If you experience any of the following signs of allergy, stop using Motusol Max and tell a doctor or pharmacist immediately. 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. if you are allergic to diclofenac or any of the other ingredients of this medicine listed in the ingredients tab,

When diclofenac is applied to the skin as a gel (or a patch), instead of it having an effect on all of your body, it only works on the area that you have applied it to. It is absorbed into your skin and then moves deeper into areas of your body where there is inflammation (for example, your muscle). Using a topical product means that the total amount of diclofenac in your body remains low. This in turn means that you are much less likely to have a side-effect to the medicine. There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). Do not use this medicine in children and adolescents under 14 years of age (see warnings sections).

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. 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. 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. 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.

Diclofenac gel may cause your skin to become more sensitive to sunlight than normal. Do not use sunbeds, and protect any treated areas from strong sunlight until you know how your skin reacts. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2) 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. 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. 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. 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. possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. 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 duration of use depends on the symptoms and the underlying disease. Motusol 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). 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. 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),

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Do not use Motusol Max during the last trimester of pregnancy as it could harm your unborn child or cause problems at delivery. If you are planning a pregnancy or during the first and second trimester of pregnancy, Motusol Max should be used only after consultation with your doctor. Breast-feeding 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–

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.

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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 systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended: Biotransformation of diclofenac involves partly glucuronidation of the intact molecule, but mainly single and multiple hydroxylation resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of the phenolic metabolites are biologically active, however, to a much smaller extent than diclofenac. 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. Motusol Max should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. Do not apply Motusol Max on the breasts if you are a nursing mother nor elsewhere on large areas of skin or for a prolonged period of time.