Ortodermina lidocaine anesthetic cream 5% 10g 005556028

ORTHODERMINE * CREAM 10G 5%

Therapeutic indications

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

Dosage and method of use

Apply the cream on the injured part in an appropriate manner; if the skin shows tears, it is recommended to spread the cream using a sterile gauze pad. In dentistry, in the anesthesia of the mucous membrane of the oral cavity, dry the latter with a cotton swab and with a saliva ejector in order to minimize the dilution of the cream and favor the maximum absorption of lidocaine. When adapting a new denture, spread the cream on the surface in contact with the mucosa (Important: the settling period). In case of anorectal itching, to facilitate administration, it is possible to use the applicator cannula (included in the 3 g pack). The daily application should not exceed 35 g of cream.

Contraindications

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

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 impaired tolerance. Cardiovascular depression and nervous excitement may occur in these cases followed by sedation with drowsiness or loss of consciousness. In such cases it is necessary to take the appropriate emergency measures. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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-sospetta-reazione-avversa

Special warnings

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

Pregnancy and breastfeeding

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

Expiration and retention

Not necessary.

Interactions with other drugs

There are no known interactions with other substances.

Overdose

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

Active principles

100 g of cream contain 6.15 g of Lidocaine hydrochloride, equal to Lidocaine base 5 g. 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.