ACTION AND MECHANISM Ibuprofen is a non-steroidal anti-inflammatory drug (ANSI) and analgesic that works by preventing the synthesis of prostaglandins and other prostanoids through the inhibition of cyclooxygenase, which is involved in inflammatory processes. SPECIAL WARNINGS - If symptoms persist for more than 7 days or irritation or worsening occurs, the patients clinical condition should be evaluated. - Sun exposure of the treated area may cause photosensitivity. PATIENT ADVICE - Avoid contact with eyes and mucous membranes. - Do not use with occlusive dressings or apply simultaneously to the same area as other topical preparations. - Do not use for prolonged periods or on large areas. - Use only on intact skin, not on open wounds, mucous membranes, or eczematous skin. - Do not expose the treated area to sunlight. - Wash hands after each application. CONTRAINDICATIONS - Hypersensitivity to ibuprofen or any of the components of this medicine. - [NSAID ALLERGY], [SALICYLATE ALLERGY]: Although local administration minimizes the risks associated with systemic use, prolonged topical application to large areas of skin, open wounds, mucous membranes, or eczematous skin, with occlusive dressings, can cause systemic effects. Therefore, it is important to remember that its use is not recommended in patients who have experienced allergic reactions (rhinitis, asthma, pruritus, angioedema, urticaria, shock, or others) caused by acetylsalicylic acid or other NSAIDs due to the possibility of cross-sensitivity. -Third trimester of pregnancy -Do not use on sunburns. ADVANCED AGE No specific problems have been described in the elderly that would require a dosage adjustment. PREGNANCY Animal safety: no teratogenic effects were detected in toxicity studies conducted on animals. Safety in humans: Adequate and well-controlled studies in humans are not available. Systemic ibuprofen is not indicated during pregnancy, especially during the third trimester, as it inhibits prostaglandin synthesis and may cause dystocia, interfere with or delay labor, as well as premature closure of the ductus arteriosus. Although systemic absorption is very low, its administration is only acceptable if there are no safer therapeutic alternatives and the benefits outweigh the potential risks. Effects on fertility: no specific studies have been conducted in humans. INDICATIONS - Local symptomatic relief of painful or inflammatory conditions of traumatic or degenerative origin of the joints, tendons, ligaments and muscles ([ARTHRITIS], periarthritis, [CAPSULITIS], arthrosynovitis, [TENOSYNOVITIS], [BURSITIS], sprains, meniscal injuries of the knee, [MUSCLE CONTRACTURE], [TENDINITIS], [CONTUSION], [SPRAIN], [LUMBALGIA], [TORTICOLLIS], [MYALGIA], [DISLOCATION]). INTERACTIONS They have not been described in cutaneous use, since very low systemic concentrations of the drug are reached, but it will be assessed whether it should be used in conjunction with other topical analgesics. LACTATION Animal safety: no data available. Safety in humans: The concentrations of ibuprofen that reach breast milk are very low and it is not expected to produce adverse reactions in infants when administered topically. Therefore, it can be used during breastfeeding. GUIDELINES FOR PROPER ADMINISTRATION For cutaneous use only, external use. Apply the solution with a light and prolonged massage to the area to be treated. Hands should be washed thoroughly after each application, unless they are the area being treated. POSOLOGY One application (1 to 3 seconds), 3 or 4 times a day. The duration of treatment is limited to 7 days (5 days in the case of adolescents). PRECAUTIONS - [ASTHMA]: Asthmatic patients are more likely than other patients to develop hypersensitivity reactions to acetylsalicylic acid and other NSAIDs. Severe adverse skin reactions have been identified, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Most of these reactions occurred during the first month of treatment. If signs and symptoms suggestive of these reactions appear, treatment should be discontinued immediately. PRECAUTIONS RELATING TO EXCIPIENTS - Because it contains benzyl alcohol, it should not be administered to premature infants or newborns. Doses of benzyl alcohol exceeding 90 mg/kg/day can produce fatal toxic reactions in children under 3 years of age, so it is recommended to avoid exceeding these doses. Doses of benzyl alcohol below 90 mg/kg/day can cause anaphylactoid and toxic reactions in children under three years of age. ADVERSE REACTIONS - Moderate local erythema (0.1%-1%), dermatitis, skin irritation, pruritus (0.1%-1%), and a sensation of skin irritation may occur at the application site, which disappear upon discontinuation of treatment. - Photosensitivity reactions may occur (0.01%-0.1%). - If symptoms appear for which no justification can be found, treatment should be discontinued and the patients clinical condition reassessed. - Prolonged topical administration to large areas of skin, open wounds, mucous membranes, or eczematous skin, as well as the use of occlusive dressings, may cause the appearance of systemic adverse reactions typical of NSAIDs. OVERDOSE - Symptoms: Due to its external use, poisoning is unlikely. In case of accidental ingestion, overdose symptoms will be systemic adverse reactions that will depend on the dose ingested and the time elapsed since ingestion. - Treatment: If accidental ingestion occurs, gastric lavage and symptomatic therapy will be administered.