MIGLOCALN 15
MIGLOCALN 15
Active ingredient: Meloxicam 15 mg.
Dosage form: Tablet.
Packaging: Box of 3 blisters x 10 tablets.
Expiry date: 36 months.
Posology
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
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.
According to the therapeutic response, the dose may be reduced to 7.5 mg/day.
Do not exceed the dose of 15 mg/day.
Special populations
Elderly patients and patients with increased risks for adverse reactions (see Pharmacokinetic properties).
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 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
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 CONTRAINDICATIONS.
Hepatic impairment
No dose reduction is required in patients with mild to moderate hepatic impairment. For patients with severely impaired liver function, see CONTRAINDICATIONS.
Paediatric population
MIGLOCALN is contraindicated in children and adolescents aged under 16 years (see CONTRAINDICATIONS).
Method of administration
For oral use.
The total daily amount should be taken as a single dose, with water or another liquid, during a meal.
INDICATIONS
MIGLOCALN is indicated in adults and adolescents over 16 years of age for:
- Short-term symptomatic treatment of exacerbations of osteoarthrosis.
- Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients, or hypersensitivity to substances with a similar action, e.g. NSAID’s, aspirin. Meloxicam should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other NSAID’s.
Third trimester of pregnancy (see PREGNANT AND BREAST-FEEDING WOMEN).
Children and adolescents aged under 16 years.
Severely impaired liver function.
Non-dialysed severe renal failure.
Gastrointestinal bleeding, history of cerebrovascular bleeding or other bleeding disorders.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure.
