Lidagriks

Leaflet attached to the packaging: information for the user

Lydagriks, 10 mg/mL, solution for injection

Lydagriks, 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Lydagriks and what is it used for

The active substance of Lydagriks is lidocaine, which belongs to a group of medicines called local anesthetics. The medicine is used for anesthesia of various parts of the body during minor surgical procedures. Lydagriks temporarily blocks the transmission of pain stimuli to the brain in the nerves at the injection site.
Lydagriks 10 mg/mL can be used in adults and children over 1 year of age.
Lydagriks 20 mg/mL can be used in adults.

2. Important information before using Lydagriks

When not to use Lydagriks

When not to use Lydagriks for epidural anesthesia

• in patients with very low blood pressure,

Warnings and precautions

Before starting treatment with Lydagriks, discuss it with your doctor, pharmacist, or nurse:

• in epidural anesthesia, as central nerve blockage can cause serious side effects,
• in the eye, as the medicine can rarely cause transient or permanent side effects,
• in intra-articular infusion, as it can cause sudden loss of cartilage (chondrolysis),

Lydagriks and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.
Lydagriks may interact with medicines such as:

• other local anesthetics,
• medicines used to treat irregular heartbeat (so-called anti-arrhythmic medicines),
• cimetidine (used in the treatment of stomach ulcers) and beta-adrenolytics (used in the treatment of, among other things, high blood pressure).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Lidocaine passes through the placenta and can enter fetal tissues. However, there is no evidence that lidocaine has a negative effect on the fetus, although the risk is not fully known.
The doctor will weigh the benefits and risks of using this medicine in short-term treatment during pregnancy and childbirth. If the medicine is used in the cervix, the doctor should closely monitor the baby's pulse.
Lidocaine passes into breast milk, but it is unlikely to have any effect on the breastfed child, so breastfeeding can be continued after using this medicine.

Driving and using machines

Depending on the dose and administration site, Lydagriks may cause temporary disturbances in the ability to drive vehicles and operate machines. Do not perform these activities until normal function is fully restored.

Lydagriks contains sodium chloride.

10 mg/mL solution for injection

• A 5 mL ampoule contains less than 1 mmol of sodium (23 mg) per 5 mL ampoule, which means the medicine is considered "sodium-free".
• A 10 mL ampoule contains 27.8 mg of sodium (the main component of table salt) per 10 mL ampoule, which corresponds to 1.4% of the recommended maximum daily sodium intake in adults.
• A 20 mL vial contains 55.6 mg of sodium (the main component of table salt) per 20 mL vial, which corresponds to 2.8% of the recommended maximum daily sodium intake in adults.
• A 50 mL vial contains 139 mg of sodium (the main component of table salt) per 50 mL vial, which corresponds to 7% of the recommended maximum daily sodium intake in adults.

20 mg/mL solution for injection

• A 2 mL ampoule contains less than 1 mmol of sodium (23 mg) per 2 mL ampoule, which means the medicine is considered "sodium-free".
• A 5 mL ampoule contains less than 1 mmol of sodium (23 mg) per 5 mL ampoule, which means the medicine is considered "sodium-free".
• A 10 mL ampoule contains 23.8 mg of sodium (the main component of table salt) per 10 mL ampoule, which corresponds to 1.2% of the recommended maximum daily sodium intake in adults.
• A 20 mL vial contains 47.6 mg of sodium (the main component of table salt) per 20 mL vial, which corresponds to 2.4% of the recommended maximum daily sodium intake in adults.
• A 50 mL vial contains 119 mg of sodium (the main component of table salt) per 50 mL vial, which corresponds to 6% of the recommended maximum daily sodium intake in adults.

3. How to use Lydagriks

Lydagriks is administered only by a doctor. The method of administration depends on the type of anesthesia, the area to be anesthetized, and the duration of anesthesia. The medicine will be administered to you by injection into a vein, under the skin, or into the epidural space near the spinal cord.
The dose of the medicine is dependent on the type of pain to be relieved. It will also depend on body weight, age, physical condition, and the part of the body into which the medicine is injected. The doctor will give you the smallest dose necessary to achieve the desired effect.

Use in children and adolescents

This medicine can be used in children, and treatment should be tailored to each child individually.

Using a higher dose of Lydagriks than recommended

This medicine is administered by medical personnel, and it is unlikely that you will receive too much lidocaine.
The doctor administering the anesthesia is trained to handle any serious side effects that may occur after administration of too high a dose of this medicine.
The first symptoms of lidocaine overdose are:

• seizures,
• dizziness or a feeling of emptiness in the head,
• nausea,
• numbness or tingling of the lips or around the mouth,
• vision disturbances.

If you experience any of these symptoms or think you have received too much of this medicine, tell your doctor or nurse immediately.
Much more serious side effects than those listed above may occur after overdose of this medicine, such as: balance and coordination disorders, hearing disorders, euphoria, confusion, speech disorders, paleness, increased sweating, tremors, effects on the heart and blood vessels, loss of consciousness, coma, short-term cessation of breathing (apnea).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people)

• low blood pressure,
• nausea.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• symptoms of central nervous system toxicity, such as:
• seizures,
• numbness of the tongue or tingling around the mouth,
• hypersensitivity to sound,
• vision disturbances,
• tremors,
• feeling of intoxication,
• tinnitus,
• speech difficulties,
• loss of consciousness.

Rare(may affect up to 1 in 1,000 people)

• allergic reactions, such as hives and rash, and in severe cases, anaphylactic shock,
• irregular heartbeat or cardiac arrest (arrhythmias, cardiac arrest),
• slow or stopped breathing,
• changes in sensation or muscle weakness (neuropathy),
• inflammation of the membrane surrounding the spinal cord (arachnoiditis), which can cause back pain or pain, numbness, or weakness in the legs,
• double vision.

Reporting side effects

If you experience any side effects, including those 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 Lydagriks

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and vial label and on the carton after "EXP". The expiry date refers to the last day of the month.
Do not freeze.
Do not store above 25°C.
Do not use this medicine if you notice visible particles in the ampoule or vial.
The solution should be used immediately after opening.
Medicines should not be disposed of via wastewater or household waste. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Lydagriks contains

• The active substance is lidocaine hydrochloride.

10 mg/mL solution for injection
1 mL of solution for injection contains 10 mg of lidocaine hydrochloride.
One 5 mL ampoule contains 50 mg of lidocaine hydrochloride.
One 10 mL ampoule contains 100 mg of lidocaine hydrochloride.
One 20 mL vial contains 200 mg of lidocaine hydrochloride.
One 50 mL vial contains 500 mg of lidocaine hydrochloride.
20 mg/mL solution for injection
1 mL of solution for injection contains 20 mg of lidocaine hydrochloride.
One 2 mL ampoule contains 40 mg of lidocaine hydrochloride.
One 5 mL ampoule contains 100 mg of lidocaine hydrochloride.
One 10 mL ampoule contains 200 mg of lidocaine hydrochloride.
One 20 mL vial contains 400 mg of lidocaine hydrochloride.
One 50 mL vial contains 1000 mg of lidocaine hydrochloride.

• The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), water for injections.

What Lydagriks looks like and contents of the pack

Clear, colorless or slightly yellowish solution, without visible particles.
10 mg/mL solution for injection
Ampoules
The medicine is packed in ampoules made of colorless borosilicate glass type I of hydrolytic resistance class with a single break point, with a volume of 5 mL or 10 mL. The ampoules are marked with a colored ring. The ampoules are packed in cardboard boxes, 5 or 10 pieces each.
Vials
The medicine is packed in vials made of colorless molded borosilicate glass type I, with a scored neck, with a volume of 20 mL or 50 mL. The vials are closed with a 20 mm bromobutyl rubber stopper and a 20 mm aluminum seal (flip-off type). The vials are packed in cardboard boxes, 10 pieces each.
20 mg/mL solution for injection
Ampoules
The medicine is packed in ampoules made of colorless borosilicate glass type I of hydrolytic resistance class with a single break point, with a volume of 2 mL, 5 mL, or 10 mL. The ampoules are marked with a colored ring. The ampoules are packed in cardboard boxes, 5 or 10 pieces each.
Vials
The medicine is packed in vials made of colorless molded borosilicate glass type I, with a scored neck, with a volume of 20 mL or 50 mL. The vials are closed with a 20 mm bromobutyl rubber stopper and a 20 mm aluminum seal (flip-off type). The vials are packed in cardboard boxes, 10 pieces each.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: + 371 67083205
fax: + 371 67083505
e-mail: [email protected]

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

Austria
Lidocain Grindeks 10 mg/ml Injektionslösung
Lidocain Grindeks 20 mg/ml Injektionslösung
Belgium
Lydagriks 10 mg/ml oplossing voor injectie
Lydagriks 10 mg/ml solution injectable
Lydagriks 10 mg/ml Injektionslösung
Lydagriks 20 mg/ml oplossing voor injectie
Lydagriks 20 mg/ml solution injectable
Lydagriks 20 mg/ml Injektionslösung
Bulgaria
Lidocaine Grindeks 10 mg/ml инжекционен разтвор
Lidocaine Grindeks 20 mg/ml инжекционен разтвор
Finland
Lidocaine Grindeks 10 mg/ml injektioneste
Lidocaine Grindeks 20 mg/ml injektioneste
France
Lidocaine Grindeks 10 mg/ml SANS CONSERVATEUR, solution injectable
Lidocaine Grindeks 20 mg/ml SANS CONSERVATEUR, solution injectable
Latvia
Lisendum 10 mg/ml šķīdums injekcijām
Lisendum 20 mg/ml šķīdums injekcijām
Germany
Lidocain Grindeks 10 mg/ml Injektionslösung
Lidocain Grindeks 20 mg/ml Injektionslösung
Poland
Lydagriks
Portugal
Lidocaine Grindeks 10 mg/ml solução injetável
Lidocaine Grindeks 20 mg/ml solução injetável
Romania
Livohep 10 mg/ml soluție injectabilă
Livohep 20 mg/ml soluție injectabilă
Sweden
Lydagriks
Hungary
Lydagriks 10 mg/ml oldatos injekció
Lydagriks 20 mg/ml oldatos injekció
Italy
Lidocaina Grindeks

Date of last revision of the leaflet: --------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
The medicinal product must not be stored in contact with metals, e.g., needles or metal parts of syringes, as dissolved metal ions may cause swelling at the injection site.
Incompatibility of lidocaine hydrochloride with amphotericin B solution, sodium sulfadiazine, sodium methohexital, sodium cefazolin, and sodium phenytoin has been reported.
Medicines stable in an acidic environment, such as adrenaline hydrochloride, noradrenaline tartrate, 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 a pH above 6.5.