NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Paracetamol (Noumed), 500 mg, uncoated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Paracetamol (BP) 500 mg/tablet
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white capsule shaped biconvex tablets with break line between P and 500
on one side and plain on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the temporary relief of pain and discomfort from the following:
• Headache • Back ache • Migraine headache • Muscular aches • Symptoms of cold &
flu • Arthritis/ rheumatics / osteoarthritis • Period pain • Toothache • Sore throat
• Also reduces fever.
4.2 Dose and method of administration
Adults and children aged 12 years and over:
1 to 2 tablets every four to six hours as required. Maximum of 8 tablets in 24 hours.
Maximum daily dose: 4000 mg.
Children 7 to 11 years:
½ to 1 tablet every four to six hours as required. Maximum of 4 tablets in 24 hours.
Do not exceed the stated dose.
Adults: Do not take this medicine for longer than a few days at a time unless
advised by a doctor.
Children and Adolescents: Do not take this medicine for longer than 48 hours at a time
unless advised by a doctor.
New Zealand Data Sheet Page 1 of 7
NEW ZEALAND DATA SHEET
Not suitable for children under six years of age.
Take orally with water or other fluid.
The lowest dose necessary to achieve efficacy should be used for the shortest duration
of treatment. Should not be used with other paracetamol-containing products.
Minimum dosing interval: 4 hours.
4.3 Contraindications
These products are contraindicated in patients with a previous history of
hypersensitivity to paracetamol or any of the excipients.
4.4 Special warnings and precautions for use
Contains paracetamol. Do not use with any other paracetamol- containing products. The
concomitant use with other products containing paracetamol may lead to an overdose.
Paracetamol overdose may cause liver failure which may require liver transplant or lead
to death.
Paracetamol should be used with caution in patients with:
• Impaired liver function: Underlying liver disease increases the risk of
paracetamol-related liver damage.
• Impaired kidney function: Administration of paracetamol to patients with
moderate to severe renal impairment may result in accumulation of
paracetamol conjugates.
Patients who have been diagnosed with liver or kidney impairment must seek medical
advice before taking this medication. The restrictions related to the use of paracetamol
products in patients with liver or kidney impairment are primarily a consequence of the
paracetamol content of the drug.
Cases of hepatic dysfunction/failure have been reported in patients with depleted
glutathione levels, such as those who are severely malnourished, anorexic, have a low
body mass index, are chronic heavy users of alcohol or have sepsis.
In patients with glutathione depleted states the use of paracetamol may increase the
risk of metabolic acidosis.
If symptoms persist, medical advice must be sought.
Keep out of sight and reach of children.
New Zealand Data Sheet Page 2 of 7
NEW ZEALAND DATA SHEET
Use in children: Not recommended for children under seven years of age.
4.5 Interaction with other medicines and other forms of interaction
The following interactions with paracetamol have been noted:
The anticoagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular daily use of paracetamol with increased risk of bleeding; occasional
doses have no significant effect. Anticoagulant dosage may require reduction if
paracetamol medication is prolonged.
Paracetamol absorption is increased by substances that increase gastric emptying, eg
metoclopramide.
Paracetamol absorption is decreased by substances that decrease gastric emptying, eg
propantheline, antidepressants with anticholinergic properties and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially
hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and
anticonvulsant drugs.
Paracetamol excretion may be affected, and plasma concentrations altered when
given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within one hour
of paracetamol.
4.6 Fertility, pregnancy and lactation
Use in pregnancy
As with the use of any medicine during pregnancy, pregnant women should seek
medical advice before taking paracetamol.
Pregnancy Category A
Paracetamol has been taken by a large number of pregnant women and women of
childbearing age without any proven increase in the frequency of malformations or
other direct or indirect harmful effects on the foetus having been observed.
Use in lactation
Paracetamol is excreted in breast milk but not in a clinically significant amount at
recommended dosages. Available published data do not contraindicate breast-feeding.
New Zealand Data Sheet Page 3 of 7
NEW ZEALAND DATA SHEET
4.7 Effects on ability to drive and use machines
Paracetamol is unlikely to cause an effect on the ability to drive or use machinery.
4.8 Undesirable effects
Adverse events from historical clinical trial data are both infrequent and from small
patient exposure. Accordingly, events reported from extensive post-marketing
experience at therapeutic/labelled dose and considered attributable are tabulated
below by System Organ Class and frequency.
The following convention has been utilised for the classification of undesirable effects:
very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare
(≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from
available data).
Adverse event frequencies have been estimated from spontaneous reports received
through post-marketing data.
Body system Undesirable effect Frequency
Blood and lymphatic system Thrombocytopenia Very rare
disorders
Immune system disorders Anaphylaxis Very rare
Cutaneous hypersensitivity reactions
including, among others, skin rashes,
angioedema, Stevens Johnson
syndrome and Toxic Epidermal
Necrolysis
Respiratory, thoracic and Bronchospasm, especially in patients Very rare
mediastinal disorders sensitive to aspirin and other NSAIDs
Hepatobiliary disorders Hepatic dysfunction Very rare
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important.
It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare
professionals are asked to report any suspected adverse reactions
https//nzphvc.otago.ac.nz/reporting/
4.9 Overdose
Experience following overdose with paracetamol indicates that the clinical signs of liver
injury occur usually after 24 to 48 hours and have peaked after 4 to 6 days.
Paracetamol overdose may cause liver failure which may require liver transplant or lead
to death. Acute pancreatitis has been observed, usually with hepatic dysfunction and
liver toxicity.
New Zealand Data Sheet Page 4 of 7
NEW ZEALAND DATA SHEET
Immediate medical management is required in the event of an overdose, even if the
symptoms of overdose are not present.
If an overdose is taken or suspected, contact the Poisons Information Centre
immediately for advice (0800 764 766), or the patient should go to the nearest hospital
straight away. This should be done even if they feel well because of the risk of delayed,
serious liver damage.
Administration of N-acetylcysteine may be required.
In cooperative adults, activated charcoal may reduce absorption of the medicine if
given within one hour after ingestion.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
CAS: 103-90-2 (paracetamol)
Paracetamol MW 151.17
ATC code Paracetamol, N02BE01
Paracetamol is a para-aminophenol derivative that exhibits analgesic and anti—pyretic
activity. Its mechanism of action is believed to include inhibition of prostaglandin
synthesis, primarily within the central nervous system. It is given by mouth or rectally
(suppositories) for mild to moderate pain and fever.
The lack of peripheral prostaglandin inhibition confers important pharmacological
properties such as the maintenance of the protective prostaglandins within the
gastrointestinal tract. Paracetamol is, therefore, particularly suitable for patients with a
history of disease or on concomitant medication, where peripheral prostaglandin
inhibition would be undesirable (such as, for example, those with a history of
gastrointestinal bleeding or the elderly).
5.2 Pharmacokinetic properties
Absorption
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal
tract. Food intake delays paracetamol absorption.
New Zealand Data Sheet Page 5 of 7
NEW ZEALAND DATA SHEET
Distribution
Paracetamol is distributed into most body tissues. Binding to the plasma proteins is
minimal at therapeutic concentrations but increases with increasing doses.
Metabolism
Paracetamol is metabolised in the liver and excreted in the urine mainly as
glucuronide and sulphate conjugates.
The metabolites of paracetamol include a minor hydroxylated intermediate which has
hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with
glutathione. However, it can accumulate following paracetamol overdosage (more
than 200 mg/kg or 10 g total paracetamol ingested) and, if left untreated, can cause
irreversible liver damage.
Paracetamol is metabolised differently by infants and children compared to adults, the
sulphate conjugate being predominant.
Excretion
Paracetamol is excreted in the urine mainly as the glucuronide and sulphate
conjugates. Less than 5% is excreted as unmodified paracetamol with 85% to 90% of
the administered dose eliminated in the urine within 24 hours of ingestion. The
elimination half-life varies from one to three hours. The mean plasma half-life is about
2.3 hours.
5.3 Preclinical safety data
N/A
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised starch, povidone K-30, Stearic acid, water purified.
6.2 Incompatibilities
No known incompatibilities.
6.3 Shelf life
36 months from date of manufacture.
New Zealand Data Sheet Page 6 of 7
NEW ZEALAND DATA SHEET
6.4 Special precautions for storage
Store below 25oC. Protect from Moisture.
6.5 Nature and contents of container
Blister pack of 1000 tablets.
Bottle pack of 1000 tablets, containing a silica gel desiccant.
6.6 Special precautions for disposal and other handling
No special requirements
7. MEDICINE SCHEDULE
Prescription Medicine
8. SPONSOR
Noumed Pharmaceuticals Limited,
Auckland,
New Zealand
Freephone 0800 527545
9. DATE OF FIRST APPROVAL
8/02/2019
10. DATE OF REVISION OF THE TEXT
29/04/2021
SUMMARY TABLE OF CHANGES
Section changes Summary of new information
8 Sponsor address updated.
10 Date of revision of text
New Zealand Data Sheet Page 7 of 7
