MELOXICAM Orodispersible tablet Ref.[7314] Active ingredients: Meloxicam

Oral Use.

Exacerbations of Osteoarthrosis: 7.5 mg/day (one 7.5 mg tablet); if necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two 7.5 mg tablets).

Rheumatoid arthritis, Ankylosing Spondylitis: 15 mg/day (two 7.5 mg tablets).

(See also ‘Special Populations’)

According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one 7.5 mg tablet).

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 reevaluated periodically, especially in patients with osteoarthritis.

Do not exceed the dose of 15 mg/day.

Meloxicam Orodispersible Tablets should be placed in the mouth on the tongue and allowed to dissolve slowly for five minutes (the tablet should not be chewed and should not be swallowed undissolved), before swallowing with a drink of 240 ml of water.

Water may be used to moisten the buccal mucosa in patients with a dry mouth.

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 (see section 5.2)

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).

Children and adolescents

Meloxicam Orodispersible Tablets is contraindicated in children and adolescents aged under 16 years (see section 4.3).

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 NSAID and may occur following an overdose.

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.

3 years.

The medicinal product does not require any special storage conditions.

Boxes containing 2 Alu/PA-Alu-PVC blister packs of 10 tablet each.

Boxes containing 3 Alu/PA-Alu-PVC blister packs of 10 tablet each.

Boxes with one polyethylene bottle with polypropylene child-resistant tamper evident screw cap with desiccant containing 30 tablets each.

Boxes with one polyethylene bottle with polypropylene child-resistant tamper evident screw cap with desiccant containing 200 tablets each.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.