NUROMOL DUAL ACTION PAIN

What it is

Nuromol Dual Action Pain Relief contains ibuprofen and paracetamol, with 200 mg of ibuprofen and 500 mg of paracetamol per tablet. The medicine is available as off-white, pearlescent, oval-shaped film coated tablets de-bossed with an identifying helix.

Approved indications

Nuromol Dual Action Pain Relief is indicated for the temporary relief of acute (short term) pain and/or inflammation associated with: — Headache — Migraine headache — Tension headache — Sinus pain — Toothache — Dental procedures — Backache — Muscular aches and pains — Period pain — Sore throat — Tennis elbow — Rheumatic pain and arthritis — Aches and pains associated with colds and flu

Dosing overview

Adults under 65 and children from 12 years take 1 tablet every 8 hours as necessary, with a maximum of 3 tablets in 24 hours. Nuromol Dual Action Pain Relief should not be used for more than 3 days at a time (or not more than 2 days at a time for adolescents aged 12 to 17 years) unless on medical advice.

Key safety warnings

The hazard of paracetamol overdose is greater in patients with non-cirrhotic alcoholic liver disease, and immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage. Observational studies have indicated that NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use, with patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors at greater risk. Gastrointestinal bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome, Drug Reaction with Eosinophilia with Systemic Symptoms, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis, which can be life threatening or fatal, have been reported in association with the use of ibuprofen and paracetamol, with most of these reactions occurring within the first month; if signs and symptoms suggestive of these reactions appear, Nuromol Dual Action Pain Relief should be withdrawn immediately. Nuromol Dual Action Pain Relief can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection, particularly in bacterial community acquired pneumonia and bacterial complications to varicella; when administered for fever or pain relief in relation to infection, monitoring of infection is advised.

Contraindications

Nuromol Dual Action Pain Relief is contraindicated in patients with a known hypersensitivity to ibuprofen, paracetamol or any other constituent of the medicinal product, and in patients with a history of hypersensitivity reactions (such as bronchospasm, angioedema, rhinitis or urticaria) associated with aspirin or other anti-inflammatory drugs or analgesic drugs. The medicine is also contraindicated in patients with a history of, or an existing gastrointestinal ulceration/perforation or bleed, or other stomach disorder. It is contraindicated in patients with impaired hepatic function, impaired renal function or heart failure, patients with asthma, patients with conditions that predispose to renal failure, and in concomitant use with ibuprofen or other NSAID-containing products, including cyclooxygenase-2 specific inhibitors and aspirin or other anti-inflammatories. It is also contraindicated in concomitant use with other paracetamol-containing products. The product is contraindicated in patients aged 65 years and over and in children under 12 years. Nuromol Dual Action Pain Relief is contraindicated for use during pregnancy.

PBS listing

No Pharmaceutical Benefits Scheme listing information is available for this medicine.

Regulatory history

Nuromol Dual Action Pain Relief tablets were first listed on the Australian Register of Therapeutic Goods on 4 July 2014. A liquid capsule variant (ibuprofen 200 mg and paracetamol 500 mg) was listed on 16 October 2019.