MELOXICAM

4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis. 5mg per day. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day.

Rheumatoid arthritis, ankylosing spondylitis: 15mg per day (see also “Special populations”). 5mg per day. DO NOT EXCEED THE DOSE OF 15mg per day. 5mg per day. 4). 5mg per day. e. patients with a creatinine clearance of greater than 25ml/min).

3). 3). 3). 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 has 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 15mg 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.

The frequency grouping is defined using the following convention:

Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

4), flushing Respiratory, thoracic and mediastinal disorders Rare Asthma in individuals allergic to aspirin or other NSAIDs Very Common Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea Uncommon Occult or macroscopic gastrointestinal haemorrhage2, stomatitis, gastritis, eructation Rare Colitis, gastroduodenal ulcer2, oesophagitis Very rare Gastrointestinal perforation2 Gastrointestinal disorders Not known Pancreatitis MeDRA System Organ Class Frequency Adverse Reaction Uncommon Liver function disorders (eg raised transaminases or bilirubin)Hepatobiliary disorders Very Rare Hepatitis.

5). 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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 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. Gastrointestinal effects Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

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

5). When gastrointestinal bleeding or ulceration occurs in patients receiving Meloxicam, 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 including meloxicam (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. 6); − Children and adolescents aged under 16 years; − 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; − 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