on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes; When Motusol Max is applied to a large area of skin and over a prolonged period, the possibility of systemic side-effects from the application of Motusol Max cannot be excluded. The gel should therefore be used with caution by patients with reduced kidney function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum. Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect up to 1 in 10,000 people). There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3).

Undesirable effects similar to those observed following an overdose of systemic diclofenac can occur if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1,160 diclofenac diethylamine corresponding to 1,000 mg diclofenac sodium). g of gel contains diclofenac as 23.2 mg diclofenac diethylamine corresponding to 20 mg of diclofenac sodium.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). Diclofenac preferentially distributes and persists in inflamed tissue. It is found in concentrations up to 20 times higher than in plasma. Diclofenac is used for short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma

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. 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. PregnancyWhen 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. 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. Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist if you are allergic to diclofenac or any of the other ingredients of this medicine listed in the ingredients tab, 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.

Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity. g of gel contains 54 mg of propylene glycol (E1520), 0.2 mg butylhydroxytoluene (E321) and 1 mg fragrance (contains 0.15 mg benzyl alchohol (E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, linalool). shoppingListJS = new ShoppingListJS({storeId: '11352',catalogId: '28501',langId: '-1'}, {id: '2709733', name: 'Motusol Max 2.32% w/w Gel 50g', image: '', type: 'ItemBean', components: {}, skus: []}, {}, "shoppingListJS"); If you experience any of the following signs of allergy, stop using Motusol Max and tell a doctor or pharmacist immediately. 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.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. 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) 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.Topical diclofenac may be used with a non-occlusive bandages but not with an airtight occlusive dressing (see section 5.2). 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. In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicinal products should be used. Gastric lavage and the use of activated charcoal should be considered, especially within a short time of ingestion. 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.