Lidagriks

Package Leaflet: Information for the User

Lydagriks, 10 mg/mL, Solution for Injection

Lydagriks, 20 mg/mL, Solution for Injection

Lidocaine Hydrochloride

Read the Package Leaflet Carefully Before Using the Medication, 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 medications called local anesthetics. The medication is used for anesthesia of various body parts during minor surgical procedures. Lydagriks temporarily blocks the transmission of pain stimuli to the brain in the area of injection.
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 nervous system blockade may cause serious side effects,
• in the eye, as the medication may cause transient or permanent side effects,
• in intra-articular infusion, as it may cause sudden loss of cartilage (chondrolysis),

Lydagriks and Other Medications

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

• other local anesthetics,
• medications used to treat irregular heartbeat (anti-arrhythmic medications),
• cimetidine (used to treat stomach ulcers) and beta-adrenolityki (used to treat 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 medication.
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.
Your doctor will weigh the benefits and risks of using this medication during short-term treatment during pregnancy and childbirth. If the medication is used in the cervix, your 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 you can breastfeed after using this medication.

Driving and Operating 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

• Ampoule 5 mL: This medication contains less than 1 mmol of sodium (23 mg) per 5 mL ampoule, which means the medication is considered "sodium-free".
• Ampoule 10 mL: This medication contains 27.8 mg of sodium (a major component of table salt) per 10 mL ampoule, which corresponds to 1.4% of the recommended maximum daily intake of sodium for adults.
• Vial 20 mL: This medication contains 55.6 mg of sodium (a major component of table salt) per 20 mL vial, which corresponds to 2.8% of the recommended maximum daily intake of sodium for adults.
• Vial 50 mL: This medication contains 139 mg of sodium (a major component of table salt) per 50 mL vial, which corresponds to 7% of the recommended maximum daily intake of sodium for adults.

20 mg/mL Solution for Injection

• Ampoule 2 mL: This medication contains less than 1 mmol of sodium (23 mg) per 2 mL ampoule, which means the medication is considered "sodium-free".
• Ampoule 5 mL: This medication contains less than 1 mmol of sodium (23 mg) per 5 mL ampoule, which means the medication is considered "sodium-free".
• Ampoule 10 mL: This medication contains 23.8 mg of sodium (a major component of table salt) per 10 mL ampoule, which corresponds to 1.2% of the recommended maximum daily intake of sodium for adults.
• Vial 20 mL: This medication contains 47.6 mg of sodium (a major component of table salt) per 20 mL vial, which corresponds to 2.4% of the recommended maximum daily intake of sodium for adults.
• Vial 50 mL: This medication contains 119 mg of sodium (a major component of table salt) per 50 mL vial, which corresponds to 6% of the recommended maximum daily intake of sodium for 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 medication 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 medication is determined by the type of pain to be relieved. It will also depend on your body weight, age, physical condition, and the part of the body where the medication is injected. Your doctor will give you the smallest dose necessary to achieve the desired effect.

Use in Children and Adolescents

This medication can be used in children, and treatment should be individualized for each child.

Overdose of Lydagriks

This medication 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 serious side effects that may occur after administration of too much of this medication.
The first symptoms of lidocaine overdose are:

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

If you experience any of these symptoms or think you have received too much of this medication, tell your doctor or nurse immediately.
More serious side effects than those listed above may occur after overdose of this medication, such as: balance and coordination disorders, hearing disorders, euphoria, confusion, speech disorders, pallor, excessive 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Lydagriks 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 prickling sensation,
• 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,
• hyperacusis,
• visual 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 may 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 Drug Safety Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Lydagriks

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

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 medication is packaged in clear glass ampoules of type I hydrolytic resistance with a single break point, volume 5 mL or 10 mL. The ampoules are marked with a colored ring. The ampoules are packaged in cardboard boxes of 5 or 10 pieces.
Vials
The medication is packaged in clear glass vials with a karbowane neck, volume 20 mL or 50 mL. The vials are closed with a 20 mm rubber stopper and a 20 mm aluminum seal (flip-off closure). The vials are packaged in cardboard boxes of 10 pieces.
20 mg/mL Solution for Injection
Ampoules
The medication is packaged in clear glass ampoules of type I hydrolytic resistance with a single break point, volume 2 mL, 5 mL or 10 mL. The ampoules are marked with a colored ring. The ampoules are packaged in cardboard boxes of 5 or 10 pieces.
Vials
The medication is packaged in clear glass vials with a karbowane neck, volume 20 mL or 50 mL. The vials are closed with a 20 mm rubber stopper and a 20 mm aluminum seal (flip-off closure). The vials are packaged in cardboard boxes of 10 pieces.
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 Medication is Authorized for Use 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.
Medications 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 pH above 6.5.