Active ingredients: Lidocaine (Lidocaine hydrochloride)
LUAN 2.5% gel
Luan package inserts are available for pack sizes:- LUAN 2.5% gel
- LUAN 1% gel
Indications Why is Luan used? What is it for?
Luan contains the active substance lidocaine hydrochloride which belongs to a group of medicines called local anesthetics which block the sensation of pain in the area where they are applied.
Luan is indicated to facilitate endourethral maneuvers, such as: the introduction of catheters into the urethra; dilations and examinations of the bladder (cystoscopy) for exploratory and curative purposes.
Contraindications When Luan should not be used
Do not use Luan if:
- you are allergic to lidocaine hydrochloride, to similar substances (local anesthetics of the amide type) or to any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Luan
Talk to your doctor or pharmacist before using Luan.
This medicine should be used in the minimum amount necessary to achieve the desired effect and should be avoided the application for long periods of time, because allergic reactions (sensitization phenomena) can occur. In this case, it is recommended to stop the treatment and inform the doctor who will prescribe a suitable therapy.
This medicine should be used with caution if in the application area:
- has severely damaged or inflamed mucous membranes;
- have a severe infection (sepsis) of the mucous membranes.
In these cases, in fact, an excessive amount of lidocaine can pass into the blood and cause serious disorders of the nervous system (CNS), heart and circulation (cardiovascular system), especially in children, the elderly and debilitated people (see the paragraph "Possible side effects").
Interactions Which drugs or foods can change the effect of Luan
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Use Luan with caution if you are taking the following medicines as they may increase the effects of lidocaine:
- propranolol, used to treat high blood pressure;
- cimetidine, used to treat stomach upset.
Warnings It is important to know that:
Children
This medicine should be used with caution in children, especially if there is damage, inflammation or severe mucosal infection at the site of application.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Luan contains para-hydroxybenzoates and sodium benzoate
This medicinal product contains para-hydroxybenzoates which may cause allergic reactions (including delayed). Luan contains sodium benzoate, which is mildly irritating to the skin, eyes and mucous membranes.
Dose, Method and Time of Administration How to use Luan: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Luan will be administered directly into the urethra by squeezing the tube and applying urethral forceps for 10 minutes after which the desired endourethral maneuvers can be performed. The contents of the tube are sufficient to completely fill the urethra.
To facilitate the introduction of the medicine and avoid the pain caused by direct contact with the metal parts of the tube, at the moment of use it is possible that the plastic applicator present in the package is screwed onto the tube.
This medicine should be used with caution if you have damaged mucous membranes or a severe infection (sepsis) (See section "Warnings and precautions").
Overdose What to do if you have taken too much Luan
If you are given too much of this medicine you may experience the following symptoms:
- tremors and convulsions followed by depression (neuroexcitatory manifestations), severe breathing problems (respiratory failure) and profound unconsciousness (coma);
- heart and circulation problems (cardiovascular changes) with low blood pressure (hypotension) and slow heart beat (bradycardia).
Your doctor will decide which therapy is best for you, based on the severity of your symptoms. If you are concerned that too much medicine may have been used, tell your doctor immediately.
Side Effects What are the side effects of Luan
Like all medicines, Luan can cause side effects, although not everybody gets them.
The side effects that can occur are listed below:
- allergic (hypersensitivity) reactions at the application site, characterized by pain, burning and itching;
- severe allergic reaction (anaphylactic shock).
When the medicine is applied to irritated or broken skin, over large areas of the body, at high doses or in the presence of fever, the risk of side effects and toxic effects affecting the whole body (systemic) increases. (See the section "Warnings and precautions").
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP".
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other_information "> Other information
What Luan contains
- The active ingredient is lidocaine hydrochloride. 100 g of gel contains 2.5 g of lidocaine hydrochloride.
- The other ingredients are: carmellose sodium, glycerol, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate, purified water.
Description of what Luan looks like and contents of the pack
Pack containing one aluminum tube with screw cap of 15 g of gel with plastic applicator.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
LUAN GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
LUAN 2.5% gel
100 g contain:
Lidocaine hydrochloride g 2.5
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 g 1
Excipients: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM -
Gel
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
• LUAN 2.5% gel:
It facilitates endourethral maneuvers (introduction of catheters, dilations, cystoscopies, etc.) by combining the lubricating action with the anesthetic action.
• LUAN 1% gel:
Esophagoscopic intubations and for curaric anesthesia, pharyngoscopies, tracheo-bronchoscopies, gastroscopies and rectoscopies, and in all endoscopic indications of an exploratory and curative nature.
By associating the lubricating action with the anesthetic action, the product avoids spastic reactions and reflexes originating from the mucous membranes with which the instruments come into contact during endoscopic maneuvers.
04.2 Posology and method of administration -
LUAN 2.5% gel
Push the ointment directly into the urethra by squeezing the tube and massaging the posterior urethra at the same time, applying urethral forceps for 10 minutes, after which the desired endourethral maneuvers can be performed. The contents of the tube are sufficient to completely fill the urethra.
In order to facilitate the introduction of the drug 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 equipped with a plastic extension to be screwed to the tube itself at the moment 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 the various types of intubations do not cloud. their rubber parts do not deteriorate.
LUAN should be used with caution in patients with severely damaged mucous membranes and sepsis in the region to which it is to be applied.
Caution in children, the elderly and seriously ill patients (see also section 4.4 Special warnings and precautions for use).
04.3 Contraindications -
Hypersensitivity to amide-type local anesthetics or to any of the excipients.
04.4 Special warnings and appropriate precautions for use -
The efficacy and safety of lidocaine depend on a correct dosage and application technique. Therefore, the minimum quantity of the preparation sufficient to obtain the desired effect and avoid application for very prolonged periods should be used. with caution in patients with severely damaged mucous membranes or site of inflammatory processes or sepsis in the region where the application is to be carried out as there could be an excessive absorption of the active ingredient. A high absorption of lidocaine can cause severe reactions to the S.N.C. and of the cardiovascular system in particular in children, the elderly and debilitated subjects (see section 4.2).
Products for topical application, especially if used for a prolonged time or repeatedly, can give rise to sensitization phenomena. In this case, treatment must be interrupted and appropriate therapy instituted.
Information about some of the ingredients of LUAN
The medicine contains sodium benzoate: it can be mildly irritating to the skin, eyes and mucous membranes.
The medicine contains parahydroxybenzoates: it can cause allergic reactions, even delayed ones.
04.5 Interactions with other medicinal products and other forms of interaction -
Propranolol prolongs the plasma half-life of lidocaine.
Cimetidine can raise the plasma levels of lidocaine.
04.6 Pregnancy and breastfeeding -
Studies in rats and rabbits revealed no risk to the fetus. However, its safety in men has not been established. This should be borne 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.
04.7 Effects on ability to drive and use machines -
LUAN does not affect the ability to drive or use machines.
04.8 Undesirable effects -
Locally, hypersensitivity reactions characterized by pain, burning, itching can occur. Systemic reactions are usually rare. However, hypersensitivity reactions up to anaphylactic shock may occur.
In the presence of irritated or broken skin, the risk of systemic absorption and toxicity increases.
The treatment of large areas and / or the use of high dosages 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 of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 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. Seizures can be controlled by administering short-acting barbiturates or benzodiazepines.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Lidocaine is a surface local anesthetic that works by blocking the sensitive nerve endings of the skin and mucous membranes.
05.2 "Pharmacokinetic properties -
G04BX - Other urologicals (Luan 2.5% gel)
N01BB02 - Local anesthetics, starches, lidocaine (Luan 1% gel)
Lidocaine can be absorbed through the mucous membranes. 50 ml of 2% lidocaine gel can be used for urethral anesthesia, although other authors recommend not using more than 15 ml.
Lidocaine is metabolised in the liver with the formation of various metabolites including renally eliminated monoethylglycinxylidide and glycinxylidide. The apparent volume of distribution is approximately 1.3 liters / kg, the plasma protein binding is 40-80%, the plasma half-life is approximately 100 minutes.
05.3 Preclinical safety data -
Acute toxicity:
LD50 in mice: 278 mg / kg s.c .; 27 mg / kg i.v.
LD50 in rats: 469 mg / kg s.c .; 167 mg / kg i.p.
Subchronic toxicity:
Epicutaneous treatment with 10% Luan ointment for 6 days a week for 4 weeks did not cause any systemic toxic effect or histological changes in the skin.
Prolonged use may cause sensitization.
06.0 PHARMACEUTICAL INFORMATION -
06.1 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.
06.2 Incompatibility "-
Lidocaine hydrochloride causes the precipitation of amphotericin. In solution, lidocaine hydrochloride (2g / L) forms a precipitate when mixed with sodium methohexitone (2 g / L) and a crystalline precipitate with sodium sulfadiazine (4 g / L).
06.3 Period of validity "-
5 years
06.4 Special precautions for storage -
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
LUAN 2.5% gel
Aluminum tube with closed tip and screw cap, internally coated with a plastic film, contained in a cardboard box. The package includes a plastic applicator.
LUAN 1% gel
Painted aluminum tube, internally coated with a plastic film, with closed tip and screw cap, contained in a cardboard box.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
L. Molteni & C. dei F.lli Alitti Company of Exercise S.p.A., Strada Statale 67, locality Granatieri, 50018 Scandicci (Florence)
08.0 MARKETING AUTHORIZATION NUMBER -
005638010 2.5% gel, 15 g tube + applicator
005638022 1% gel, tube of 100 g
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
1951 / February 2012
10.0 DATE OF REVISION OF THE TEXT -
December 2015
