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CEROTTO BERTELLI 96,5 MG MEDICAL CEROTTOM

active ingredients

A medicated patch contains: active ingredient: 96.5 mg of Capsico oleoresina refined and titulated, with dried ripe fruits Capsicum annuum L. var. minimum Miller (Heiser) or Capsicum frutescens L. varieties with small fruits, corresponding to 12,2 mg (32 mcg/cm2) of capsaicinoids expressed as capsaicin. Extraction solvent: minimum ethanol 90% V/V. For the full list of excipients, see paragraph 6.1.

Excellent

Arnica essence, olibane, natural rubber, iron oxide, resin staybelite, staybelite ester 3, Hercolin, iride rhizome, methyl p-hydroxy-benzoate, 2.2' metilen-bis- (4 metil-6 tertbutylphenol), castor oil (excipient of plant preparation).

Therapeutic indications

Symptomatic treatment of muscle pain such as lombalgia.

Contraindications

Hypersensitivity to the active ingredient or other sources of capsaicinoids (e.g. pepper or chilli plants. Bones, wounds and eczema.

Population

Adult Posology The recommended dose is 1 medicated patch per day to be applied to the affected area and to be maintained for at least 4-12 hours. It must spend at least 12 hours before applying a new patch on the same application area. Do not exceed the recommended maximum daily dose. Pediatric population Cerotto Bertelli’s safety and effectiveness in children and adolescents has not been established. Data is not available. How to administer Skin Use. Apply on dry skin and adhere with a light massage. Duration of treatment Use for a short period. Prolonged use should be established after proper clinical evaluation.

Conservation

Do not store at temperature above 30°C.

Warnings

It is recommended to remove Cerotto Bertelli by using a cotton ball with warm water or olive oil. The medicine should not be applied near the eyes or mucous membranes. During treatment, additional heat sources should be avoided (e.g. solar or infrared radiation, thermal cushion or hot water). The effect of heat can also be intensified by physical activity (sudoration). Treatment should be interrupted if the heat effect is excessive. In this case the plaster must be removed. If symptoms worsen during use of the medicine, consult your doctor or pharmacist.

Interactions

There are no known interactions of any kind with others medicamenti.Non interaction studies have been carried out. The patch is not designed to be applied simultaneously to other topical products [ad es. altri rubefacenti (che aumentano la perfusione e causano arrossamento della cute) o gel antidolorifici] on the same application site. Interactions with other products applied on the same application site may occur even up to 12 hours after removal of the patch.

Effects

The prolonged use of the product for topical use can give rise to awareness-raising phenomena. The active ingredient causes an increase in local blood circulation with marked redness of the skin and a feeling of warmth. This reaction is part of the normal pharmacological action of the preparation and generally attenuates in a short time after the removal of the plaster. In rare cases (≈1/10.000, Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

A relative overdose may be due to inadequate use of the preparation which can determine local irritative phenomena requiring the suspension of the drug and a generic anti-inflammatory treatment.

Contraindications to use are not described during pregnancy and nursing. Pregnancy There is no data on use in pregnant women. Nursing Animal studies have shown toxicity for reproduction after high subcutaneous doses of capsaicin. Capsaicin crosses the placenta and can pass into breast milk. Although prenatal and neonatal effects have occurred at doses exceeding the maximum clinical dose of plaster, the patch must be used during pregnancy and nursing only after careful assessment of the risk-benefit ratio. Fertility There is no fertility data available.

Source: Farmadati