MELOXICAM

Posology The daily dose should be taken all at once. 4). The patient's need for symptomatic relief and response to therapy should be re- evaluated periodically, especially in patients with osteoarthritis. 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. 5 mg/day (see also section ‘Special populations’ below). DO NOT EXCEED THE DOSE OF 15MG/DAY. 4). 5 mg per day. 3). 5 mg/day. e. patients with a creatinine clearance of greater than 25 ml/min).

3). 3). This medicine comes in other forms and strengths that may be more appropriate. 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.

4). Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. The most commonly-observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis, glossitis, pancreatitis, oesophagitis and oesophageal lesions have been observed.

4). The frequencies of adverse drug reactions given below are based on corresponding occurrences of reported adverse events in 27 clinical trials with a treatment duration of at least 14 days. 5 or 15 mg meloxicam tablets or capsules over a period of up to one year.

Adverse drug reactions that have come to light as a result of reports received in relation to administration of the marketed product are included. 000); very rare (<1/10,000), not known (cannot be estimated from the available data) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions possibly or probably related to meloxicam based on clinical trial experience and post-marketing surveillance: Blood and lymphatic system disorders Uncommon: Anaemia ia Rare: Blood count abnormal (including differential white cell count), leukopenia, thrombocytopenia Very rare cases of agranulocytosis have been reported (see section c).

Immune system disorders Uncommon:

Allergic reactions other than anaphylactic or anaphylactoid reactions Not known: Anaphylactic reaction, anaphylactoid reaction Psychiatric disorders Rare: Mood altered, nightmares Not known: Confusional state, disorientation Nervous system disorders Common: Headache Uncommon: Dizziness, somnolence Eye disorders Rare: Visual disturbance including vision blurred; conjunctivitis Ear and labyrinth disorders Uncommon: Vertigo Rare: Tinnitus Cardiac disorders Rare: Palpitations Cardiac failure has been reported in association with NSAID treatment.

2, and gastrointestinal and cardiovascular risks below). The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect, nor should an additional NSAID be added to the therapy because this may increase the toxicity while therapeutic advantage has not been proven.

5). Meloxicam is not appropriate for the treatment of patients requiring relief from acute pain. In the absence of improvement after several days, the clinical benefit should be reassessed. Any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure before starting treatment with meloxicam.

Attention should routinely be paid to the possible onset of a recurrence in patients treated with meloxicam and with a past history of this type. Gastrointestinal effects GI bleeding or ulceration/perforation, which can be fatal, have been reported related to the use of meloxicam as to other NSAIDs at any time during the treatment, with or without warning symptoms or a history of serious GI events.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

5). When GI bleeding or ulceration occurs in patients receiving Meloxicam tablets, the treatment should be withdrawn. 8). Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical monitoring of blood pressure for patients at risk is recommended at baseline and especially during treatment initiation with meloxicam. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

g. NSAIDs, aspirin. Meloxicam tablets 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 NSAIDs; - 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); - Severely impaired liver function; - Non-dialysed severe renal failure; - Gastrointestinal bleeding, history of cerebrovascular bleeding or other bleeding disorders; - Severe heart failure.