“Directions
For short-term treatment. Local symptomatic relief of pain associated with acute muscle strains, dislocations or contusions of the extremities following non-penetrating trauma.
Composition
Active ingredients
Each medicated patch contains 140 mg diclofenac sodium.
Excipients with known effect: 2.8 mg butylhydroxytoluene (E321) and 1400 mg propylene glycol (E1520) per patch.
Excipients
glycerol propylene glycol (E1520) diisopropyl adipate sorbitol liquid (crystallizing) (E420) carmellose sodium salt of polyacrylic acid sodium salt basic butylated copolymer edetate methacrylate disodium sodium sulfite (E221) butylhydroxytoluene (E321) bis(sulfate) aluminum potassium colloidal anhydrous light kaolin (natural) macrogol lauryl ether (9 units of EO) levomenthol tartaric acid purified water non-woven polyester carrier protective polypropylene film
Method of administration and dosage
Adults should stick the medicated patch to the painful area twice a day, in the morning and in the evening. The maximum daily dose is 2 medicated patches, even if more than one area is to be treated. Only one painful area should be treated at a time. The diclofenac medicated patch should be used for the shortest possible period of time, depending on the indication for use.
Paediatric population Children and adolescents under 16 years of age: the use of this medicated patch is not recommended in children and adolescents under 16 years of age, as there is insufficient data to evaluate the safety and efficacy of the medicine.
Directions for use
For cutaneous use only. The product should only be applied to intact, healthy skin and should not be left on the skin while bathing or showering. Cut open the medicated patch pouch as directed. Remove the medicated patch, remove the plastic film used to protect the adhesive surface and apply the patch to the painful joint or surface. If necessary, the medicated patch can be secured in place with an elastic bandage. Carefully seal the pouch with the sliding fastener. The patch must be used in one piece.
Duration of use
Based on the limited data available, short-term treatment is recommended. The therapeutic effect of taking the medicine for more than 7 days has not been established. If no improvement is observed after the recommended treatment period, a doctor should be consulted (see section 4.4). In adults and adolescents over 16 years of age, if pain relief requires more than 7 days of treatment or if symptoms worsen, patients or parents of adolescents should consult a doctor.
Contraindications
Hypersensitivity to the active substance or to any of the listed excipients.
Last trimester of pregnancy.
Hypersensitivity to other analgesics and antirheumatic drugs (non-steroidal anti-inflammatory drugs [NSAIDs], including acetylsalicylic acid).
Patients who have experienced attacks of asthma, urticaria or acute rhinitis in the past after taking acetylsalicylic acid or other NSAIDs.
Active peptic ulcer.
Use on damaged skin, regardless of the type of lesion: exudative dermatitis, open wounds, burns, skin infections or eczema.
Contraindicated for use in children and adolescents under 16 years of age.”
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