ACTION AND MECHANISM Rubefacient. The main component of Capsicum frutescens is capsaicin, which, when applied topically, triggers local irritation and hyperalgesia, a burning sensation with itching and erythema. This effect is attributed to a process of selective excitation of the afferent neurons of the sensory C fibers, causing the release of substance P and other neuropeptides. Repeated application leads to long-lasting desensitization to pain, increasing the pain threshold. This effect is reversible. PATIENT ADVICE PATIENT ADVICE - It is recommended not to scratch or rub the application area to avoid skin damage. - Avoid applying other heat sources during treatment, as it should be discontinued if excessive heat is felt. - It is advisable to consult a specialist before starting treatment if the pain is accompanied by skin redness, swelling or heat in the joints, persistent joint discomfort, severe back pain radiating to the legs, whether or not associated with neurological syndromes such as numbness and tingling. CONTRAINDICATIONS Hypersensitivity to the active ingredient, other sources of capsaicinoids or to any of the excipients. PREGNANCY Category B. There are no conclusive animal data on the safety of capsaicin during pregnancy. Prenatal and neonatal effects of capsaicin occurred at doses much higher than those recommended; therefore, it should only be used after a benefit-risk assessment. INDICATIONS - [MYALGIA]: local treatment, such as [LUMBALGIA]. LACTATION There is no data to support its safety during breastfeeding, therefore this medication should only be used during breastfeeding after consulting a doctor. CHILDREN Safety and efficacy have not been evaluated in children under 12 years of age, so the use of capsaicin is not recommended. GUIDELINES FOR PROPER ADMINISTRATION - Apply to dry, unbroken skin. - A minimum interval of 12 hours should elapse before applying a new dressing to the same area. If necessary, and if pain persists, apply one dressing for up to 7 days of treatment. - The application area must be clean and free of any previously used product. - Do not apply to broken skin or wounds, or near the eyes or mucous membranes. POSOLOGY DOSAGE: - Adults, topical: 1 patch/24 h directly on the painful area, at least 4 h up to a maximum of 8 h. - Children: Due to a lack of experience in children under 12 years of age, its use is not recommended. ADVERSE REACTIONS It usually causes hyperemia with pronounced erythema, which is part of the normal pharmacological action of the treatment and usually subsides after removal of the dressing. If during the first few days of treatment these stinging sensations (and/or itching or tingling) seem excessive, the treatment should be discontinued. - Allergic/dermatological: Rare (0.01-0.1%): [HYPERSENSITIVITY REACTIONS] of the skin such as [URTICARIA] or blistering.