Lignocaine hydrochloricum wzf 1%

Package leaflet: information for the patient

LIGNOCAINUM HYDROCHLORICUM WZF 1%, 10 mg/ml solution for injection
Lidocaini hydrochloridum monohydricum
LIGNOCAINUM HYDROCHLORICUM WZF 2%, 20 mg/ml solution for injection
Lidocaini hydrochloridum monohydricum
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% are and what they are used for
2. Important information before use of Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
3. How to use Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
4. Possible side effects
5. How to store Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%
6. Contents of the package and other information

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

Lidocaine is a local anaesthetic and antiarrhythmic agent administered by a physician.
It works by inhibiting the generation and conduction of impulses in nerve fibres and in the cardiac conduction system.
Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% are used:

• for regional anaesthesia – infiltration, nerve blocks, plexus and peripheral nerve blocks, spinal and epidural anaesthesia – in general surgery, urology, orthopaedics, gynaecology, obstetrics, as well as in various diagnostic and therapeutic procedures;
• in ventricular cardiac arrhythmias (ventricular premature beats, ventricular tachycardia), particularly during acute myocardial infarction or following overdose of cardiac glycosides;
• for the treatment of perioperative pain, as a component of preventive analgesia and multimodal analgesia;
• for the treatment of neuropathic pain, as a second-line agent.

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

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

Warnings and precautions

Before starting treatment with Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2%, discuss this with your doctor or pharmacist. The patient should inform the doctor if:

• suffering from heart disease, especially severe hypertension;
• suffering from neurological disorders such as neuromuscular disorders, multiple sclerosis, hemiplegia, or transverse paralysis;
• having liver problems;
• having blood disorders (reduced circulating blood volume);
• having disturbances in water and electrolyte balance (symptoms include: dry mouth, thirst, weakness, lethargy, drowsiness, motor restlessness, seizures, disorientation, muscle pain and cramps, muscle fatigue, hypotension, oliguria, tachycardia, 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:

• must ensure access to resuscitation equipment, oxygen, and essential medications, and be prepared to take appropriate action in case of complications;
• must 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. Following a large dose administered via spinal anaesthesia, 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 use. Inform the doctor if the patient is taking:

• anticonvulsants, e.g. phenytoin;
• antiarrhythmics;
• antihypertensives, e.g. propranolol;
• medications for peptic ulcer disease, e.g. cimetidine.

High doses of lidocaine may enhance the effects of muscle relaxants (e.g. suxamethonium). Intravenous lidocaine may potentiate 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 might 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 and 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 administered. 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). This corresponds 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). This corresponds 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). This corresponds 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). This corresponds to 2.36% of the maximum recommended daily dietary sodium intake for adults.

The product 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 ready-to-use medicinal product 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 physician adjusts the dosage according to the patient's general condition, age, body weight, concomitant diseases, type of procedure, anaesthesia, and concomitant medications.
Lignocainum hydrochloricum WZF 1% and Lignocainum hydrochloricum WZF 2% may 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 injection directly into a blood vessel, into a highly vascular area, or after 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 not everyone experiences them.
If the patient develops 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 not known (cannot be estimated from the available data):

• anaphylactoid reactions (allergy-like symptoms, but with a different mechanism of occurrence);
• metallic taste in the mouth;
• 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;
• slowed 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.

After intravenous administration of lidocaine in multimodal analgesia (multimodal pain management), the most commonly observed adverse reactions were: drowsiness, feeling of fatigue, nausea, numbness of the lips, metallic taste in the mouth, and dizziness.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

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

Keep this medicine out of 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 specified 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 if not used within 24 hours.
Medicines must 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 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: 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 exclusively for medical professionals:
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% may be administered intravenously, infiltratively, intrathecally, and epidurally.

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

• To open the ampoule, hold it vertically with both hands, with the coloured dots facing each other – 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 portion of the medicinal product must be destroyed 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 (b.w.)). The doses indicated are approximate and apply to adult patients in good general health without concomitant diseases.
In children, the dose should not exceed 3 mg/kg b.w. Lidocaine should be dosed individually, based on body weight and the patient's general condition. During anaesthesia, the patient must be supervised and vital functions 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 onset, prolongs duration, and intensifies local anaesthetic effect.
Lidocaine, like other local anaesthetics, should be administered slowly after prior aspiration to avoid inadvertent intravascular injection.
When performing epidural anaesthesia, administration of the main dose of anaesthetic 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 marked 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 of the drug, which may lead to complete spinal anaesthesia.
Intervals between successive doses administered epidurally should not be less 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 may 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 body weight/min) under continuous ECG monitoring. The infusion should be discontinued when arrhythmias resolve or signs 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 body weight, which may be repeated as needed up to a total dose of 3 to 5 mg/kg body weight. Lidocaine may also be administered by continuous intravenous infusion at a rate of 10 to 50 µg/kg body weight/min.

Perioperative pain management
Intravenous lidocaine during the perioperative period is used in adult patients as an adjuvant in multimodal (multimodal) therapy and in preventive (prophylactic) analgesia. Lidocaine is administered intravenously during surgical procedures involving minor to moderate or extensive tissue trauma.
Typical dosing regimen:

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

If lidocaine is used simultaneously in the patient as a local anesthetic (infiltration), e.g., for infiltration along the anticipated incision line, as well as 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, hepatic, and/or renal insufficiency, the dose of lidocaine should be reduced and cardiovascular function should be monitored.

Treatment of patients with neuropathic pain
Adults
Continuous intravenous infusion at a dose of 3–5 mg/kg body weight 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.