Lidocaine hydrochloride noridem

Package leaflet: Information for the patient

Lidocaini hydrochloridum Noridem, 20 mg/ml, solution for injection
Lidocaine hydrochloride
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v) is and what it is used for
2. Important information before using Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v)
3. How to use Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v)
4. Possible side effects
5. How to store Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v)
6. Contents of the package and other information

1. What Lidocaini hydrochloridum Noridem 20 mg/ml is and what it is used for

The active substance in Lidocaini hydrochloridum Noridem 20 mg/ml is lidocaine hydrochloride.
Lidocaine is a local and regional anaesthetic medicine. It is used to numb a specific area of the body before a surgical procedure.
This medicine may be administered to adults and children. However, special precautions must be taken when administering the medicine to children (see also "How to use Lidocaini hydrochloridum Noridem, 20 mg/ml"). In particular, it should be noted that data on the use of this medicine in children under 2 years of age are limited.

Additionally, the medicine may be used to manage severe forms of rapid or irregular heart rhythm (ventricular arrhythmia or tachyarrhythmia), but only when the physician considers the patient's condition to be life-threatening.
This medicine may be administered to adults and children. However, special precautions must be taken when administering the medicine to children (see also "How to use Lidocaini hydrochloridum Noridem, 20 mg/ml"). In particular, it should be noted that data on the use of this medicine in children are limited.

2. Information before using Lidocaini hydrochloridum Noridem 20 mg/ml

mg/ml
Do not use Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v)

• if the patient is allergic to lidocaine hydrochloride or similar substances also used as local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).
  Local and regional anaesthesia
  Do not use the medicine for spinal or epidural anaesthesia (administration of anaesthetic drug near the spinal cord) if the patient has:
• uncorrected low blood volume (hypovolemia),
• impaired blood clotting (coagulopathy);
• increased intracranial pressure;
• bleeding within the skull or spinal column.

Control of accelerated or irregular heart rhythm
Do not use the medicine if:

• the patient has severe heart disorders, especially irregular or slowed heart rhythm;
• the patient has suffered a heart attack within the last 3 months;
• the patient's heart ability to pump blood throughout the body is significantly reduced, unless the patient's condition is life-threatening.

Warnings and precautions
Before administering this medicine, the physician must ensure availability of emergency and resuscitation equipment.
The medicine is administered only under strict medical supervision. The physician must exercise particular caution if the patient has any of the following conditions:

• previous allergy to local anaesthetic medicines,
• heart or lung problems,
• liver or kidney disease,
• autoimmune disease causing muscle weakness (myasthenia),
• severe shock,
• any condition increasing the risk of seizures or convulsions (epilepsy).

Local and regional anaesthesia
Especially in elderly patients, the physician should consider the possibility of low blood pressure as a complication following spinal or epidural anaesthesia (administration of anaesthetic drug near the spinal cord). Additionally, the physician knows that injecting this medicine into inflamed tissue may lead to increased absorption of the drug into the bloodstream and consequently reduced local effectiveness.
In patients under 30 years of age, there is a risk of headache after epidural anaesthesia. To minimize this risk, the physician will use a small needle. Additionally, there is a risk of severe adverse reactions when removing the compression bandage after intravenous injection. Therefore, the physician will administer the medicine in several injections.

The physician should consider that administration of this medicine in the head and neck area carries an increased risk of adverse effects on the nervous system.
Control of accelerated or irregular heart rhythm
In the treatment of heart problems, this medicine must be administered with special caution if the patient has significant blood acidification (acidosis).
Before administering high doses of this medicine, the physician will correct any low potassium levels in the blood, oxygen deficiency, and disturbed acid-base balance. If the patient receives this medicine for a prolonged period, the physician will monitor fluid balance, blood electrolyte levels, and acid-base balance. During administration, heart function, blood pressure, level of consciousness, and respiration are monitored.

Note:
If the patient is anaesthetized, the physician closely monitors the patient's condition, as adverse effects on the nervous and cardiovascular systems may occur without prior warning signs.

Using Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v) with other medicines
Inform the physician about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.
This is necessary because the physician must assess whether the patient's medicines are metabolized by specific enzymes or affect their function (cytochrome P450 1A2 and 3A4). This procedure aims to avoid interactions between Lidocaini hydrochloridum Noridem 20 mg/ml (2% w/v) and other medicines taken by the patient.
In particular, inform the physician if the patient is taking any of the following medicines:

• certain heart medications, such as beta-blockers (e.g. metoprolol, propranolol) or calcium channel blockers (e.g. amiodarone);
• antiarrhythmic drugs – used to treat heart rhythm disorders;
• vasoconstrictive agents (vasoconstrictors, e.g. epinephrine, norepinephrine);
• cimetidine – a medicine used to treat heartburn;
• antiviral drugs (e.g. drugs used in HIV treatment);
• sedatives and medicines that reduce consciousness or cause drowsiness;
• phenobarbital, phenytoin, carbamazepine or primidone – medicines used to treat epilepsy;
• medicines increasing the risk of seizures or convulsions (e.g. tramadol, bupropion);
• erythromycin – an antibiotic;
• antipsychotic medicines (fluvoxamine) – used to treat psychiatric disorders;
• muscle relaxants used in general anaesthesia;
• other anaesthetics.

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 physician or pharmacist before using this medicine. The decision on using this medicine during pregnancy and breastfeeding will be made by the physician.

Pregnancy
If the patient is pregnant, the physician will administer this medicine only if necessary. The dose should be as low as possible.

Breastfeeding
Lidocaine and its metabolites pass into breast milk in small amounts. Therefore, if the patient is breastfeeding, the physician will exercise particular caution. However, generally, at usual doses, this medicine will not affect the breastfed infant. There is therefore no need to interrupt breastfeeding.

Driving and operating machinery
The effect of lidocaine on the ability to drive and operate machinery depends on the type of procedure performed and the dose of medicine used. Consult the physician, especially if areas of the body involved in driving or operating machinery have been anaesthetized. If the physician considers it necessary, the patient should refrain from driving and operating machinery.

Lidocaini hydrochloridum Noridem 20 mg/ml contains sodium

Ampoules 2 ml, 5 ml and 10 ml:
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

Ampoules 20 ml:
The medicine contains 38.1–41.0 mg of sodium (main component of table salt) in each 20 ml ampoule. This corresponds to 1.90–2.05% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Lidocaini hydrochloridum Noridem, 20 mg/ml

This medicine is administered by a physician.
This medicine is given as an injection into a vein, under the skin, near a muscle, bone, spine, or nerve.

Dosage
The dose is determined by the physician and depends on the individual condition of the patient.

Local and regional anaesthesia
Adults
The usual maximum dose is 4.5 mg/kg body weight (or 300 mg). When administered together with a vasoconstrictor, the maximum dose may be increased to 7 mg/kg body weight (or 500 mg).

Children and adolescents
For children and adolescents, the dose is individually determined based on age, body weight, and type of procedure. In children, the maximum dose is 5 mg/kg body weight. When administered together with a vasoconstrictor, the maximum dose may be increased to 7 mg/kg body weight.
For anaesthesia in children, a lower concentration of the medicine (0.5%) should be used. For a special technique called motor block, a higher concentration (1% w/v) may be required.
Lidocaini hydrochloridum Noridem, 20 mg/ml should be used with caution in children under 2 years of age.

Control of accelerated or irregular heart rhythm
The dose should be adjusted according to individual requirements and the desired therapeutic effect. This is particularly important for patients with heart, liver, or kidney problems, as well as for pregnant women.
Reduced doses of lidocaine are recommended for the following patient groups:

• pregnant women,
• infants,
• younger children,
• children with high body weight,
• elderly patients,
• patients in poor general health,
• patients with impaired protein binding capacity,
• patients with renal impairment,
• patients with heart and/or liver disease.

Use of higher than recommended doses of Lidocaini hydrochloridum Noridem, 20 mg/ml
The occurrence of overdose symptoms in patients depends on the drug concentration in the blood. The higher the amount of lidocaine circulating in the blood and the faster it is administered, the more frequently and severely overdose symptoms may occur.

Mild overdose primarily affects the central nervous system. If adverse effects occur, they usually resolve spontaneously after discontinuation of lidocaine administration.

Early symptoms of lidocaine toxicity include:

• unpleasant sensation around the mouth,
• tingling, pricking, or numbness (paresthesia), restlessness, drowsiness, dizziness,
• speech disturbances, blurred vision,
• visual and auditory disturbances, tinnitus,
• muscle tremors, seizures,
• transient flushing,
• elevated blood pressure,
• rapid heartbeat,
• nausea, vomiting,
• hallucinations, euphoria, anxiety,
• chills.

More serious symptoms include:

• sudden drop in blood pressure,
• pale skin,
• disturbances or even loss of consciousness (coma),
• respiratory arrest,
• pulse disappearance,
• heart attack, slowed or irregular heartbeat,
• death.

In case of severe symptoms, the physician will know how to proceed and will administer necessary treatment.

If you have any further doubts regarding the use of this product, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not in all patients do they occur.

The frequency and severity of adverse reactions to this medicine depend on the administered dose, the technique used for administration, and the individual patient's response to lidocaine.

After administration of this medicine, symptoms of local toxicity may occur. Systemic adverse reactions may occur when the blood concentration of lidocaine exceeds 5–10 mg/L. The patient may experience symptoms affecting the central nervous system, cardiovascular system, and heart (see also section "Use of a higher than recommended dose of Lidocaini hydrochloridum Noridem, 20 mg/ml").

Depending on the route of administration of this medicine, systemic adverse reactions are more frequently associated if the patient received the medicine to control a rapid or irregular heartbeat.

Local and regional anaesthesia

The following adverse reactions may be serious. If any of the following adverse reactions occur, inform a doctor immediately. Immediate intervention may be necessary:

Rare (may affect up to 1 in 1000 patients):

• Allergic reactions – from rash and swelling to severe allergic reactions such as hypotension, breathing difficulties, bronchospasm, and shock;
• Spinal cord compression due to haematoma;
• Partial or complete paralysis;
• Persistent numbness or paralysis of limbs over time;
• Cauda equina syndrome: compression of a specific type of nerve roots, characterized by muscle weakness in the lower limbs, loss of control over bowel and bladder function, and loss of sensation in the saddle area;
• Damage to cranial nerves.

Other adverse reactions include:

Very common (may affect more than 1 in 10 patients):

• Nausea, vomiting

Common (may affect up to 1 in 10 patients):

• Pain in the legs and lower back after epidural or spinal anaesthesia. The pain may last up to 5 days and resolves spontaneously without treatment.

Rare (may affect up to 1 in 1000 patients):

• Sensations such as tickling, tingling, burning, pricking, or numbness;
• Headaches associated with photophobia (light sensitivity) and tinnitus;
• Ptosis (drooping eyelid(s)) together with miosis (constricted pupils) and sometimes also reduced sweating (Horner’s syndrome) – this may occur after epidural anaesthesia or administration of anaesthetic in the head or neck area;
• Chills, deafness, or injury;
• Transient irritation of nerve endings as a result of spinal anaesthesia.

Control of rapid or irregular heartbeat

The following adverse reactions may be serious. If any of the following adverse reactions occur, inform a doctor immediately. Immediate intervention may be necessary:

Rare (may affect up to 1 in 1000 patients):

• Allergic reactions – from rash and swelling to severe allergic reactions such as hypotension, breathing difficulties, bronchospasm, and shock;
• Muscle tremors progressing to generalized seizures and convulsions;
• Reduced level of consciousness up to coma;
• Slowed heart rate, heart block up to myocardial infarction;
• Low blood pressure;
• Breathing difficulties up to respiratory arrest.

Very rare (may affect up to 1 in 10,000 patients):

• Increased heart rate

Other adverse reactions include:

Very common (may affect more than 1 in 10 patients):

• Nausea, vomiting;
• Restlessness, difficulty swallowing;

Common (may affect up to 1 in 10 patients):

• Disorientation, restlessness, irritability, euphoria, hallucinations, depression;
• Drowsiness, dizziness, vertigo, speech disturbances, tinnitus, blurred vision;
• Sensations of tickling, tingling, burning, pricking, or numbness of the skin.

Elderly patients
Elderly patients may be more susceptible to the occurrence of some of the above-mentioned adverse reactions.

Children
The frequency, type, and severity of adverse reactions in children are likely the same as in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw,
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows further collection of information on the safety of medicine use.

5. How to store Lidocaini hydrochloridum Noridem, 20 mg/ml

The medicine should be stored in a place inaccessible and out of sight of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the ampoule and packaging
following “EXP”. The expiry date refers to the last day of the stated month.
The injection solution should be administered immediately after opening the container.
The packaging is for single use only. After opening, the container must be discarded
together with any unused contents.
The injection solution is suitable for use only if it is clear, colourless,
and practically free from particles, and the container and closure are undamaged.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at both 25°C
and 2 to 8°C, when diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%).
From a microbiological standpoint, the product should be used immediately.
If the ready-to-use injection solution is not used immediately, the user is responsible
for the storage duration and conditions prior to use, which must not exceed 24 hours
at 2 to 8°C, unless dilution took place under controlled and validated aseptic conditions.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What Lidocaini hydrochloridum Noridem, 20 mg/ml, solution for injection contains

• The active substance is lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate). Each millilitre of solution contains 20 mg of lidocaine hydrochloride. Each 2 ml ampoule contains 40 mg of lidocaine hydrochloride. Each 5 ml ampoule contains 100 mg of lidocaine hydrochloride. Each 10 ml ampoule contains 200 mg of lidocaine hydrochloride. Each 20 ml ampoule contains 400 mg of lidocaine hydrochloride.
• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

What Lidocaini hydrochloridum Noridem, 20 mg/ml, solution for injection looks like and contents of the pack
Lidocaini hydrochloridum Noridem, 20 mg/ml, solution for injection is a clear and colourless solution.
Polypropylene (PP) ampoules with a capacity of 2 ml, 5 ml, 10 ml and 20 ml in a cardboard box. Each pack contains 5, 10, 20, 50 or 100 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia
Cyprus

Manufacturer:
DEMO S.A.
PHARMACEUTICAL INDUSTRY
21st km National Road Athens-Lamia
14568 Krioneri
Attica, Greece
T: +30 210 8161802, F: +30 2108161587

This medicinal product is authorised in the European Economic Area countries under the following names:
United Kingdom

Information intended exclusively for medical professionals:

Use of lidocaine for local and regional anesthesia during pregnancy
The use of lidocaine for topical anesthesia, pudendal nerve block, caudal block, or cervical anesthesia may exert toxic effects on the fetus and newborn to varying degrees (e.g., causing bradycardia, hypotonia, or respiratory depression). Accidental subcutaneous injection of lidocaine into the fetus during cervical anesthesia or perineal block may result in apnea, hypotension, and seizures, thus posing a life-threatening risk to the newborn.
In general, during pregnancy, lidocaine should be used at a concentration of 10 mg/mL.
Further information, especially regarding dosage and administration, can be found in the product's summary of characteristics.