Luan Gel 1% 100 g gel

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

• LUAN 2.5% gel: Facilitates endourethral maneuvers (introduction of catheters, dilations, cystoscopies, etc.) by combining the lubricating and anesthetic action. • LUAN 1% gel: Esophagoscopic intubations and for curative anesthesia, pharyngoscopies, tracheo-bronchoscopies, gastroscopies and rectoscopies, and in all endoscopic indications of an exploratory and curative nature. The product, combining the lubricating action with the anesthetic action, allows spastic reactions and reflexes starting from the mucous membranes with which the instruments come into contact during endoscopic maneuvers to be avoided.

CONTRAINDICATIONS

Hypersensitivity to amide-type local anesthetics or to any of the excipients.

WARNINGS AND PRECAUTIONS FOR USE

The effectiveness and safety of lidocaine depend on correct dosage and application technique. It is therefore necessary to use the minimum quantity of the preparation sufficient to obtain the desired effect and avoid application for very prolonged periods. LUAN must be used with caution in patients with severely damaged mucous membranes or the site of inflammatory processes or sepsis in the region in which the application is to be carried out as there could be excessive absorption of the active ingredient. High absorption of lidocaine can cause serious reactions in the CNS. and the cardiovascular system in particular in children, the elderly and debilitated subjects (see paragraph 4.2). Products for topical application, especially if used for a long time or repeatedly, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute suitable therapy. Information on some excipients of LUAN The medicine contains sodium benzoate: it can be slightly irritating to the skin, eyes and mucous membranes. The medicine contains parahydroxybenzoates: it can cause allergic reactions, even delayed ones.

INTERACTIONS

Propranolol prolongs the plasma half-life of lidocaine. Cimetidine may increase plasma levels of lidocaine.

SIDE EFFECTS

Locally, hypersensitivity reactions characterized by pain, burning and itching may occur. Systemic reactions are generally rare. However, hypersensitivity reactions up to anaphylactic shock may occur. In the presence of irritated or damaged skin, the risk of systemic absorption and toxicity increases. The treatment of large areas and/or the use of high doses or the increase in body temperature may increase the risk of systemic absorption and a potential increase in toxicity. 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/it/responsabili.