LIDOCAINA 10 mg /Ml Инъекционный Раствор

Содержание инструкции

1. Lidocaina Grindeks 10 mg/mL injectable solution, 20 mg/mL injectable solution
   1. What is Lidocaina Grindeks and what is it used for
   2. What you need to know before you are given Lidocaina Grindeks
   3. How Lidocaina Grindeks will be administered to you
   4. Possible side effects
   5. How to store Lidocaina Grindeks
   6. Package contents and other information

Lidocaina Grindeks 10 mg/mL injectable solution, 20 mg/mL injectable solution

lidocaine hydrochloride

generic medicine

Read this leaflet carefully before you are given this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section
• 4.

Contents of this leaflet:

• 1. What Lidocaina Grindeks is and what it is used for
• 2. What you need to know before you are given Lidocaina Grindeks
• 3. How Lidocaina Grindeks will be given to you
• 4. Possible side effects
• 5. How to store Lidocaina Grindeks
• 6. Contents of the pack and other information

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

Lidocaina Grindeks contains the active substance lidocaine, which is a local anesthetic. It is used to
numb (anesthetize) parts of the body during minor surgical procedures. It temporarily
prevents the nerve from transmitting pain messages to the brain in the area where it is injected.
Lidocaina Grindeks 10 mg/mL can be used in adults and children over 1 year of age.
Lidocaina Grindeks 20 mg/mL can be used in adults.

2. What you need to know before you are given Lidocaina Grindeks

You will not be given Lidocaina Grindeks

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

Do not use Lidocaina Grindeks for epidural anaesthesia if you have

• very low blood pressure
• a life-threatening condition in which, due to heart problems, the heart is unable to pump enough blood to meet the body's needs (cardiogenic shock)
• a life-threatening condition in which severe blood or fluid loss makes the heart unable to pump enough blood to meet the body's needs (hypovolaemic shock).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Lidocaina Grindeks.

• if you are elderly or in a generally weakened condition, as the dose may need to be reduced
• if you have heart problems such as slow or irregular heartbeat (heart block, AV block)
• if you have problems with your liver or kidneys, as the dose may need to be reduced
• in dorsal anaesthesia (epidural anaesthesia), as blocking the central nerves can cause serious side effects

collateral

• in the eye, as the medicine can, in rare cases, cause transient or permanent side effects
• by infusion directly into the joint space (intra-articular infusion), as it can cause rapid loss of joint cartilage (chondrolysis)
• if you suffer from a disease called acute porphyria.

Other medicines and Lidocaina Grindeks
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Lidocaina Grindeks can influence or be influenced by other medicines, such as:

• other local anaesthetics
• medicines for heart rhythm disorders (so-called antiarrhythmics)
• cimetidine (medicine for stomach ulcers) and beta-blockers (medicines for high blood pressure, among others)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before you are given this medicine.
Lidocaine crosses the placenta and reaches the foetus. However, there is no evidence that lidocaine causes
harmful effects on the foetus, although the risk is not entirely known.
The doctor will assess the benefits and risks of using this medicine for short-term treatment
during pregnancy and at the time of delivery. If the medicine is used in the cervix, the doctor
will carefully monitor the baby's heartbeat.
Lidocaine passes into breast milk, but it is unlikely to have effects on the breastfed baby
and therefore breastfeeding is possible after treatment with this medicine.

Driving and using machines
Depending on the dose and the area where Lidocaina Grindeks has been administered, it may have
temporary effects on your ability to drive or use machines. You should not perform these activities until
normal functions are fully restored.

Lidocaina Grindeks contains sodium

10 mg/mL injectable solution

• 5 mL vial: this medicine contains less than 1 mmol of sodium (23 mg) per 5 mL vial, i.e. essentially "sodium-free".
• 10 mL vial: this medicine contains 27.8 mg of sodium (the main component of table salt) in each 10 mL vial. This is equivalent to 1.4% of the recommended maximum daily intake of sodium for an adult.
• 20 mL vial: This medicine contains 55.6 mg of sodium (the main component of table salt) per 20 mL vial. This is equivalent to 2.8% of the recommended maximum daily dose of sodium for an adult.
• 50 mL vial: This medicine contains 139 mg of sodium (the main component of table salt) per 50 mL vial. This is equivalent to 7% of the recommended maximum daily intake of sodium for an adult.

20 mg/mL injectable solution

• 2 mL vial: this medicine contains less than 1 mmol of sodium (23 mg) per 2 mL vial, i.e. essentially "sodium-free".
• 5 mL vial: this medicine contains less than 1 mmol of sodium (23 mg) per 5 mL vial, i.e. essentially "sodium-free".
• 10 mL vial: this medicine contains 23.8 mg of sodium (the main component of table salt) in each 10 mL vial. This is equivalent to 1.2% of the recommended maximum daily intake of sodium for an adult.
• 20 mL vial: This medicine contains 47.6 mg of sodium (the main component of table salt) per 20 mL vial. This is equivalent to 2.4% of the recommended maximum daily dose of sodium for an adult.
• 50 mL vial: This medicine contains 119 mg of sodium (the main component of table salt) per 50 mL vial. This is equivalent to 6% of the recommended maximum daily intake of sodium for an adult.

3. How Lidocaina Grindeks will be administered to you

Lidocaina Grindeks will be administered to you by a doctor. Depending on the type of anesthesia required, the area
to be anesthetized and the duration of the anesthetic, the drug will be administered as an injection into a vein,
under the skin or into the epidural space near the spinal cord.
The dose that the doctor will administer to you will depend on the type of pain relief you need. It also depends
on your body weight, age, physical condition and the part of the body into which the
drug is injected. The lowest possible dose will be administered to produce the desired effect.

Use in children and adolescents
This medicine can be used in children and treatment will be individually adapted for each
child.

If you are given more Lidocaina Grindeks than you should
It is very unlikely that you will be given more solution than necessary as the medicine will be
administered by medical personnel.
The staff caring for you are trained to manage the serious side effects resulting from taking an
excessive amount of medicine. The first signs of an overdose of lidocaine are usually
the following:

• seizures,
• feeling dizzy or lightheaded,
• nausea,
• numbness or tingling of the lips and mouth,
• vision problems.

If any of these situations occur to you or if you think you have received an excessive amount of medicine, inform
your doctor or nurse immediately.
Administering an excessive amount of medicine can cause more serious side effects, such as
disturbances of balance and coordination, hearing changes, euphoria, confusion, speech disorders, paleness, sweating, tremors, effects on the heart and blood vessels, loss of consciousness, coma
and temporary respiratory arrest.
If you have 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.
manifest.

Very Common(may affect more than 1 in 10 people)

• Lowering of blood pressure
• Nausea

Common(may affect up to 1 in 10 people)

• Increase in blood pressure
• Dizziness
• Pins and needles sensation (tingling)
• Decrease in heart rate
• Vomiting

Uncommon(may affect up to 1 in 100 people)

• Signs of toxic reactions at the level of the central nervous system, such as:
• Cramps
• Numbness of the tongue or tingling around the mouth
• Increased sensitivity to sounds
• Visual disturbances
• Tremor
• Feeling of intoxication
• Tinnitus
• Difficulty speaking
• Loss of consciousness

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

• Allergic reactions with symptoms such as hives and rash and, in the most severe cases, anaphylactic shock
• Irregular or interrupted heartbeat (cardiac arrhythmias, cardiac arrest)
• Slowed or stopped breathing
• Changes in sensations or muscle weakness (neuropathy)
• Inflammation of a membrane surrounding the spinal cord (arachnoiditis) which can cause pain in the lower back, or pain, numbness or weakness in the legs
• Double vision

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lidocaina Grindeks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not freeze.
Do not use this medicine if you notice particles in the vial or bottle.
The solution must be used immediately after opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lidocaina Grindeks contains

• The active ingredient is lidocaine hydrochloride

10 mg/mL injectable solution
1 mL of injectable solution contains 10 mg of lidocaine hydrochloride.
One 5 mL vial contains 50 mg of lidocaine hydrochloride.
One 10 mL vial 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 injectable solution
1 mL of injectable solution contains 20 mg of lidocaine hydrochloride.
One 2 mL vial contains 40 mg of lidocaine hydrochloride.
One 5 mL vial contains 100 mg of lidocaine hydrochloride.
One 10 mL vial contains 200 mg of lidocaine hydrochloride.
One 20 mL vial contains 400 mg of lidocaine hydrochloride.
One 50 mL vial contains 1,000 mg of lidocaine hydrochloride.
The other ingredients are sodium chloride, sodium hydroxide (to adjust the pH) and water for
injections.

Description of the appearance of Lidocaina Grindeks and package contents
Lidocaina Grindeks appears as a clear, particle-free, colorless or
slightly yellowish solution.

10 mg/mL injectable solution
Vials
Transparent glass vials of 5 mL or 10 mL, made of borosilicate glass
class I, resistant to hydrolytic action, with a breaking point, are used for packaging. The vials are marked
with a colored ring. 5 or 10 vials are packaged in a cardboard box.
Vials
Injection vials of 20 mL and 50 mL made of transparent type I borosilicate glass with a crimp neck. The vials are closed with 20 mm bromobutyl rubber stoppers and 20 mm aluminum flip-
off seals. 10 vials are packaged in a cardboard box.

20 mg/mL injectable solution
Vials
Vials made of colorless borosilicate glass of 2 mL, 5 mL or 10
mL, type I, resistant to hydrolytic action, with a breaking point, are used for packaging. The vials are marked with a
colored ring. 5 or 10 vials are packaged in a cardboard box.
Vials
Injection vials of 20 mL and 50 mL made of transparent type I borosilicate glass with a crimp neck. The vials are closed with 20 mm bromobutyl rubber stoppers and 20 mm aluminum flip-
off seals. 10 vials are packaged in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga LV-1057,
Latvia

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
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

Germany:Lidocain Grindeks 10 mg/mL Injektionslösung;
Lidocain Grindeks 20 mg/mL Injektionslösung

Hungary:Lydagriks 10 mg/mL oldatos injekció;
Lydagriks 20 mg/mL oldatos injekció

Italy:Lidocaina Grindeks

Latvia:Lisendum 10 mg/mL šķīdums injekcijām;
Lisendum 20 mg/mL šķīdums injekcijām

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
The medicinal product should not be brought into contact with metals, such as needles or metal parts of
syringes, as dissolved metal ions can cause swelling at the injection site.
Lidocaine hydrochloride has been reported to be incompatible in solutions with amphotericin B, sodium sulfadiazine,
sodium methosital, cefazolin sodium or sodium phenytoin.
Acid-stable drugs, such as adrenaline hydrochloride, noradrenaline tartrate acid or isoprenaline, may begin to
deteriorate within a few hours of mixing with lidocaine hydrochloride, as lidocaine solutions can raise the pH of the final solution beyond the maximum pH for their
stability.
Alkalinization can lead to precipitation, as lidocaine is only slightly soluble at pH
values above 6.5.