Lidocaine hydrochloride noridem

Patient Information Leaflet

Lidocaini hydrochloridum Noridem, 10 mg/ml, solution for injection
Lidocaine hydrochloride
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v) is and what it is 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 pack and other information

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

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

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 to similar substances used as local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).
• for epidural or spinal anaesthesia (administration of anaesthetic near the spinal cord) if the patient has:
  • uncorrected low blood volume (hypovolemia),
  • reduced blood clotting (coagulopathy),
  • increased intracranial pressure,
  • bleeding within the skull or spinal cord.

Warnings and precautions

Before administering this medicine, the doctor will ensure that emergency and resuscitation equipment is available.
This medicine must be administered only under strict medical supervision. The doctor will 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 gravis),
• severe shock,
• any condition increasing the risk of seizures (epilepsy).

In particular, in elderly patients, the doctor will consider the possibility of low blood pressure as a complication of epidural or spinal anaesthesia (administration of anaesthetic near the spinal cord). Additionally, the doctor is aware that injecting this medicine into inflamed tissue may lead to increased absorption into the bloodstream and thus reduced effectiveness of the anaesthetic. In patients under 30 years of age, there is a risk of headache after spinal anaesthesia. To minimize this risk, the doctor will use a fine needle. There is also an increased risk of severe adverse effects when a compression bandage is removed after intravenous injection. Therefore, the doctor will administer the medicine in several injections. The doctor takes into account that administration of this medicine in the head and neck area carries an increased risk of adverse effects on the nervous system.

Use of Lidocaini hydrochloridum Noridem, 10 mg/ml with other medicines

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 the doctor must assess whether the medicines you are taking are metabolized by specific enzymes or affect their function (cytochrome P450 1A2 and 3A4). This step aims 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),
• antiarrhythmic medicines – used to treat irregular heartbeat,
• vasoconstrictive medicines (e.g. epinephrine, norepinephrine),
• cimetidine – a medicine used to treat heartburn,
• antiviral medicines (e.g. medicines used in HIV treatment),
• sleeping medicines and medicines that reduce consciousness (sedatives) or cause drowsiness,
• phenobarbital, phenytoin, carbamazepine or primidone – medicines used to treat epilepsy,
• medicines increasing the risk of seizures (e.g. tramadol, bupropion),
• the antibiotic erythromycin,
• antipsychotic medicines (fluvoxamine) – used to treat psychiatric disorders,
• medicines used to relax muscles during general anaesthesia,
• other local anaesthetics.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
The decision on using this medicine during pregnancy or breastfeeding will be made by the doctor.

Pregnancy
If you are pregnant, the doctor will administer this medicine only if considered 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, generally, at normal doses, this medicine will not affect the breastfed infant. There is therefore no need to interrupt 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 administered. You should consult your doctor, especially if areas involved in driving or operating machinery have been anaesthetized. If the doctor considers it necessary, you should refrain from driving and operating machinery.

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

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

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

Dosage
The dose is determined by the doctor and depends on the individual patient's condition.

Adults
The usual maximum dose is 4.5 mg/kg body weight (or 300 mg). When used together with a vasoconstrictor, the maximum dose may 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 type of procedure. In children, the maximum dose is 5 mg/kg body weight. When used 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 "complete motor block," a higher concentration (1% w/v) may be required.
This medicine should be used with caution in children under 2 years of age.

Reduced doses of lidocaine are used in certain patient groups, including:

• 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 kidney failure,
• patients with heart and/or liver disease.

Use of more than the recommended dose of Lidocaini hydrochloridum Noridem, 10 mg/ml
Symptoms of overdose depend on the level of the medicine in the blood. The higher the concentration of lidocaine 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, in most cases they resolve spontaneously after stopping lidocaine administration.

Early symptoms of lidocaine toxicity include:

• unpleasant sensation around the mouth,
• tingling, pricking, or numbness (paresthesia),
• anxiety, drowsiness, dizziness,
• speech disturbances, blurred vision,
• visual and auditory disturbances, tinnitus,
• muscle tremors, convulsions,
• transient flushing,
• increased blood pressure,
• rapid heartbeat,
• nausea, vomiting,
• hallucinations, euphoria, restlessness,
• 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 doctor will know how to proceed and will administer necessary treatment. If you have any further questions regarding the use of this product, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The frequency and severity of side effects of this medicine depend on the dose administered,
the technique used for administration, and the individual patient's reaction to lidocaine.
After administration of this medicine, local toxicity symptoms may occur. When blood concentrations
of lidocaine exceed 5–10 mg/l, systemic side effects affecting the whole body may occur. The patient
may experience symptoms involving the central nervous system, cardiovascular system, and heart
(see also section "Use of a higher than recommended dose of Lidocaini hydrochloridum Noridem 10 mg/ml (1% w/v)").
The following side effects may be serious. If any of the following occur,
contact your doctor immediately. Immediate action may be required:

Rare (may occur in less than 1 out of 1,000 patients):

• Allergic reactions – from skin rash and swelling to severe allergic reactions such as low blood pressure, breathing difficulties, bronchospasm, and shock,
• Spinal cord compression due to hematoma,
• Partial or complete paralysis,
• Persistent tingling or paralysis of limbs over time,
• Cauda equina syndrome: compression of a specific type of nerve roots, characterized by weakness of lower limb muscles, loss of control over bowel and bladder function, and loss of sensation in the perianal area,
• Damage to cranial nerves.

Other side effects include:

Very common (may occur in more than 1 out of 10 patients):

• Nausea, vomiting

Common (may occur in up to 1 out of 10 patients):

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

Rare (may occur in up to 1 out of 1,000 patients):

• Sensations such as tickling, tingling, burning, pricking, or twitching,
• Headaches associated with sensitivity to bright light (photophobia) and ringing in the ears,
• Drooping eyelid(s) in combination with constricted pupils and sometimes also reduced sweating (Horner’s syndrome) – this may occur after epidural anaesthesia or administration of anaesthetic medicine in the head or neck area,
• Chills, deafness, or injury,
• Transient irritation of nerve roots as a result of spinal anaesthesia.

Elderly patients
Elderly patients may be more susceptible to the occurrence of some of the above-mentioned side effects.

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

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or nurse. Side effects can also 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,
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to collect more information on the safety of using this medicine.

5. How to store Lidocaini hydrochloridum Noridem 10 mg/ml
Keep the medicine 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 packaging after: "EXP". The expiry date refers to the last day of the specified month.
The injection solution should be administered immediately after opening the container.
The packaging is for single use only. After opening, the container and any unused contents should be discarded.
The injection solution is suitable for use only if it is clear, colourless, practically free of particles, and the container and closure are undamaged.
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 either sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution. 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 storage conditions and duration prior to administration, which must not exceed 24 hours at 2–8°C, unless dilution was performed 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 package 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 millilitre of 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.
• 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 pack
Lidocaini hydrochloridum Noridem, 10 mg/ml, solution for injection is a clear, colourless solution.
PP ampoules 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:

Information intended exclusively for medical professionals:

Use of lidocaine for local and regional anaesthesia during pregnancy
The use of lidocaine for topical anaesthesia, pudendal nerve block, caudal block, or cervical anaesthesia 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 anaesthesia or perineal block may result in apnoea, 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 product characteristics.