Product Dossier
ASSISTPRO
Product Dossier for ASSISTPRO (paracetamol 500 mg, AssistPro Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: AssistPro Pharmaceuticals
- Active ingredient: paracetamol 500 mg
- Therapeutic area: Pain Management
- Related brand: CHEMISTS’
- Related brand: CODASIG
- Related brand: GUARDIAN
- Same area: PALEXIA
- Same area: OXYCONTIN
What it is
AssistPro is a paracetamol 500 mg capsule-shaped tablet formulation presented as white film-coated oval-shaped compound convex tablets. Paracetamol is a para-aminophenol derivative that exhibits analgesic and anti-pyretic activity and does not possess anti-inflammatory activity, with its mechanism of action believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system. The tablet formulation contains sodium bicarbonate and is intended to increase the rate of gastric emptying thereby allowing more rapid absorption of paracetamol.
Approved indications
AssistPro is used for temporary relief of pain and discomfort associated with: — Headache and tension headache — Migraine headache — Muscular aches — Period pain — Toothache — Cold and flu
AssistPro reduces fever.
Dosing overview
For adults and children aged 12 years and over, the dose is 1 to 2 caplets every four to six hours with water as required, with a maximum of 8 caplets in 24 hours. Maximum daily dose is 4000 mg. AssistPro is not recommended for children under the age of 12 years. Adults should not use AssistPro for more than a few days at a time without medical advice. Children aged 12–17 years should not use AssistPro for more than 48 hours except on medical advice. The minimum dosing interval is 4 hours. AssistPro should not be used with other paracetamol-containing products.
Key safety warnings
AssistPro should not be used with any other paracetamol-containing products, as concomitant use may lead to an overdose, and 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 as underlying liver disease increases the risk of paracetamol-related liver damage, and patients who have been diagnosed with liver impairment must seek medical advice before taking this medication. Paracetamol should be used with caution in patients with impaired kidney function as administration to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates, 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 (such as chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin, and if HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.
Contraindications
AssistPro is contraindicated in patients with a previous history of hypersensitivity to paracetamol or to any of the excipients.
Regulatory history
AssistPro Paracetamol Capsule Shaped Tablets (ARTG 517793) was first listed on 30 October 2025.