MIMS Revision Date: 01 September 2025

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Panadol Tablets. Active ingredient: Paracetamol 500 mg/tablet.
Each tablet contains potassium sorbate as a preservative, which may cause allergic reactions.
Panadol Mini Caps. Active ingredient: Paracetamol 500 mg/mini cap.
Excipients. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Panadol Tablets. White, film-coated tablet with bevelled edge, shallow convex, double radius 1.27 cm diameter. Marked Panadol on one side and with a break bar on the reverse side.
Panadol Mini Caps. Capsule shaped tablet with a gelatin coating which is one half green and the other half white.

4 Clinical Particulars

4.1 Therapeutic Indications

For fast effective temporary relief of pain and discomfort associated with headache, muscular aches, period pain, arthritis/osteoarthritis, toothache, migraine headache, cold and flu symptoms, tension headache, sinus pain/headache and backache. Reduces fever.

4.2 Dose and Method of Administration

See Table 1.

General dosage instructions. Adults. Do not use for more than a few days at a time without medical advice.
Children 7-17 years. Do not use for more than 48 hours except on medical advice.
Should not be used with other paracetamol-containing products.
Minimum dosing interval: 4 hours.
If symptoms persist, medical advice must be sought.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
Minimum dosing interval: 4 hours.
Maximum daily dose for children 12 years of age to adults: 4,000 mg.
Keep out of sight and reach of children.

4.3 Contraindications

Contraindicated in patients with a previous history of hypersensitivity to paracetamol or to any of the excipients.

4.4 Special Warnings and Precautions for Use

Identified precautions. 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.
If symptoms persist, medical advice must be sought.
Keep out of sight and reach of children.
High anion gap metabolic acidosis. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Use in hepatic impairment. Paracetamol should be used with caution in patients with impaired liver function: Underlying liver disease increases the risk of paracetamol-related liver damage.
Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication.
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.
Use in renal impairment. Paracetamol should be used with caution in patients with 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 kidney impairment must seek medical advice before taking this medication.
Use in the elderly. No data available.
Paediatric use. Panadol Tablets and Panadol Mini Caps are not recommended for children under seven years of age.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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 and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by substances that decrease gastric emptying, e.g. 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 agents.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see Section 4.4)

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category A)
As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.
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 small amounts (< 0.2%) in breast milk. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants. Available published data do not contraindicate breastfeeding.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
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 doses 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. See Table 2.

4.9 Overdose

If an overdose is taken or suspected, contact the Poisons Information Centre immediately for advice (131 126), 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.
Treatment. Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.
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.
Administration of N-acetylcysteine may be required.
Activated charcoal may reduce absorption of paracetamol if given within one hour after oral ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Paracetamol is a para-aminophenol derivative that exhibits analgesic and anti-pyretic activity. It does not possess anti-inflammatory 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 to reduce fever.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Absorption. Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma concentration occurring about 10 to 60 minutes after oral administration. Food intake delays paracetamol absorption. Following rectal administration of paracetamol, there is considerable variation in peak plasma concentrations attained, and time to reach peak plasma concentrations is substantially longer than after oral administration.
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 extensively in the liver and excreted in the urine mainly as inactive 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 150 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 inactive glucuronide and sulphate conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about one to three hours. Approximately 85% of a dose of paracetamol is excreted in urine as free and conjugated paracetamol within 24 hours after ingestion.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Panadol Tablets. Excipients: Starch - pregelatinised maize, Starch - maize, Talc - purified, Stearic acid, Hypromellose, Povidone, Glycerol triacetate, Potassium sorbate, Carnauba wax.
Panadol Mini Caps. Excipients: Gelatin capsules hard, Starch - pregelatinised maize, Croscarmellose sodium, Povidone, Stearic acid, Hypromellose, Titanium dioxide, Quinoline yellow, Brilliant blue FCF, Allura red AC.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Panadol Tablets. Store below 30°C.
Panadol Mini Caps. Store below 25°C.

6.5 Nature and Contents of Container

Panadol Tablets. Blister packs of 2, 12, 16, 20, 48, 50 and 100 tablets.
Panadol Mini Caps. Blister packs of 12, 16, 20, 48 and 96 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number. 103-90-2.

7 Medicine Schedule (Poisons Standard)

Packs of 16 tablets or Mini Caps or less. Unscheduled.
Packs larger than 16 tablets or Mini Caps but less than 50 tablets or Mini Caps. S2, Pharmacy Medicine.
Packs larger than 50 tablets or Mini Caps. S3, Pharmacist Only Medicine.

Date of Revision

10 July 2025

Summary Table of Changes