Lidocaini hidrohloridum Noridem

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

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

Lidocaine hydrochloride

You should carefully read the contents of this leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4. Table of contents of the leaflet :
• 1. What is Lidocaini hydrochloridum Noridem 20 mg/ml (2 % w/v) and what is it 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 packaging and other information

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

used for
The active substance of Lidocaini hydrochloridum Noridem, 20 mg/ml is lidocaine hydrochloride.
Lidocaine is a local and regional anesthetic. It is used to anesthetize a specific area of the body before a surgical procedure.
This medicine can be administered to adults and children. However, when administering the medicine to a child, special precautions should be taken (see also "How to use Lidocaini hydrochloridum Noridem, 20 mg/ml"). In particular, it should be taken into account that there is limited data available on the use of the medicine in children under 2 years of age.
Additionally, the medicine can be used to control severe ventricular arrhythmias (ventricular tachycardia or tachyarrhythmia), but only if the doctor considers the patient's condition life-threatening.
This medicine can be administered to adults and children. However, when administering the medicine to a child, special precautions should be taken (see also "How to use Lidocaini hydrochloridum Noridem, 20 mg/ml"). In particular, it should be taken into account that there is limited data available on the use of the medicine in children.

2. Important information before using Lidocaini hydrochloridum Noridem, 20 mg/ml

mg/ml

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

• if you are allergic to lidocaine hydrochloride or other similar substances also used as local anesthetics or any of the other ingredients of this medicine (listed in section 6). Local and regional anesthesia Do not use the medicine for epidural or spinal anesthesia (administration of an anesthetic in the area around the spinal cord), if you have:
• uncontrolled low blood volume (hypovolemia),
• low blood clotting (coagulopathy);
• increased intracranial pressure;
• bleeding in the skull or spine. Control of ventricular arrhythmias Do not usethemedicine if:
• you have severe heart rhythm disorders, especially irregular or slow heart rhythm;
• you have had a heart attack in the last 3 months;
• your heart's ability to pump blood throughout the body is significantly reduced, unless your condition is life-threatening.

Warnings and precautions

Before administering this medicine to you, your doctor will ensure that emergency equipment is available.
The medicine is administered only under close medical supervision. The doctor will be particularly cautious if you have any of the following conditions:

• previous allergy to local anesthetics,
• heart or lung problems,
• liver or kidney disease,
• autoimmune disease leading to muscle weakness (myasthenia)
• severe shock,
• any condition that increases the risk of seizures and convulsions (epilepsy), Local and regional anesthesia Especially in elderly patients, the doctor will consider the possibility of hypotension as a complication of epidural or spinal anesthesia (administration of an anesthetic in the area around the spinal cord). Additionally, the doctor knows that injecting this medicine into inflamed tissue can lead to increased absorption of the medicine into the bloodstream and thus weaken its effect on the body. In patients under 30 years of age, there is a risk of headache after spinal anesthesia. To minimize this risk, the doctor uses a small needle. Additionally, there is a risk of increased side effects when removing the tourniquet after intravenous injection. Therefore, the doctor administers the medicine in several injections.

Your doctor will consider that there is an increased risk of neurological side effects when this medicine is administered in the head and neck area.
Control of ventricular arrhythmias
In the treatment of heart problems, if you have severe acidosis (acidosis),
this medicine is administered with caution.
Before administering large doses of this medicine to you, your doctor will correct any low potassium levels in your blood, oxygen deficiency, and acid-base imbalance. If you receive this medicine for a long period, your doctor will monitor your fluid balance, electrolyte levels in your blood, and acid-base balance. During administration of the medicine, your doctor will monitor your heart rate, blood pressure, level of consciousness, and breathing.
Note:
If you are anesthetized, your doctor will closely monitor your condition, as side effects from the nervous system and heart may go unrecognized and occur without prior warning signs.

Using Lidocaini hydrochloridum Noridem 20 mg/ml (2 % w/v) with other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is necessary because your doctor needs to assess whether the medicines you are taking are metabolized by specific enzymes or affect their function (cytochrome P450 1A2 and 3A4). This is done to avoid interactions between Lidocaini hydrochloridum Noridem 20 mg/ml (2 % w/v) and other medicines you are taking.
In particular, you should inform your doctor if you are taking any of the following medicines:

• certain heart medicines, such as beta-blockers (e.g., metoprolol, propranolol) or calcium channel blockers (e.g., amiodarone)
• anti-arrhythmic medicines - used to treat heart rhythm disorders;
• medicines that constrict blood vessels (vasoconstrictors, e.g., epinephrine, norepinephrine);
• cimetidine - a medicine used to treat heartburn;
• antiviral medicines (e.g., medicines used to treat HIV);
• sedatives and medicines that lower the level of consciousness (sedatives) or cause drowsiness;
• phenobarbital, phenytoin, carbamazepine, or primidone - medicines used to treat epilepsy;
• medicines that increase the risk of seizures and convulsions (e.g., tramadol, bupropion);
• the antibiotic erythromycin;
• antipsychotic medicines (fluvoxamine) - used to treat mental illnesses;
• medicines used to relax muscles during general anesthesia;
• other anesthetic medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before using this medicine. The use of the medicine during pregnancy and breastfeeding will be decided by your doctor.
Pregnancy
If you are pregnant, your doctor 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 you are breastfeeding, your doctor will be cautious. However, in general, at usual doses, this medicine will not affect the breastfed baby. There is no need to stop breastfeeding.

Driving and using machines

The effect of lidocaine on the ability to drive and use machines depends on the type of procedure performed and the dose used. You should consult your doctor, especially if the areas of the body that were anesthetized are involved in driving or using machines. If your doctor considers it necessary, you should avoid driving and using machines.

Lidocaini hydrochloridum Noridem, 20 mg/ml contains sodium

Ampoules of 2 ml, 5 ml, and 10 ml:
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".
Ampoules of 20 ml:
The medicine contains 38.1-41.0 mg of sodium (the main component of table salt) in each 20 ml ampoule.
This corresponds to 1.90-2.05% of the maximum recommended daily intake of sodium in the diet for adults.

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

This medicine is administered by a doctor.
This medicine is administered by injection into a vein, under the skin, into a muscle, bone, spine, or nerve.

Dosage

The dose is determined by your doctor. It depends on your individual condition.
Local and regional anesthesia
Adults
The usual maximum dose is 4.5 mg/kg body weight (or 300 mg). If the medicine is used together with a vasoconstrictor, the maximum dose can be increased to 7 mg/kg body weight (or 500 mg).
Children and adolescents
In children and adolescents, the dose is determined individually, based on age, body weight, and the type of procedure. In children, the maximum dose is 5 mg/kg body weight. If the medicine is used together with a vasoconstrictor, the maximum dose can be increased to 7 mg/kg body weight.
In children, a lower concentration of the medicine (0.5%) should be used for anesthesia. For a special technique called complete motor block, a higher concentration (1% w/v) may be necessary.
In children under 2 years of age, this medicine should be used with caution.
Control of ventricular arrhythmias
The dose should be adjusted to individual needs and expected therapeutic effect.
This is especially important in patients with heart, liver, or kidney problems, as well as in pregnant women.
In some patient groups, a reduced dose of lidocaine is used. These include:

• pregnant women,
• infants,
• younger children,
• children with high body weight,
• elderly patients,
• patients with poor overall health,
• patients with impaired protein binding,
• patients with kidney failure,
• patients with heart and/or liver disease.

Using a higher dose of Lidocaini hydrochloridum Noridem, 20 mg/ml than recommended

The occurrence of overdose symptoms in you depends on the level of lidocaine in your blood. The more lidocaine circulating in your blood and the faster it is administered, the more likely and severe the overdose symptoms will be.
Mild overdose mainly affects the central nervous system. If side effects occur, in most cases, they will resolve on their own after the administration of lidocaine is stopped.
The initial symptoms of lidocaine poisoning are:

• unpleasant sensation around the mouth,
• tingling, numbness, or prickling sensation (paresthesia), anxiety, drowsiness, dizziness,
• speech disorders, blurred vision,
• visual and hearing disturbances, tinnitus,
• muscle twitching, convulsions,
• flushing, increased blood pressure,
• rapid heart rate, nausea, vomiting,
• hallucinations, euphoria, anxiety, chills. More severe symptoms include:
• sudden drop in blood pressure,
• pallor, disturbances, and even loss of consciousness (coma),
• respiratory arrest, cardiac arrest, slow or irregular heart rhythm, death. In case of severe symptoms, your doctor will know how to act and will administer the necessary treatment to you.

In case of any further questions related to the use of this product, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency and severity of side effects of this medicine depend on the dose administered, the technique used, and your individual reaction to lidocaine.
After administration of this medicine, local toxicity symptoms may occur. Systemic side effects may occur when the lidocaine concentration in your blood exceeds 5-10 mg/l. You may experience symptoms from the central nervous system, cardiovascular system, and heart (see also "Using a higher dose of Lidocaini hydrochloridum Noridem, 20 mg/ml than recommended").

Local and regional anesthesia

The following side effects can be serious. If you experience any of the following side effects, you should immediately inform your doctor. Immediate action may be necessary:
rarely (may occur in less than 1 in 1000 patients):

• allergic reactions - from rash and edema to severe allergic reactions, such as low blood pressure, difficulty breathing, bronchospasm, and shock,
• spinal cord compression due to hematoma,
• partial or complete paralysis,
• permanent numbness or paralysis of the limbs,
• cauda equina syndrome:a specific type of nerve root compression, characterized by weakness of the lower limbs, loss of control over bowel and bladder function, and loss of sensation in the perianal area ,
• cranial nerve damage. Other side effects include: very common (may occur in more than 1 in 10 patients):
• nausea, vomiting common (may occur in less than 1 in 10 patients)
• pain in the legs and lower back after epidural or spinal anesthesia. The pain can last for up to 5 days and resolves on its own without treatment.

rarely (may occur in less than 1 in 1000 patients):

• sensations such as tingling, numbness, burning, prickling, or itching,
• headaches with accompanying photophobia and tinnitus,
• ptosis (drooping eyelid) in combination with miosis (constricted pupils) and sometimes decreased sweating (Horner's syndrome) - occurs after epidural or spinal anesthesia or administration of an anesthetic in the head or neck area,
• chills, deafness, or trauma,
• transient irritation of nerve endings due to spinal anesthesia.

Control of ventricular arrhythmias
The following side effects can be serious. If you experience any of the following side effects, you should immediately inform your doctor. Immediate action may be necessary:
rarely (may occur in less than 1 in 1000 patients):

• allergic reactions - from rash and edema to severe allergic reactions, such as low blood pressure, difficulty breathing, bronchospasm, and shock,
• muscle twitching and even generalized seizures and convulsions,
• decreased level of consciousness and even coma,
• slow heart rate, heart block, and even heart attack,
• low blood pressure, difficulty breathing, and even respiratory arrest.

very rare (may occur in less than 1 in 10,000 patients):

• rapid heart rate

very common (may occur in more than 1 in 10 patients):

• nausea, vomiting,
• anxiety, difficulty swallowing, common (may occur in less than 1 in 10 patients)
• disorientation, anxiety, irritability, euphoria, hallucinations, depression,
• drowsiness, dizziness, feeling of spinning, speech disorders, tinnitus, blurred vision,
• sensations such as tingling, numbness, burning, prickling, or itching of the skin,

Elderly patients
Elderly patients may be more prone to certain side effects mentioned above.
Children
The frequency, type, and severity of side effects in children are likely to be the same as in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or nurse. Side effects can also be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Reporting side effects will help to gather more information on the safety of this medicine.

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

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the ampoule and carton after "EXP". The expiry date refers to the last day of the month stated.
The solution for injection should be administered immediately after opening the packaging.
The packaging is for single use only. After opening, the packaging should be discarded along with any unused contents.
The solution for injection is suitable for use only if it is clear, colorless, and practically free of particles, and the packaging and closure are not damaged.
Chemical and physical stability after dilution has been demonstrated for up to 24 hours at both 25°C and 2-8°C when diluted with sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution. From a microbiological point of view, the product should be used immediately. If the ready-to-use solution for injection is not used immediately, the in-use storage time and conditions are the responsibility of the user and would not normally be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

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

• The active substance of the medicine is lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate). Each milliliter of the 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 does Lidocaini hydrochloridum Noridem, 20 mg/ml, solution for injection look like and what does the packaging contain

Lidocaini hydrochloridum Noridem, 20 mg/ml, solution for injection is a clear and colorless solution.
PP ampoules of 2 ml, 5 ml, 10 ml, and 20 ml in a cardboard box. Each packaging contains 5, 10, 20, 50, or 100 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
Phone: +30 210 8161802, Fax: +30 2108161587

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Data of the last update of the leaflet:

Information intended for healthcare professionals only:

Use of lidocaine for local and regional anesthesia during pregnancy
The use of lidocaine for epidural, pudendal nerve block, or cervical anesthesia may have toxic effects on the fetus and newborn (e.g., bradycardia, hypotension, or respiratory depression). Accidental subcutaneous injection of lidocaine into the fetus during cervical or pudendal nerve block may cause apnea, hypoxia, and seizures, and thus pose a risk to the newborn's life.
In general, during pregnancy, lidocaine should be used at a concentration of 10 mg/ml.
More information, especially on dosing and administration, can be found in the summary of product characteristics.