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

Product Information

The duration of use depends on the symptoms and the underlying disease. Motusol Max should not be used longer than 1 week without medical advice. 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. 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. Pharmacotherapeutic group: Topical products for joint and muscular pain; Anti-inflammatory preparations, non-steroids for topical use If you experience any of the following signs of allergy, stop using Motusol Max and tell a doctor or pharmacist immediately.

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. 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. 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).

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The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium). possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

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). When Motusol Max is applied to a large area of skin and over a prolonged period, the possibility of systemic side-effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) - as they occur possibly after systemic administration of diclofenac-containing medicines cannot be completely excluded. 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. Motusol Max contains fragrances This medicine 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. In addition, benzyl alcohol may cause mild local irritation.

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Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2) Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect up to 1 in 10,000 people). 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 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–