Lidocaine hydrochloride 1%

Package leaflet: Information for the patient

LIGNOCAINUM HYDROCHLORICUM WZF 1%, 10 mg/ml solution for injection
Lidocaini hydrochloridum
LIGNOCAINUM HYDROCHLORICUM WZF 2%, 20 mg/ml solution for injection
Lidocaini hydrochloridum
Please read this leaflet carefully 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

1. What is Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% and what are they used for
2. Important information before using Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
3. How to use Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
4. Possible adverse reactions
5. How to store Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
6. Contents of the pack and other information

1. What is Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% and what are they used for

Lidocaine is a locally anesthetic and antiarrhythmic medicine administered by a physician.
It works by inhibiting the generation and conduction of impulses in nerve fibers and in the cardiac conduction system.
Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% are used:

• in regional anesthesia – infiltration, nerve blocks, plexus and trunk nerve blocks, subarachnoid, and epidural anesthesia – in general surgery, urology, orthopedics, gynecology, obstetrics, as well as in various diagnostic and therapeutic procedures;
• in ventricular cardiac arrhythmias (ventricular premature beats, ventricular tachycardia), especially during acute myocardial infarction or after overdose of cardiac glycosides;
• in the treatment of perioperative pain, as a component of preventive and multimodal analgesia;
• in the treatment of neuropathic pain, as a second-line agent.

2. Information before using Lignocainum hydrochloricum WZF 1%

and Lignocainum hydrochloricum WZF 2%

When not to use Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%:

• if the patient is allergic to lidocaine or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction to other local anaesthetics;
• if there are contraindications to performing specific anaesthetic techniques, especially spinal and epidural anaesthesia – this will be decided by the physician.

Intravenous infusion of lidocaine used for pain management in the perioperative period is contraindicated if regional anaesthesia is simultaneously administered, particularly techniques involving bolus administration or high doses of local anaesthetic (e.g. epidural anaesthesia, nerve plexus and trunk blocks).

Warnings and precautions

Before starting treatment with Lignocainum hydrochloricum WZF 1% or Lignocainum hydrochloricum WZF 2%, discuss this with your doctor or pharmacist.

The patient should inform the doctor if they:

• have heart disease, especially severe hypertension;
• suffer from neurological disorders such as neuromuscular disorders, multiple sclerosis, hemiplegia, or transverse myelopathy;
• have liver problems;
• have blood disorders (reduced circulating blood volume);
• have disturbances in water and electrolyte balance (symptoms include: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pain and cramps, muscle fatigue, hypotension, oliguria, rapid heartbeat, nausea and vomiting).

Anaesthetic procedures must be performed by a physician experienced in the relevant techniques and trained in the diagnosis and management of lidocaine overdose.

During administration of Lignocainum hydrochloricum WZF 1% or Lignocainum hydrochloricum WZF 2%, the physician:

• will ensure access to resuscitation equipment, oxygen, and necessary medications, and will take appropriate actions in case of complications;
• will continuously monitor cardiac and respiratory function, level of consciousness, and other vital functions.

Repeated administration of lidocaine may lead to toxic symptoms – see section 4 of the leaflet. When a large dose is administered intrathecally, severe disturbances of the circulatory and respiratory systems may occur.

Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% with other medicines

Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient intends to take.

Inform the doctor if the patient is taking:

• antiepileptic drugs, e.g. phenytoin;
• antiarrhythmic drugs;
• antihypertensive drugs, e.g. propranolol;
• medications for peptic ulcer disease, e.g. cimetidine.

High doses of lidocaine may potentiate the effects of muscle relaxants (e.g. suxamethonium). Intravenous lidocaine may enhance the analgesic effect of painkillers used in monotherapy. Perioperative use of lidocaine reduces the need for opioids.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The decision on using this medicine during pregnancy or breastfeeding will be made by the physician.

Driving and operating machinery

The effect of lidocaine on the ability to drive or operate machinery depends on the type of procedure performed and the dose used.

Patients should not drive or operate machinery for at least 24 hours after completion of the procedure involving lidocaine.

Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% contain sodium

Lignocainum hydrochloricum WZF 1% contains 2.75 mg of sodium per ml of solution.

2 ml ampoules:
Lignocainum hydrochloricum WZF 1% contains 5.5 mg of sodium (main component of table salt) per ampoule (2 ml solution), equivalent to 0.28% of the maximum recommended daily dietary sodium intake for adults.

20 ml vials:
Lignocainum hydrochloricum WZF 1% contains 55 mg of sodium (main component of table salt) per vial (20 ml solution), equivalent to 2.75% of the maximum recommended daily dietary sodium intake for adults.

Lignocainum hydrochloricum WZF 2% contains 2.36 mg of sodium per ml of solution.

2 ml ampoules:
Lignocainum hydrochloricum WZF 2% contains 4.72 mg of sodium (main component of table salt) per ampoule (2 ml solution), equivalent to 0.24% of the maximum recommended daily dietary sodium intake for adults.

20 ml vials:
Lignocainum hydrochloricum WZF 2% contains 47.2 mg of sodium (main component of table salt) per vial (20 ml solution), equivalent to 2.36% of the maximum recommended daily dietary sodium intake for adults.

This medicine may be diluted with 0.9% sodium chloride solution. The sodium content originating from the diluent should be taken into account when calculating the total sodium content in the prepared diluted solution. For accurate information on sodium content in the diluent used, refer to the patient leaflet of the diluent.

In patients with impaired renal function, the sodium content in the final medicinal product for administration should be considered.

3. How to use Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%

Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% are administered by a physician.
The dosage is adjusted by the doctor according to the patient's general condition, age, body weight, concomitant diseases, type of procedure, type of anesthesia, and concomitant medications.
Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% can be administered intravenously, infiltratively, intrathecally, and epidurally.

Use of a higher than recommended dose of Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
Overdose may occur following direct injection of the drug into a blood vessel, administration into a highly vascularized area, or exceeding the maximum recommended dose. Symptoms of overdose are described below in section 4. "Possible adverse reactions".

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences first signs of hypersensitivity (e.g. swelling of the face, lips, tongue,
throat, causing difficulty in breathing or swallowing), inform the doctor immediately.
Such symptoms are very rare. The doctor will then assess the severity of the symptoms and decide on further management.
Adverse reactions to lidocaine most commonly occur as a result of exceeding permissible concentrations in body fluids, e.g. due to overdose, disturbances in absorption, distribution, metabolism and excretion, or use of an inappropriate injection technique.
Very rare (less than 1 in 10,000 people):

• allergic reactions (skin changes, urticaria, oedema);
• loss of sensation, inability to perform movements (paralysis).

Frequency unknown (cannot be estimated from available data):

• anaphylactoid symptoms (symptoms similar to allergic reactions, but with a different mechanism of occurrence);
• metallic taste in the mouth;
• feeling of dizziness;
• excitation;
• anxiety;
• euphoria;
• muscle tremors;
• drowsiness;
• disturbances of consciousness;
• headache and dizziness;
• tinnitus;
• sensation of heat, cold or numbness;
• loss of consciousness;
• seizures;
• decreased blood pressure;
• slowing of heart function, in extremely severe cases leading to cardiac arrest;
• severe breathing difficulties, in extremely severe cases leading to respiratory arrest;
• visual disturbances;
• nausea, vomiting.

Following intravenous administration of lidocaine in multimodal analgesia, the most commonly observed reactions were: drowsiness, feeling of fatigue, nausea, numbness of lips, metallic taste in the mouth, and dizziness.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, ampoule, or vial after EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Store in the original packaging to protect from light, at a temperature below 25°C. Do not freeze.
After the first dose has been withdrawn, any unused contents of the vial must be discarded after 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Lignocainum hydrochloricum WZF 1% contains

• The active substance is lidocaine hydrochloride monohydrate. Each ml of solution contains 10 mg of lidocaine hydrochloride monohydrate. Each ampoule (2 ml of solution) contains 20 mg of lidocaine hydrochloride monohydrate. Each vial (20 ml of solution) contains 200 mg of lidocaine hydrochloride monohydrate.
• Other ingredients: sodium chloride, sodium hydroxide 10% (for pH adjustment), water for injections.

What Lignocainum hydrochloricum WZF 2% contains

• The active substance is lidocaine hydrochloride monohydrate. Each ml of solution contains 20 mg of lidocaine hydrochloride monohydrate. Each ampoule (2 ml of solution) contains 40 mg of lidocaine hydrochloride monohydrate. Each vial (20 ml of solution) contains 400 mg of lidocaine hydrochloride monohydrate.
• Other ingredients: sodium chloride, sodium hydroxide 10% (for pH adjustment), water for injections.

What Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% look like and contents of the pack
The solution is colourless and clear.
Pack sizes: 10 ampoules of 2 ml or 5 vials of 20 ml in a cardboard box.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Information intended for healthcare professionals only:
LIGNOCAINUM HYDROCHLORICUM WZF 1%, 10 mg/ml solution for injection
Lidocaini hydrochloridum
LIGNOCAINUM HYDROCHLORICUM WZF 2%, 20 mg/ml solution for injection
Lidocaini hydrochloridum

Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% do not contain preservatives.
Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% can be administered intravenously, infiltratively, intrathecally, and epidurally.

Instructions for opening the ampoule
Before opening the ampoule, ensure that the entire solution is in the lower part of the ampoule. Gently shake the ampoule or tap it with your finger to help the solution flow down.
Each ampoule has a coloured dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically in both hands with the coloured dot facing towards you – see Figure 2. The upper part of the ampoule should be held so that the thumb is positioned above the coloured dot.
• Press in the direction of the arrow shown in Figure 3. Ampoules are intended for single use only and should be opened immediately before use. Any unused medicinal product should be disposed of in accordance with applicable regulations.

Figure 1 Figure 2 Figure 3

Dosage
The medicinal product may be administered intravenously, infiltratively, intrathecally, and epidurally.

Regional anaesthesia
The maximum single dose of lidocaine for an adult patient is 200 mg (4.5 mg/kg body weight). The doses provided are approximate and apply to adults in good general health without concomitant diseases.
In children, the dose should not exceed 3 mg/kg body weight. Lidocaine should be dosed individually according to the patient's body weight and general condition. During anaesthesia, vital functions must be supervised and monitored.
The intensity and duration of lidocaine's effect depend on the concentration and volume of the solution used. Increasing the volume and concentration accelerates, prolongs, and intensifies the local anaesthetic effect.
Lidocaine, like other local anaesthetics, should be administered slowly after prior aspiration to avoid inadvertent intravascular administration.
When performing epidural anaesthesia, administration of the main dose should be preceded by a test dose (3 to 5 ml of lidocaine hydrochloride with added adrenaline). If inadvertently injected intravascularly, the adrenaline contained in the test dose will cause a distinct increase in heart rate. Therefore, ECG monitoring should be observed on the monitor screen for 5 minutes after administration. A negative test result permits injection (at a rate of 25 to 50 mg/min) of the remaining anaesthetic dose. During this time, continuous verbal contact with the patient should be maintained, and if even mild symptoms of overdose occur, administration must be stopped immediately. The test dose also helps avoid risks associated with inadvertent intrathecal injection, which could lead to complete spinal anaesthesia.
Intervals between successive doses administered epidurally should not be shorter than 90 minutes.
The maximum dose of lidocaine administered during cervical plexus block (during labour and in gynaecology) should not exceed 200 mg every 90 minutes.
The lowest effective dose of lidocaine should always be used to minimize the risk of overdose. The medicinal product can be diluted with 0.9% sodium chloride solution.

Cardiac arrhythmias
For the treatment of arrhythmias in adults, lidocaine is administered intravenously in a single dose of 50 to 100 mg, or in divided doses of 25 to 50 mg per minute. If the initial dose is ineffective, a subsequent dose (50 to 100 mg) may be administered after 5 minutes. The dose should not exceed 200 to 300 mg within one hour.
In patients with a tendency to recurrent arrhythmias or resistant to oral antiarrhythmic drugs, continuous intravenous infusion of lidocaine may be used at a rate of 1 to 4 mg/min (20 to 50 \μg/kg b.w./min) under continuous ECG monitoring. The infusion should be discontinued when arrhythmias resolve or symptoms of overdose appear. In elderly patients, the dose should be adjusted according to the patient's general condition.
Cardiac arrhythmias in children are treated with intravenous lidocaine at a dose of 0.8 to 1 mg/kg b.w., which may be repeated as needed up to a total dose of 3 to 5 mg/kg b.w. Lidocaine may also be administered via continuous intravenous infusion at a rate of 10 to 50 \μg/kg b.w./min.

Management of perioperative pain
Intravenous lidocaine administered during the perioperative period is used in adult patients as an adjuvant in multimodal (multi-target) therapy and in preventive analgesia. Lidocaine is administered intravenously during surgical procedures associated with mild to significant and extensive tissue trauma.
Typical dosing regimen:

• Loading dose of 1.5 mg/kg b.w. given as a bolus, followed by a continuous infusion of 1.5 to 3 mg/kg b.w./hour via intravenous infusion during surgery; administration of lidocaine should ideally begin 30 minutes before anesthesia induction, but no later than at the time of induction;
• Postoperatively: 1 to 3 mg/kg b.w./hour via continuous infusion for 24 to 48 hours.

If lidocaine is used simultaneously in the same patient as a local anesthetic (infiltrative), e.g., for infiltration along the anticipated incision line, and as an intravenous infusion, the total dose of lidocaine should be reduced.
If necessary, intravenous lidocaine infusion may be initiated 4 to 8 hours after the last dose (bolus) of a drug used for regional anesthesia. In case of failed epidural anesthesia, after discontinuation of continuous epidural infusion and without administering a bolus dose into the epidural space, continuous intravenous lidocaine infusion may be started immediately, but without administering an intravenous bolus.
The dose of lidocaine should be reduced in conditions where an increased free fraction of the drug in serum may occur—acidosis, hypercapnia, hypoxia, hypoproteinemia, and impaired liver and/or kidney function. In patients with circulatory, liver, and/or kidney impairment, the lidocaine dose should be reduced and cardiovascular function monitored.

Treatment of patients with neuropathic pain
Adults
Continuous intravenous infusion at a dose of 3–5 mg/kg b.w. for a minimum of 30 minutes, but not longer than 6 hours, once daily.

Note: The drug is incompatible and should not be mixed in the same syringe with solutions containing sodium bicarbonate or other alkaline solutions.