Lidocaini hidrohloridum Noridem

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: patient information

Lidocaini hydrochloridum Noridem, 10 mg/ml, solution for injection

Lidocaine hydrochloride

Read carefully the contents of the leaflet 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v) and what is it used for
• 2. Important information before using Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v)
• 3. How to use Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v)
• 4. Possible side effects
• 5. How to store Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v)
• 6. Contents of the packaging and other information

1. What is Lidocaini hydrochloridum Noridem, 10 mg/ml and what is it used for

The active substance of Lidocaini hydrochloridum Noridem, 10 mg/ml is lidocaine hydrochloride.
It is used to anesthetize a specific area of the body before a surgical procedure in adults and children. However, when administering the medicine to a child, special precautions should be taken (see also "How to use Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v)"). In particular, it should be taken into account that in the case of children under 2 years of age, only limited data are available.

• 2. In children under 2 years of age, only limited data are available.

2. Important information before using Lidocaini hydrochloridum Noridem, 10 mg/ml

Do not use Lidocaini hydrochloridum Noridem, 10 mg/ml (1% w/v)

if you are allergic to lidocaine hydrochloride or similar substances also used as local anesthetics or any of the other ingredients of this medicine (listed in section 6). Do not use the medicine for epidural or spinal anesthesia if you have:

• uncorrected low blood volume (hypovolemia),
• low blood clotting (coagulopathy),
• increased intracranial pressure,
• bleeding in the brain or spinal cord.

Warnings and precautions

Before administering this medicine, the doctor will ensure that emergency equipment is available.
The medicine is administered only under close medical supervision. The doctor will exercise particular caution if the patient has a history of:

• 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), especially in elderly patients, the doctor will consider the possibility of low blood pressure as a complication of epidural or spinal anesthesia. Additionally, the doctor will be aware that injecting this medicine into inflamed tissue may lead to increased absorption into the bloodstream and thus weaken the effect of the medicine 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 will use a small needle. Furthermore, there is a risk of severe side effects when removing the tourniquet after intravenous injection. Therefore, the doctor will administer the medicine in several injections. The doctor will consider that when administering this medicine in the head and neck area, there is an increased risk of neurological side effects.

Using Lidocaini hydrochloridum Noridem, 10 mg/ml with other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or might take.

This is necessary because the 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 to avoid interactions between Lidocaini hydrochloridum Noridem, 10 mg/ml (1% w/v) and other medicines you are taking.
In particular, 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 irregular heartbeat,
• 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 reduce 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 local anesthetics.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The use of the medicine during pregnancy and breastfeeding will be decided by the doctor.
Pregnancy
If you are pregnant, the 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, the doctor will exercise particular caution. 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 anesthetized areas are involved in driving or using machines. If the doctor considers it necessary, you should avoid driving and using machines.

Lidocaini hydrochloridum Noridem, 10 mg/ml contains sodium

Ampoules of 2 ml and 5 ml:
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".
Ampoules of 10 ml and 20 ml:
The medicine contains 26.8-27.4 mg of sodium (the main component of table salt) per 10 ml ampoule and 53.6-54.9 mg of sodium per 20 ml ampoule. This corresponds to 1.34-1.37% and 2.68-2.74% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v)

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

Dosage

The dose is decided by the doctor. It depends on the individual patient's condition.
Adults
The usual maximum dose is 4.5 mg/kg body weight (or 300 mg). When used with a vasoconstrictor, the maximum dose can be increased to 7 mg/kg body weight (or 500 mg).
Children and adolescents
The dose is determined individually based on age, body weight, and the type of procedure. The maximum dose for children is 5 mg/kg body weight. When used 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 stronger concentration (1% w/v) may be necessary. In children under 2 years of age, this medicine should be used with caution.
In some patient groups, a reduced dose of lidocaine is used. These include:

• women who are pregnant,
• infants,
• younger children,
• children with a 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, 10 mg/ml

The occurrence of overdose symptoms in a patient depends on the level of the medicine in the blood. The more lidocaine circulating in the blood and the faster it is administered to the patient, 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.
Symptoms that may occur at the beginning of lidocaine poisoning include:

• unpleasant sensation around the mouth,
• tingling, stinging, or burning sensation (paresthesia),
• restlessness, drowsiness, dizziness,
• speech disorders, blurred vision,
• visual and hearing disturbances, tinnitus,
• muscle twitching, convulsions,
• flushing, increased blood pressure,
• rapid heart rate,
• vomiting, nausea,
• hallucinations, euphoria, restlessness,
• chills. More severe symptoms include:
• sudden drop in blood pressure,
• pallor,
• disorders, including loss of consciousness (coma),
• respiratory arrest,
• cardiac arrest, slow or irregular heart rate,
• death. In case of severe symptoms, the doctor will know how to act and will provide the necessary treatment to the patient. If you have any further questions about the use of this product, ask 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 used, the technique of administration, and the individual patient's reaction to lidocaine.
After administration of this medicine, local toxicity symptoms may occur. At a lidocaine concentration in the blood exceeding 5-10 mg/l, systemic side effects may occur. The patient may experience symptoms in the central nervous system, cardiovascular system, and heart (see also "Using a higher dose of Lidocaini hydrochloridum Noridem, 10 mg/ml (1% w/v)").

The following side effects may occur. If you experience any of the following side effects, tell your doctor immediately:

• allergic reactions - from rash and edema to severe allergic reactions, such as low blood pressure, difficulty breathing, bronchospasm, and anaphylaxis,
• spinal cord compression due to hematoma,
• partial or complete paralysis,
• permanent numbness or paralysis of the lower 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 perineal area,
• cranial nerve damage. Other side effects include:

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

• nausea, vomiting
• Common (may affect up to 1 in 10 people):
• leg and lower back pain after epidural or spinal anesthesia. The pain may last for up to 5 days and will resolve on its own without treatment.
• Uncommon (may affect up to 1 in 100 people):
• sensations such as tingling, numbness, burning, stinging, or prickling,
• headache with accompanying photophobia and tinnitus,
• ptosis (drooping eyelid) with miosis (constricted pupil) and sometimes decreased sweating (Horner's syndrome) - occurs after epidural or spinal anesthesia or injection of the anesthetic in the head or neck area,
• chills, deafness, or trauma,
• transient irritation of nerve roots due to spinal anesthesia.

Elderly patients
Elderly patients may be more susceptible 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, tell your doctor, pharmacist, 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,
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 side effects will help to gather more information on the safety of this medicine.

5. How to store Lidocaini hydrochloridum Noridem, 10 mg/ml

Keep the medicine out of the 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 used immediately after opening the packaging.
The packaging is for single use only. After opening, discard the packaging with any unused contents.
The solution for injection is suitable for use only if it is clear, colorless, and practically free from particles, and the packaging and closure are not damaged.
Chemical and physical stability after dilution for up to 24 hours at 25°C and 2-8°C has been demonstrated for dilution with sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) solutions. 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 times and conditions are the responsibility of the user and would normally not 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. 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 Lidocaini hydrochloridum Noridem, 10 mg/ml, solution for injection contains

• The active substance is lidocaine hydrochloride (in the form of lidocaine hydrochloride monohydrate). Each milliliter of the solution contains 10 mg of lidocaine hydrochloride. Each 2 ml ampoule contains 20 mg of lidocaine hydrochloride. Each 5 ml ampoule contains 50 mg of lidocaine hydrochloride. Each 10 ml ampoule contains 100 mg of lidocaine hydrochloride. Each 20 ml ampoule contains 200 mg of lidocaine hydrochloride.
• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

What Lidocaini hydrochloridum Noridem, 10 mg/ml, solution for injection looks like and contents of the packaging

Lidocaini hydrochloridum Noridem, 10 mg/ml, solution for injection is a clear and colorless solution.
Ampoules made of polypropylene with a capacity 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:

Date of last revision 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, caudal 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.
Generally, 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.