TRAXAM Cutaneous foam Ref.[27616] Active ingredients: Felbinac

It should only be used on non-diseased skin. Use of this medicine should be limited to intact skin. Contact with mucous membranes and the eyes should be avoided. Patients should avoid actuation of the aerosol can near their face or eyes.

This medicine should not be applied with occlusive dressings or simultaneously to the same site as other topical preparations.

To avoid the possibility of photosensitivity, patients should be advised against excessive exposure to sunlight of treated areas.

Safe use of felbinac in early childhood has not been established.

Felbinac is highly protein bound. However, serum levels following topical application are extremely low and therefore clinical drug interactions are unlikely.

Since the safety of felbinac in human pregnancy has not been established, it is not recommended for use in these circumstances. As with other non-steroidal anti-inflammatory agents which inhibit prostaglandin synthesis, dystocia and delayed parturition have been observed in animal studies when felbinac is administered late in pregnancy.

None.

A low incidence of mild local irritation, erythema, dermatitis, pruritis and paraesthesia which recovers spontaneously upon cessation of treatment may be expected with this medicine.

Systemic side effects are rare; hypersensitivity reactions such as widespread rashes including urticaria and bronchospasm have been reported with felbinac. Gastrointestinal disturbances have been reported occasionally.

Skin photosensitivity has been reported.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None.