Very rare side effects (may affect up 1 in 10,000 people) Pustular rash, gastrointestinal complaints, hypersensitivity reactions (including hives), sensitivity to light with appearance of skin reactions after exposition to sunlight. Diclofenac is a potent non-steroidal anti-inflammatory drug. It develops its therapeutic efficacy mainly via inhibition of prostaglandin synthesis by cyclooxygenase 2 (COX-2). Diclofenac has proven to be effective via the prostaglandin synthesis inhibition in the conventional animal-experiment inflammation models. In humans, diclofenac reduces inflammatory-related pain, swellings and fever. Furthermore, diclofenac inhibits reversibly the ADP and the collagen-induced thrombocyte aggregation. If you are exposed to direct sunlight or artificial sun there is a risk of skin reactions. You should avoid sunlight or artificial sun during treatment and for two weeks after stopping treatment.

In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicinal products should be used. Gastric lavage and the use of activated charcoal should be considered, especially within a short time of ingestion.For adults and adolescents aged 14 years and over. Do not use if you are allergic to diclofenac or any of the ingredients. If you have ever developed breathing problems, hives, runny nose, or swelling of the face or tongueafter taking/using Asprin or another non-steroidal anti-inflammatory drug. In the last trimester of pregnancy Product Specification Fragrance (contains citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol)

The total systemic clearance of diclofenac from plasma is 263 ± 56 ml/min. The terminal plasma half-life is 1-2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1-3 hours. One metabolite, 3'¬hydroxy-4'-methoxy-diclofenac, has a longer half-life but is virtually inactive. Diclofenac and its metabolites are excreted mainly in the urine. The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium). There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). Twist and remove the plastic seal from the tube. Use the gel as described in this leaflet. Do not use if the seal is broken.Absorption amounts to about 6 % of the applied dose of diclofenac after topical application of 2.5 g diclofenac gel on 500 cm² skin, determined by measuring total renal elimination of diclofenac and its hydroxylated metabolites, compared with the oral administration of diclofenac sodium. Due to a depot-effect in the skin, there is a delayed and prolonged release of active substance into the underlying tissue and the plasma. Under occlusive conditions (10 hours), percutaneous absorption of diclofenac in adults can be increased three-fold (serum concentration).

patients with a history of hypersensitivity reactions, such as asthma, bronchospasmus, urticaria, acute rhinitis or angioedema in response to acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs).No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored. In the event of accidental ingestion , resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicinal products should be used. Gastric lavage and the use of activated charcoal should be considered, especially within a short time of ingestion. g of gel contains diclofenac as 23.2 mg diclofenac diethylamine corresponding to 20 mg of diclofenac sodium. When the gel is applied on large areas of skin and over a prolonged period, the possibility of systemic undesirable effects (e.g. renal, hepatic or gastrointestinal undesirable effects, systemic hypersensitivity reactions) – as they occur possibly after systemic administration of diclofenac-containing medicinal products cannot be excluded.