Luan Gel 1% 100 g gel

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

ACTIVE INGREDIENTS

LUAN 2.5% gel 100 g contain: Lidocaine hydrochloride 2.5 g Excipients: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate For the full list of excipients, see section 6.1 LUAN 1% gel 100 g contain: Lidocaine hydrochloride 1 g Excipients: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate For the full list of excipients, see section 6.1

EXCIPIENTS

LUAN 2.5% gel Excipients: carmellose sodium, glycerol, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate, purified water. LUAN 1% gel Excipients: carmellose sodium, glycerol, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

LUAN 2.5% gel Push the ointment directly into the urethra by squeezing the tube and at the same time massaging the posterior urethra, applying urethral forceps for 10 minutes, after which you can practice the desired endourethral maneuvers. The contents of the tube are sufficient to completely fill the urethra. In order to facilitate the introduction of the medicine and to eliminate the pain that can be caused by the contact of the metal tip of the tube with particularly painful parts, the package is accompanied by a plastic extension to be screwed onto the tube itself at the time of use. LUAN 1% gel Carefully spread a layer of product on the instrument before introducing it. The neutrality of the vehicle of both formulations of the product, its complete solubility in water and the absence of fatty substances mean that, even with continued use of LUAN, the lenses of the instruments used for various types of intubations do not fog up and their rubber parts do not deteriorate. LUAN should be used with caution in patients who have severely damaged mucous membranes and sepsis in the region on which the application is to be made. Use caution in children, the elderly and seriously ill patients (see also section 4.4 Special warnings and precautions for use).

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

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.

OVERDOSE

Symptoms of overdose (absolute or relative) are characterized by neuroexcitatory manifestations (tremors, convulsions followed by depression, respiratory failure and coma) and by cardiovascular alterations with hypotension and bradycardia. Treatment is symptomatic. Any seizures can be controlled with the administration of barbiturates or short-acting benzodiazepines.

PREGNANCY AND BREASTFEEDING

Studies on rats and rabbits have not highlighted any risks to the fetus. However, its safety in humans has not been established. This should be kept in mind before administration to pregnant women, particularly in the early stages. Since lidocaine is distributed in breast milk, the use of topical preparations, especially if applied to the tracheobronchial mucosa, must be used with caution in breastfeeding women.

EFFECTS ON DRIVING ABILITY

LUAN does not affect the ability to drive or use machines.