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

Product Information

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 occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms.

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 Diclofenac is a potent non-steroidal anti-inflammatory drug. It develops its therapeutic efficacy mainly via inhibition of prostaglandin synthesis by cyclooxygenase 2 (COX-2). Diclofenac has proven to be effective via the prostaglandin synthesis inhibition in the conventional animal-experiment inflammation models. In humans, diclofenac reduces inflammatory-related pain, swellings and fever. Furthermore, diclofenac inhibits reversibly the ADP and the collagen-induced thrombocyte aggregation.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. 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.

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 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. 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.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. 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. The duration of use depends on the symptoms and the underlying disease. Motusol should not be used longer than 1 week without medical advice. 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. 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.

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. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2) 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.Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2) No special dose adjustment is required. Because of the potential undesirable-effect profile, elderly people should be carefully monitored.