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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Feldene Topigel 5mg/g Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 5mg piroxicam.
Excipients: Propylene glycol 200mg/g
_For full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Gel
Clear, pale-yellow gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For local symptomatic relief of pain and inflammation in the trauma of the tendons, ligaments, muscles and joints and
in localised forms of soft tissue rheumatism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Feldene Topigel is for external use only. Apply 1g of the gel, corresponding to 3cms, (approximately 1 1/4 inches)
and rub into the affected site three to four times daily leaving no residual material on the skin. Occlusive dressings
should not be used.
NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest
dose compatible with adequate safe clinical control should be employed. _See also section 4.4_
In the absence of experience, Feldene Topigel should not be used in children.
4.3 CONTRAINDICATIONS
Feldene Topigel should not be used in patients who have previously shown a hypersensitivity to the gel or piroxicam in
any of its forms. The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents.
Patients with active peptic ulceration.
Patients with a history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to Feldene
Topigel, aspirin or non-steroidal anti-inflammatory drugs.
Feldene Topigel should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory agents
induce the symptoms of asthma, rhinitis, angioedema or urticaria.
Use in areas affected by open l
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