Topical diclofenac should be applied only to intact non-diseased skin, and not to skin wounds or open injuries. Concomitant use of oral NSAID's should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase.ĭiclofenac 1% Gel should be discontinued at the first signs of rash, mucosal injuries or other hypersensitivity manifestations. Apparently the risk of occurrence of these reactions is higher at the beginning of the treatment and in most cases these reactions are manifested during the first month of treatment. The possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).Ĭutaneous safety of NSAIDs: Serious skin reactions, some of them fatal, have been reported very rarely, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the administration of NSAIDs (see section 4.8.). The occurrence of systemic undesirable effects with the topical use of diclofenac is low when compared with the frequency of undesirable effects with the oral use of diclofenac. No dosage adjustment is required in patients with hepatic impairment.ĭiclofenac 1% Gel is contraindicated in patients with renal impairment.Īfter application, the hands should be washed, unless these are being treated.ĭiclofenac 1% Gel can be used as additional treatment to the oral administration of non-steroidal anti-inflammatory drugs. There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also section 4.3). In adolescents aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patients/parents of the adolescent is/are advised to consult a doctor.ĭiclofenac 1% Gel can be used as additional treatment to the oral administration of non-steroidal anti-inflammatory drugs.Ĭhildren and adolescents aged below 14 years It is recommended that the treatment should be evaluated 7 days after its beginning. The treatment duration depends on the indications and the patient's response to the treatment. Adults and adolescents aged 14 years and overĪpply thin layers of Diclofenac 1% Gel in the affected area, 3-4 times daily according to the need of the situation (about 2-4 g, quantity as big as a cherry or a walnut) and rub gently.
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