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

Product Information

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.

Diclofenac preferentially distributes and persists in inflamed tissue. It is found in concentrations up to 20 times higher than in plasma. 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.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 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.

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. 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. 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. 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.possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

The maximum daily dose is 16 g of gel corresponding to 185.6 mg of diclofenac, diethylamine salt (corresponding to 160 mg diclofenac sodium). For adults and adolescents aged 14 years and over. Do not use if you are allergic to diclofenac or any of the ingredients. If you have ever developed breathing problems, hives, runny nose, or swelling of the face or tongueafter taking/using Asprin or another non-steroidal anti-inflammatory drug. In the last trimester of pregnancy Product Specification Motusol Max contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). 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:

The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice. 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. Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity. 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). 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.

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 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. No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored. If you experience any of the following signs of allergy, stop using Motusol Max and tell a doctor or pharmacist immediately.For adults and adolescents aged 14 years and over For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma. 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. 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. 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. 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.