MELOX Tablet Ref.[28337] Active ingredients: Meloxicam

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Posology

• Exacerbations of osteoarthrosis: 7.5 mg/day. If necessary, in the absence of improvement the dose may be increased to 15 mg/day.
• Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day. (see also section ‘Special populations’ below).

According to the therapeutic response the dose may be reduced to 7.5mg a day.

DO NOT EXCEED THE DOSE OF 15 MG/DAY.

Special Populations

Elderly patients and patients with increased risks for adverse reaction (see section 5.2)

The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day (see section 4.4).

Renal impairment

In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day.

No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min). (For patients with non-dialysed severe renal failure, see section 4.3)

Hepatic impairment (see section 5.2)

No dose reduction is required in patients with mild to moderate hepatic impairment (For patients with severely impaired liver function, see section 4.3).

Paediatric population

Children and adolescents: Melox is contraindicated in children and adolescents aged under 16 years (see section 4.3).

Method of administration

Oral use.

The total daily amount should be taken as a single dose, with water or another liquid, during a meal.

Symptoms

Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.

Management

Patients should be managed with symptomatic and supportive care following an NSAID overdose. Accelerated removal of meloxicam by 4 g oral doses of cholestyramine given three times a day was demonstrated in a clinical trial.

24 months.

Store below 25°C in the original package, in order to protect from light and moisture.

Tablets are packaged in Polyvinyl chloride/Poyvinynylidene chloride film-aluminium foil blisters with a patient in packs of 10, 20 and 30 tablets.

Not all pack sizes may be marketed.

No special requirements.