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.

Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect up to 1 in 10,000 people). on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes, Unscrew the cap from the tube. To open the safety seal of the tube, reverse the cap and engage with the nozzle. Do not use scissors or other sharp objects! The maximum daily dose is 8 g of gel corresponding to 185.6 mg of diclofenac, diethylamine (corresponding to 160 mg diclofenac sodium). No special dose adjustment is required. Because of the potential undesirable-effect profile, elderly people should be carefully monitored.

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There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3) The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice. Precautions should be taken to prevent children from touching the area to which the gel is applied. Topical diclofenac may be used with a non-occlusive bandages but not with an airtight occlusive dressing (see section 5.2). Diclofenac preferentially distributes and persists in inflamed tissue. It is found in concentrations up to 20 times higher than in plasma.

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). The occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms. possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2)

It is important that you don't cover any area of skin treated with the gel with any dressings or bandages. This is because more diclofenac may be absorbed by your skin than is intended, and this could lead to unwanted effects. 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. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre-and post-implantation loss and embryofetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2) 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.