Xilocaine 2%

Leaflet attached to the packaging: information for the user

Xylocaine 2%, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Xylocaine 2% and what is it used for

Xylocaine 2% contains the active substance lidocaine hydrochloride, which belongs to a group of medicines called local anesthetics of the amide type.
Xylocaine 2% is indicated for use in adults and adolescents over 12 years of age for:

• infiltration anesthesia,
• peripheral nerve blocks, such as brachial plexus block, intercostal block,
• central blocks with epidural and spinal anesthesia.

In children from 1 year to 12 years of age, it is recommended to use another medicine with a lower concentration of lidocaine hydrochloride.

2. Important information before using Xylocaine 2%

When not to use Xylocaine 2%:

• if the patient is allergic to lidocaine hydrochloride, other local anesthetics of the amide type, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to methyl and (or) propyl parahydroxybenzoate [methyl and (or) propylparaben] or their metabolite, para-aminobenzoic acid (PABA),
• if, for any reason, local anesthesia is contraindicated, for epidural anesthesia in patients with very low blood pressure, e.g., in cardiogenic or hypovolemic shock, for spinal anesthesia, or for caudal anesthesia.

Warnings and precautions

Before starting treatment with Xylocaine 2%, discuss it with your doctor or nurse:

• if the patient has experienced an allergic reaction (hypersensitivity) during or after anesthesia, if the patient has been diagnosed with an allergy to local anesthetics,
• if the patient is breastfeeding,
• if the patient has severe liver disease or reduced liver blood flow,
• if the patient has kidney function disorders,
• if the patient has heart rhythm disorders (e.g., partial or complete heart block),
• if the patient has circulatory disorders,
• if the patient has fluid in the chest cavity (pleural effusion),
• if the patient has blood poisoning (sepsis),
• if the patient is taking antiarrhythmic medications, such as amiodarone,
• if the patient has acute porphyria.

Rarely, in some types of anesthesia, nerve damage may occur, which can sometimes be permanent. Certain types of injections near the eye can very rarely cause transient blindness and prolonged eye muscle disorders.

Children and adolescents

Xylocaine 2% is indicated for use in adolescents over 12 years of age.
In children from 1 year to 12 years of age, it is recommended to use another medicine - a solution for injection with a lower concentration of lidocaine hydrochloride.

Xylocaine 2% and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as medicines the patient plans to take, including those available without a prescription.
Also, inform your doctor about any worrying reactions that have occurred after taking other medicines.
In particular, inform your doctor about taking any of the following medicines:

• other local anesthetics
• medicines used to treat irregular heartbeat (e.g., amiodarone, mexiletine)
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine)
• beta-blockers (medicines used to treat high blood pressure and hyperthyroidism)

Xylocaine 2% with food and drink

Not applicable.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Lidocaine crosses the placenta and may enter fetal tissues.
Lidocaine enters human milk in small amounts, but its effect on the breastfed child is unlikely if used in recommended doses.

Driving and operating machinery

Depending on the dose, local anesthetics may have a slight effect on mental functions, as well as affect motor functions and coordination.

Xylocaine 2% contains methyl parahydroxybenzoate (E 218) and sodium

The medicine may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm. The medicine should not be used for spinal anesthesia, or for caudal anesthesia.
The medicine contains 124.5 mg of sodium (main component of common salt) per vial (50 ml). This corresponds to 6.23% of the maximum recommended daily sodium intake in adults.

3. How to use Xylocaine 2%

Xylocaine 2% is administered by a doctor in a hospital setting.
The doctor will determine the appropriate dose of Xylocaine 2% based on the type of anesthesia and the patient's general condition.

Using Xylocaine 2% in elderly patients

In elderly patients, the dose of the medicine should be reduced.

Using a higher than recommended dose of Xylocaine 2%

Severe side effects due to overdose are extremely rare and require specialized treatment. The doctor is properly qualified and has the necessary equipment in such situations.
The first symptoms indicating an overdose of the medicine are: dizziness, feeling of numbness around the mouth, numbness of the tongue, hypersensitivity to sound. You should immediately tell your doctor if such symptoms occur. Blurred vision and muscle tremors are serious signs.
In the case of severe overdose or intravascular administration, seizures or loss of consciousness and respiratory arrest may occur.
Stopping the administration of the medicine as soon as the first symptoms of overdose appear reduces the risk of severe side effects.

Stopping the use of Xylocaine 2%

If you have any further doubts about the use of the medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects directly caused by the medicine are sometimes difficult to distinguish from the physiological effects of nerve blocks (e.g., decrease in blood pressure, bradycardia), the direct effect of needle puncture (e.g., nerve damage), or are an indirect effect of the puncture (e.g., subarachnoid hemorrhage).

Severe allergic reactions (rare, occurring in less than 1 in 1000 patients):

In the event of a severe allergic reaction, you should immediately tell your doctor.
Symptoms may include sudden onset of:

• swelling of the face, lips, tongue, or throat. This can cause difficulty swallowing
• severe or sudden swelling of the hands, feet, or ankles
• difficulty breathing
• severe itching of the skin (with a rash)
• very low blood pressure, which can cause fainting or loss of consciousness

Other possible side effects:

Very common (may occur in more than 1 in 10 treated patients)

• nausea
• significant decrease in blood pressure (hypotension)

Common (may occur in less than 1 in 10 treated patients)

• significant slowing of heart rate (bradycardia)
• significant increase in blood pressure (hypertension)
• paresthesia (sensory disturbances)
• dizziness
• seizures
• vomiting

Uncommon (may occur in less than 1 in 100 treated patients)

• symptoms of central nervous system toxicity (seizures, feeling of numbness around the mouth, numbness of the tongue, hypersensitivity to sound, visual disturbances, loss of consciousness, muscle tremors, dizziness, tinnitus, speech disorders)

Rare (may occur in less than 1 in 1000 treated patients)

• neuropathy, i.e., nerve disease causing a feeling of tingling, numbness, or weakness of the innervated muscle
• peripheral nerve damage
• arachnoiditis
• double vision
• cardiac arrest
• heart rhythm disorders
• respiratory depression

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can 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
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Xylocaine 2%

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the vial after "EXP". The expiry date refers to the last day of the month.
Shelf life after first opening of the vial: 3 days (72 hours).
Do not store above 25°C.
Do not leave needles or any metal objects in the opened vial. This may cause the release of metal ions, which can cause swelling at the injection site.
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 Xylocaine 2% contains

• The active substance of the medicine is lidocaine. 1 ml of Xylocaine 2% contains 20 mg of lidocaine hydrochloride. Each 50 ml vial contains 1000 mg of lidocaine hydrochloride.
• The other ingredients are: sodium chloride, methyl parahydroxybenzoate (E 218), sodium hydroxide 2 mol/l and (or) hydrochloric acid 2 mol/l to adjust the pH to 5.0-7.0, and purified water.

What Xylocaine 2% looks like and what the pack contains

Xylocaine 2% is a clear, colorless solution for injection.
It is supplied in vials made of colorless glass, in a cardboard box.
Pack size: 5 vials of 50 ml each.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
tel: +48 22 104 21 00

Manufacturer

Recipharm Monts
18 Rue de Montbazon
Monts, 37260
France

Date of last revision of the leaflet: 10/2024

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products https://www.urpl.gov.pl