Motusol Max 2.32% w/w Gel 30g – Targeted Pain Relief of Joints & Muscles in Acute strains & sprains

Product Information

The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium).

This medicinal product contains fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions. There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). 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).

There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). year toxicity study, a dose-dependent increase in the incidence of thrombosis of the heart was observed in diclofenac-treated rats. No special dose adjustment is necessary. If you are elderly, you should pay special attention to side effects and, if necessary, consult a doctor or pharmacist. 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.

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. Precautions should be taken to prevent children from touching the area to which the gel is applied. The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice. 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. The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium).

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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. possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. When Motusol Max is applied to a large area of skin and over a prolonged period, the possibility of systemic side-effects from the application of Motusol Max cannot be excluded. The gel should therefore be used with caution by patients with reduced kidney function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.