Package leaflet: Information for the patient

LIGNOSOL
20 mg/g, gel
Lidocaini hydrochloridum monohydricum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What LIGNOSOL is and what it is used for
Important information before using LIGNOSOL
How to use LIGNOSOL
Possible side effects
How to store LIGNOSOL
Contents of the pack and other information

1. What LIGNOSOL is and what it is used for

The active substance in LIGNOSOL is an amide derivative exhibiting local anesthetic action.
Medicines containing lidocaine are used for local anesthesia of mucous membranes or skin. It does not irritate tissues and does not dilate blood vessels. Due to its high viscosity and low surface tension, it reduces the friction coefficient between the mucous membrane and medical instruments in contact with it.
The effect of the medicine begins 2–3 minutes after application and lasts for approximately 30–60 minutes.
After local administration, the medicine is absorbed into the systemic circulation, most rapidly from mucous membranes.
Indications for use
LIGNOSOL is used in anesthesiology and laryngology:

for coating endotracheal and tracheostomy tubes, gastric tubes, and catheters;
for superficial anesthesia of nasal and nasopharyngeal mucous membranes before laryngoscopy, surgery of nasal polyps, or removal of hypertrophic tonsils;
as preliminary anesthesia for intubation in conscious patients.

2. Important information before using LIGNOSOL

When not to use LIGNOSOL:

if the patient is allergic to lidocaine or other local anaesthetics containing substances with an amide structure, or to any of the other ingredients of this medicine (listed in section 6);
for lubricating metallic tracheal tube stiffeners.

Warnings and precautions
If any of the warnings below apply to the patient, consult a doctor, pharmacist, or nurse before using LIGNOSOL.
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Use with caution:

in patients treated with tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors);
on infected or damaged mucous membranes;
in patients with heart diseases or circulatory disorders;
care should be taken to avoid lidocaine entering the lumen of the tracheostomy tube.

The lowest effective doses should be used to avoid high blood concentrations of lidocaine and severe adverse effects.

LIGNOSOL and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Lidocaine:

enhances the effect of skeletal muscle relaxants;
reduces the effectiveness of sulfonamides.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should talk to a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if clearly necessary.
Caution should be exercised when using the gel in breastfeeding women.

Driving and operating machinery
Use of this medicine may temporarily and slightly impair the ability to drive or operate machinery.
If in doubt about performing such activities, consult a doctor.

LIGNOSOL contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions).

3. How to use LIGNOSOL

This medicine should always be used according to the instructions given by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
LIGNOSOL is administered intranasally and oropharyngeally.
The medicine is applied directly to the nasal mucosa, nasopharyngeal cavity, and for coating the surfaces of medical instruments.

Anesthesiology and laryngology
Before laryngological procedures, the gel is applied to the mucous membranes by brushing.

Warning!
Lidocaine is readily and rapidly absorbed from mucous membranes. When used in children, the dose should be calculated according to body weight.
The dose should not exceed 3 mg/kg body weight.
The same applies to weakened patients, those with low body weight, elderly patients, and when large amounts of the drug are used.

Use of a higher than recommended dose of LIGNOSOL
May result in a drop in arterial pressure, excitation, clonic-tonic seizures, cardiovascular depression. If these symptoms occur, immediate medical assistance is required.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
After local administration, lidocaine may cause allergic reactions and, following absorption, systemic effects.
The occurrence and severity of systemic effects depend on the drug concentration in serum, the patient's general condition, liver function, age, body weight, heart disease, and hyperthyroidism.
Cardiac disorders:
bradycardia (slow heart rate), cardiovascular collapse leading to cardiac arrest.
Vascular disorders:
reduction in blood pressure.
Nervous system disorders:
dizziness, paraesthesia;
drowsiness after administration of lidocaine is usually an early sign of high blood concentration, for example due to very rapid absorption.
Psychiatric disorders:
agitation, anxiety, disorientation.
Skin and subcutaneous tissue disorders:
skin changes, urticaria, oedema.
Immune system disorders:
anaphylactic reactions.
Other adverse reactions may occur in some individuals during the use of LIGNOSOL medicine.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safe use of the medicine.
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5. How to store LIGNOSOL medicine
Keep the medicine out of the sight and reach of children.
No special storage conditions are required. Do not store in a refrigerator or freeze.
Do not use this medicine after the expiry date stated on the cardboard box and tube after:
EXP
The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the tube: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What LIGNOSOL contains

The active substance is lidocaine hydrochloride monohydrate. 1 g of gel contains 20 mg of lidocaine hydrochloride monohydrate.
Other components are: hydroxyethylcellulose, methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216, purified water.

What LIGNOSOL looks like and contents of the pack
LIGNOSOL is a clear or slightly opalescent, colourless, homogeneous gel.
Available pack: 1 tube of 30 g
Aluminium tube with an internal epoxy-phenolic lacquer coating, fitted with a nozzle and a cap made of HDPE, packed in a cardboard box.
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
Poland
Tel.: +48 81 463 48 82
{logo of the marketing authorisation holder}
Manufacturer:
Mako Pharma Sp. z o.o.
Władysława Reymonta 2
05-092 Dziekanów Leśny
Medicofarma S.A.
Tarnobrzeska 13
26-613 Radom
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