FELDENE

Posology Adults No occlusive dressings should be employed. Apply 1 g of Gel, corresponding to 3cm, and rub into the affected site three to four times daily leaving no residual material on the skin. Therapy should be reviewed after 4 weeks.

Paediatric population Dosage recommendations and indications for the use of Feldene Gel in children have not been established. Elderly No special precautions are required. Method of administration Feldene Gel is for external use only.

Feldene Gel is well tolerated. Mild to moderate local irritation, erythema, pruritus and dermatitis may occur at the application site. The systemic absorption of Feldene Gel is very low. In common with other topical non-steroidal anti-inflammatory agents, systemic reactions occur infrequently and have included minor gastro-intestinal side-effects such as nausea and dyspepsia.

Cases of abdominal pain and gastritis have been reported rarely. 3). 4). Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from post-marketing experience. 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.

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. 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. 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. This medicinal product contains propylene glycol and may cause skin irritation. If local irritation develops, the use of the Feldene Gel should be discontinued and appropriate therapy instituted as necessary.

Because this medicine contains propylene glycol, Feldene Gel should not be used on open wounds or large areas of broken or damaged skin (such as burns). This medicinal product contains benzyl alcohol which may cause mild local irritation.

1. The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents (NSAIDs). Feldene Gel should not be given to patients in whom aspirin and other non- steroidal anti-inflammatory agents induce the symptoms of asthma, nasal polyps, angioneurotic oedema or urticaria.