FELDENE

The prescription of Feldene should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases. Posology The maximum recommended daily dose is 20 mg.

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review.

g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients. Elderly Elderly, frail or debilitated patients may tolerate side-effects less well and such patients should be carefully supervised.

As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For oral administration. To be taken preferably with or after food.

4).

4), Non- thrombocytopenic purpura (Henoch- Schoenlein), Onycholysis, Alopecia, Urticaria Reproductive system and breast disorders Female fertility decreased System Organ Class Common ≥1/100 to <1/10 Uncommon ≥1/1000 to <1/100 Rare ≥1/10 000 to <1 000 Very Rare <1/10000 Not Known (cannot be estimated from available data) General disorders and administration site conditions Oedema (mainly of the ankle) Malaise Investigations Decreases in haemoglobin and haematocrit un- associated with obvious gastro- intestinal bleeding, Increased serum transaminase levels, Weight increase Positive ANA (antinuclear antibody), Weight decrease Gastro-intestinal: These are the most commonly encountered side-effects but in most instances do not interfere with the course of therapy.

Objective evaluations of gastric mucosa appearances and intestinal blood loss show that 20mg/day of Feldene administered either in single or divided doses is significantly less irritating to the gastrointestinal tract than aspirin.

Some epidemiological studies have suggested that piroxicam is associated with higher risk of gastrointestinal adverse reactions compared with some NSAIDs, but this has not been confirmed in all studies. 2). Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

The possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should therefore be borne in mind. 4).

Liver function:

Changes in various liver function parameters have been observed.

Other:

Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes. 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.

2, and GI and cardiovascular (CV) risks below). The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.

Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation NSAIDs, including piroxicam, can cause serious GI adverse events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal.

2). Administration of doses of greater than 20 mg per day carries an increased risk of GI side effects. Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.

These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. 3 and below). g. 2). Serious GI Complications Identification of at-risk subjects The risk for developing serious GI complications increases with age.

Age over 70 years is associated with high risk of complications. The administration to patients over 80 years should be avoided. 5). g. misoprostol or proton pump inhibitors) must be considered for these at-risk patients. Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during piroxicam treatment.

Patients should be asked to report any new or unusual abdominal symptom during treatment. If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.

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.

History of gastro-intestinal ulceration, bleeding or perforation. Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis.

Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding. Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid at analgesic doses. 5). History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

1, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications. Patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.

Severe heart failure. During the last trimester of pregnancy.