“Directions
Cerotto Bertelli is a medicated plaster used in the treatment of: lumbago, muscle strains, intercostal neuralgia and painful conditions of rheumatic nature.
Excipients
Arnica essence, olibanum, natural gum, iron oxide, steibelite resin, steibelite ester 3, hercolin, iris rhizome, methyl p-hydroxybenzoate, 2,2′ methylene-bis-(4 methyl-6 tert-butylphenol), castor oil (excipient of the herbal preparation).
Method of administration and dosage
Dosage Adults: The recommended dose is 1 medicated plaster per day, which should be applied to the affected area and left on for at least 4-12 hours. At least 12 hours should pass before applying a new plaster to the same area. Do not exceed the maximum recommended daily dose. Paediatric population The safety and efficacy of Cerotto Bertelli in children and adolescents have not been established. No data available. Method of administration: Topical application. Apply to dry skin and massage gently. Duration of treatment Apply for a short period. Long-term use should be determined after adequate clinical assessment.
Warnings
It is recommended to remove Cerotto Bertelli with a cotton pad soaked in warm water or olive oil. The product should not be applied to mucous membranes or in the eye area. During treatment, avoid using additional heat sources (e.g. solar or infrared radiation, heating pad or hot water). The effect of heat may also be increased by physical activity (sweating). Treatment should be discontinued if the thermal effect becomes excessive. In this case, the patch should be removed. If symptoms worsen while taking the product, consult a doctor or pharmacist.
Contraindications
Hypersensitivity to the active substance or other sources of capsaicinoids (e.g. peppers or chili plants). Damaged skin, wounds and eczema.
Side effects
Use of the topical product, especially long-term, may lead to sensitization phenomena. The active ingredient causes an increase in local blood circulation, causing pronounced reddening of the skin and a feeling of warmth. This reaction is part of the normal pharmacological action of the drug and usually disappears shortly after removing the patch. In rare cases (≈1/10,000, <1/1,000): increased skin sensitivity and allergic reactions (e.g. urticaria, vesicles and blisters at the site of application) may occur. In these cases, treatment must be stopped immediately. Particularly in the first days of treatment, a feeling of irritation or itching may occur. If in individual cases the side effects are excessive, treatment should be stopped. Reporting suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of a medicinal product is important. It allows for continuous monitoring of the benefit/risk balance of the medicinal product.
Composition
Active ingredients
One medicinal patch contains: Active substance: 50.3 mg purified and titrated oleoresin of capsicum, obtained from dried ripe fruits of Capsicum annuum L. var. min. Miller’s (Heiser’s) or Capsicum frutescens L., corresponding to 6.3 mg (32 μg/cm²) of capsaicinoids, expressed as capsaicin. Extraction solvent: ethanol minimum 90% v/v.”
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