MELOXICAM

5 mg/day (half a 15 mg tablet); if necessary, in the absence of improvement, the dose may be increased to 15 mg/day. • Rheumatoid arthritis, Ankylosing Spondylitis: 15 mg/day (one 15 mg tablets). 5 mg/day (half a 15 mg tablet). 4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

DO NOT EXCEED THE DOSE OF 15 MG/DAY. Method of administration Precautions to be taken before handling or administering the medicinal product 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. 5 mg (half a 15 mg tablet) per day. 4). 5 mg (half a 15 mg tablet) per day. e. patients with a creatinine clearance of greater than 25 ml/min). 3). 3). 3).

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 - Special warnings and precautions for use) have been reported following administration.

Less frequently, gastritis has been observed. 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. Adverse reactions have been ranked under headings of frequency using the following convention: Very common ( > 1/10); common ( > 1/100, < 1/10); uncommon ( > 1/1000, < 1/100); rare ( > 1/10000, < 1/1000); very rare ( < 1/10000) b) Table of adverse reactions Blood and lymphatic system disorders Uncommon: Anaemia 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:

Hypersensitivity, 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.

4). g. ) General disorders and administration site conditions Uncommon: Oedema including oedema of the lower limbs. 5). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

2, and GI 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.

The use of Meloxicam Orodispersible Tablets with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. Meloxicam Orodispersible Tablets is not appropriate for the treatment of patients requiring relief from acute pain.

In the absence of improvement after several days, the clinical benefit of the treatment 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. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Gastrointestinal effects GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous 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.

g. NSAIDs, 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 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); • Active intestinal inflammatory disease (Crohn´s disease, ulcerative colitis); • Severely impaired liver function; • Non-dialysed severe renal failure; • Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders; • Severe heart failure; • Meloxicam is contraindicated in treatment of perioperative pain after coronary artery bypass surgery (CABG).