Ortodermina 5% 50 g cream

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Anesthetic of the accessible mucous membranes of the oro-pharyngeal cavity, anorectal itching. Anesthetic in case of minor skin lesions.

ACTIVE INGREDIENTS

100 g of cream contains 6.15 g of Lidocaine hydrochloride, equal to 5 g Lidocaine base. Excipients with known effects: cetostearyl alcohol, Methyl p-hydroxybenzoate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Cetostearyl alcohol, Macrogol cetostearyl ether, Vaseline oil, White stringy Vaseline, Methyl p-hydroxybenzoate, Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Apply the cream on the injured part appropriately; if the skin shows lacerations, it is recommended to spread the cream using a sterile gauze pad. In dentistry, during anesthesia of the mucosa of the oral cavity, dry the latter with a cotton ball and with a saliva ejector in order to minimize the dilution of the cream and promote maximum absorption of the lidocaine. When fitting a new denture, spread the cream on the surface in contact with the mucosa (Important: the settling-in period). In case of anal-rectal itching, to facilitate administration, it is possible to use the applicator cannula (included in the 3 g package). Daily application must not exceed 35 g of cream.

CONSERVATION

Not necessary.

WARNINGS

ORTODERMINA must be used with caution by those subjects who have particularly traumatized mucosa and sepsis in the region intended for application of the cream. In any case, the safety of use depends on the dosage, correct application technique and the adoption of precautionary measures. The product should be used at the minimum effective dose, appropriately reducing the dose in relation to age and physical condition in children, the elderly and acutely ill patients.

INTERACTIONS

There are no known interactions with other substances.

SIDE EFFECTS

Local and general allergic reactions up to anaphylactoid manifestations may occur with the use of lidocaine. The appearance of systemic signs is rare and is due to excessive dosage, rapid absorption, hypersensitivity or reduced tolerance. In these cases, cardiovascular depression and nervous excitation may occur followed by sedation with drowsiness or loss of consciousness. In such cases it is necessary to take appropriate emergency measures. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa

OVERDOSE

Excessive dosage, rapid absorption and hypersensitivity or reduced tolerance cause the appearance of cardiovascular depression and nervous excitation followed by sedation with drowsiness or loss of consciousness. In such cases it is necessary to take appropriate emergency measures.

PREGNANCY AND BREASTFEEDING

In pregnant women and in early childhood, the product must be used only in case of actual need and under direct medical supervision.

EFFECTS ON DRIVING ABILITY

Not applicable.