PANADOL

What it is

PANADOL OSTEO contains paracetamol 665 mg . It is a white to off-white film coated capsule shaped tablet with flat edges.

Approved indications

— Relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache — Temporary relief of pain and discomfort associated with headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures — Reduction of fever

Dosing overview

Adults and children aged 12 years and over should take 2 caplets swallowed whole three times a day every 6 to 8 hours. The maximum is 6 caplets in 24 hours. The caplets must not be chewed or sucked, as this impairs the sustained release properties. PANADOL OSTEO is not recommended for children under the age of 12 years.

Key safety warnings

PANADOL OSTEO must not be used with any other paracetamol-containing products as concomitant use may lead to an overdose, which may cause liver failure requiring liver transplant or leading to death. Paracetamol should be used with caution in patients with impaired liver function, and patients who have been diagnosed with liver impairment must seek medical advice before taking this medication. Cases of hepatic dysfunction or 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, and in such patients paracetamol may increase the risk of metabolic acidosis. Paracetamol should be used with caution in patients with impaired kidney function, and patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication. Cases of high anion gap metabolic acidosis 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 who were treated with paracetamol at therapeutic dose for a prolonged period, and if this condition is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, and anticoagulant dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time. 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 risk factors.

Contraindications

PANADOL OSTEO is contraindicated in patients with a previous history of hypersensitivity to paracetamol or to any of the excipients.

Regulatory history

PANADOL OSTEO was first registered on the ARTG on 17 February 2005 (ARTG 116619) and subsequently underwent reformulation, with the new version registered on 24 September 2015 (ARTG 260264).