Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Life-threatening cutaneous reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of systemic administration of piroxicam. These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be ruled out.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first week of treatment.
If signs or symptoms of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued.
The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.
If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re-started in this patient at any time.

Cases of fixed drug eruption (FDE) have been reported with piroxicam. Piroxicam should not be reintroduced in patients with history of piroxicam-related FDE. Potential cross reactivity might occur with other oxicams.
Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection.

NSAIDs, including piroxicam, may cause interstitial nephritis, nephrotic syndrome and renal failure. There have also been reports of interstitial nephritis, nephrotic syndrome and renal failure with topical piroxicam, although the causal relationship to treatment with topical piroxicam has not been established. As a result, the possibility that these events may be related to the use of topical piroxicam cannot be ruled out.

Excipient Information

This medicinal product contains ethanol, propylene glycol and benzyl alcohol (see section 2).
The ethanol may cause a burning sensation on damaged skin. In neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).

Propylen glycol may cause skin irritation. If local irritation develops, the use of the Feldene Gel should be discontinued and appropriate therapy instituted as necessary. Feldene Gel should not be used in neonates with open wounds or large areas of broken or damaged skin (such as burns).

Benzyl alcohol may cause mild local irritation and may also cause allergic reactions.

Effects on Driving