AMCAL

What it is

AMCAL Paracetamol contains paracetamol 500mg 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

AMCAL Paracetamol is indicated for temporary relief of pain associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow and colds and flu, and for reducing 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. AMCAL Paracetamol is not recommended for children under 7 years.

Key safety warnings

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

Contraindications

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

Regulatory history

AMCAL Paracetamol 500mg tablets in blister pack formulation was first approved on 28 June 2016.