LIDOCAINE 20 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: 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 all of this leaflet carefully before using this medicine because it contains important information for you.
   2. Contents of the pack
4. What Lidocaine Fresenius Kabi is and what it is used for
5. What you need to know before you use 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 more than the recommended dose of Lidocaine Fresenius Kabi
7. Possible side effects
   1. Seek immediate medical attention if you experience an allergic reaction including:
   2. Reporting side effects
8. How to store Lidocaine Fresenius Kabi
9. Contents of the pack 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:

Package Leaflet: 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 all of this leaflet carefully before using this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Lidocaine Fresenius Kabi is and what it is used for
• 2. What you need to know before you use 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 pack and other information

1. What Lidocaine Fresenius Kabi is and what it is 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. What you need to know before you use Lidocaine Fresenius Kabi

When not to use Lidocaine Fresenius Kabi:

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

Warnings and precautions

Before starting treatment with Lidocaine Fresenius Kabi, discuss with your doctor, pharmacist, or nurse:

• if you have ever had allergic reactions or side effects, such as skin rash or shortness of breath after local anesthesia;
• if you have heart disease, especially heart rhythm disorders;
• if you are taking medicines for heart rhythm disorders, such as amiodarone;
• if you are in shock;
• if you have lung disease or breathing disorders;
• if you have had seizures or epilepsy;
• if you have muscle weakness (myasthenia gravis);
• if you have bleeding disorders and are being treated with anticoagulant medicines;
• if you are elderly or in a state of general weakness;
• if you feel unwell or are tired for any reason;
• if you have kidney or liver disease;
• if you have blood diseases or any abnormalities in your blood count, especially low potassium levels in your blood, which can cause muscle cramps and constipation (hypokalemia);
• if you have increased acidity of the blood and tissues or insufficient oxygen levels;
• if you have recently had vomiting, diarrhea, or bleeding, or if you have not taken enough fluids;
• if you or your family members have been diagnosed with a rare hereditary blood disorder (porphyria) that affects the skin and nervous system;
• if you have inflammation or infection in the area where the medicine is to be injected;
• if you are pregnant, planning to become pregnant, or breastfeeding.

Children

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

Lidocaine Fresenius Kabi and other medicines

Tell your doctor or nurse about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
In particular, inform your doctor if you are taking any of the following medicines, as they may interact with Lidocaine Fresenius Kabi:

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

If lidocaine is administered with adrenaline (epinephrine), you should inform your doctor if you have high blood pressure, reduced blood flow to the brain, hyperthyroidism, or are taking antidepressant medicines. If you have previously received lidocaine with adrenaline (epinephrine) for anesthesia, you should inform your doctor. If you are taking any of the above medicines, inform your doctor before using Lidocaine Fresenius Kabi.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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 your ability to drive or operate machinery. Ask your doctor when it is safe to drive or operate machinery.
Patients should not drive or operate machinery 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 is equivalent to 4.25% of the maximum recommended daily intake of sodium 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 is equivalent to 1.6% of the maximum recommended daily intake of sodium for adults.

3. How to use Lidocaine Fresenius Kabi

Your doctor will adjust the dose of Lidocaine Fresenius Kabi individually based on your age, overall physical condition, site of administration, type of procedure, and response to anesthesia.

Using more than the recommended dose of Lidocaine Fresenius Kabi

Since the medicine is administered by trained medical personnel, there is a low risk of administering too much Lidocaine Fresenius Kabi.
However, if you think you have received too much medicine or experience dizziness, feeling of emptiness in the head, tingling, or numbness of the mouth or surrounding area, or ringing in the ears, inform the person performing the anesthesia immediately.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Seek immediate medical attention if you experience an allergic reaction including:

• swelling of 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 (feeling sick).

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);
• feeling of emptiness in the head, drowsiness, loss of consciousness, shakiness, numbness of the tongue, difficulty speaking (these symptoms may indicate that too much lidocaine has been administered).

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 feeling of tiredness 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 stopping breathing.

If you experience any of the following symptoms after epidural administration of Lidocaine Fresenius Kabi, inform your doctor:
pain or numbness in the back or legs;
difficulty walking;
problems controlling urination and bowel movements;
feeling of fainting or emptiness in the head;
slow heart rate or pulse.

Information for patients who are discharged from the hospital before the numbness or loss of sensation caused by the local anesthetic has worn off
Be careful and avoid injuries until the numbness or loss of sensation in the affected area has resolved.
Severe injuries can occur even without your knowledge while the area is still numb. Be careful and avoid injuries until the numbness or loss of sensation in the affected area has resolved.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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].
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lidocaine Fresenius Kabi

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
After opening the ampoule, the contents should be used immediately and any unused solution discarded.
Do not use this medicine 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.
Do not use this medicine 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lidocaine Fresenius Kabi contains

• The active substance is lidocaine hydrochloride.

Lidocaine 1% Fresenius Kabi, 10 mg/mL, Solution for Injection:
One mL of solution for injection contains 10 mg of lidocaine hydrochloride, which corresponds to 8.11 mg of lidocaine.
Each 5 mL of solution for injection contains 50 mg of lidocaine hydrochloride.
Each 10 mL of solution for injection contains 100 mg of lidocaine hydrochloride.
Each 20 mL of solution for injection contains 200 mg of lidocaine hydrochloride.
Lidocaine 2% Fresenius Kabi, 20 mg/mL, Solution for Injection:
One mL of solution for injection contains 20 mg of lidocaine hydrochloride, which corresponds to 16.22 mg of lidocaine.
Each 5 mL of solution for injection contains 100 mg of lidocaine hydrochloride.
Each 10 mL of solution for injection contains 200 mg of lidocaine hydrochloride.
Each 20 mL of 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, free from 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
For more information, 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 drug has not been established in this age group to avoid toxic effects, such as seizures 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 for particulate matter and discoloration prior to administration, and not used if it contains particles or is discolored.
If the solution is diluted in sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution, under strictly aseptic conditions, it should be used within 12 hours.
Lidocaine is incompatible with solutions containing amphotericin B, sulfadiazine sodium, methohexital sodium, cefazolin sodium, phenytoin, and triazotan glycerol, as well as other solutions with a basic pH. Therefore, it is not recommended to mix Lidocaine Fresenius Kabi with other substances.
Medicines that are stable in acidic environments, such as adrenaline hydrochloride, noradrenaline vinian, or isoprenaline, may degrade when mixed with lidocaine hydrochloride, as lidocaine solutions may increase the pH of the solution above the maximum value at which these medicines are stable.
Disposal of unused medicinal products
Any unused medicinal products or waste materials should be disposed of in accordance with local requirements.