Codalgin

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Codeine phosphate hemihydrate 8 mg; Paracetamol 500 mg (As 521mg paracetamol DC)
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Codeine phosphate hemihydrate 8 mg
Dosage:
500mg/8mg
Pharmaceutical form:
Tablet
Composition:
Active: Codeine phosphate hemihydrate 8 mg Paracetamol 500 mg (As 521mg paracetamol DC) Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Purified talc Wheat starch
Units in package:
Blister pack, PVC/Al, 20 tablets
Class:
Restricted
Prescription type:
Restricted
Manufactured by:
GlaxoSmithKline Australia Pty Ltd
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/Al - 20 tablets - 24 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-6972
Authorization date:
2002-09-24

Page 1/11

New Zealand Data Sheet

1 PRODUCT NAME CODALGIN TABLETS

Paracetamol 500 mg, Codeine Phosphate 8 mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Codalgin tablets contain the following Active ingredients –

Paracetamol 500 mg, codeine phosphate hemihydrate 8 mg.

It also contains the following Inactives - gelatin, magnesium stearate, microcrystalline

cellulose, purified talc, wheat starch

3 PHARMACEUTICAL FORM

Tablet - 12.7mm round, flat bevelled edge, white, with a break-bar on one side

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For the temporary relief of pain and discomfort associated with migraine,

earache, period pain and rheumatic pain. Reduces fever.

4.2 Dose and method of administration

Adults and children over 12 years:

One to two tablets to be taken every

four to six hours as necessary. The maximum dosage of tablets in 24 hours is

8 tablets.

Children 7 - 12 years: Half to one tablet to be taken every four to six hours

as necessary. The maximum dosage of tablets in 24 hours is 4 doses.

Codalgin should not be given to children under 7 years of age.

4.3 Contraindications

Paracetamol should not be used in patients with active alcoholism as

chronic

excessive

alcohol

ingestion

predisposes

patients

paracetamol hepatotoxicity.

Paracetamol

should

used

patients

with

history

intolerance to the drug.

Page 2/11

Codeine should not be used in cases of acute respiratory depression

acute

asthma,

acute

exacerbations

chronic

obstructive

pulmonary disease) since codeine may exacerbate the condition.

Codalgin should not be used in patients with a past history of allergic

reactions to codeine.

Hypersensitivity to any of the tablet excipients.

Due to codeine’s structural similarity to morphine and oxycodone,

patients experiencing systemic allergy (generalised rash, shortness of

breath) to these drugs should not receive codeine.

Codeine is contraindicated in patients with diarrhoea caused by

poisoning, until the toxic substance has been eliminated from the

gastrointestinal

tract,

diarrhoea

associated

with

pseudomembranous colitis caused by antibiotic administration since

codeine may slow the elimination of the toxic material or antibiotic.

4.4 Special warnings and precautions for use

Warnings and Precautions

Profound sedation, respiratory depression, coma, and death may result from

the concomitant use of CODALGIN with benzodiazepines or other CNS

depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics,

tranquilizers, muscle relaxants, general anaesthetics, medicines with

antihistamine-sedating actions such as antipsychotics, other opioids, alcohol).

Because of these risks, reserve concomitant prescribing of these drugs for

use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid

analgesics and benzodiazepines increases the risk of medicine-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

Section 4.5 Interactions with other medicines and other forms of interaction].

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

CODALGIN is used with benzodiazepines or other CNS depressants

(including alcohol and illicit drugs). Advise patients not to drive or

Page 3/11

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 Section 4.5 Interactions with other medicines and other

forms of interaction].

Codalgin should be given with care to patients with impaired renal or hepatic

function, viral hepatitis, and to patients taking other drugs which affect the

liver. In view of the increased risk of hepatotoxicity, the benefit should be

weighed against the risk when administering Codalgin to patients with viral

hepatitis or pre existing hepatic disease. In such patients, hepatic function

determinations may be required at periodic intervals during high dose or long-

term therapy.

Codeine should be used with caution in patients with a history of drug abuse

or with recent gastrointestinal tract surgery.

Codalgin may cause drowsiness. Those affected should not drive or operate

machinery.

Physical

and/or

psychological

dependence

occur

with

repeated

administration of codeine. Tolerance may also result following repeated

administration.

Codeine should be administered with great caution in patients with head

injury, brain tumour or increased intracranial pressure since codeine may

increase the risk of respiratory depression and further elevate intracranial

pressure. In addition codeine can produce side effects such as confusion,

miosis and vomiting which are important signs in following the clinical course

of patients with head injuries.

Codeine should be administered with great caution in patients with decreased

respiratory reserve (e.g. in emphysema, kyphoscoliosis, hypoxia, hypercapnia

or even severe obesity) or cor pulmonale, or chronic obstructive pulmonary

disease since codeine may exacerbate respiratory impairment.

Codeine should be administered with great caution if at all in patients with

CNS depression, since codeine may exacerbate the condition.

Codeine should be used with caution in elderly or debilitated patients because

of the danger of respiratory or cardiac depression.

Codeine should be administered with caution in patients with acute abdominal

conditions since codeine may obscure the diagnosis or the course of the

disease.

Codeine

should

administered

with

caution

patients

with

severe

inflammatory bowel disease (risk of toxic megacolon may be increased,

especially with repeated dosing).

Codeine should be administered with caution in patients with hypothyroidism,

adrenocortical insufficiency (eg Addison’s disease), shock, myxedema, acute

alcohol intoxication or delerium tremens since codeine may exacerbate the

symptoms or increase the risk of respiratory and/or CNS depression.

Page 4/11

Codeine should be administered with caution in patients taking Monoamine

Oxidase Inhibitors (MAOI’s) – see Interactions with Other Drugs.

Codeine should be administered with caution in patients with a history of

convulsive

disorders

(convulsions

induced

exacerbated

codeine).

Codeine

should

administered

with

caution

patients

with

prostatic

hypertrophy, urethral stricture or recent urinary tract surgery since codeine

may cause urinary retention.

Use in Children:

Codalgin can be given in reduced doses to children 7 years and over (see

Dosage and Administration). This medication is not suitable for children under

7 years of age.

Use in the Elderly:

The elderly are more likely to have age-related renal impairment and may be

more

susceptible

respiratory

effects

opioid

analgesics.

Dose

reduction may be required.

4.5 Interaction with other medicines and other forms of

interaction

Benzodiazepines and other Central Nervous System (CNS) Depressants

Clinical Impact

Due to additive pharmacologic effect, the concomitant use

of benzodiazepines or other CNS depressants including

alcohol, increases the risk of respiratory depression,

profound sedation, coma, and death.

Intervention

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 Section 4.4 Warnings and

Precautions].

Examples

Benzodiazepines and other sedatives/hypnotics,

anxiolytics, tranquilizers, muscle relaxants, general

anaesthetics, drugs with antihistamine-sedating actions

such as antipsychotics, other opioids, alcohol.

Salicylates and NSAIDs:

Prolonged concurrent use of paracetamol and salicylates or non-steroidal

anti-inflammatory drugs may increase the risk of adverse renal effects.

Diflunisal:

Diflunisal may increase the plasma concentrations of paracetamol by 50%.

Page 5/11

General anaesthetics:

Codeine may potentiate the effects of general anaesthetics.

Tranquillisers, sedatives and hypnotics:

Codeine may potentiate the effects of these drugs.

CNS depressants:

Codeine may potentiate the effects of CNS depressants.

Alcohol:

Codeine may potentiate the effects of alcohol and the likelihood of toxicity

may be increased by its concomitant use. The likelihood of toxicity may also

be increased by the concomitant use of alcohol with paracetamol.

Opioid analgesics:

Concurrent use of codeine and other opioid agonists is usually inappropriate

as additive CNS depression, respiratory depressant and hypotensive effects

may occur. Opioid agonists that decrease gastric emptying will decrease the

absorption of paracetamol.

Anticholinergics:

Concomitant use of codeine and anticholinergic agents may increase the risk

of severe constipation and/or urinary retention. Anticholinergics that decrease

the gastric emptying such as propantheline, will decrease the absorption of

paracetamol.

Monoamine Oxidase Inhibitors:

Non-selective MAOI’s intensify the effects of opioid drugs which can cause

anxiety,

confusion

significant

respiratory

depression.

Severe

sometimes fatal reactions have occurred in patients concurrently administered

MAO inhibitors and pethidine. Codeine should not be given to patients taking

non-selective MAOI’s or within 14 days of stopping such treatment. As it is

unknown

whether

there

interaction

between

selective

MAOI’s

(Reversible Inhibitors of Monoamine Oxidase A) and codeine, caution is

advised

with

this

drug

combination.

absorption

paracetamol

decreased by MAO inhibitors that decrease gastric emptying.

Barbiturates and antiepileptic medications:

The likelihood of toxicity may be increased by the concomitant use of enzyme

inducing agents such as alcohol, barbiturates or anti epileptic drugs.

Coumarins:

Repeated high doses of paracetamol increase the anti coagulant response to

coumarins.

Chloramphenicol:

Paracetamol may also increase chloramphenicol concentrations.

Antihypertensives:

Hypotensive effects of antihypertensive agents may be potentiated when used

concurrently with codeine and lead to orthostatic hypotension.

Antiperistaltic antidiarrhoeals (including kaolin, pectin, loperamide):

Concurrent use of these agents with codeine may increase the risk of severe

constipation.

Page 6/11

Metoclopramide:

Drugs

that

increase

gastric

emptying

such

metoclopramide,

accelerate

absorption

paracetamol.

Codeine

antagonise

effects of metoclopramide on gastrointestinal motility.

Neuromuscular blocking agents:

Codeine may enhance the effects of neuromuscular blocking agents resulting

in increased respiratory depression.

Cholestyramine:

Cholestyramine reduces the absorption of paracetamol if given within one

hour of paracetamol administration.

Effects on Laboratory Tests

Plasma amylase and lipase activity:

Codeine may cause increased biliary tract pressure, thus increasing plasma

amylase and/or lipase concentrations.

Gastric emptying studies:

Gastric emptying is delayed by codeine, so gastric emptying studies will not

be valid.

4.6 Fertility, pregnancy and laction

Carcinogenicity, Mutagenicity, Impairment of Fertility:

Clinical toxicity studies in animals have shown that high doses of paracetamol

cause testicular atrophy and inhibition of spermatogenesis; the relevance of

this finding to use in humans is not known.

Use in Pregnancy: Category A

Paracetamol crosses the placenta, however problems in humans have not

been documented.

Opioid analgesics cross the placenta. Regular use during pregnancy may

cause physical dependence in the foetus, leading to withdrawal symptoms in

the neonate. Administration of codeine during labour may cause respiratory

depression in the newborn infant.

Use in Lactation:

Paracetamol

excreted

breast

milk

neither

paracetamol

metabolites were detected in the urine of nursing infants after 650 mg

maternal dose.

Codeine does pass into breast milk so it should be avoided in breastfeeding

women.

Codalgin tablets should not be administered while breast-feeding.

Page 7/11

4.7 Effects on ability to drive and use machines

Codalgin may cause drowsiness. Those affected should not drive or operate

machinery.

4.8 Undesirable effects

Adverse effects of Codalgin tablets are generally infrequent and include:

Haematologic

Less frequent to rare

Agranulocytosis

Anaemia

Thrombocytopenia

Genitourinary

Less frequent to rare

Renal failure

Uraemia

Urinary retention or hesitancy

Hypersensitivy

Less frequent to rare

Skin rashes and other allergic reactions

Histamine release (hypotension, flushing of the face,

tachycardia, breathlessness)

Gastrointestinal

Common

Constipation

Nausea

Vomiting

Neurological

Common

Drowsiness

Dizziness

Less frequent to rare

Euphoria, dysphoria

higher

doses,

codeine

cause

respiratory

depression

4.9 Overdose

Overdosage with Codalgin tablets involves treatment of both paracetamol and

codeine poisoning.

Symptoms:

Paracetamol:

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea,

vomiting, anorexia, and abdominal pain. Liver damage may become apparent

12 to 48 hours after ingestion. Abnormalities of glucose metabolism and

Page 8/11

metabolic

acidosis

occur.

severe

poisoning,

hepatic

failure

proceed to encephalopathy, coma and death. Acute renal failure with acute

tubular necrosis may develop in the absence of severe liver damage. Cardiac

arrhythmias have been reported. Liver damage is likely in adults who have

taken 10 g or more of paracetamol, due to excess quantities of a toxic

metabolite becoming irreversibly bound to liver tissue.

Codeine:

Symptoms of codeine overdosage include vomiting, hypotension, sweating,

central stimulation with exhilaration and convulsions in children, drowsiness,

respiratory depression, cyanosis, miosis and coma.

Treatment:

Contact the Poisons Information Centre on 0800 764 766 immediately.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Actions

Paracetamol has analgesic and antipyretic activity similar to aspirin. The

analgesic

effect

paracetamol

thought

inhibition

prostaglandin synthesis in the central nervous system and in the periphery,

and, to a lesser extent, by blocking pain impulse generation in the periphery.

The antipyretic effect is due to a central action on the hypothalamic heat-

regulating centre to produce peripheral vasodilatation and subsequent heat

loss.

Codeine phosphate is an opioid analgesic that binds with stereospecific

receptors at many sites within the CNS to alter processes affecting both the

perceptions of pain and the emotional response to pain. There are multiple

sub-types of opioid receptors, each mediating various therapeutic and/or side

effects of drugs. Its analgesic effect is thought to be due to its partial

metabolic

conversion

morphine.

Codeine

about

one-sixth

analgesic activity of morphine. Codeine can also cause other effects eg CNS

depression, nausea and vomiting, orthostatic hypotension and constipation.

It has been shown that the analgesic effects of paracetamol and codeine are

additive due to their different mechanisms of action.

5.2 Pharmacokinetic properties

Absorption:

Paracetamol is readily absorbed from the gastrointestinal tract with peak

plasma concentrations occurring some 30 minutes to 2 hours after ingestion.

Page 9/11

The onset of therapeutic action is 30 minutes and the duration of effect is 4

hours.

Codeine is well absorbed from the gastrointestinal tract and peak plasma

concentrations are reached one hour after oral administration. Onset of action

occurs in 15-30 minutes and analgesia is maintained for 4-6 hours.

Distribution:

Paracetamol is rapidly and uniformly distributed into most body tissues. It

crosses the placenta and is present in breast milk.

Codeine

rapidly

distributed

skeletal

muscle,

kidneys,

liver,

gastrointestinal tract, lungs, spleen and brain. It crosses the placenta and is

distributed in low levels in breast milk.

Metabolism:

Approximately 90-95% of the paracetamol dose is metabolised in the liver,

primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. An

intermediate metabolite which may accumulate in overdosage is hepatotoxic

and possibly nephrotoxic.

Codeine is metabolised mainly in the liver. The major metabolic pathway

involves glucuronidation of codeine to codeine-6-glucuronide. Codeine can

also undergo O- and N-demethylation catalysed by CYP2D6 and CYP3A4

respectively. About 10% of an administered dose of codeine is converted by

O-demethylation to morphine which subsequently undergoes glucuronidation

to morphine-3 or morphine-6 glucuronide, or N-demethylation to normorphine.

Approximately 5-10% of the Caucasian population cannot convert codeine to

morphine as they are deficient in the CYP2D6 enzyme. Codeine is also

converted by N-demethylation to norcodeine which subsequently undergoes

glucuronidation

norcodeine

glucuronide

O-demethylation

normorphine.

Excretion:

Approximately 85% of a dose of paracetamol is recovered from the urine

within

hours

after

ingestion.

About

unchanged,

balance

consisting mainly of the glucuronide and sulfate conjugates. The elimination

half-life varies from 1 to 4 hours and may be prolonged in acute overdosage,

in liver disease, the elderly and the neonate.

Codeine is excreted mainly by the kidneys as its metabolite codeine-6-

glucuronide.

5-25%

excreted

unchanged

approximately

excreted as unchanged or conjugated morphine. The plasma half-life of

codeine is 2-4 hours. Only traces of codeine and its metabolites are found in

the faeces.

5.3 Preclinical safety data

Page 10/11

PHARMACEUTICAL

PARTICULARS

6.1

List

of

excipients

Codalgin contains the following excipients - gelatin, magnesium stearate,

microcrystalline cellulose, purified talc, wheat starch.

6.2 Incompatabilities

6.3 Shelf life

Store below 30°C in a dry place.

6.4 Special precautions for storage

Store away from heat and moisture

6.5 Nature and contents of container

Available in blister packs of 50 and 100 tablets

6.6 Special precautions for disposal

7 MEDICINE SCHEDULE

Prescription Medicine

8 SPONSOR

Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics

58 Richard Pearce Drive

Airport Oaks

Auckland, New Zealand

Ph (09) 918 5100 Fax (09) 901 5101

9 DATE OF FIRST APPROVAL

Page 11/11

6/10/2011

10 DATE OF REVISION OF THE TEXT

22 June 2017

SUMMARY TABLE OF CHANGES

Reformatted old data sheet (2014) into new style format.

Added in new Warnings/precautions text as per MEDSAFE letter of 12

April 2017.

Added in new interactions text as per MEDSAFE letter of 12 April 2017

concerning - Benzodiazepines and other Central Nervous System

(CNS) Depressants.

Similar products

Search alerts related to this product

Share this information