENT

OF OVERDOSAGE, Codeine).

Children less than 12 years old.

WARNINGS AND PRECAUTIONS

SERIOUS WARNINGS AND PRECAUTIONS

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended

doses, and because of the risks of overdose and death with immediate release opioid

formulations, TEVA-LENOLTEC No. 4 (acetaminophen and codeine phosphate tablets)

should only be used in patients for whom alternative treatment options (e.g., non-opioid

TEVA-LENOLTEC No. 4

Product Monograph

Page 5 of 35

analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide

appropriate management of pain (see DOSAGE AND ADMINISTRATION).

Addiction, Abuse, and Misuse

TEVA-LENOLTEC No. 4 poses risks of opioid addiction, abuse, and misuse, which can lead

to overdose and death. Each patient’s risk should be assessed prior to prescribing

TEVA-

LENOLTEC No. 4, and all patients should be monitored regularly for the development of

these behaviours or conditions (see WARNINGS AND PRECAUTIONS). TEVA-

LENOLTEC No. 4 should be stored securely to avoid theft or misuse.

Life-threatening Respiratory Depression: OVERDOSE

Serious, life-threatening, or fatal respiratory depression may occur with use of TEVA-

LENOLTEC No. 4. Infants exposed in-utero or through breast milk are at risk of life-

threatening respiratory depression upon delivery or when nursed. Patients should be

monitored for respiratory depression, especially during initiation of TEVA-LENOLTEC No.

4 or following a dose increase.

TEVA-LENOLTEC No. 4 must be swallowed whole. Cutting, breaking, crushing, chewing,

or dissolving TEVA-LENOLTEC No. 4 can lead to dangerous adverse events including

death (see WARNINGS AND PRECAUTIONS). Further, instruct patients of the hazards

related to taking opioids including fatal overdose.

Accidental Exposure

Accidental ingestion of even one dose of TEVA-LENOLTEC No. 4, especially by children,

can result in a fatal overdose of acetaminophen and codeine phosphate (see DOSAGE AND

ADMINISTRATION, Disposal, for instructions on proper disposal).

Neonatal Opioid Withdrawal Syndrome (NOWS)

Prolonged maternal use of TEVA-LENOLTEC No. 4 during pregnancy can result in

neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND

PRECAUTIONS).

Interaction with Alcohol

The co-ingestion of alcohol with TEVA-LENOLTEC No. 4 should be avoided as it may

result in dangerous additive effects, causing serious injury or death (see WARNINGS AND

PRECAUTIONS and DRUG INTERACTIONS).

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS)

depressants, including alcohol, may result in profound sedation, respiratory depression,

coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG

INTERACTIONS).

Reserve concomitant prescribing of TEVA-LENOLTEC No. 4 and benzodiazepines or

other CNS depressants for use in patients for whom alternative treatment options are

inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

TEVA-LENOLTEC No. 4

Product Monograph

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General

Patients should be instructed not to give TEVA-LENOLTEC No. 4 (acetaminophen, and

codeine phosphate) tablets to anyone other than the patient for whom it was prescribed, as

such inappropriate use may have severe medical consequences, including death. TEVA-

LENOLTEC No. 4 should be stored securely to avoid theft or misuse.

TEVA-LENOLTEC No. 4 should only be prescribed by persons knowledgeable in the

administration of potent opioids, in the management of patients receiving potent opioids

for the treatment of pain, and in the detection and management of respiratory depression,

including the use of opioid antagonists.

Patients should be cautioned not to consume alcohol while taking TEVA-LENOLTEC No. 4 as it

may increase the chance of experiencing serious adverse events, including death.

Hyperalgesia that will not respond to a further dose increase of opioids can occur at particularly

high doses. A codeine dose reduction or change in opioid may be required.

Patients should be counselled to consult a physician if redness or swelling is present in an area of

pain, if symptoms do not improve or if they worsen, or if new symptoms such as high fever, rash,

itching, wheezing or persistent headache occur, as these may be signs of a condition which

requires medical attention.

Acetaminophen should not be taken for pain for more than 5 days or for fever for more than

3 days, unless directed by a physician. Do not take continuously without medical review.

Patients should be counselled to contact a physician if pain or fever persists or gets worse, or if

new symptoms occur.

Patients should be counselled not to use with other products containing acetaminophen, an

opioid, or codeine.

Patients should be counselled to discontinue codeine products and to seek urgent medical help at

the earliest sign of codeine toxicity including symptoms such as confusion, shallow breathing, or

extreme sleepiness which may be life threatening.

Abuse and Misuse

Like all opioids, TEVA-LENOLTEC No. 4 is a potential drug of abuse and misuse, which

lead to overdose and death. Therefore, TEVA-LENOLTEC No. 4 should be prescribed

handled with caution.

Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being

prescribed opioids. All patients receiving opioids should be routinely monitored for signs of

misuse and abuse.

Opioids, such as codeine, should be used with particular care in patients with a history of alcohol

and illicit/prescription drug abuse. However, concerns about abuse, addiction, and diversion

should not prevent the proper management of pain.

TEVA-LENOLTEC No. 4

Product Monograph

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TEVA-LENOLTEC No. 4 is intended for oral use only. The tablets should be swallowed

whole.

Abuse of oral dosage forms can be expected to result in serious adverse events, including

death.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals on whether acetaminophen or codeine have

a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in

animals to determine whether acetaminophen has a potential for impairment of fertility.

Acetaminophen and codeine have been found to have no mutagenic potential using the Ames

Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the

Micronucleus test on mouse bone marrow.

Cardiovascular

Codeine administration may result in severe hypotension in patients whose ability to maintain

adequate blood pressure is compromised by reduced blood volume, or concurrent administration

of drugs such as phenothiazines and other tranquilizers, sedative/hypnotics, tricyclic

antidepressants or general anesthetics. These patients should be monitored for signs of

hypotension after initiating or titrating the dose of TEVA-LENOLTEC No. 4.

The use of TEVA-LENOLTEC No. 4 in patients with circulatory shock should be avoided

as it

may cause vasodilation that can further reduce cardiac output and blood pressure.

Dependence/Tolerance

As with other opioids, tolerance and physical dependence may develop upon repeated

administration of TEVA-LENOLTEC No. 4 and there is a potential for development of

psychological dependence.

Physical dependence and tolerance reflect the neuroadaptation of the opioid receptors to chronic

exposure to an opioid, and are separate and distinct from abuse and addiction. Tolerance, as well

as physical dependence, may develop upon repeated administration of opioids, and are not by

themselves evidence of an addictive disorder or abuse.

Patients on prolonged therapy should be tapered gradually from the drug if it is no longer

required for pain control. Withdrawal symptoms may occur following abrupt discontinuation of

therapy or upon administration of an opioid antagonist. Some of the symptoms that may be

associated with abrupt withdrawal of an opioid analgesic include body aches, diarrhea,

gooseflesh, loss of appetite, nausea, nervousness or restlessness, anxiety, runny nose, sneezing,

tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in

sweating, palpitations, unexplained fever, weakness and yawning (see ADVERSE

REACTIONS, DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage).

Use in Drug and Alcohol Addiction

TEVA-LENOLTEC No. 4 is an opioid with no approved use in the management of addictive

disorders. Its proper usage in individuals with drug or alcohol dependence, either active

or in

remission is for the management of pain requiring opioid analgesia. Patients with a history of

addiction to drugs or alcohol may be at higher risk of becoming addicted to TEVA-LENOLTEC

No. 4; unless used under extreme caution and awareness.

TEVA-LENOLTEC No. 4

Product Monograph

Page 8 of 35

Endocrine

Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more

often following greater than one month of use. Presentation of adrenal insufficiency may include

non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness,

dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis

with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with

physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow

adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.

Other opioids may be tried as some cases reported use of a different opioid without recurrence of

adrenal insufficiency. The information available does not identify any particular opioids as being

more likely to be associated with adrenal insufficiency.

Gastrointestinal Effects

Codeine and other morphine-like opioids have been shown to decrease bowel motility. Codeine

may obscure the diagnosis or clinical course of patients with acute abdominal conditions (see

CONTRAINDICATIONS).

Neonatal Opioid Withdrawal Syndrome (NOWS)

TEVA-LENOLTEC No. 4 is not recommended to be used in pregnant women unless, in the

judgement of the physician, the potential benefits outweigh the risks. If TEVA-LENOLTEC No.

4 was used during pregnancy, special attention to NOWS is warranted.

Prolonged maternal use of opioids during pregnancy can result in withdrawal signs in the

neonate. Neonatal opioid withdrawal syndrome (NOWS), unlike opioid withdrawal syndrome in

adults, may be life-threatening.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep

pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset,

duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid

used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug

by the newborn.

Neurologic

Serotonin Syndrome: TEVA-LENOLTEC No. 4 could cause a rare but potentially life-

threatening condition resulting from concomitant administration of serotonergic drugs (e.g. anti-

depressants, migraine medications). Treatment with the serotoninergic drug should be

discontinued if such events (characterized by clusters of symptoms such as hyperthermia,

rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental

status changes including confusion, irritability, extreme agitation progressing to delirium and

coma) occur and supportive symptomatic treatment should be initiated. TEVA-LENOLTEC No.

4 should not be used in combination with MAO inhibitors or serotonin-precursors (such as L-

tryptophan, oxitriptan) and should be used with caution in combination with other

serotonergic

drugs (triptans, certain tricyclic antidepressants, lithium, tramadol, St. John’s Wort) due to the

risk of serotonergic syndrome (see DRUG INTERACTIONS).

TEVA-LENOLTEC No. 4

Product Monograph

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Interactions with Central Nervous System Depressants (including benzodiazepines and

alcohol):

Codeine should be used with caution and in a reduced dosage during concomitant administration

of other opioid analgesics, general anesthetics, phenothiazines and other tranquilizers, sedative-

hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, benzodiazepines, centrally-

active anti-emetics and other CNS depressants. Respiratory depression, hypotension and

profound sedation, coma or death may result.

Observational studies have demonstrated that concomitant use of opioid analgesics and

benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics

alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with

the concomitant use of other CNS depressant drugs with opioid analgesics (see DRUG

INTERACTIONS). If the decision is made to prescribe a benzodiazepine or other CNS

depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and

minimum durations of concomitant use. In patients already receiving an opioid analgesic,

prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in

the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated

in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial

dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for

signs and symptoms of respiratory depression and sedation.

Advise both patients and caregivers about the risks of respiratory depression and sedation when

TEVA-LENOLTEC No. 4 is used with benzodiazepines or other CNS depressants

(including

alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the

effects of concomitant use of the benzodiazepine or other CNS depressant have been

determined. Screen patients for risk of substance use disorders, including opioid abuse and

misuse, and warn them of the risk for overdose and death associated with the use of additional

CNS depressants including alcohol and illicit drugs (see DRUG INTERACTIONS).

TEVA-LENOLTEC No. 4 should not be consumed with alcohol as it may increase the

chance of

experiencing dangerous side effects, including death (see CONTRAINDICATIONS,

ADVERSE REACTIONS, Sedation, and DRUG INTERACTIONS).

Severe pain antagonizes the subjective and respiratory depressant actions of opioid analgesics.

Should pain suddenly subside, these effects may rapidly become manifest.

Head Injury: The respiratory depressant effects of codeine, and the capacity to elevate

cerebrospinal fluid pressure, may be greatly increased in the presence of an already elevated

intracranial pressure produced by trauma. Also, codeine may produce confusion, miosis,

vomiting and other side effects which obscure the clinical course of patients with head injury. In

such patients, codeine must be used with extreme caution and only if it is judged essential (see

CONTRAINDICATIONS).

Risk of Death in Ultra-Rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype.

These individuals convert codeine into its active metabolite, morphine, more rapidly and

completely than other people. This rapid conversion results in higher than expected serum

TEVA-LENOLTEC No. 4

Product Monograph

Page 10 of 35

morphine levels. Even at labelled dosage regimens, individuals who are ultra-rapid metabolizers

may have life-threatening or fatal respiratory depression or experience overdose symptoms such

as extreme sleepiness, confusion, or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in

Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African

Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for

other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective

dose for the shortest period of time and inform their patients about these risks and the signs of

morphine overdose (see DOSAGE AND ADMINISTRATION, Dosing Considerations).

Peri-Operative Considerations

TEVA-LENOLTEC No. 4 is not indicated for pre-emptive analgesia (administration pre-

operatively for the management of post-operative pain).

In the case of planned chordotomy or other pain-relieving operations, patients should not be

treated with TEVA-LENOLTEC No. 4 for at least 24 hours before the operation and

TEVA-

LENOLTEC No. 4 should not be used in the immediate post-operative period.

Physicians should individualize treatment, moving from parenteral to oral analgesics as

appropriate. Thereafter, if TEVA-LENOLTEC No. 4 is to be continued after the patient

recovers from the post-operative period, a new dosage should be administered in accordance

with the changed need for pain relief. The risk of withdrawal in opioid-tolerant patients should

be addressed as clinically indicated.

The administration of analgesics in the peri-operative period should be managed by healthcare

providers with adequate training and experience (e.g., by an anesthesiologist).

Codeine and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a

common post-operative complication, especially after intra-abdominal surgery with opioid

analgesia. Caution should be taken to monitor for decreased bowel motility in post-operative

patients receiving opioids. Standard supportive therapy should be implemented.

TEVA-LENOLTEC No. 4 should not be used in the early post-operative period (12 to 24 hours

post-surgery) unless the patient is ambulatory and gastrointestinal function is normal.

Psychomotor Impairment

TEVA-LENOLTEC No. 4 may impair the mental and/or physical abilities needed for certain

potentially hazardous activities such as driving a car or operating machinery. Patients

should be

cautioned accordingly. Patients should also be cautioned about the combined effects of codeine

with other CNS depressants, including other opioids, phenothiazine, sedative/hypnotics and

alcohol.

Respiratory

Respiratory Depression: Serious, life-threatening, or fatal respiratory depression has been

reported with the use of opioids, even when used as recommended. Respiratory depression from

TEVA-LENOLTEC No. 4

Product Monograph

Page 11 of 35

opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death.

Management of respiratory depression may include close observation, supportive measures, and

use of opioid antagonists, depending on the patient’s clinical status. Codeine should be used with

extreme caution in patients with substantially decreased respiratory reserve, pre-existing

respiratory depression, hypoxia or hypercapnia (see CONTRAINDICATIONS).

While serious, life-threatening, or fatal respiratory depression can occur at any time during the

use of TEVA-LENOLTEC No. 4, the risk is greatest during the initiation of therapy or following

a dose increase. Patients should be closely monitored for respiratory depression when initiating

therapy with TEVA-LENOLTEC No. 4 and following dose increases.

Life-threatening respiratory depression is more likely to occur in the elderly, cachectic, or

debilitated patients because they may have altered pharmacokinetics or altered clearance

compared to younger, healthier patients.

To reduce the risk of respiratory depression, proper dosing and titration of TEVA-LENOLTEC

No. 4 are essential. Overestimating the TEVA-LENOLTEC No. 4 dose when converting

patients from another opioid product can result in a fatal overdose with the first dose. In these

patients, the use of non-opioid analgesics should be considered, if feasible (see

WARNINGS

AND PRECAUTIONS, Special Populations, Special Risk Groups, and

DOSAGE AND

ADMINISTRATION).

Respiratory depression and death have occurred in children who received codeine in the

postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being

ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450

isoenzyme 2D6 or high morphine concentrations). Children with obstructive sleep apnea who are

treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly

sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to

morphine. Codeine-containing products are contraindicated for post-operative pain management

in all pediatric patients undergoing tonsillectomy and/or adenoidectomy for obstructive sleep

apnoea syndrome (see CONTRAINDICATIONS).

Use in Patients with Chronic Pulmonary Disease: Monitor patients with significant chronic

obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased

respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression for respiratory

depression, particularly when initiating therapy and titrating with TEVA-LENOLTEC No. 4, as

in these patients, even usual therapeutic doses of TEVA-LENOLTEC No. 4 may

decrease

respiratory drive to the point of apnea. In these patients, use of alternative non-opioid analgesics

should be considered, if possible. The use of TEVA-LENOLTEC No. 4 is

contraindicated in

Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus

(see CONTRAINDICATIONS).

Sensitivity

Serious Skin Reactions

Rarely, acetaminophen can cause serious skin reactions such as acute generalized exanthematous

pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN),

which can be fatal. It is important to recognize and react quickly to the initial symptoms of these

reactions which may occur without warning but may be manifested by any serious skin reactions.

TEVA-LENOLTEC No. 4

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Patients should be informed about the signs of serious skin reactions, and use of the drug should

be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Sexual Function/Reproduction

Long-term use of opioids may be associated with decreased sex hormone levels and symptoms

such as low libido, erectile dysfunction, or infertility (see ADVERSE REACTIONS, Post-

Marketing Experience).

Special Populations

Special Risk Groups: Codeine should be administered with caution to patients with a history of

alcohol and drug abuse and in a reduced dosage to debilitated patients, and in patients with

severely impaired pulmonary function, Addison’s disease, hypothyroidism, myxedema, toxic

psychosis, prostatic hypertrophy or urethral stricture.

Pregnant Women: Studies in humans have not been conducted. TEVA-LENOLTEC No. 4

crosses the placental barrier and should not be administered to pregnant women unless in the

judgment of the physician, potential benefits outweigh the risks.

Pregnant women using opioids should not discontinue their medication abruptly as this can cause

pregnancy complications. Tapering should be slow and under medical supervision to avoid serious

adverse events to the fetus.

Prolonged maternal use of opioids during pregnancy can result in withdrawal signs in the

neonate. Neonatal opioid withdrawal syndrome (NOWS), unlike opioid withdrawal syndrome in

adults, may be life-threatening (see WARNINGS AND PRECAUTIONS, Neonatal Opioid

Withdrawal Syndrome, ADVERSE REACTIONS, Post-marketing Experience).

Labour, Delivery and Nursing Women: Since opioids can cross the

placental barrier and are

excreted in breast milk, TEVA-LENOLTEC No. 4 is

contraindicated in nursing women and

during labour and delivery. Life-threatening respiratory depression can occur in the

infant if

opioids are administered to the mother. Naloxone, a drug that counters the effects of opioids,

should be readily available if TEVA-LENOLTEC No. 4 is used in this population.

Codeine is secreted into human milk. In women with normal codeine metabolism (normal

CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent.

Despite the common use of codeine products to manage postpartum pain, reports of adverse

events in infants are rare. However, some women are ultra-rapid metabolizers of codeine.

These women achieve higher-than-expected serum levels of

codeine’s

active metabolite,

morphine, leading to higher-than-expected levels of morphine in breast milk and

potentially dangerously high serum morphine levels in their breastfed infants. Therefore,

maternal use of codeine can potentially lead to serious adverse reactions, including death,

in nursing infants (see WARNINGS AND PRECAUTIONS, Risk of Death in Ultra-Rapid

Metabolizers of Codeine).

Pediatrics (< 18 years of age): There are limited safety and efficacy studies with acetaminophen

and codeine in the pediatric population. Therefore, use of TEVA-LENOLTEC No. 4 is not

recommended in patients over 12 and under 18 years of age. TEVA-LENOLTEC No. 4 contains

codeine and is contraindicated in children under 12 years of age (see

TEVA-LENOLTEC No. 4

Product Monograph

Page 13 of 35

CONTRAINDICATIONS).

Geriatrics (> 65 years of age): In general, dose selection for an elderly patient should be

cautious, usually starting at the low end of the dosing range and titrate slowly, reflecting the

greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or

other drug therapy (see DOSAGE AND ADMINISTRATION).

Patients with Hepatic Impairment:

Acetaminophen

TEVA-LENOLTEC No. 4 is contraindicated in patients with severe hepatic impairment. In

patients with compromised liver function, acetaminophen could exacerbate liver insufficiency.

The half-life of acetaminophen can be prolonged in patients with severe liver disease which

could

lead to increased exposure. Liver function should be monitored in patients with liver

disease (see

Laboratory Tests).

Patients with or without liver disease should not exceed the daily maximum dose of

acetaminophen (4,000 mg). The maximum daily dose of acetaminophen includes all routes of

administration (intravenous, oral and rectal) and all products containing acetaminophen (oral

solutions/drops, syrup, pills, capsules, suppositories etc.).

Codeine

In patients with hepatic impairment, pain control may be compromised because codeine may not

be adequately metabolized. Alternative pain medication could be considered due to the possible

insufficient analgesic effect.

Patients with Renal Impairment:

TEVA-LENOLTEC No. 4 is contraindicated in patients with severe renal impairment, and

acetaminophen has been reported to cause toxicity this population. Use of codeine is not

recommended in patients with a Glomerular Filtration Rate (GFR) <30 mL/min. Patients with

renal

dysfunction have increased risk of toxicity. Renal function should be monitored in patients with

renal disease (see Laboratory Tests).

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with

serial liver and/or renal function tests.

ADVERSE REACTIONS

Adverse Drug Reaction Overview

Adverse effects of TEVA-LENOLTEC No. 4 (acetaminophen and codeine phosphate)

tablets are

similar to those of other opioid analgesics, and represent an extension of pharmacological effects

of the drug class. The major hazards of opioids include respiratory and central nervous system

depression and to a lesser degree, circulatory depression, respiratory

arrest, shock and cardiac

arrest.

The most frequently observed adverse effects of acetaminophen and codeine phosphate tablets are

TEVA-LENOLTEC No. 4

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drowsiness, light-headedness, dizziness, sedation, shortness of breath, nausea, and vomiting.

These effects seem to be more prominent in ambulatory patients than in non-ambulatory patients,

and some of these adverse reactions may be alleviated if the patient lies down. Other adverse

reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus,

rash, thrombocytopenia, dry mouth, hyperhidrosis, somnolence and agranulocytosis. The

incidence and severity of gastrointestinal upset is less than that after salicylate administration.

The classic gastrointestinal irritation associated with non-steroidal anti-inflammatory drugs,

including acetylsalicylic acid (ASA), does not occur with acetaminophen. Sensitivity reactions

are rare and may manifest as rash or urticaria. Cross-reactivity in ASA-sensitive persons has

been rarely reported. If sensitivity is suspected, discontinue use of the drug.

Sedation: Sedation is a common side effect of opioid analgesics, especially in opioid naïve

individuals. Sedation may also occur partly because patients often recuperate from prolonged

fatigue after the relief of persistent pain. Most patients develop tolerance to the sedative effects

of opioids within three to five days and, if the sedation is not severe, will not require any

treatment except reassurance. If excessive sedation persists beyond a few days, the dose of the

opioid should be reduced and alternate causes investigated. Some of these are: concurrent CNS

depressant medication, hepatic or renal dysfunction, brain metastases, hypercalcemia and

respiratory failure. If it is necessary to reduce the dose, it can be carefully increased again after

three or four days if it is obvious that the pain is not being well controlled. Dizziness and

unsteadiness may be caused by postural hypotension, particularly in elderly or debilitated

patients, and may be alleviated if the patient lies down.

Nausea and Vomiting: Nausea is a common side effect on initiation of therapy with opioid

analgesics and is thought to occur by activation of the chemoreceptor trigger zone, stimulation of

the vestibular apparatus and through delayed gastric emptying. The prevalence of nausea

declines following continued treatment with opioid analgesics. When instituting therapy with an

opioid for chronic pain, the routine prescription of an antiemetic should be considered. In the

cancer patient, investigation of nausea should include such causes as constipation, bowel

obstruction, uremia, hypercalcemia, hepatomegaly, tumor invasion of celiac plexus and

concurrent use of drugs with emetogenic properties. Persistent nausea which does not respond to

dosage reduction may be caused by opioid-induced gastric stasis and may be accompanied by

other symptoms including anorexia, early satiety, vomiting and abdominal fullness. These

symptoms respond to chronic treatment with gastrointestinal prokinetic agents.

Constipation: Practically all patients become constipated while taking opioids on a persistent

basis. In some patients, particularly the elderly or bedridden, fecal impaction may result. It is

essential to caution the patients in this regard and to institute an appropriate regimen of bowel

management at the start of prolonged opioid therapy. Stimulant laxatives, stool softeners, and

other appropriate measures should be used as required. As fecal impaction may present as

overflow diarrhea, the presence of constipation should be excluded in patients on opioid therapy

prior to initiating treatment for diarrhea.

Post-marketing Experience

Adverse drug reactions (ADRs) identified during post-marketing experience with codeine,

acetaminophen or the combination are shown below according to their System Organ Class

(SOC). The frequencies are estimated from spontaneous reports and sales data.

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Gastrointestinal Disorders: (very rare) abdominal pain, dyspepsia.

Immune System Disorders: (very rare) anaphylactic reaction, hypersensitivity,

Investigations: (very rare) transaminases increased.

Nervous System Disorders: (very rare) headache, sedation

Psychiatric Disorders: (very rare) agitation, dependence, drug withdrawal syndrome, euphoric

mood

Respiratory, Thoracic and Mediastinal Disorders: (very rare) bronchospasm, dyspnoea,

respiratory depression, angioedema

Vascular Disorders: (very rare) flushing

Skin and Subcutaneous Tissue Disorders: (very rare) pruritus, rash, urticaria

Androgen deficiency: Chronic use of opioids may influence the hypothalamic-pituitary-gonadal

axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile

dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of

hypogonadism is unknown because the various medical, physical, lifestyle, and psychological

stressors that may influence gonadal hormone levels have not been adequately controlled for in

studies conducted to date. Patients presenting with symptoms of androgen deficiency should

undergo laboratory evaluation.

DRUG INTERACTIONS

Drug-Drug Interactions

Interaction with Benzodiazepines and Central Nervous System (CNS) Depressants: Due to

additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants

(e.g. other opioids, sedatives/hypnotics, antidepressants, anxiolytics, tranquilizers, muscle

relaxants, general anesthetics, antipsychotics, phenothiazines, neuroleptics, antihistamines,

antiemetics, and alcohol) and beta-blockers, increases the risk of respiratory depression,

profound sedation, coma, and death. Reserve concomitant prescribing of these drugs for use in

patients for whom alternative treatment options are inadequate. Limit dosages and durations to

the minimum required. Follow patients closely for signs of respiratory depression and sedation

(see WARNINGS AND PRECAUTIONS, Neurologic, Interactions with Central Nervous

System Depressants (including benzodiazepines and alcohol) and Psychomotor

Impairment). TEVA-LENOLTEC No. 4 should not be consumed with alcohol as it may

increase the chance of experiencing dangerous side effects.

Drugs Associated with a Risk of Serotonin Syndrome:

Coadministration of codeine with a serotonergic agent, such as a Selective Serotonin Re-uptake

Inhibitor or a Serotonin Norepinephrine Re-uptake Inhibitor, may increase the risk of serotonin

syndrome, a potentially life-threatening condition (see WARNINGS AND PRECAUTIONS).

CYP2D6 inhibitors: Codeine analgesia is believed to be dependent upon the cytochrome P450

isoenzyme CYP2D6 catalyzed o-demethylation to form the active metabolite morphine although

other mechanisms have been cited. An interaction with quinidine, methadone, and paroxetine

(CYP2D6 inhibitors) leading to decreased plasma concentrations of morphine has been

described, which may have the potential to decrease codeine analgesia.

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Warfarin-like compounds: Patients who concomitantly medicate with warfarin-type

anticoagulants and regular doses of acetaminophen have occasionally been reported to have

unforeseen elevations in their international normalized ratio (INR). Physicians should be

cognizant of this potential interaction and monitor the INR in such patients closely while therapy

is established. Many factors, including diet, medications, and environmental and physical states,

may affect how a patient responds to anticoagulant therapy. There have been several reports that

suggest that acetaminophen may produce hypoprothrombinemia (elevated INR or prothrombin

time) when administered with coumarin derivatives. In other studies, prothrombin time did not

change. Reported changes have been generally of limited clinical significance, however,

periodic evaluation of prothrombin time should be performed when these agents are administered

concurrently.

In the period immediately following discharge from the hospital or whenever other medications

are initiated, discontinued, or taken regularly, it is important to monitor patient response to

anticoagulation therapy with additional prothrombin time of INR determinations.

Drug-Laboratory Interactions

Codeine may increase serum amylase levels.

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Drug-Lifestyle Interactions

The concomitant use of alcohol should be avoided (see WARNINGS AND PRECAUTIONS).

DOSAGE AND ADMINISTRATION

TEVA-LENOLTEC No. 4 should only be used in patients for whom alternative

treatment options are ineffective or not tolerated (e.g., non-opioid analgesics).

TEVA-LENOLTEC No. 4 must be swallowed whole. Cutting, breaking, crushing, chewing,

or dissolving TEVA-LENOLTEC No. 4 can lead to dangerous adverse

events including

death (see WARNINGS AND PRECAUTIONS).

For acute pain, it is recommended that TEVA-LENOLTEC No. 4 be used for a maximum of

5 days at the lowest dose that provides adequate pain relief. For fever, it is recommended

that TEVA-LENOLTEC No. 4 be used for a maximum of 3 days at the lowest dose that

provides adequate fever relief.

All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is

increased with higher doses. If TEVA-LENOLTEC No. 4 is used for more than 5 days for

the management of chronic non-cancer, non-palliative pain, it is recommended that a

maximum daily dosage of 6 tablets not be exceeded; the maximum daily dosage is equivalent

to 360 mg codeine (54 morphine milligram equivalent) of TEVA-LENOLTEC No. 4. Each

patient should be assessed for their risk prior to prescribing TEVA-LENOLTEC No. 4, as

the likelihood of experiencing serious adverse events can depend upon the type of opioid,

duration of treatment, level of pain as well as the patient’s own level of tolerance. In

addition, the level of pain should be assessed routinely to confirm the most appropriate dose

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and the need for further use of TEVA-LENOLTEC No. 4 (see Recommended Dose and

Dosage Adjustment below).

Dosing Considerations

TEVA-LENOLTEC No. 4 (acetaminophen and codeine phosphate) tablets should be used with

caution within 12 hours pre-operatively and within the first 12-24 hours post-operatively

(see

WARNINGS AND PRECAUTIONS, Peri-operative Considerations).

TEVA-LENOLTEC No. 4 is not indicated for rectal administration.

TEVA-LENOLTEC No. 4 may be taken with or without food, with a glass of water.

TEVA-LENOLTEC No. 4 is contraindicated in children less than 12 years old (see

CONTRAINDICATIONS).

Codeine, including TEVA-LENOLTEC No. 4, should be prescribed at the lowest effective

dose for

the shortest period of time. Dosing should be as needed every 4 to 6 hours and not on scheduled

intervals.

Do not co-administer with other drugs containing acetaminophen.

The maximum recommended dose of TEVA-LENOLTEC No. 4 should not be exceeded.

Overdose may result in severe or possibly fatal liver damage (see WARNINGS AND

PRECAUTIONS, Special Populations, Hepatic Impairment).

Dosage should be adjusted according to severity of pain and response of the patient. However, it

should be kept in mind that tolerance to codeine can develop with continued use and that the

incidence of untoward effects is dose related. Adult doses of codeine, higher than 60 mg, fail to

give commensurate relief of pain but merely prolong analgesia, and are associated with an

appreciably increased incidence of undesirable side effects.

TEVA-LENOLTEC No. 4 tablets are given orally.

Recommended Dose and Dosage Adjustment

Adults

TEVA-LENOLTEC No. 4 tablets:

Take 1 tablet every 4-6 hours as required, not to exceed 6 tablets in 24 hours.

Based on the dosage guidance, the number of tablets per dose and the maximum number of

tablets per 24 hours should be conveyed in the prescription.

Patients with Hepatic Impairment:

No dosage adjustment is recommended in patients with mild to moderate hepatic impairment.

TEVA-LENOLTEC No. 4 is contraindicated in patients with severe hepatic impairment

(see

CONTRAINDICATIONS).

Patients with Renal Impairment:

No dosage adjustment is recommended in patients with mild to moderate renal impairment.

TEVA-LENOLTEC No. 4 is contraindicated in patients with severe renal impairment (see

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CONTRAINDICATIONS).

Geriatrics:

Respiratory depression has occurred in the elderly following administration of large initial doses

of opioids to patients who were not opioid-tolerant or when opioids were co-administered with

other agents that can depress respiration. TEVA-LENOLTEC No. 4 should be initiated at

a low

dose and slowly titrated to effect (see WARNINGS AND PRECAUTIONS).

Dose Titration:

Dose titration is the key to success with opioid analgesic therapy. Proper optimization of doses

scaled to the relief of the individual's pain should aim at administration of the lowest dose

which will achieve the overall treatment goal of satisfactory pain relief with acceptable side

effects.

Dosage adjustments should be based on the patient's clinical response.

Adjustment or Reduction of Dosage:

Physical dependence with or without psychological dependence tends to occur with chronic

administration of opioids, including TEVA-LENOLTEC No. 4. Withdrawal (abstinence)

symptoms may occur following abrupt discontinuation of therapy. These symptoms may include

body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny

nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping,

unusual increase in sweating, palpitations, unexplained fever, weakness and yawning.

Patients on prolonged therapy should be withdrawn gradually from the drug if it is no longer

required for pain control. In patients who are appropriately treated with opioid analgesics and

who undergo gradual withdrawal for the drug, these symptoms are usually mild (see

WARNINGS AND PRECAUTIONS). Tapering should be individualized and carried out

under medical supervision.

Patient should be informed that reducing and/or discontinuing opioids decreases their

tolerance to these drugs. If treatment needs to be re-initiated, the patient must start at the

lowest dose and titrate up to avoid overdose.

Disposal

TEVA-LENOLTEC No. 4 should be kept in a safe place, out of the sight and reach of

children before, during and after use. TEVA-LENOLTEC No. 4 should not be used in front

of children, since they may copy these actions.

TEVA-LENOLTEC No. 4 should never be disposed of in household trash. Disposal via a

pharmacy take back program is recommended. Unused or expired TEVA-LENOLTEC No. 4

should be properly disposed of as soon as it is no longer needed to prevent

accidental exposure to

others, including children or pets. If temporary storage is required before

disposal, a sealed child-

proof container, such as a biohazard waste container or a lockable

medication box could be

obtained from a pharmacy.

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Missed Dose

If the patient forgets to take one or more doses, they should take their next dose at the next

scheduled time and in the normal amount.

OVERDOSAGE

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

Acetaminophen:

In adults and adolescents (≥ 12 years of age), hepatic toxicity may occur following ingestion of

greater than 7.5 to 10 g over a period of 8 hours or less. Fatalities are infrequent (less than 3 to

4% of untreated cases) and have rarely been reported with overdoses of less than 15 g. In

children (< 12 years of age), an acute overdosage of less than 150 mg/kg has not been associated

with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include:

anorexia, nausea, vomiting, diaphoresis, pallor and general malaise. Clinical and laboratory

evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen

overdose in young children, possibly because of differences in the way they metabolize

acetaminophen.

Symptoms: The following are clinical events associated with acetaminophen overdose that if

seen with overdose are considered expected, including fatal events due to fulminant hepatic

failure or its sequelae.

Table 1: Adverse Drug Reactions Identified with Overdose of Acetaminophen

Metabolism and Nutrition Disorders:

Anorexia

Gastrointestinal Disorders:

Vomiting, Nausea, Abdominal discomfort

Hepatobiliary Disorders:

Hepatic necrosis, Acute hepatic failure, Jaundice, Hepatomegaly, Liver tenderness

General Disorders and Administration Site Conditions:

Pallor, Hyperhidrosis, Malaise

Investigations:

Blood bilirubin increased, Hepatic enzymes increased, International normalized ratio increased,

Prothrombin time prolonged, Blood phosphate increased, Blood lactate increased

The following clinical events are sequelae to acute hepatic failure and may be fatal. If these

events occur in the setting of acute hepatic failure associated with acetaminophen overdose

(adults and adolescents ≥ 12 years of age: > 7.5 g within 8 hours; children < 12 years of age:

>150 mg/kg within 8 hours), they are considered expected.

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Table 2: Expected Sequelae to Acute Hepatic Failure Associated with Acetaminophen

Overdose

Infections and Infestations:

Sepsis, Fungal infection, Bacterial infection

Blood and Lymphatic System Disorders:

Disseminated intravascular coagulation, Coagulopathy, Thrombocytopenia

Metabolism and Nutrition Disorders:

Hypoglycemia, Hypophosphatemia, Metabolic acidosis, Lactic acidosis

Nervous System Disorders:

Coma (with massive acetaminophen overdose or multiple drug overdose), Encephalopathy, Brain

edema

Cardiac Disorders:

Cardiomyopathy

Vascular Disorders:

Hypotension

Respiratory, Thoracic and Mediastinal Disorders:

Respiratory failure

Gastrointestinal Disorders:

Pancreatitis, Gastrointestinal hemorrhage

Renal and Urinary Disorders:

Acute renal failure

General Disorders and Administration Site Conditions:

Multi-organ failure

Typical Toxidrome: Significant overdoses of acetaminophen may result in potentially fatal

hepatotoxicity. The physician should be mindful that there is no early presentation that is

pathognomonic for the overdose. A high degree of clinical suspicion must always be maintained.

Due to the wide availability of acetaminophen, it is commonly involved in single and mixed drug

overdose situations and the practitioner should have a low threshold for screening for its

presence in a patient's serum. Acute toxicity after single dose overdoses of acetaminophen can

be anticipated when the overdose exceeds 150 mg/kg. Chronic alcohol abusers, cachectic

individuals, and persons taking pharmacologic inducers of the hepatic P450 microsomal enzyme

system may be at risk with lower exposures. Chronic intoxication has rarely been reported in

persons consuming in excess of 150 mg/kg of acetaminophen daily for several days.

Specific Antidote: NAC (N-acetylcysteine) administered by either the intravenous or the oral

route is known to be a highly effective antidote for acetaminophen poisoning. It is most

effective when administered within 8 hours of a significant overdose but reports have indicated

benefits to treatment initiated well beyond this time period. It is imperative to administer the

antidote as early as possible in the time course of acute intoxication to reap the full benefits of

the antidote's protective effects.

Treatment: When the possibility of acetaminophen overdose exists, treatment should begin

immediately and include appropriate decontamination of the gastrointestinal tract, proper

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supportive care, careful assessment of appropriately timed serum acetaminophen estimations

evaluated against the Matthew-Rumack nomogram, timely administration of NAC as required and

appropriate follow-up care. Physicians unfamiliar with the current management of acetaminophen

overdose should consult with a poison control centre immediately. Delays in initiation of

appropriate therapy may jeopardize the patient's chances for full recovery.

Codeine:

Symptoms: Risks of codeine overdose include asthenia, cardiorespiratory arrest, cerebral

edema, coma, confusional state, convulsion, drug dependence, fatigue, hypotension, hypoxia,

ileus, miosis, renal failure, respiratory depression and respiratory failure, stupor, vomiting, and

withdrawal syndrome.

Typical Toxidrome: Narcotic/Opiate

Specific Antidote: Naloxone HCl

Treatment: Stabilize the patient (A, B, C's), undertake appropriate gastrointestinal tract

decontamination procedures, initiate supportive care, administer antidote as needed (see

manufacturer's product monograph), consult with a Regional Poison Control Centre regarding

ongoing management, and arrange for appropriate follow-up care.

ACTION AND CLINICAL PHARMACOLOGY

Mechanism of Action

TEVA-LENOLTEC No. 4 (acetaminophen and codeine phosphate) combines the

analgesic

effects of codeine with acetaminophen.

Pharmacodynamics

Central Nervous System:

Codeine produces respiratory depression by direct action on brain stem respiratory centres. The

respiratory depression involves both a reduction in the responsiveness of the brain stem centres

to increases in CO

tension and to electrical stimulation.

Codeine depresses the cough reflex by direct effect on the cough centre in the medulla.

Antitussive effects may occur with doses lower than those usually required for analgesia.

Codeine causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but

are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce

similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of

codeine overdose.

Gastrointestinal Tract and Other Smooth Muscle:

Codeine causes a reduction in motility associated with an increase in smooth muscle tone in the

antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and

propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased,

while tone may be increased to the point of spasm resulting in constipation. Other opioid-

induced effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of the

sphincter of Oddi, and transient elevations in serum amylase.

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Cardiovascular System:

Codeine may produce release of histamine with or without associated peripheral vasodilation.

Manifestations of histamine release and/or peripheral vasodilatation may include pruritus,

flushing, red eyes, hyperhidrosis and/or orthostatic hypotension.

Endocrine System:

Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that

can be seen include an increase in serum prolactin, and decreases in plasma cortisol and

testosterone. Clinical signs and symptoms may be manifest from these hormonal changes.

Immune System:

In vitro and animal studies indicate that opioids have a variety of effects on immune functions,

depending on the context in which they are used. The clinical significance of these findings is

unknown.

Pharmacokinetics

Absorption:

Acetaminophen and codeine phosphate are well absorbed while taken orally.

Following oral administration of acetaminophen in combination with codeine, both drugs are

rapidly absorbed with peak plasma levels occurring within 60 minutes. Given two tablets of

300 mg acetaminophen, 15 mg caffeine and 30 mg codeine phosphate, 600 mg of

acetaminophen produces a peak plasma level of 6.25 mcg/mL within 40 minutes; 60 mg

codeine phosphate produces a peak plasma level of 150 ng/mL within 60 minutes.

Distribution:

Acetaminophen is distributed throughout most tissues of the body.

Metabolism:

Acetaminophen is metabolized primarily in the liver.

Metabolism for acetaminophen and codeine is relatively rapid; the principal metabolites are

conjugates of glucuronic acid which are excreted in the urine.

Once absorbed, codeine undergoes complex metabolism through the cytochrome P450 2D6

(CYP2D6) and 3A4 (CYP3A4) isoenzymes. The metabolites undergo further glucuronidation

through the uridyl glucuronosyltransferase-2B7 (UGT2B7) isoenzyme to form 3- and 6-

glucuronide metabolites which are eliminated through the urine. Approximately 10% of absorbed

codeine is metabolized to morphine and morphine-6-glucuronide, which are equipotent and the

predominant source of the analgesic effects of codeine.

CYP2D6 and UGT2B7 are known to have genotype polymorphism. For CYP2D6, the genotype

polymorphism results in ultra-rapid, extensive, intermediate, and poor metabolizers. For

UGT2B7, a single-nucleotide polymorphism in its coding region (UGT2B7*2) increases the

activity of the gene product. The increase may be further enhanced in individuals of homozygous

UGT2B7*2. It is estimated that homozygous UGT2B7*2 occurs in 25.3% of the Caucasian

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populations, with a combined CYP2D6 ultra-rapid metabolizer and UGT2B7*2 genotype at

1.4% (range 0.25–2.5%).

Excretion:

The individual plasma elimination half-life (t

) ranges from 1.5 to 3.5 hours for acetaminophen

and 1.5 to 4 hours for codeine. Less than 1% of an administered dose of codeine and less than

4% of an administered dose of acetaminophen, is excreted unchanged in the urine.

Special Populations and Conditions

Pediatrics: The use of TEVA-LENOLTEC No. 4 is not recommended in patients over 12 and

under 18 years of age. TEVA-LENOLTEC No. 4 contains codeine and is

contraindicated in

children under 12 years of age (see CONTRAINDICATIONS).

STORAGE AND STABILITY

TEVA-LENOLTEC No. 4 Tablets: Keep bottle tightly closed. Store between 15ºC -30ºC.

Protect

from light.

Do not use if neckband is damaged.

Keep out of the sight and reach of children.

SPECIAL HANDLING INSTRUCTIONS

Not applicable.

DOSAGE FORMS, COMPOSITION AND PACKAGING

TEVA-LENOLTEC No. 4 tablets: Each round, white, biplane tablet, with beveled edges,

engraved “TEC 4” on one side, reverse side plain, contains: acetaminophen 300 mg and codeine

phosphate 60 mg. Also, contains as non- medicinal ingredients: Croscarmellose Sodium,

Magnesium Stearate, Microcrystalline Cellulose, and Silica Colloidal Anhydrous. Paraben and

Gluten-free. Energy: 0.118 Kcal. Available in bottles of 100 tablets.

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PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION

Drug Substance

Proper name:

Acetaminophen

Chemical name:

N-(4-hydroxyphenyl) acetamide or 4'-hydroxyacetanilide

Molecular formula: C

Molecular weight:

151.2 g/mol

Structural formula:

Proper name:

Codeine Phosphate

Chemical name:

7, 8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol-

phosphate(l:l) (salt) hemihydrate

Molecular formula: C

H

½H

Molecular weight:

406.4 g/mol

Structural formula:

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REFERENCES

Product Monograph for

TYLENOL

with Codeine No. 4

by Janssen Inc., Control No.

213755, Date of revision June 6, 2018.

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READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION

N

TEVA-LENOLTEC No. 4

Acetaminophen and codeine phosphate tablets

300 mg acetaminophen and 60 mg codeine phosphate

Read this carefully before you start taking TEVA-LENOLTEC No. 4 and each time you get a

refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your

healthcare professional about your medical condition and treatment and ask if there is any

information about TEVA-LENOLTEC No. 4.

Serious Warnings and Precautions

Even if you take TEVA-LENOLTEC No. 4 as prescribed you are at a risk for opioid

addiction, abuse and misuse. This can lead to overdose and death.

When you take TEVA-LENOLTEC No. 4 it must be swallowed whole. Do not cut, break,

crush, chew or dissolve the tablet. This can be dangerous and can lead to death or

seriously harm you.

You may get life-threatening breathing problems while taking TEVA-LENOLTEC No. 4.

This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk

of life-threatening breathing problems if their mothers take opioids while pregnant or

nursing.

You should never give anyone your TEVA-LENOLTEC No. 4. They could die from taking

it. If a person has not been prescribed TEVA-LENOLTEC No. 4, taking even one dose can

cause a fatal overdose. This is especially true for children.

If you took TEVA-LENOLTEC No. 4 while you were pregnant, whether for short or long

periods of time or in small or large doses, your baby can suffer life-threatening

withdrawal symptoms after birth. This can occur in the days after birth and for up to 4

weeks after delivery. If your baby has any of the following symptoms:

has changes in their breathing (such as weak, difficult or fast breathing)

is unusually difficult to comfort

has tremors (shakiness)

has increased stools, sneezing, yawning, vomiting, or fever

Seek immediate medical help for your baby.

Taking TEVA-LENOLTEC No. 4 with other opioid medicines, benzodiazepines, alcohol,

or other central nervous system depressants (including street drugs) can cause severe

drowsiness, decreased awareness, breathing problems, coma, and death.

What is TEVA-LENOLTEC No. 4 used for?

TEVA-LENOLTEC No. 4 is used for the short-term relief of moderate to severe pain.

TEVA-LENOLTEC No. 4 should not be taken for pain for more than 5 days, or fever for

more than 3 days, unless directed by your healthcare professional.

How does TEVA-LENOLTEC No. 4 work?

TEVA-LENOLTEC No. 4 is a painkiller belonging to the class of drugs known as opioids. It

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relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in TEVA-LENOLTEC No. 4?

Medicinal ingredients: Acetaminophen and Codeine Phosphate.

Non-medicinal ingredients: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline

Cellulose, and Silica Colloidal Anhydrous.

TEVA-LENOLTEC No. 4 comes in the following dosage form:

300 mg acetaminophen and 60 mg codeine phosphate tablets.

Do not use TEVA-LENOLTEC No. 4 if:

your doctor did not prescribe it for you

you are allergic to acetaminophen, codeine or any of the other ingredients in TEVA-

LENOLTEC No. 4

you can control your pain by the occasional use of other pain medications. This includes

those

available without a prescription

you have severe asthma, trouble breathing or other breathing problems

you have any heart problems

you have bowel blockage or narrowing of the stomach or intestines

you have severe pain in your abdomen

you have a head injury

you are at risk for seizures

you suffer from alcoholism

you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor

(MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or

selegiline)

you are going to have or recently had, a planned surgery

you are in labour

you are breastfeeding

you are less than 18 years old and are having (or have recently had) your tonsils or

adenoids removed because of frequent interruption of breathing during sleep

you have serious liver or kidney problems

you have slow or shallow breathing, elevated carbon dioxide levels in the blood or a

condition

called “cor pulmonale” in which part of the heart is enlarged or does not work

correctly due

to high blood pressure in the lungs

you convert codeine into its active metabolite more rapidly and completely than other people

(see Ultra-Rapid Metabolizers of Codeine)

you are less than 12 years old

To help avoid side effects and ensure proper use, talk to your healthcare professional

before you take TEVA-LENOLTEC No. 4. Talk about any health conditions or

problems

you may have, including if you:

have a history of illicit or prescription drug or alcohol abuse

have severe kidney, liver, or lung disease

have low blood pressure

TEVA-LENOLTEC No. 4

Product Monograph

Page 28 of 35

have past or current depression

suffer from chronic or severe constipation

have problems with your thyroid, adrenal or prostate gland

have difficulty urinating

have, or had in the past hallucinations or other severe mental problems

develop allergic reactions such as wheezing, rash or itching

feel sedated or drowsy, are confused or have slow, shallow breathing

have redness or swelling present in an area of pain, if symptoms do not improve or if they

worsen, or if new symptoms such as high fever, rash, itching, wheezing or persistent

headache occur

have pain that lasts more than 5 days or for fever more than 3 days

are less than 18 years and are having breathing problems

have difficulty breathing, asthma or chronic lung disease

are pregnant or are planning to get pregnant

suffer from migraines

are elderly or debilitated

take tranquilizers, sedatives, sedating antihistamines or other depressants, salicylates, other

pain and fever relief medications or nonsteroidal anti-inflammatory drugs (NSAIDs)

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical

dependence and addiction. It is important that you talk to your doctor if you have questions or

concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery:

Do not use TEVA-LENOLTEC No. 4 while nursing, during labour or delivery. Opioids can be

transferred to your baby through breast milk or while still in the womb. TEVA-LENOLTEC No. 4

can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant, your doctor will determine if the benefits of using TEVA-LENOLTEC No. 4

outweigh the risks to your unborn baby. In addition, if you are pregnant and are taking this

medication, it is important that you don’t stop taking it all of a sudden. Your doctor will monitor

and guide you on how to slowly stop taking TEVA-LENOLTEC No. 4. This may help avoid

serious harm to your unborn baby.

Driving and using machines: Before you do tasks which may require special attention, you

should

wait

until

know

react

TEVA-LENOLTEC

TEVA-

LENOLTEC No. 4 can cause:

drowsiness

dizziness

lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal

insufficiency. This means that your adrenal gland is not making enough of certain hormones. You

may experience symptoms such as:

TEVA-LENOLTEC No. 4

Product Monograph

Page 29 of 35

nausea, vomiting

feeling tired, weak or dizzy

decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids

for longer than one month. Your doctor may do tests, give you another medication, and slowly take

you off TEVA-LENOLTEC No. 4.

Serotonin Syndrome: TEVA-LENOLTEC No. 4 can cause Serotonin Syndrome, a rare but

potentially life-threatening condition. It can cause serious changes in how your brain, muscles and

digestive system work. You may develop Serotonin Syndrome if you take TEVA-LENOLTEC No.

4 with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

fever, sweating, shivering, diarrhea, nausea, vomiting;

muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;

fast heartbeat, changes in blood pressure;

confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and

coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone

levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Ultra-Rapid Metabolizers of Codeine:

Some individuals process codeine more rapidly and completely than others. This rapid

processing in the body results in higher than expected drug levels. Even at the recommended

doses, people whose bodies are ultra-rapid processors may have life-threatening or fatal effects

on their breathing or experience overdose symptoms such as extreme sleepiness, confusion, or

shallow breathing.

Drug Abuse and Dependence:

Codeine can produce drug dependence and has the potential for being abused. Tolerance,

psychological and physical dependence may develop over time with repeated use of TEVA-

LENOLTEC No. 4. Your healthcare professional should prescribe and administer TEVA-

LENOLTEC No. 4 with the same degree of caution appropriate to the use of other oral opioid

medications. Using these products for a prolonged period of time is not recommended.

Serious skin reactions (Stevens - Johnson Syndrome, Toxic Epidermal Necrolysis,

Hypersensitivity Syndrome):

Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands,

trunk, arms and legs. This condition is life-threatening. Stop taking TEVA-LENOLTEC

No. 4

and contact your healthcare professional immediately if you develop a rash during treatment (see

table of Serious side effects and what to do about them, below).

Liver injury:

Taking acetaminophen in doses higher than recommended may result in liver injury, including

the risk of severe liver disease and death. Do not exceed the maximum recommended daily dose

of acetaminophen including all routes of administration (intravenous, oral and rectal) and all

TEVA-LENOLTEC No. 4

Product Monograph

Page 30 of 35

products containing acetaminophen (oral solutions/drops, syrup, pills, capsules, suppositories

etc.).

Tell your healthcare professional about all the medicines you take, including any drugs,

vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TEVA-LENOLTEC No. 4:

Alcohol. This includes prescription and non-prescription medications that contain alcohol.

Do not drink alcohol while you are taking TEVA-LENOLTEC No. 4. It can lead to:

drowsiness

unusually slow or weak breathing

serious side effects or

a fatal overdose

other sedative drugs which may enhance the drowsiness caused by TEVA-LENOLTEC No. 4

other opioid analgesics (drugs used to treat pain)

general anesthetics (drugs used during surgery)

benzodiazepines (drugs used to help you sleep or that help reduce anxiety)

antidepressants (for depression and mood disorders). Do not take TEVA-LENOLTEC

No. 4

with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.

drugs used to treat serious mental or emotional disorders (such as schizophrenia)

drugs used to treat migraines (e.g., triptans)

antihistamines (drugs used to treat allergies)

anti-emetics (drugs used for the prevention of vomiting)

drugs used to treat muscle spasms and back pain

warfarin (such as COUMADIN

) and other anticoagulants (used for prevention or

treatment

of blood clots)

anti-retroviral drugs (used to treat viral infections)

anti-fungal drugs (used to treat fungal infections)

antibiotic drugs (used to treat bacterial infections)

some heart medication (such as beta blockers)

St. John’s Wort

How to take TEVA-LENOLTEC No. 4:

Use the smallest effective dose for the shortest period of time. Only take this medication when

you need it, and never more often than every 4 to 6 hours.

Do not take with other drugs containing acetaminophen.

Do not exceed the maximum recommended dose. Overdose may result in severe or possibly

fatal liver damage.

Swallow whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous

and can lead to death or seriously harm you.

TEVA-LENOLTEC No. 4

Product Monograph

Page 31 of 35

Usual Adult Starting Dose:

TEVA-LENOLTEC No. 4 tablets:

Your doctor will prescribe the lowest dose that works to control your pain or fever. It is

recommended that you take TEVA-LENOLTEC No. 4 for a maximum of 3 days for fever and a

maximum of 5 days for pain, unless otherwise directed by your healthcare professional. If you

need to take TEVA-LENOLTEC No. 4 for longer, your doctor will determine the best dose for

you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a

greater chance of overdose.

Take 1 tablet every 4-6 hours as required, not to exceed 6 tablets in 24 hours.

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing

instructions exactly. Do not increase or decrease your dose without consulting your doctor.

Review your pain regularly with your doctor to determine if you still need TEVA-LENOLTEC

No. 4. Be sure to use TEVA-LENOLTEC No. 4 only for the condition for which it was

prescribed.

If your pain increases or you develop any side effect as a result of taking TEVA-LENOLTEC

No. 4, tell your doctor immediately.

Stopping your Medication

If you have been taking TEVA-LENOLTEC No. 4 for more than a few days you should not

stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop

taking TEVA-LENOLTEC No. 4. You should do it slowly to avoid uncomfortable symptoms

such as having:

body aches

diarrhea

goosebumps

loss of appetite

nausea

feeling nervous or restless

runny nose

sneezing

tremors or shivering

stomach cramps

rapid heart rate (tachycardia)

having trouble sleeping

an unusual increase in sweating

heart palpitations

an unexplained fever

weakness

yawning

TEVA-LENOLTEC No. 4

Product Monograph

Page 32 of 35

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you

start treatment again, you will need to start at the lowest dose. You may overdose if you restart at

the last dose you took before you slowly stopped taking TEVA-LENOLTEC No. 4.

Refilling your Prescription for TEVA-LENOLTEC No. 4:

A new written prescription is required from your doctor each time you need more TEVA-

LENOLTEC No. 4. Therefore, it is important that you contact your doctor before your current

supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not

seek prescriptions from other doctors unless you switch to another doctor for your pain

management.

Overdose:

Overdose may result in severe or possibly fatal liver damage.

If you think you have taken too much TEVA-LENOLTEC No. 4, contact your healthcare

professional, hospital emergency department or regional Poison Control Centre

immediately,

even if there are no symptoms.

Signs of overdose may include:

unusually slow or weak breathing

dizziness

confusion

extreme drowsiness

Missed Dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose,

then skip the missed dose. Do not take two doses at once. If you miss several doses in

a row, talk

to your doctor before restarting your medication.

What are possible side effects from using TEVA-LENOLTEC No. 4?

These are not all the possible side effects you may feel when taking TEVA-LENOLTEC

No. 4.

If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

Drowsiness

Insomnia

Dizziness

Fainting

Nausea, vomiting, or a poor appetite

Dry mouth

Headache

Problems with vision

TEVA-LENOLTEC No. 4

Product Monograph

Page 33 of 35

Weakness, uncoordinated muscle movement

Itching

Sweating

Constipation

Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using

TEVA-LENOLTEC No. 4.

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare professional

Stop taking drug

and get

immediate

medical help

Only if severe

In all cases

RARE

Overdose: hallucinations,

confusion, inability to walk

normally, slow or weak

breathing, extreme

sleepiness, sedation, or

dizziness, floppy

muscles/low muscle tone,

cold and clammy skin.

Respiratory Depression:

Slow, shallow or weak

breathing.

Allergic Reaction: rash,

hives, swelling of the face,

lips, tongue, or throat,

difficulty swallowing or

breathing.

Bowel Blockage (impaction):

abdominal pain, severe

constipation, nausea

Withdrawal: nausea, vomiting,

diarrhea, anxiety, shivering, cold

and clammy skin, body aches,

loss of appetite, sweating.

Fast, Slow or Irregular

Heartbeat: heart palpitations.

Low Blood Pressure:

dizziness, fainting, light-

headedness.

Serotonin Syndrome: agitation

or restlessness, loss of muscle

control or muscle twitching,

tremor, diarrhea

TEVA-LENOLTEC No. 4

Product Monograph

Page 34 of 35

Serious Skin Reactions

(Stevens Johnson Syndrome,

Toxic Epidermal Necrolysis,

Hypersensitivity Syndrome):

any combination of itchy skin

rash, redness, blistering and

peeling of the skin and/or of

lips, eyes, mouth, nasal

passages

or genitals,

accompanied by fever, chills,

headache, cough,

body aches

or joint pain, yellowing of the

skin or eyes,

dark urine.

VERY RARE

Liver Injury: yellowing of the

skin or eyes, dark urine,

abdominal pain, nausea,

vomiting, loss of appetite.

Redness or swelling in the

area

of pain, symptoms that

do not

improve, or if new

symptoms appear such as

fever, rash, itching, wheezing

or persistent

headache.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough

to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health

Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-

canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html)

for information on how to report online, by mail or by fax; or

Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side

effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep bottle tightly closed. Store between 15ºC to 30ºC. Protect from light. Do not use if

neckband is damaged.

Keep unused or expired TEVA-LENOLTEC No. 4 in a secure place to prevent theft,

TEVA-LENOLTEC No. 4

Product Monograph

Page 35 of 35

misuse or accidental exposure.

Keep TEVA-LENOLTEC No. 4 under lock, out of sight and reach of children and pets.

Never take medicine in front of small children as they will want to copy you. Accidental

ingestion by a child is dangerous and may result in death. If a child accidentally takes

TEVA-LENOLTEC No. 4, get emergency help right away.

Disposal:

TEVA-LENOLTEC No. 4 should never be thrown into household trash, where

children

and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about TEVA-LENOLTEC No. 4:

Talk to your healthcare professional.

For questions or concerns contact the manufacturer, Teva Canada Limited, at

www.tevacanada.com.

Find the full Product Monograph that is prepared for healthcare professionals and

includes this Patient Medication Information by visiting the Health Canada website

https://www.canada.ca/en/health-canada.html); the manufacturer’s website

(www.tevacanada.com), or by calling 1-800-268-4127 ext.3; or email

druginfo@tevacanada.com.

This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9.

Last Revised: October 4, 2018

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