Product Dossier

MOBIC

Product Dossier for MOBIC (meloxicam, Boehringer Ingelheim). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

MOBIC is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which has shown anti-inflammatory, analgesic and antipyretic properties. The medicine is available as capsules containing either 7.5 mg or 15 mg of meloxicam. MOBIC works by inhibiting the biosynthesis of prostaglandins, known mediators of inflammation, through inhibition of cyclooxygenase (COX).

Approved indications —

Symptomatic treatment of osteoarthritis — Symptomatic treatment of rheumatoid arthritis

Dosing overview

MOBIC should be used at the lowest dose and for the shortest duration consistent with effective treatment. The maximum recommended daily dose is 15 mg. In patients with increased risks of adverse reactions, such as a history of gastrointestinal disease or risk factors for cardiovascular disease, treatment should be started at 7.5 mg per day and increased to 15 mg per day only if clinically justified.

Key safety warnings

Gastrointestinal bleeding, ulceration or perforation, potentially fatal, can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The consequences of such events are generally more serious in the elderly. Patients with a prior history of ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than tenfold higher risk of developing a gastrointestinal bleed than patients with neither of these factors. Long-term therapy with some COX-2 selective NSAIDs has been shown to increase the risk of serious cardiovascular thrombotic events. MOBIC is a COX-2 selective NSAID. All NSAIDs, both COX-2 selective and non-selective, may cause an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke, which may increase with dose and duration of use. To minimise the potential risk of an adverse cardiovascular event in patients taking MOBIC, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment. NSAIDs inhibit the synthesis of renal prostaglandins, which play a supportive role in the maintenance of renal perfusion. In patients whose renal blood flow and blood volume are decreased, administration of an NSAID may precipitate overt renal decompensation. Patients at greatest risk include elderly individuals, dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease.

Contraindications

MOBIC is contraindicated in peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery (CABG) and in patients with known hypersensitivity to meloxicam or any excipients in this medicine. Use is contraindicated in patients with signs or symptoms of asthma, nasal polyps, angioedema or urticaria following the administration of aspirin or other NSAIDs, active gastrointestinal ulceration or perforation, active inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis), severe hepatic insufficiency, severe uncontrolled heart failure, and in children and adolescents under 18 years of age. MOBIC is also contraindicated during breastfeeding and with concomitant administration of drugs known to inhibit CYP 2C9. Use is contraindicated in patients with rare hereditary galactose intolerance due to the lactose content in this medicine. As with all NSAIDs, MOBIC is contraindicated in patients with recent cerebrovascular bleeding or established systemic bleeding disorders.

Regulatory history

MOBIC was first registered on the Australian Register of Therapeutic Goods on 23 February 2001, with registrations for both 7.5 mg and 15 mg tablet and capsule formulations. The product information was last revised on 15 October 2025.