Generic name: Diclofenac Diethylamine + Methyl salicylate + Racementhol Gel
In the treatment of localized forms of soft-tissue rheumatism (e.g. tendovaginitis, shoulder-hand syndrome, bursitis and periathropathy), localized rheumatic diseases (e.g. osteo-arthritis of the spine and peripheral joints) and post-traumatic inflammation of the tendons, ligamnets, muscles and joints (e.g. due to sprains, strains or bruises)
Dosage regimen and direction for use
Use as directed by the physician or
Depending on the size of the painful area to be treated, 2-4 g Gel should be applied 3-4 times daily to the affected sites and gently rubbed in. the duration of treatment depends on the indication and the patient’s response. It is advisable to review the treatment after two weeks.
It is contraindicated in patients with known hypersensitivity to Diclofenac, Methyl Salicylate or any of the other ingredients of this preparation
Side effects and adverse reactions
Local reactions: occasionally, allergic or non-allergic contact dermatitis (with symptoms and signs such as itching, reddening of the skin, oedema, papules, vesicles, bullae or scaling).
Systemic reactions – isolated cases: generalized rash, hypersensitivity reactions (e.g. asthma attack, angioedema) and photosensitivity reactions. The likelihood of systemic reactions occurring during topical ttreatment with diclofenac is small compared with the frequency of side effects seen during oral administration
As the systemic absorption is low, the risk of any interaction is very less
Precaution and warnings
Diclofenac Gel should be applied only to intact skin and not to broken skin or open wounds. The preparation should not come into contact with the eyes or mucous membranes. Keep the medicine out of reach of children.
Use in pregnancy and lactation
Safety of Diclofenac Gel has not been established in pregnant women. During the last trimester of pregnancy the use of prostaglandin synthetase inhibitors may result in premature closure of the ductus arteriosus or in uterine inertia.
Usage in paediatrics:
No dosage recommendation and indications have been established to date for the use of Dicloper-Activa Gel in children