Consumer medicine information

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Active ingredient. Paracetamol 665 mg.
Chemical structure. See Section 6.7 Physicochemical Properties.
Excipients. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off-white film coated capsule shaped tablets with flat edges. Embossed with the logo "8" on the front face and plain on the back face.

4 Clinical Particulars

4.9 Overdose

Poisons information centre. 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 (see Section 4.8 Adverse Effects (Undesirable Effects)).
Because Panadol Osteo is a sustained-release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Panadol Osteo is suspected, that an additional plasma paracetamol level be obtained 4-6 hours after the initial measurement. If either level is above or close to the treatment line on the paracetamol overdose nomogram, administration of antidote would be indicated.
Treatment. 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.
Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.
Administration of N-acetylcysteine may be required.
In cases of overdosage, methods of reducing absorption of ingested drug are important. Activated charcoal may reduce absorption of the medicine 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

5.3 Preclinical Safety Data

No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Active ingredient. Paracetamol.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARCET.gif CAS number. CAS registry number 103-90-2.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PANOSTST.gif