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. 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! 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). 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). 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.

The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice. After applying the gel on the skin you can use a permeable (non-occlusive) bandage but allow the gel to dry on the skin for a few minutes. Do not use an airtight occlusive dressing. The possibility of systemic undesirable effects from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. The gel should therefore be used with caution by patients with reduced renal function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.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. There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3).

if you are allergic to diclofenac or any of the other ingredients of this medicine listed in the ingredients tab, No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored. Diclofenac preferentially distributes and persists in inflamed tissue. It is found in concentrations up to 20 times higher than in plasma. Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity. 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.

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

The maximum daily dose is 8 g of gel corresponding to 185.6 mg of diclofenac, diethylamine (corresponding to 160 mg diclofenac sodium). 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 embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. No special dose adjustment is required. Because of the potential undesirable-effect profile, elderly people should be carefully monitored.Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2) 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 urticaria. 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. 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. Frequencies are defined as: Very common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1,000 to <1/100); Rare (>1/10,000 to <1/1,000); Very rare (< 1/10,000), Not known (cannot be estimated from the available data).

possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. 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. The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice.if you have ever developed breathing problems (asthma, bronchospasm), hives, runny nose, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g. ibuprofen),