MOXICAM Tablet Ref.[50024] Active ingredients: Meloxicam

MOXICAM should be used at the lowest dose and for the shortest duration consistent with effective treatment.

The maximum recommended daily dose of MOXICAM is 15 mg. A dose of 15 mg/day should not be exceeded. As a dose for children has not been established, use should be restricted to adults (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Paediatric Use).

The dose of MOXICAM in patients with end-stage renal failure on haemodialysis should not exceed 7.5 mg/day (see Section 5.2 PHARMACOKINETIC PROPERTIES – Renal Impairment and Section 5.2 PHARMACOKINETIC PROPERTIES – Haemodialysis). No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 mL/min) nor in patients with mild to moderate hepatic impairment. In non-dialysed patients with severe renal impairment MOXICAM is contraindicated (see Section 4.3 CONTRAINDICATIONS).

In patients with increased risks of adverse reactions, e.g. a history of gastrointestinal disease or risk factors for cardiovascular disease, the treatment should be started at a dose of 7.5 mg/day and increased to 15 mg/day only if clinically justified.

Patients on long term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.

Osteoarthritis

The recommended dose of MOXICAM is 7.5 mg once daily, to be swallowed with fluid, in conjunction with food. Depending on the adequacy of response, the severity of the arthritic condition and the patient’s concomitant diseases, the dose may be increased to 15 mg/day.

Patients should generally be maintained on the lowest dose consistent with achieving a satisfactory therapeutic response.

Rheumatoid Arthritis

The recommended dose of MOXICAM is 15 mg once daily, to be swallowed with fluid, in conjunction with food. Depending on the adequacy of response and the severity of the condition, the dose may be reduced to 7.5 mg/day.

Patients should generally be maintained on the lowest dose consistent with achieving a satisfactory therapeutic response.

Pregnancy

See Section 4.3 CONTRAINDICATIONS and Section 4.6 FERTILITY, PREGNANCY AND LACTATION.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Patients should be managed with symptomatic and supportive care following an NSAID overdose. In cases of acute overdose, activated charcoal is recommended. Administration of activated charcoal is recommended for patients who present 1–2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly.

It has been shown in a clinical trial that colestyramine accelerates the elimination of meloxicam.

The typical signs and symptoms of NSAID overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness. Rare cases of seizures, hypotension, apnoea, coma and renal failure have been reported with severe NSAID overdose.

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

MOXICAM meloxicam 7.5 mg tablets: Store below 25°C.

MOXICAM meloxicam 15 mg tablets: Store below 25°C.

MOXICAM meloxicam 7.5 mg tablets: PVC/PVDC/Al blister packs of 10 and 30 tablets.

MOXICAM meloxicam 15 mg tablets: PVC/PVDC/Al blister packs of 10 and 30 tablets.

Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG):

AUST R 126214 – MOXICAM meloxicam 7.5 mg tablet blister pack.
AUST R 126215 – MOXICAM meloxicam 15 mg tablet blister pack.

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.