Diclofenac 1% Gel is indicated in adults and adolescents aged 14 years and over as anti-inflammatory and analgesic agent in the treatment of:
mild to moderate muscle pain;
Adults and adolescents aged 14 years and over
Apply 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.
The treatment duration depends on the indications and the patient's response to the treatment. It is recommended that the treatment should be evaluated 7 days after its beginning.
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.
Diclofenac 1% Gel can be used as additional treatment to the oral administration of non-steroidal anti-inflammatory drugs.
Children and adolescents aged below 14 years
There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age.
The usual adult dosage may be used.
Hepatic and renal impairment
No dosage adjustment is required in patients with hepatic impairment.
Diclofenac 1% Gel is contraindicated in patients with renal impairment.
Directions for Use:
For topical use only.
Apply on healthy skin only.
After application, the hands should be washed, unless these are being treated.
Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus, The prolonged use of diclofenac in a relatively extensive area can cause systemic side effects such as nausea, vomiting, diarrhoea or epigastric pain.
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. 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).
Cutaneous 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. 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.
Concomitant use of oral NSAID's should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase.
Diclofenac 1% Gel should be discontinued at the first signs of rash, mucosal injuries or other hypersensitivity manifestations.
Topical diclofenac should be applied only to intact non-diseased skin, and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.
The area treated with Diclofenac 1% Gel should not be exposed to sunlight.
Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Store at temperature not exceeding 30°C. Protect from light.
Keep the medicine out of reach of children.
Lami tube closed with a screw cap, containing 30 g of gel. Such 01 tube with package insert in a carton.