Lidocaine Accord

Leaflet attached to the packaging: information for the user

Lidocaine Accord, 10 mg/ml, solution for injection

Lidocaine Accord, 20 mg/ml, solution for injection

Lidocaine hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor.
• If the patient experiences any side effects, including any side effects 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 Accord and what is it used for
• 2. Important information before using Lidocaine Accord
• 3. How to take Lidocaine Accord
• 4. Possible side effects
• 5. How to store Lidocaine Accord
• 6. Contents of the packaging and other information

1. What is Lidocaine Accord and what is it used for

Lidocaine Accord is a local anesthetic. The medicine is used to anesthetize different parts of the body during minor surgical procedures. The medicine blocks the transmission of pain stimuli to the brain in the nerves and thus blocks the sensation of pain. The effect of the medicine is felt after a few minutes of administration and slowly disappears after the end of the surgical procedure.

2. Important information before using Lidocaine Accord

When not to use Lidocaine Accord

• if the patient is allergic to lidocaine hydrochloride, other local anesthetics of the amide group, or any of the other ingredients of this medicine (listed in section 6);
• 6);
• if the patient has very low blood pressure or has lost too much blood or other body fluids, or their heart is not able to pump enough blood for other reasons, Lidocaine Accord should not be injected into the spinal canal.

If any of the above applies to the patient before taking the medicine, they should consult a doctor.

Warnings and precautions

Before starting to take Lidocaine Accord, the patient should consult a doctor, pharmacist, or nurse if:

• the patient is elderly or in poor general condition,
• the patient has heart rhythm disorders such as slow or irregular heartbeat, heart failure,
• the patient has respiratory or lung diseases,
• the patient has liver or kidney function disorders,
• the patient has epilepsy,
• the patient has inflammation or infection in the area where the medicine is to be administered,
• the patient has porphyria (a rare inherited disease affecting the skin and nervous system),
• the patient has blood coagulation disorders,
• the patient is in the third trimester of pregnancy. If there are any doubts as to whether any of the above situations apply to the patient, they should consult a doctor before using Lidocaine Accord.

Lidocaine Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should inform their doctor about the use of the following medicines:

• other local anesthetics,
• medicines used to treat stomach or duodenal ulcers (e.g., cimetidine),
• medicines used to treat irregular heartbeat (e.g., amiodarone).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

Depending on the dose and site of administration, Lidocaine Accord may cause temporary disturbances in the ability to drive vehicles and operate machines. The patient should consult a doctor about when it is safe to perform these activities.

Lidocaine Accord contains sodium

One ml of the solution for injection contains approximately 0.118 mmol of sodium (in the case of using a 10 mg/ml solution) or 0.082 mmol of sodium (in the case of using a 20 mg/ml solution). This should be taken into account by people controlling their sodium intake.

3. How to take Lidocaine Accord

Lidocaine Accord is administered only by a doctor, in the form of an intravenous, intramuscular, subcutaneous, or epidural injection near the spinal cord. The dose of the medicine depends on the type of pain to be relieved. It will also depend on the patient's body weight, age, physical condition, and the part of the body into which the medicine is injected. The doctor will administer the smallest dose necessary to achieve the desired anesthetic effect.

Use in children and adolescents

The dose for children and patients in poor general condition should be reduced. Lidocaine Accord is usually administered near the site to be operated on.

Using a higher dose of Lidocaine Accord than recommended

The doctor administering the anesthetic is trained to properly handle adverse reactions that may occur as a result of administering too high a dose of Lidocaine Accord. The first symptoms of overdose of Lidocaine Accord are usually:

• seizures,
• restlessness,
• dizziness, feeling of fainting,
• nausea,
• numbness or tingling of the mouth and surrounding area,
• visual disturbances. If the patient experiences any of these symptoms or thinks they have received too much Lidocaine Accord, they should immediately inform their doctor or nurse. More severe adverse reactions than those listed above may occur after overdosing on Lidocaine Accord, including: balance and coordination disorders, hearing disorders, euphoria, confusion, speech disorders, pallor, excessive sweating, tremors, seizures, effects on the heart and blood vessels, loss of consciousness, coma, short-term cessation of breathing (apnea). If there are any further doubts about the use of this medicine, the patient should consult a doctor.

4. Possible side effects

Like all medicines, Lidocaine Accord can cause side effects, although not everybody gets them. In case of a severe allergic reaction (angioedema or anaphylactic shock), the patient should immediately inform their doctor or nurse. Symptoms may include:

• sudden swelling of the face, lips, tongue, and throat, which may cause difficulty swallowing,
• severe or sudden swelling of the hands, feet, and ankles,
• difficulty breathing,
• intensive itching of the skin (with the appearance of hives),
• fever,
• drop in blood pressure. These side effects are rare (less than 1 in 1000 patients). Other possible side effects: Very common(occurring more often than 1 in 10 patients)
• low blood pressure,
• nausea. Common(occurring less often than 1 in 10 patients)
• tingling or numbness
• dizziness
• slow heart rate
• high blood pressure
• vomiting Uncommon(occurring less often than 1 in 100 patients)
• seizures
• numbness of the tongue or tingling around the mouth
• ringing in the ears and hypersensitivity to sounds
• visual disturbances
• loss of consciousness
• tremors
• drowsiness
• confusion
• ringing in the ears
• feeling of intoxication
• difficulty speaking Rare(occurring less than 1 in 1000 patients)
• hypersensitivity reactions such as urticaria, rash, angioedema, and in severe cases, anaphylactic shock
• changes in sensation or muscle weakness (neuropathy)
• inflammation of the membrane surrounding the spinal cord (arachnoiditis), which may cause back pain or a feeling of numbness and weakness in the legs
• double vision
• irregular heartbeat, up to cardiac arrest
• slow or cessation of breathing

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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 will help gather more information on the safety of the medicine.

5. How to store Lidocaine Accord

The medicine should be stored out of sight and reach of children. There are no special recommendations for storage conditions. Do not use this medicine after the expiry date stated on the label of the ampoule/vial and on the carton after: EXP. The expiry date refers to the last day of the given month. For single use only, the solution should be used immediately after the first opening, and any unused portion should be destroyed. The solution should not be used if it has changed color or if solid particles are visible. 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 Accord contains

The active substance of the medicine is lidocaine hydrochloride. Lidocaine Accord, 10 mg/ml, solution for injection: 1 ml of the solution contains 10 mg of lidocaine hydrochloride. Lidocaine Accord, 20 mg/ml, solution for injection: 1 ml of the solution contains 20 mg of lidocaine hydrochloride. The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid, and water for injection.

What Lidocaine Accord looks like and what the packaging contains

Lidocaine Accord is a clear, colorless, sterile solution for injection. It is available in two concentrations, 10 mg/ml and 20 mg/ml. Lidocaine Accord, 10 mg/ml, is available in packages: 5 ampoules of 2 mL, in a cardboard box, 10 ampoules of 2 mL, in a cardboard box, 20 ampoules of 2 mL, in a cardboard box, 5 ampoules of 5 mL, in a cardboard box, 10 ampoules of 5 mL, in a cardboard box, 20 ampoules of 5 mL, in a cardboard box, 10 ampoules of 10 mL, in a cardboard box, 20 ampoules of 10 mL, in a cardboard box, 1 vial of 20 mL, in a cardboard box. Lidocaine Accord, 20 mg/ml, is available in packages: 5 ampoules of 2 mL, in a cardboard box, 10 ampoules of 2 mL, in a cardboard box, 20 ampoules of 2 mL, in a cardboard box, 5 ampoules of 5 mL, in a cardboard box, 10 ampoules of 5 mL, in a cardboard box, 20 ampoules of 5 mL, in a cardboard box, 5 ampoules of 10 mL, in a cardboard box, 10 ampoules of 10 mL, in a cardboard box, 20 ampoules of 10 mL, in a cardboard box, 1 vial of 20 mL, in a cardboard box. Not all pack sizes may be marketed.

Responsible entity

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands, Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, 95-200 Pabianice

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: August 2022

-----------------------------------------------------------------------------------------------------------------------------
Information intended only for healthcare professionals or healthcare workers:
Due to the lack of compatibility studies, the medicinal product should not be mixed with other medicinal products.
For single use only. Use immediately after the first opening. Any unused portion should be destroyed.
The solution should not be used if it has changed color or if solid particles are visible.
Method of administration
The medicinal product Lidocaine Accord should be used only by or under the supervision of a doctor with experience in administering local anesthesia and performing resuscitation.
Necessary resuscitation equipment should be available during the administration of local anesthesia.
To obtain information on dosing, refer to the Summary of Product Characteristics.