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

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possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. if you are allergic to diclofenac or any of the other ingredients of this medicine listed in the ingredients tab, 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– During the first and second trimester of pregnancy, diclofenac should not be used unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium).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 suffer from asthma, hay fever, swelling of the nasal membrane (so-called nasal polyps)or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with hay fever-like symptoms) or hypersensitivity to other painkillers and anti-rheumatic medicines of any kind. 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 hives. 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). There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3)

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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.

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. 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. There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3). 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 required. Because of the potential undesirable effect profile, elderly people should be carefully monitored.

Tell your doctor or pharmacist if you are taking, have recently taken or might take/use any other medicines. In intended, cutaneous use of Motusol Max no interactions have become known so far. 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 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.