Lidocaine Grindeks

Leaflet attached to the packaging: information for the user

Lidocaine Grindeks, 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, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Lidocaine Grindeks and what is it 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 packaging and other information

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

Lidocaine Grindeks is a local anesthetic. The medicine is used for anesthesia of various parts of the body during minor surgical procedures in adults. The medicine blocks the transmission of pain signals to the brain and thus the sensation of pain. The effect of the medicine starts a few minutes after administration and slowly disappears after the end 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 local anesthetics or any of the other ingredients of this medicine (listed in section 6),
• if the patient has very low blood pressure or has lost too much blood or other body fluids or the heart is not able to pump enough blood for other reasons, Lidocaine Grindeks should not be injected into the spine.

Warnings and precautions

Consult a doctor or nurse before injecting Lidocaine Grindeks if:

• the patient is elderly or generally weakened,
• the patient has heart rhythm disorders such as slow or irregular heartbeat (arrhythmia), heart failure,
• the patient has respiratory and lung diseases,
• the patient has liver or kidney function disorders,
• the patient suffers from epilepsy,
• the patient is being treated with medicines used for irregular heartbeat (e.g. amiodarone),
• there is inflammation or infection in the area where the medicine is to be administered,
• the patient suffers from a rare blood disease called porphyria or this disease has occurred in the family.

Inform the attending physician about all diseases before starting to take Lidocaine Grindeks.

Children and adolescents

Other pharmaceutical forms and strengths are more suitable for administration to children and adolescents.

Lidocaine Grindeks and other medicines

Inform the doctor about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use. In particular, inform the doctor if any of the following medicines are being or have been used:

• another local anesthetic,
• medicines used to treat irregular heartbeat (arrhythmia) such as amiodarone,
• medicines used to treat stomach or duodenal ulcers such as cimetidine.

Pregnancy and breastfeeding

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

Driving and operating machinery

Depending on the dose and site of administration, Lidocaine Grindeks may cause temporary movement and coordination disorders.

3. How to use Lidocaine Grindeks

Lidocaine Grindeks is administered only by a doctor, in the form of an injection intravenously, intramuscularly, subcutaneously or epidurally near the spinal cord. The dose of the medicine depends on the type of pain to be relieved. It will also depend on body weight, age, physical condition, and the part of the body to which the medicine will be injected. The doctor will administer the smallest dose necessary to achieve the desired anesthetic effect. Intravenous local 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 used along the spine)
Lumbar anesthesia: 12.5-20 ml of solution (250-400 mg of lidocaine hydrochloride).
Chest 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 to be operated on.

Use in children and adolescents

Other forms/strengths of this medicine may be more suitable for children and adolescents, ask a doctor or nurse.

If you have received more Lidocaine Grindeks than you should

The doctor administering the anesthesia is trained to handle any adverse reactions that may occur as a result of administering too much Lidocaine Grindeks. The first symptoms of Lidocaine Grindeks overdose are:

• seizures,
• restlessness,
• dizziness, balance disorders,
• nausea,
• numbness or tingling of the mouth and surrounding area,
• vision problems.

If the patient experiences any of these symptoms or thinks they have received too much Lidocaine Grindeks, they should immediately inform their doctor. More severe adverse reactions (than those listed above) may occur with Lidocaine Grindeks overdose, including: balance and coordination disorders, hearing changes, euphoria, confusion, speech problems, paleness, sweating, trembling, convulsions, effects on the heart and blood vessels, loss of consciousness, coma, short-term cessation of breathing (apnea). In case of any further doubts about the use of the medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Severe allergic reactions are very rare. If severe allergic reactions occur during treatment with the medicine, the doctor should be informed immediately. The symptoms of an allergic reaction are:

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

Other possible side effects: Very common side effects(may affect more than 1 in 10 people):

• low blood pressure
• nausea

Common side effects(may affect 1 to 10 in 100 people):

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

Uncommon side effects(may affect 1 to 10 in 1000 people):

• seizures
• numbness of the tongue or tingling around the mouth
• ringing in the ears and sensitivity to sounds
• vision disorders
• loss of consciousness
• trembling
• drowsiness
• dizziness
• ringing in the ears
• feeling of intoxication
• speech difficulties

Rare side effects(may affect 1 to 10 in 10,000 people):

• hypersensitivity reactions such as hives, 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
• slowed or stopped breathing

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lidocaine Grindeks

Do not freeze.
The medicine should be stored 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 specified month.
Do not use this medicine if visible particles are seen in the ampoule.
The solution should be used immediately after opening.
Any unused product or waste material should be disposed of in accordance with local regulations.

6. Contents of the packaging and other information

What Lidocaine Grindeks contains

The active substance of the medicine is lidocaine hydrochloride.
1 ml of solution contains 20 mg of lidocaine hydrochloride.
Each 5 ml ampoule contains 100 mg of lidocaine hydrochloride.
The other ingredients (excipients) of the medicine are: sodium chloride, sodium hydroxide (1M) (for pH adjustment), water for injections.

What Lidocaine Grindeks looks like and contents of the packaging

Clear, colorless or pale yellow liquid, without visible particles.
Ampoules made of colorless glass containing 5 ml of solution.
Pack size: 10 ampoules.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
Fax: +371 67083505
E-mail: grindeks@grindeks.lv

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

Sweden:

Lidocaine Grindeks 20 mg/ml injection solution

Hungary:

Lidocaine Grindeks 20 mg/ml solution for injection

Poland:

Lidocaine Grindeks, 20 mg/ml, solution for injection

Romania:

Lidocaine Grindeks 20 mg/ml injectable solution

Iceland:

Lidocaine Grindeks 20 mg/ml solution for injection

Belgium:

Lidocaine Grindeks 20 mg/ml solution for injection/injectable solution/Injektionslösung
Netherlands:
Lidocaine Grindeks 20 mg/ml solution for injection
Date of last revision of the leaflet:2018-09-19
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Information intended for healthcare professionals only:
Incompatibility of lidocaine hydrochloride with amphotericin B solution, sulfadiazine sodium, methohexital sodium, cefazolin sodium, and phenytoin sodium has been reported.
Medicines stable in an acidic environment, such as adrenaline hydrochloride, noradrenaline bitartrate, or isoprenaline, may degrade within a few hours of mixing with lidocaine hydrochloride, as lidocaine solutions may increase the final pH of the solution above the maximum pH at which they are stable.
Alkalization may cause precipitation, as lidocaine is poorly soluble at pH above 6.5.