Contact with eyes and mucous membranes as well as oral use should be avoided. Diclofenac sodium 4% Spray Gel (DicloFlex®) should only be administered onto intact skin, not on open wounds or diseased skin areas. Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity. Discontinue if any rash develops. Not for use with occlusive dressings. The concomitant use of Diclofenac sodium 4% Spray Gel (DicloFlex®) with oral NSAIDs should be cautioned as the incidence of systemic side effects may increase (see section 4.5).
Where DDiclofenac sodium 4% Spray Gel (DicloFlex®) is applied to a relatively large area of skin (i.e. more than 600 square centimetres of the body surface) and over a prolonged period (i.e. more than 4 weeks), the possibility of systemic side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on diclofenac oral dosage forms should be consulted (for example, there is the potential for hypersensitivity, asthmatic and renal adverse reactions).
Bronchospasm may be precipitated in patients suffering from or with previous history of bronchial asthma or allergenic disease.
Diclofenac sodium 4% Spray Gel (DicloFlex®) should only be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, bleeding diathesis or inflammatory bowel disease as isolated cases with topical diclofenac have been reported.
Diclofenac sodium 4% Spray Gel (DicloFlex®) contains propylene glycol which may cause skin irritation.
Diclofenac sodium 4% Spray Gel (DicloFlex®) contains peppermint oil which may cause allergic reactions.