Lidocaine accord

Patient Information Leaflet

Lidocaine Accord, 10 mg/ml, solution for injection
Lidocaine Accord, 20 mg/ml, solution for injection
Lidocaini hydrochloridum
Please read this leaflet carefully before using this medicine, as it contains important information
for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Lidocaine Accord is a local anaesthetic medicine. It is used to numb various parts of the body during minor surgical procedures. The medicine blocks the transmission of pain signals in nerves to the brain, thereby preventing the sensation of pain. The effect of the medicine is felt within a few minutes after administration and gradually wears off after completion 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 anaesthetics of the amide group, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has very low blood pressure, has lost excessive amounts of blood or other body fluids, or if their heart is unable to pump sufficient blood for other reasons, Lidocaine Accord must not be administered into the spinal canal.

If any of the above apply to the patient, consult a doctor before administering the medicine.

Warnings and precautions

Before starting treatment with Lidocaine Accord, consult a doctor, pharmacist, or nurse if:

• the patient is elderly or in poor general health,
• the patient has heart problems such as slow or irregular heartbeat, heart failure,
• the patient has respiratory or lung diseases,
• the patient has impaired liver or kidney function,
• the patient has epilepsy,
• the patient has inflammation or infection at the site intended for administration of the medicine,
• the patient has porphyria (a rare inherited disorder affecting the skin and nervous system),
• the patient has blood clotting disorders,
• the patient is in the last trimester of pregnancy.

If in doubt whether any of the above conditions apply, consult a doctor before using Lidocaine Accord.

Lidocaine Accord and other medicines

Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used. In particular, inform the doctor about the use of the following medicines:

• other local anaesthetics,
• medicines used to treat peptic ulcer disease (e.g. cimetidine),
• medicines used to treat irregular heartbeat (e.g. amiodarone).

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Depending on the dose and site of administration, Lidocaine Accord may cause transient impairment of the ability to drive or operate machinery. Consult the doctor to determine when it is safe to perform such activities.

Lidocaine Accord contains sodium

One ml of injection solution contains approximately 0.118 mmol of sodium (when using the 10 mg/ml solution) or 0.082 mmol of sodium (when using the 20 mg/ml solution). This should be taken into account by individuals on a controlled sodium diet.

3. How to take Lidocaine Accord

Lidocaine Accord is administered exclusively by a doctor, as 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, as well as on body weight, age, physical condition and the part of the body into which the medicine will be injected. The doctor will administer the lowest dose necessary to achieve the appropriate anaesthetic effect.
Use in children and adolescents
The dose for children and patients in poor general health should be reduced.
Lidocaine Accord is usually administered near the site of the planned surgical procedure.
Administration of a higher than recommended dose of Lidocaine Accord
The doctor administering the anaesthetic is trained to manage adverse reactions that may occur following administration of an excessive dose of Lidocaine Accord.
The first signs of overdose with Lidocaine Accord are usually:

• seizures,
• anxiety,
• dizziness, feeling faint,
• nausea,
• numbness or tingling of the lips and areas around the mouth,
• visual disturbances. If the patient experiences any of these symptoms or suspects having received too much Lidocaine Accord, they should immediately inform the doctor or nurse. More severe adverse reactions than those listed above may occur following overdose of Lidocaine Accord, including: loss of balance and coordination, hearing disturbances, euphoria, confusion, speech disturbances, pallor, excessive sweating, tremor, seizures, effects on the heart and blood vessels, loss of consciousness, coma, temporary cessation of breathing (apnoea). If in doubt about any aspect of the use of this medicine, consult a doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If a severe allergic reaction occurs (angioedema or anaphylactic shock), you should immediately inform your doctor or nurse.
Symptoms may include sudden onset of:

• swelling of the face, lips, tongue and throat, which may cause difficulty swallowing,
• severe or sudden swelling of hands, feet and ankles,
• difficulty breathing,
• intense itching of the skin (with appearance of hives),
• fever,
• drop in blood pressure.

These adverse effects are rare (occurring in fewer than 1 in 1,000 patients).

Other possible adverse effects:

Very common (occurring in more than 1 in 10 patients)

• low blood pressure,
• nausea.

Common (occurring in fewer than 1 in 10 patients)

• tingling and numbness,
• dizziness,
• slow heart rate,
• high blood pressure,
• vomiting.

Uncommon (occurring in fewer than 1 in 100 patients)

• seizures,
• numbness or tingling of the tongue or around the mouth,
• ringing in the ears and sensitivity to sound,
• visual disturbances,
• loss of consciousness,
• tremor,
• drowsiness,
• dizziness (sensation of spinning),
• tinnitus,
• feeling of intoxication,
• difficulty speaking.

Rare (occurring in fewer than 1 in 1,000 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 (meningitis), which may cause lower back pain or numbness and weakness in the legs,
• double vision,
• irregular heartbeat, up to cardiac arrest,
• slowed or stopped breathing.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lidocaine Accord

The medicine should be stored out of sight and reach of children.
There are no special requirements for storage conditions.
Do not use this medicine after the expiry date stated on the ampoule/vial and on the outer carton after EXP.
The expiry date refers to the last day of the stated month.
For single use only; the solution should be used immediately after first opening.
Any unused portion of the solution must be discarded.
Do not use the solution if it changes colour or if solid particles are visible.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

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

What Lidocaine Accord looks like and contents of the pack
Lidocaine Accord is a clear, colourless, 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 the following pack sizes:
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 the following pack sizes:
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.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended solely for medical or healthcare personnel:

Due to lack of compatibility studies, this medicinal product must not be mixed
with other medicinal products.
For single use only. Use immediately after first opening.
Any unused portion of the solution must be discarded.
The solution should not be used if discoloration occurs or if particulate matter is visible.
Method of administration
The medicinal product Lidocaine Accord should be administered only by, or under the supervision of, a physician
experienced in administering local anaesthesia and in resuscitation procedures.
Resuscitation equipment must be readily available during administration of local anaesthesia.
For dosage information, refer to the Product Characteristics information.