PARABEX OSTEO

What it is

Parabex Osteo contains paracetamol 500 mg per tablet. The tablets are white to off-white, caplet-shaped with a score notch on one side and "P" debossed on the other.

Approved indications

— Temporary relief of pain associated with headache — Temporary relief of pain associated with migraine headache — Temporary relief of pain associated with tension headache — Temporary relief of pain associated with sinus pain — Temporary relief of pain associated with toothache — Temporary relief of pain associated with dental procedures — Temporary relief of pain associated with backache — Temporary relief of pain associated with muscular aches and pains — Temporary relief of pain associated with arthritis — Temporary relief of pain associated with osteoarthritis — Temporary relief of pain associated with rheumatic pain — Temporary relief of pain associated with period pain — Temporary relief of pain associated with fibrositis — Temporary relief of pain associated with neuralgia — Temporary relief of pain associated with sore throat — Temporary relief of pain associated with tennis elbow — Temporary relief of pain associated with colds and flu — Reduces fever

Dosing overview

Children aged 7–12 years should take half to 1 caplet every 4 to 6 hours as required, not exceeding 4 caplets per 24 hours. Adults and children aged 12 years and over should take 1 to 2 caplets every 4 to 6 hours as required, not exceeding 8 caplets per 24 hours. Parabex Osteo is not recommended for children under 7 years.

Key safety warnings

Parabex Osteo may be dangerous when used in large amounts or for long periods. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction. Hepatotoxicity may develop following as little as 10 to 15 g of paracetamol and hepatic failure is known to occur occasionally with long-term use. To avoid the risk of overdose, check that paracetamol is absent from the composition of other medicinal products taken concurrently. Life-threatening cutaneous reactions Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported with paracetamol use. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs of these conditions occur, patients should stop paracetamol treatment immediately and seek medical advice. Patients with known analgesic intolerance or known bronchial asthma must only use Parabex Osteo after having consulted a physician due to possible hypersensitivity reactions including bronchospasm.

Contraindications

Parabex Osteo is contraindicated in patients who are hypersensitive to paracetamol or to any of the excipients. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency. Parabex Osteo must not be used in patients with impaired liver function.

Regulatory history

Parabex Osteo received its first approval on 28 June 2016. The paracetamol 665 mg modified-release tablet blister pack (ARTG 281995) was first listed on 1 November 2016, and the paracetamol 665 mg modified-release tablet bottle (ARTG 376685) was first listed on 21 October 2021.