Luan

Patient Information Leaflet: Information for the User

LUAN 2.5% gel

Lidocaine hydrochloride
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Luan is and what it is used for
2. What you need to know before using Luan
3. How to use Luan
4. Possible side effects
5. How to store Luan
6. Contents of the pack and other information

1. What Luan is and what it is used for

Luan contains the active substance lidocaine hydrochloride, which belongs to a group of
medicines called local anaesthetics that block the sensation of pain in the area where
they are applied.
Luan is indicated to facilitate endourethral procedures, such as:
insertion of catheters into the urethra; dilatations and bladder examinations (cystoscopy) for diagnostic and therapeutic purposes.

2. What you need to know before using Luan

Do not use Luan if:

• you are allergic to lidocaine hydrochloride, to similar substances (amide-type local anaesthetics), or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
  Talk to your doctor or pharmacist before using Luan.
  This medicine should be used in the smallest necessary amount to achieve the desired effect, and prolonged application should be avoided, as allergic reactions (sensitization phenomena) may occur. In such cases, treatment should be discontinued and your doctor should be informed so that appropriate therapy can be prescribed.

This medicine must be used with caution if, in the area of application:

• mucous membranes are severely damaged or inflamed;
• you have a severe infection (sepsis) of the mucous membranes.
  In these cases, excessive amounts of lidocaine may pass into the bloodstream and cause serious disturbances of the nervous system (CNS), heart and circulation (cardiovascular system), especially in children, elderly patients, and debilitated individuals (see section “Possible side effects”).

Children
This medicine should be used with caution in children, especially if there is damage, inflammation, or severe infection of the mucous membranes at the site of application.

Other medicines and Luan
Inform your doctor or pharmacist if you are currently 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 disorders.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

Luan contains parahydroxybenzoates and sodium benzoate
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
Luan contains sodium benzoate, which is slightly irritating to the skin, eyes, and mucous membranes.

3. How to use Luan

Use this medicine exactly as stated in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Luan will be administered directly into the urethra by squeezing the tube and applying a urethral clamp for 10 minutes; after which desired endourethral procedures may be performed. The contents of the tube are sufficient to completely fill the urethra.
To facilitate the introduction of the medicine and to avoid pain caused by direct contact with the metallic parts of the tube, at the time of use the tube may be fitted with the plastic applicator provided in the package.
This medicine must be used with caution if you have damaged mucous membranes or a severe infection (sepsis) (see section “Warnings and precautions”).
If you use more Luan than you should
If you are administered an excessive amount of this medicine, the following symptoms may occur:

• tremors and convulsions followed by depression (neuroexcitatory manifestations), severe breathing problems (respiratory failure), and deep unconsciousness (coma);
• heart and circulatory problems (cardiovascular alterations) with low blood pressure (hypotension) and slowed heart rate (bradycardia).
  Your doctor will determine the most appropriate treatment for you, depending on the severity of the symptoms. If you are concerned that a higher than recommended dose of medicine may have been used, inform your doctor immediately.

4. Possible side effects

Like all medicines, Luan may cause side effects, although not everybody gets them.
The side effects that may occur are listed below:

• allergic reactions (hypersensitivity) at the application site, characterized by pain, burning, and itching;
• severe allergic reaction (anaphylactic shock);

When the medicine is applied to irritated or damaged skin, to large areas of the body, at high doses, or in the presence of fever, the risk of systemic (whole-body) adverse and toxic effects increases. (See section "Warnings and precautions").
Reporting of side effects
If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.

5. How to store Luan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after "Exp.".
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Luan contains

• The active substance is lidocaine hydrochloride. 100 g of gel contain 2.5 g of lidocaine hydrochloride.
• The other components are: sodium carmellose, glycerol, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate, purified water.

Description of the appearance of Luan and the contents of the package
Pack containing an aluminium tube with a screw cap containing 15 g of gel with a plastic applicator.

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 - Località Granatieri - Scandicci (Florence)

Package leaflet: Information for the user

LUAN 1% gel

Lidocaine hydrochloride
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Luan is and what it is used for
2. What you need to know before using Luan
3. How to use Luan
4. Possible side effects
5. How to store Luan
6. Contents of the pack and other information

1. What Luan is and what it is used for

Luan contains the active substance lidocaine hydrochloride, which belongs to a group of
medicines called local anesthetics that block the sensation of pain in the area where they
are applied.
Luan is indicated to facilitate the insertion of anesthetic tubes and into the esophagus (esophagoscopy intubation) and for the insertion of probes into the pharynx, trachea, bronchi or rectum (pharyngoscopies, tracheobronchoscopies, gastroscopies and proctoscopies), as well as for all endoscopic procedures, whether diagnostic or therapeutic.

2. What you need to know before using Luan

Do not use Luan if:

• you are allergic to lidocaine hydrochloride, to similar substances (amide-type local anaesthetics), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Luan.
This medicine should be used in the smallest quantity necessary to achieve the desired effect, and prolonged application should be avoided, as allergic reactions (sensitization phenomena) may occur. In such cases, treatment should be discontinued and your doctor should be informed so that appropriate therapy can be prescribed.

This medicine should be used with caution if, in the area of application:

• mucous membranes are severely damaged or inflamed;
• you have a severe mucosal infection (sepsis).
  In these cases, excessive amounts of lidocaine may pass into the bloodstream and cause serious disorders of the nervous system (CNS), heart, and circulation (cardiovascular system), especially in children, elderly people, and debilitated individuals (see section “Possible side effects”).

Children
This medicine should be used with caution in children, especially if there is damage, inflammation, or severe infection of the mucous membranes at the site of application.

Other medicines and Luan
Inform your doctor or pharmacist if you are currently 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 disorders.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Luan contains parahydroxybenzoates and sodium benzoate
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
Luan contains sodium benzoate, which is mildly irritating to the skin, eyes, and mucous membranes.

3. How to use Luan

Use this medicine exactly as stated in this leaflet or as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Luan will be applied directly to the instrument, before starting the surgical procedure.
This medicine must be used with caution if you have damaged mucous membranes or a severe infection (sepsis), in children, elderly patients, and severely ill patients (see section “Warnings and precautions”).
If you use more Luan than you should
If you are administered an excessive amount of this medicine, the following symptoms may occur:

• tremors and seizures followed by depression (neuroexcitatory manifestations), severe breathing problems (respiratory failure), and deep unconsciousness (coma);
• heart and circulatory problems (cardiovascular alterations) with low blood pressure (hypotension) and slowed heart rate (bradycardia).
  Your doctor will determine the most appropriate treatment for you, depending on the severity of the symptoms. If you are concerned that a higher than intended dose may have been used, inform your doctor immediately.

4. Possible side effects

Like all medicines, Luan can cause side effects, although not everybody gets them.

The side effects that may occur are listed below:

• allergic reactions (hypersensitivity) at the application site, characterized by pain, burning, and itching;
• severe allergic reaction (anaphylactic shock);

When the medicine is applied to irritated or damaged skin, over large areas of the body, at high doses, or when fever is present, the risk of unwanted and toxic effects affecting the whole body (systemic effects) increases. (See section “Warnings and precautions”).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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.

5. How to store Luan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after "Exp.".
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Luan contains

• The active substance is lidocaine hydrochloride. 100 g of gel contain 1 g of lidocaine hydrochloride.
• The other components are: sodium carmellose, glycerol, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium benzoate, purified water.

Description of the appearance of Luan and contents of the pack
Pack containing an aluminium tube with a screw cap, 100 g of gel.
Marketing Authorization Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 - Località
Granatieri - Scandicci (Florence)