Motusol Max 2.32% w/w Gel 30g – Targeted Pain Relief of Joints & Muscles in Acute strains & sprains

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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. 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.

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.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. Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect up to 1 in 10,000 people). 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 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: 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).

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.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 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)

In these patients, Motusol 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. 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. 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. If you experience any of the following signs of allergy, stop using Motusol Max and tell a doctor or pharmacist immediately. Diclofenac preferentially distributes and persists in inflamed tissue. It is found in concentrations up to 20 times higher than in plasma.

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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 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium). In animal studies on reproductive toxicity, systemically administered diclofenac caused inhibition of ovulation in rabbits and impairment of implantation and early embryonic development in rats. Gestation and duration of parturition were prolonged by diclofenac. The embryotoxic potential of diclofenac was investigated in three animal species (rat, mouse, rabbit). Fetal death and growth retardation occurred at materno-toxic dose levels. Based on the available non-clinical data, diclofenac is regarded as being non-teratogenic. Doses below the maternotoxic threshold had no impact on the postnatal development of the offspring. There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3).