Lidocaine grindeks

Package leaflet: Information for the user

Lidocaine Grindeks, 20 mg/ml, solution for injection
lidocaini hydrocholoridum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

Lidocaine Grindeks is a local anaesthetic medicine. It is used to numb different parts of the body during minor surgical procedures in adults. The medicine blocks the transmission of pain signals to the brain, thereby preventing the sensation of pain. The effect begins a few minutes after administration and gradually wears off after completion of the surgical procedure.

2. Important information before using Lidocaine Grindeks

When not to use Lidocaine Grindeks

• if the patient is allergic to lidocaine hydrochloride, amide-type local anaesthetics, 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 the heart is unable to pump sufficient blood for other reasons, Lidocaine Grindeks must not be administered into the spinal canal.

Warnings and precautions
Talk to your doctor or nurse before receiving Lidocaine Grindeks if:

• the patient is elderly or generally debilitated,
• the patient has heart problems such as slow or irregular heartbeat (arrhythmia), heart failure,
• the patient has respiratory or lung diseases,
• the patient has impaired liver or kidney function,
• the patient suffers from epilepsy,
• the patient is being treated with medicines used for irregular heartbeat (e.g. amiodarone),
• the patient has inflammation or infection at the site intended for administration of the medicine,
• the patient suffers from a rare blood disorder called porphyria or if this disease has occurred in the family.

All medical conditions should be reported to the treating physician before starting treatment with Lidocaine Grindeks.
Children and adolescents
Other pharmaceutical forms and strengths are more suitable for administration in children and adolescents.
Lidocaine Grindeks and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
In particular, inform the doctor if any of the following medicines have been or are being used:

• another local anaesthetic medicine,
• medicines used to treat irregular heartbeat (arrhythmia), e.g. amiodarone,
• medicines used for peptic ulcer disease, e.g. cimetidine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Driving and using machines
Depending on the dose and site of administration, Lidocaine Grindeks may cause transient motor disturbances and impaired coordination.

3. How to use Lidocaine Grindeks

Lidocaine Grindeks is administered exclusively by a physician, as an intravenous,
intramuscular, subcutaneous, or epidural injection near the spinal cord.
The dose of the medication depends on the type of pain to be alleviated, as well as on
the patient's body weight, age, physical condition, and the body area to which the drug will be injected.
The physician will administer the lowest effective dose required to achieve adequate anesthesia.

Intravenous regional anesthesia
Arm: 5–10 ml of solution (100–200 mg of lidocaine hydrochloride) injected into a vein.
Leg: 10 ml of solution (200 mg of lidocaine hydrochloride) injected into a vein.

Nerve blocks
1–2 ml of solution (20–40 mg of lidocaine hydrochloride) injected into or around the nerve.

Epidural anesthesia (injection administered along the spine)
Lumbar anesthesia: 12.5–20 ml of solution (250–400 mg of lidocaine hydrochloride).
Thoracic anesthesia: 10–15 ml of solution (200–300 mg of lidocaine hydrochloride).
Sacral anesthesia (in the lower part of the spine) in surgery: 20 ml of solution (400 mg of
lidocaine hydrochloride).
Sacral anesthesia during childbirth: 10–15 ml of solution (200–300 mg of lidocaine hydrochloride).

The recommended maximum single dose of Lidocaine Grindeks is 400 mg.
The dose should be reduced in patients in poor general condition.
Lidocaine Grindeks is usually administered near the site of the planned surgical procedure.

Use in children and adolescents
Other formulations/strengths of this medication may be more suitable for children and adolescents.
Please consult your doctor or nurse.

If you have received more Lidocaine Grindeks than you should have
The physician administering the anesthesia is trained to manage adverse reactions resulting from an overdose of Lidocaine Grindeks.
The initial symptoms of overdose with Lidocaine Grindeks include:

• seizures,
• restlessness,
• dizziness, balance disturbances,
• nausea,
• numbness or tingling around the mouth and perioral area,
• visual disturbances.

If the patient experiences any of these symptoms or suspects having received too much Lidocaine Grindeks, they should immediately inform the physician.
More severe adverse reactions (in addition to those listed above) may occur in case of overdose with Lidocaine Grindeks, including: impaired balance and coordination, hearing disturbances, euphoria, confusion, speech difficulties, pallor, sweating, tremor, convulsions, effects on the heart and blood vessels, loss of consciousness, coma, transient respiratory arrest (apnea).

If you have any further doubts regarding the use of this medication, please consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Severe allergic reactions occur very rarely. If severe allergic reactions occur
during treatment with this medicine, inform your doctor immediately. Symptoms of allergy include:

• 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,
• intense itching of the skin (with appearance of lumps),
• fever,
• drop in blood pressure.

Other possible adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 people):

• low blood pressure
• nausea

Common adverse reactions (may affect 1 to 10 in 100 people):

• tingling
• dizziness
• slow heart rate
• high blood pressure
• vomiting

Uncommon adverse reactions (may affect 1 to 10 in 1,000 people):

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

Rare adverse reactions (may affect 1 to 10 in 10,000 people):

• 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 a sensation of numbness and weakness in the legs
• double vision
• irregular heartbeat, up to cardiac arrest
• slowed or stopped breathing

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions 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, PL-02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

5. How to store Lidocaine Grindeks

Do not freeze.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Do not use this medicine if visible particles are observed in the ampoule.
The solution should be used immediately after opening.
Any unused remnants of the product or waste materials must be disposed of in accordance with local regulations.

6. Contents of the packaging and other information

What Lidocaine Grindeks contains
The active substance is lidocaine hydrochloride.
1 ml of solution contains 20 mg of lidocaine hydrochloride.
Each 5 ml ampoule contains 100 mg of lidocaine hydrochloride.
Other components (excipients) are: sodium chloride, sodium hydroxide (1M) (for pH adjustment), water for injections.

What Lidocaine Grindeks looks like and contents of the pack
Clear, transparent liquid or pale yellow in colour, free from visible particles.
Ampoules made of colourless glass containing 5 ml of solution.
Pack size: 10 ampoules.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden: Lidocaine Grindeks 20 mg/ml injektionsvätska, lösning
Hungary: Lidocaine Grindeks 20 mg/ml oldatos injekció
Poland: Lidocaine Grindeks, 20 mg/ml, solution for injection
Romania: Lidocaină Grindeks 20 mg/ml soluţie injectabilă
Iceland: Lidocaine Grindeks 20 mg/ml stungulyf, lausn
Belgium: Lidocaine Grindeks 20 mg/ml oplossing voor injectie / solution injectable / Injektionslösung
Netherlands: Lidocaine Grindeks 20 mg/ml oplossing voor injectie

Information intended exclusively for medical personnel or healthcare professionals:

Incompatibility has been reported between lidocaine hydrochloride and amphotericin B solution, sodium sulfadiazine,
sodium metohexital, sodium kafazolin, and sodium phenytoin.
Drugs stable in an acidic environment, such as adrenaline hydrochloride, noradrenaline bitartrate, or
isoprenaline, may degrade within several hours after mixing with lidocaine hydrochloride, because lidocaine solutions may increase the pH of the final mixture above
the maximum pH at which these drugs remain stable.
Alkalinization may cause precipitation, as lidocaine is poorly soluble at pH above 6.5.