PHARMACOTHERAPEUTIC CATEGORY Non-steroidal anti-inflammatory drugs for topical use.
ACTIVE PRINCIPLES Flufenamic acid (N- [alpha, alpha, alpha-trifluoro-m-tolyl] -anthanilic acid) 3 g, ethylene glycol monosalicylate 2.64 g (corresponding to salicylic acid 2 g), glycosaminoglycanopolysulphate 0.2 g (PM 20000-30000 ).
EXCIPIENTS Mono-di-glycerides of fatty acids; sodium salts of sulphonated fatty alcohols; triglycerides of vegetable fatty acids; myristic alcohol; aluminum and magnesium silicate; hydrochloric acid 25%; sorbic acid; isopropanol; rosemary oil; lemon balm oil; purified water to taste 100g.
INDICATIONS Symptomatic treatment of: painful, inflammatory and degenerative localized diseases of the musculoskeletal and support systems, muscles, tendons, ligaments, joints, spinal column, intervertebral discs and soft parts; muscle tension, motor pain, lumbago, cervical stiffness, neuralgia, sciatica.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity 'to salicylates or to any of the excipients. Do not apply the cream to mucous membranes, burns, infections or other dermatoses. Do not apply to babies and children.
DOSAGE Unless otherwise prescribed by the doctor, apply a 5-10 cm drop of cream several times a day and massage lightly. To achieve an optimal therapeutic result, use the product regularly during treatment, if necessary even for a prolonged period of time.
STORAGE There are no particular methods of conservation.
WARNINGS Wash your hands thoroughly after applying the cream. In case of chronic use, skin reactions may occur. Avoid intense exposure of the treated areas to sunlight. Avoid chronic use or application on large skin areas in case of renal disease and in particular in case of renal insufficiency. Prolonged application of the cream on extensive skin areas can 'cause an increase in systemic absorption and requires caution (risk of salicylism, especially in patients with renal insufficiency). The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
INTERACTIONS Chronic use of the cream on large areas can lead to an increase in the toxicity of methotrexate and the hypoglycemic effect of sulfonylureas.
SIDE EFFECTS Skin and subcutaneous tissue disorders: it is possible that any of the components of the cream cause an allergic reaction. Rare: hypersensitivity reactions may occur in the form of skin irritation or erythema. Itching, skin rashes and photosensitivity reactions may occur. These symptoms usually resolve upon discontinuation of treatment, indicated in such cases. Gastrointestinal disorders / general conditions: if the cream has been applied to large areas for a long period of time it is possible that side effects affecting an organ or the whole system may occur, as has also been observed following the systemic administration of medicinal products containing flufenamic acid and salicylic acid (including gastrointestinal symptoms, nausea, headache, dizziness and general malaise). Consider these symptoms and discontinue treatment if they persist.
PREGNANCY AND BREASTFEEDING The product should be used only in case of actual need under the direct supervision of the doctor and limited to short periods of treatment.
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