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. 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! No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored. Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity. 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.

Diclofenac preferentially distributes and persists in inflamed tissue. It is found in concentrations up to 20 times higher than in plasma. If you experience any of the following signs of allergy, stop using Motusol Max and tell a doctor or pharmacist immediately. Precautions should be taken to prevent children from touching the area to which the gel is applied.

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Do not use a double dose to make up for a forgotten application. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Topical diclofenac may be used with a non-occlusive bandages but not with an airtight occlusive dressing (see section 5.2). 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. cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); 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. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2)

Do not use this medicine in children and adolescents under 14 years of age (see warnings sections). 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. 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. 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. The maximum daily dose is 8 g of gel corresponding to 185.6 mg of diclofenac, diethylamine (corresponding to 160 mg diclofenac sodium).