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. In animal studies on reproductive toxicity, systemically administered diclofenac caused inhibition of ovulation in rabbits and impairment of implantation and early embryonic development in rats. Gestation and duration of parturition were prolonged by diclofenac. The embryotoxic potential of diclofenac was investigated in three animal species (rat, mouse, rabbit). Fetal death and growth retardation occurred at materno-toxic dose levels. Based on the available non-clinical data, diclofenac is regarded as being non-teratogenic. Doses below the maternotoxic threshold had no impact on the postnatal development of the offspring

Based on conventional studies on safety pharmacology, genotoxicty and carcinogenic potential, the pre-clinical data do not reveal any specific hazards for humans apart from those already described in other sections of the SPC. In animal studies the chronic toxicity of diclofenac following systemic application mainly manifested as gastrointestinal lesions and ulcers. In a 2-year toxicity study, a dose-dependent increase in the incidence of thrombosis of the heart was observed in diclofenac-treated rats. There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3)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.

If you suffer from asthma, hay fever, swelling of the nasal membrane (so-called nasal polyps)or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with hay fever-like symptoms) or hypersensitivity to other painkillers and anti-rheumatic medicines of any kind. In these patients, Motusol Max may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or hives. Based on conventional studies on safety pharmacology, genotoxicty and carcinogenic potential, the preclinical data do not reveal any specific hazards for humans, apart from those already described in other sections of the SPC. In animal studies, the chronic toxicity of diclofenac following systemic application mainly manifested as gastrointestinal lesions and ulcers. In a 2-year toxicity study, a dose-dependent increase in the incidence of thrombosis of the heart was observed in diclofenac-treated rats. Also contains:isopropyl alcohol, propylene glycol (E1520), cocoyl caprylocaprate, liquid paraffin, carbomer, macrogol cetostearyl ether, diethylamine, oleic acid (E570), butylhydroxytoluene (E321), fragrance (containing citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended: