LIDOCAINE 10 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Lidocaine 1% Fresenius Kabi, 10 mg/mL, solution for injection
3. Lidocaine 2% Fresenius Kabi, 20 mg/mL, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Lidocaine Fresenius Kabi and what is it used for
5. Important information before using Lidocaine Fresenius Kabi
   1. When not to use Lidocaine Fresenius Kabi:
   2. Warnings and precautions
   3. Children
   4. Lidocaine Fresenius Kabi and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Lidocaine 1% Fresenius Kabi, 10 mg/mL, solution for injection contains sodium
   8. Lidocaine 2% Fresenius Kabi, 20 mg/mL, solution for injection contains sodium
6. How to use Lidocaine Fresenius Kabi
   1. Using a higher dose of Lidocaine Fresenius Kabi than recommended
7. Possible side effects
   1. The patient should contact their doctor immediately if they experience an allergic reaction involving:
   2. Reporting side effects
8. How to store Lidocaine Fresenius Kabi
9. Contents of the packaging and other information
   1. What Lidocaine Fresenius Kabi contains
   2. What Lidocaine Fresenius Kabi looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:
   8. Information intended for healthcare professionals only:

Leaflet attached to the packaging: information for the user

Lidocaine 1% Fresenius Kabi, 10 mg/mL, solution for injection

Lidocaine 2% Fresenius Kabi, 20 mg/mL, solution for injection

Lidocaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Lidocaine Fresenius Kabi and what is it used for
• 2. Important information before using Lidocaine Fresenius Kabi
• 3. How to use Lidocaine Fresenius Kabi
• 4. Possible side effects
• 5. How to store Lidocaine Fresenius Kabi
• 6. Contents of the packaging and other information

1. What is Lidocaine Fresenius Kabi and what is it used for

Lidocaine Fresenius Kabi is a local anesthetic.
It is used for local anesthesia and pain relief in the area of the body where the medicine has been administered.

2. Important information before using Lidocaine Fresenius Kabi

When not to use Lidocaine Fresenius Kabi:

• if the patient is allergic (hypersensitive) to lidocaine hydrochloride, other amide-type anesthetics, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a reduced amount of circulating blood in the body (hypovolemia);
• if the patient has certain heart rhythm disorders (irregular or slow heart rhythm).

Warnings and precautions

Before starting treatment with Lidocaine Fresenius Kabi, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has ever had allergic reactions or side effects, such as skin rash or shortness of breath after local anesthesia;
• if the patient has heart disease, especially heart rhythm disorders;
• if the patient is taking medicines for heart rhythm disorders, such as amiodarone;
• if the patient is in shock;
• if the patient has lung disease or breathing disorders;
• if the patient has seizures or epilepsy;
• if the patient has muscle weakness (myasthenia);
• if the patient has blood clotting disorders and is being treated with blood thinning medicines;
• if the patient is elderly or in a state of general weakness;
• if the patient feels unwell or is tired and exhausted for any reason;
• if the patient has kidney or liver disease;
• if the patient has blood diseases or any blood abnormalities, especially low potassium levels in the blood, leading to muscle cramps and constipation (hypokalemia);
• if the patient has increased blood acidity or insufficient oxygen levels;
• if the patient has recently experienced vomiting, diarrhea, or bleeding, or has not taken enough fluids;
• if the patient or their relatives have been diagnosed with a rare inherited blood disorder (porphyria) that affects the skin and nervous system;
• if the patient has inflammation or infection in the area where the medicine is to be injected;
• if the patient is pregnant, plans to become pregnant, or is breastfeeding.

Children

Lidocaine Fresenius Kabi is not recommended for use in newborns (under 1 month of age).

Lidocaine Fresenius Kabi and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
In particular, the patient should inform their doctor if they are taking any of the following medicines, as they may interact with Lidocaine Fresenius Kabi:

• medicines used to treat high blood pressure, including diuretics, beta-blockers such as propranolol, timolol, and calcium channel blockers such as verapamil, prenylamine;
• medicines used to treat heart rhythm disorders, such as amiodarone, mexiletine, phenytoin;
• medicines used to stimulate heart function or treat shock, such as dopamine;
• medicines used to treat heart failure or shock, such as dopamine;
• medicines used to prevent blood clots (anticoagulants), such as heparin;
• medicines used to treat stomach ulcers, such as cimetidine, ranitidine;
• medicines used to treat infections, such as quinupristin, dalfopristin;
• medicines used to treat viral infections, such as amprenavir, atazanavir, darunavir, lopinavir;
• strong painkillers, such as fentanyl, codeine, pethidine;
• medicines used to treat migraines, such as ergotamine;
• muscle relaxants, such as suxamethonium;
• medicines used to treat certain types of muscle spasms, such as serotonin;
• medicines used to treat mental disorders, such as sertindole, pimozide, fluvoxamine, olanzapine, quetiapine, zotepine;
• medicines used to treat nausea and vomiting, such as dolasetron, tropisetron;
• medicines that lower eye pressure, such as acetazolamide;
• oral contraceptives and hormone replacement therapy.

If lidocaine is administered with adrenaline (epinephrine), the patient should inform their doctor if they have high blood pressure, reduced blood flow to the brain, hyperthyroidism, or are taking antidepressant medicines. Patients who are scheduled to receive a strong anesthetic for sedation should inform their doctor if they have previously received lidocaine with adrenaline (epinephrine).
If the patient is taking any of the above medicines, they should inform their doctor before using Lidocaine Fresenius Kabi.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Lidocaine Fresenius Kabi can be used in pregnant and breastfeeding women when necessary.

Driving and using machines

Depending on the dose and site of administration, Lidocaine Fresenius Kabi may impair the ability to drive and use machines. The patient should ask their doctor when it will be safe to drive and use machines.
Patients should not drive or use machines if the use of Lidocaine Fresenius Kabi has affected their psychomotor performance.

Lidocaine 1% Fresenius Kabi, 10 mg/mL, solution for injection contains sodium

This medicine contains 85 mg (approximately 3.72 mmol) of sodium (the main component of common salt) per dose.
This corresponds to 4.25% of the maximum daily sodium intake recommended for adults.

Lidocaine 2% Fresenius Kabi, 20 mg/mL, solution for injection contains sodium

This medicine contains 32 mg (approximately 1.39 mmol) of sodium (the main component of common salt) per dose.
This corresponds to 1.6% of the maximum daily sodium intake recommended for adults.

3. How to use Lidocaine Fresenius Kabi

The doctor will adjust the individual dose of the medicine based on the patient's age, overall physical condition, site of administration, type of procedure, and response to anesthesia.

Using a higher dose of Lidocaine Fresenius Kabi than recommended

Since the medicine is administered by trained medical personnel, there is a low risk of administering too high a dose of Lidocaine Fresenius Kabi.
However, if the patient believes they have received too high a dose of the medicine or experiences dizziness or a feeling of emptiness in the head, numbness or tingling of the lips or around the lips, or ringing in the ears, they should immediately inform the person performing the anesthesia.
In case of any further doubts about the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Lidocaine Fresenius Kabi can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience an allergic reaction involving:

• swelling of the hands, feet, face, lips, mouth, tongue, or throat;
• difficulty breathing;
• itchy skin rash;
• fever;
• low blood pressure or shock.

Other possible side effects:
Very common(may affect more than 1 in 10 people):

• low blood pressure;
• nausea (vomiting).

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

• paresthesia (tingling, numbness);
• dizziness;
• slow heart rate;
• high blood pressure;
• vomiting.

Uncommon(may affect up to 1 in 100 people):

• seizures (convulsions);
• a feeling of emptiness in the head, drowsiness, loss of consciousness, tremors, numbness of the tongue, difficulty speaking (these symptoms may indicate an overdose of lidocaine).

Rare(may affect up to 1 in 1,000 people):

• allergic reactions, such as hives, skin rash, sudden swelling of the skin and mucous membranes, difficulty breathing, and in severe cases, low blood pressure and shock;
• facial rash, itching of the face, or facial swelling;
• pain, inflammation, or numbness at the injection site that persists after the anesthesia has worn off;
• balance and coordination disorders (peripheral nerve damage);
• inflammation of the membranes surrounding the nerves (arachnoiditis);
• blurred or double vision;
• temporary loss of vision;
• heart rhythm disorders;
• cardiac arrest (heart attack).

Frequency not known(frequency cannot be estimated from the available data):

• blue discoloration of the skin, headache, shortness of breath, and fatigue due to abnormal levels of methemoglobin (a type of hemoglobin that has limited ability to bind oxygen) in the blood;
• agitation (nervousness);
• loss of consciousness;
• ringing in the ears (tinnitus);
• increased sensitivity to sounds;
• difficulty breathing or respiratory arrest.

If the patient experiences any of the following symptoms after epidural administration of Lidocaine Fresenius Kabi, they should inform their doctor:
pain or numbness in the back or lower limbs;

• difficulty walking;
• problems controlling urination and bowel movements;
• a feeling of fainting or emptiness in the head;
• slow heart rate or pulse.

Information for patients who are discharged home before the numbness or loss of sensation caused by the local anesthetic has worn off
When numbness persists in the anesthetized area, serious injuries may occur without the patient's knowledge.
The patient should exercise caution and avoid injuries until normal sensation returns to the anesthetized area of the body.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lidocaine Fresenius Kabi

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
After opening the ampoule, the contents should be used immediately, and any unused solution should be discarded.
The medicine should not be used if the ampoule is damaged or broken.
After dilution in sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution, under strictly aseptic conditions, the solution should be used immediately.
If the diluted solution is not used immediately, it should not be stored for more than 12 hours under strictly aseptic conditions, at a temperature below 25°C.
The medicine should not be used after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Lidocaine Fresenius Kabi contains

• The active substance of the medicine is lidocaine hydrochloride.

Lidocaine 1% Fresenius Kabi, 10 mg/mL, solution for injection:
One mL of the solution for injection contains 10 mg of lidocaine hydrochloride, which corresponds to 8.11 mg of lidocaine.
Each 5 mL of the solution for injection contains 50 mg of lidocaine hydrochloride.
Each 10 mL of the solution for injection contains 100 mg of lidocaine hydrochloride.
Each 20 mL of the solution for injection contains 200 mg of lidocaine hydrochloride.
Lidocaine 2% Fresenius Kabi, 20 mg/mL, solution for injection:
One mL of the solution for injection contains 20 mg of lidocaine hydrochloride, which corresponds to 16.22 mg of lidocaine.
Each 5 mL of the solution for injection contains 100 mg of lidocaine hydrochloride.
Each 10 mL of the solution for injection contains 200 mg of lidocaine hydrochloride.
Each 20 mL of the solution for injection contains 400 mg of lidocaine hydrochloride.

• The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Lidocaine Fresenius Kabi looks like and contents of the pack

Lidocaine Fresenius Kabi is a clear, colorless, aqueous solution, without visible particles.
Lidocaine Fresenius Kabi is available in LDPE ampoules with a "twist-off" opening system.
Pack sizes:
5, 10, 20, 50, or 100 ampoules of 5 mL
5, 10, 20, 50, or 100 ampoules of 10 mL
5, 10, 20, 50, or 100 ampoules of 20 mL
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal - Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal
To obtain more detailed information, the patient should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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:

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Information intended for healthcare professionals only:

Special warnings
Lidocaine in solution for injection is not indicated for use in newborns. The optimal serum concentration of the medicine has not been established in this age group, which would allow the toxic effect to be avoided, manifested by, for example, convulsions and heart rhythm disorders.
Storage and incompatibilities
Lidocaine Fresenius Kabi solution for injection may be diluted in sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution.
The diluted solution should be inspected visually and not used if it contains opalescence, visible particles, or sediment.
If the medicine has been diluted in sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution, under strictly aseptic conditions, the solution should be used within 12 hours.
Lidocaine is incompatible with solutions containing amphotericin B, sulfadiazine sodium, methohexital sodium, cefazolin sodium, phenytoin, and glyceryl trinitrate, as well as other solutions with a alkaline reaction. Therefore, it is not recommended to mix Lidocaine Fresenius Kabi with other substances.
Medicines that are stable in an acidic environment, such as adrenaline hydrochloride, noradrenaline vinbarbitone, or isoprenaline, may degrade after mixing with lidocaine hydrochloride, as lidocaine solutions may increase the pH of the solution above the maximum value at which they are stable.
Disposal of unused medicine
Any unused medicine or waste material should be disposed of in accordance with local regulations.