PRODEINE

What it is

Prodeine contains paracetamol 500 mg and codeine phosphate hemihydrate 9.6 mg and is aspirin-free. The caplets are white capsule-shaped tablets, plain on one side and a breakline on the other.

Approved indications

— Relief of acute moderate pain and fever.

Dosing overview

Adults and children 12 years of age and older should take one or two caplets every 3 to 4 hours as needed for relief, not exceeding 8 caplets in a 24-hour period. Prodeine is not recommended for use over extended periods of time.

Key safety warnings

Prodeine should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. Prodeine poses risks of hazardous and harmful use which can lead to overdose and death. Serious, life-threatening or fatal respiratory depression may occur with the use of Prodeine, and situations which increase the risk of respiratory depression should be identified, dosing modified in patients at risk, and patients monitored closely, especially on initiation or following a dose increase. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients should be cautioned not to drink alcohol while taking Prodeine. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction, and hepatic failure is known to occur occasionally with the long-term use of paracetamol. Life-threatening cutaneous reactions including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with the use of paracetamol, patients should be monitored closely for skin reactions, and if symptoms or signs occur patients should stop paracetamol treatment immediately and seek medical advice.

Contraindications

Prodeine is contraindicated in patients with: — Known hypersensitivity to paracetamol, codeine or any of the excipients used in this product. — Severe respiratory disease, acute respiratory disease and respiratory depression, for example an acute asthma attack. — Glucose-6-phosphate-dehydrogenase deficiency. — Severely impaired liver or renal function. — Diarrhoea caused by pseudomembranous colitis or poisoning. — Chronic constipation. — Active alcoholism. — During labour when delivery of a premature infant is anticipated. — During breast-feeding. — Aged between 12–18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, due to an increased risk of developing serious and life-threatening adverse reactions. — CYP2D6 ultra-rapid metabolisers. Use in children under 12 years is contraindicated.

Regulatory history

Prodeine paracetamol 500 mg and codeine phosphate hemihydrate 9.6 mg was first listed on the ARTG on 4 September 2012. The product was first approved on 4 September 2012.