Lydagriks

Package leaflet: Information for the user

Lydagriks, 10 mg/mL, solution for injection
Lydagriks, 20 mg/mL, solution for injection
Lidocaini hydrochloridum
Please read all of this leaflet carefully before using this medicine, 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.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Lydagriks is and what it is used for
2. What you need to know 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 Lydagriks is and what it is used for

The active substance in Lydagriks is lidocaine, which belongs to a group of medicines called local anaesthetics. The medicine is used to numb various parts of the body during minor surgical procedures. Lydagriks temporarily blocks the transmission of pain signals in nerves at the site of injection, preventing them from reaching the brain.
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. Information before using Lydagriks

When not to use Lydagriks

• if the patient is allergic to lidocaine, other local anaesthetics of the amide group, or any of the other ingredients of this medicine (listed in section 6).

When not to use Lydagriks for epidural anaesthesia

• in patients with very low blood pressure,
• if the patient is in a life-threatening condition due to heart dysfunction, where the heart is unable to pump enough blood to meet the body's needs (cardiogenic shock),
• if the patient is in a life-threatening condition due to excessive loss of blood or other fluids, resulting in the heart being unable to pump sufficient blood to meet the body's needs (hypovolemic shock).

Warnings and precautions
Before starting treatment with Lydagriks, discuss with your doctor, pharmacist, or nurse:

• if the patient is elderly or generally weakened, the dose should be reduced,
• if the patient has heart problems, such as slow or irregular heartbeat (heart block, atrioventricular block),
• if the patient has impaired liver or kidney function, the dose should be reduced,
• in epidural anaesthesia, because blocking of central nerves may cause serious adverse effects,
• in the eye, because in rare cases the medicine may cause transient or permanent adverse effects,
• in direct infusion into the joint space (intra-articular infusion), because this may cause rapid loss of joint cartilage (chondrolysis),
• if the patient has acute porphyria.

Lydagriks and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Lydagriks may interact with medicines such as:

• other local anaesthetics,
• medicines used to treat irregular heartbeat (so-called antiarrhythmics),
• cimetidine (used in peptic ulcer disease) and beta-blockers (used, among others, in the treatment of hypertension).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Lidocaine crosses the placenta and may reach 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 during short-term treatment in pregnancy and childbirth. If the medicine is administered into the cervix, the doctor should carefully monitor the baby's pulse.
Lidocaine passes into breast milk, but it is unlikely to have any effect on the breastfed infant; therefore, breastfeeding may continue after administration of this medicine.

Driving and operating machinery
Depending on the dose and site of administration, Lydagriks may cause transient impairment of the ability to drive and operate machinery. These activities should not be performed until normal functioning is fully restored.

Lydagriks contains sodium chloride.
10 mg/mL injection solution

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

20 mg/mL injection solution

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

3. How to use Lydagriks

Lydagriks is administered only by a physician. The route of administration depends on the type of
anesthesia, the area to be anesthetized, and the required duration of anesthesia. The medicine will be
administered to the patient as an intravenous, subcutaneous, or epidural injection near the spinal cord.
The dose of the medicine depends on the type of pain to be blocked, as well as on body weight, age,
physical condition, and the body site into which the medicine is injected. The physician will administer the
lowest dose necessary to achieve the desired effect.
Use in children and adolescents
This medicine may be used in children, and treatment should be individually adjusted for each child.
Administration of a higher than recommended dose of Lydagriks
This medicine is administered by medical personnel, and it is unlikely that a patient will receive an excessive dose of lidocaine.
The physician administering anesthesia is trained to manage severe adverse reactions resulting from an overdose of this medicine.
The first signs of lidocaine overdose are:

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

If any of these symptoms occur, or if the patient suspects having received too much of this medicine, they should immediately inform the physician or nurse.
More severe adverse reactions than those listed above may occur following an overdose of this medicine, such as: disturbances in balance and coordination, hearing disturbances, euphoria, confusion, speech disturbances, pallor, excessive sweating, tremor, effects on the heart and blood vessels, loss of consciousness, coma, and transient respiratory arrest (apnea).
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Very common (may occur in more than 1 in 10 treated patients):

• low blood pressure,
• nausea.

Common (may occur in less than 1 in 10 treated patients):

• high blood pressure,
• dizziness,
• tingling or prickling sensation,
• slowed heart rate,
• vomiting.

Uncommon (may occur in less than 1 in 100 treated patients):

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

Rare (may occur in less than 1 in 1000 treated patients):

• hypersensitivity reactions such as urticaria and rash, and in severe cases anaphylactic shock,
• irregular heartbeat or cardiac arrest (arrhythmias, cardiac arrest),
• slowed or stopped breathing,
• changes in sensation or muscle weakness (neuropathy),
• inflammation of the membrane surrounding the spinal cord (meningitis), which may cause lower back pain or pain, numbness, or weakness in the legs,
• double vision.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lydagriks

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

6. Contents of the packaging and other information

What Lydagriks contains

• The active substance is lidocaine hydrochloride.

10 mg/mL injection solution
1 mL of injection solution 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 injection solution
1 mL of injection solution 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.

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

What Lydagriks looks like and contents of the pack
A clear, colourless or slightly yellowish solution, free from visible particles.

10 mg/mL injection solution
Ampoules
The medicine is packed in colourless borosilicate glass ampoules of type I with hydrolytic resistance class 1, with a single-point cut and a volume of 5 mL or 10 mL. The ampoules are marked with a coloured ring. The ampoules are packed in cardboard boxes containing 5 or 10 units.

Vials
The medicine is packed in colourless moulded borosilicate glass type I vials with a notched 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 aluminium seal (flip-off closure). The vials are packed in cardboard boxes containing 10 units.

20 mg/mL injection solution
Ampoules
The medicine is packed in colourless borosilicate glass ampoules of type I with hydrolytic resistance class 1, with a single-point cut and a volume of 2 mL, 5 mL or 10 mL. The ampoules are marked with a coloured ring. The ampoules are packed in cardboard boxes containing 5 or 10 units.

Vials
The medicine is packed in colourless moulded borosilicate glass type I vials with a notched 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 aluminium seal (flip-off closure). The vials are packed in cardboard boxes containing 10 units.

Not all pack sizes may be marketed.

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:
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

Information intended exclusively for medical professionals:

The medicinal product must not be stored in contact with metals, such as needles or metal parts of syringes, because dissolved metal ions may cause swelling at the injection site.
Incompatibility has been reported between hydrochloride lidocaine and amphotericin B solution, sodium sulfadiazine, sodium methohexital, sodium cefazolin, and sodium phenytoin.
Drugs stable in an acidic environment, such as hydrochloride adrenaline, bitartrate noradrenaline, or isoprenaline, may degrade within several hours after mixing with lidocaine hydrochloride, because lidocaine solutions may raise the pH of the final mixture above the maximum pH at which these drugs are stable.
Alkalinization may cause precipitation, since lidocaine is poorly soluble at pH above 6.5.