Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The most common adverse reactions are photosensitive reactions (phototoxic and photosensitivity allergic reactions), the majority of which occurs after an incorrect use of the product (exposure of the skin to sunlight or solarium before 15 days from the last application, see sections 4.3 and 4.4). There have been reports of localised skin reactions due to photosensitivity, including erythema, pruritus and burning sensations, which might spread beyond the area of application. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.

Other systemic effects of anti-inflammatory drugs: hypersensitivity, gastrointestinal and renal disorders (these depend on the transdermic spreading of the active ingredient, hence on the amount of gel applied, on the surface involved, on the degree of intactness of the skin, on the duration of the treatment and on the use of occlusive bandages).

The below mentioned adverse reactions have been collected in the post-marketing experience.

The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).

Infections and infestations
Not known: Secondary impetigo

Blood and lymphatic system disorders
Not known: Eosinophilia
Immune system disorders
Not known: Anaphylactic reaction, angioedema, hypersensitivity

Eye disorders
Not known: Eyelid oedema

Vascular disorders
Not known: Vasculitis
Gastrointestinal disorders
Not known: Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema 
Skin and subcutaneous tissue disorders
Uncommon: Rash (erythematous, generalised, maculo-papular, papular, pruritic, pustular, vesicular), eczema, pruritus, burning sensation, application site burn Rare: Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, photosensitivity allergic reaction, skin exfoliation, skin oedema, 
Renal and urinary disorders
Very rare: Acute renal failure, insufficiency aggravated
General disorders and administration site Conditions
Not known: Pyrexia

Injury, poisoning and procedural complications
Not known: Wound complication
Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti- inflammatory drugs.