Leaflet: Information for the user

Lidocaína Kabi 10 mg/ml injectable solutionEFG

Lidocaine hydrochloride (as monohydrate)

Read this leaflet carefully before you start 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 questions, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Lidocaína Kabi is a local anesthetic. It is used for:

• producing local numbness (anesthesia) and relieving pain in the area of the body where it is administered.

No use Lidocaína Kabi:

-if you are allergic to hydrochloride lidocaine, to other similar anesthetic amides or to any of the other components of this medication (listed in section 6).

-if your blood volume is decreased (hypovolemia).

-if you have certain heart problems (irregular or slow heart rhythm).

Advertencias and precautions

Consult your doctor, pharmacist or nurse before starting to use Lidocaína Kabi:

• if you have ever had an allergic reaction or a severe reaction, for example, skin rash or difficulty breathing, to any local anesthetic medication.
• if you have a heart disorder, especially if it affects your heart rate.
• if you are taking medications to treat irregular heartbeats, such as amiodarone.
• if you are in shock.
• if you have a respiratory or pulmonary disorder.
• if you suffer from seizures or have epilepsy.
• if you suffer from muscle weakness (myasthenia gravis).
• if you have a bleeding disorder in your blood and are receiving treatment with medications that prevent blood coagulation.
• if you are an elderly person or are in a weakened general state.
• if you feel unwell or exhausted for any reason.
• if you have kidney or liver disease.
• if you have a blood disorder or any imbalance in your blood constituents, particularly if you have low potassium levels in your blood, which causes muscle cramps and constipation (hypokalemia).
• if you have been informed that you have too much acid in your blood and tissues, or that you do not have enough oxygen.
• if you have had recent vomiting, diarrhea or bleeding, or if you have not been drinking normal amounts of liquid.
• if you have a rare hereditary blood pigment disorder that affects the skin and nervous system called porphyria, or if any member of your family has it.
• if you have inflammation or infection in the area to be injected.
• if you are pregnant, are likely to become pregnant or are breastfeeding.

Children

Lidocaína Kabi is not recommended for use in neonates (less than one month old).

Use of Lidocaína Kabi with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Particularly, inform your doctor if you are taking any of the following medications, as they may interact with Lidocaína Kabi:

• Medications used to treat high blood pressure, such as diuretics (medications that promote urine elimination), beta blockers such as propranolol, timolol and calcium channel blockers, such as verapamil, prenylamine.
• Medications used to treat irregular heartbeats, such as amiodarone, mexiletine, phenytoin.
• Medications used to stimulate the heart and to treat shocks, such as dopamine.
• Medications to treat heart failure and shocks, such as dopamine.
• Medications used to prevent blood coagulation (anticoagulants), such as heparin.
• Medications used in the treatment of stomach ulcers, such as cimetidine, ranitidine.
• Medications to treat infections, such as quinupristin, dalfopristin.
• Medications to treat viral infections, such as amprenavir, atazanavir, darunavir, lopinavir.
• Medications for intense pain relief, such as fentanyl, codeine and pethidine.
• Medications to treat migraine, ergotamine.
• Medications used to relax muscles, such as suxamethonium.
• Medications used to treat certain types of muscle spasms (such as serotonin).
• Medications to treat mental disorders, such as sertindol, pimozide, fluvoxamine, olanzapine, quetiapine, zotepine.
• Medications to treat nausea and vomiting, such as dolasetron, tropisetron.
• Medications used to reduce pressure within the eye, such as acetazolamide.
• Oral contraceptives or oral hormone replacement therapy.

If adrenaline (epinephrine) is to be added to your lidocaine injection, you must also inform your doctor if you have high blood pressure, lack of blood supply to the brain, hyperactive thyroid gland or if you are taking antidepressant medications. If you are to receive a strong anesthetic to put you to sleep, you must inform your doctor if you have already received a lidocaine injection containing adrenaline (epinephrine).

If you are already taking one of these medications, speak with your doctor before using Lidocaína Kabi.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Your doctor will only administer this medication during your pregnancy or during breastfeeding if they consider it necessary.

Driving and operating machines

Depending on where and how this medication is used, it is likely to affect your ability to drive or operate machines. Your doctor will advise you if you can drive or use machines.

You must not drive or use machines while under the effects of Lidocaína Kabi.

Lidocaína Kabi 10 mg/ml injectable solution contains sodium

This medication contains 85 mg (approximately 3.72 mmol) of sodium (main component of table salt) in each dose. This is equivalent to 4.25% of the maximum daily dietary intake of 2 mg of sodium recommended by the WHO for an adult.

Your doctor will decide on the most suitable dose for you based on your age and physical condition, as well as the site of injection, the method used and your response to the injection.

If you are given more Lidocaína Kabi than you should

Since this medication will be administered by a trained professional, it is unlikely that you will be given too much Lidocaína Kabi.

However, if you think you have received too much, or if you start to experience dizziness or drowsiness, numbness or tingling in the lips and around the mouth or buzzing in the ears, you should inform the person administering the injection immediately.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediately if you experience an allergic reaction, which includes::

• Swelling of the hands, feet, face, lips, tongue, or throat.
• Difficulty breathing.
• Intense itching of the skin (with rashes).
• Fever.
• Decreased blood pressure and shock.

Other possible side effects are:

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

• Decreased blood pressure
• Nausea

Common(may affect up to 1 in 10 people)

-Paresthesia (tingling, numbness)

-Dizziness

-Slow heart rate

-Increased blood pressure

-Vomiting (being sick)

Uncommon(may affect up to 1 in 100 people)

-Seizures

-Drowsiness, dizziness, loss of consciousness, tremors, tongue numbness, difficulty speaking (sometimes, these symptoms may indicate that too much lidocaine has been administered)

Rare(may affect up to 1 in 1000 people)

• Hypersensitivity reactions such as urticaria (hives), skin rash, rapid swelling of subcutaneous tissue and mucous membranes, difficulty breathing, and in severe cases, decreased blood pressure and shock
• Rash, itching, and swelling of the face
• Pain, inflammation, or numbness at the injection site after the effects of the injection have worn off
• Impaired balance and coordination (peripheral nerve damage)
• Meningitis (inflammation of the membranes surrounding the nerves)
• Blurred or double vision
• Transient loss of vision (amaurosis)
• Changes in heart rhythm
• Cardiac arrest

Unknown(cannot be estimated from available data)

• You may experience a bluish discoloration of the skin, headache, difficulty breathing, and fatigue due to abnormal levels of methemoglobin (a form of hemoglobin with reduced oxygen-carrying capacity) in the blood
• Restlessness (nervousness)
• Loss of consciousness
• Tinnitus (a ringing in the ears)
• Hyperacusis (increased sensitivity to everyday sounds)
• You may find it more difficult to breathe or that your breathing may stop

After a spinal injection of Lidocaína Kabi, inform your doctor if you experience any of the following symptoms:

• Pain or numbness in the back or lower legs.
• Difficulty walking.
• Problems controlling the bladder or intestines.
• Feeling weak or dizzy.
• Slow heart rate or pulse.

For patients who return home before the numbness or loss of sensation caused by a local anesthetic has worn off:

During the time you feel numbness in the injected area, serious injuries may occur without your knowledge. To avoid injuries, be extra careful until the anesthesia wears off or sensation and touch return.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Human Medicines Pharmacovigilance System www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

After opening the ampule, use immediately and discard the unused portion of the solution.

Do not use if the ampule is damaged or broken.

If diluted in a 9 mg/ml (0.9%) sodium chloride solution or a 50 mg/ml (5%) glucose solution in strict aseptic conditions, the solution should also be used immediately.

However, if the diluted solution is not used immediately, it should not be stored for more than 12 hours in strict aseptic conditions below 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Lidocaína Kabi

• The active substance is hydrochloride of lidocaína (as monohidrato).

Lidocaína Kabi 10 mg/ml injectable solution:

Each ml of injectable solution contains 10 mg ofhydrochloride of lidocaína (as monohidrato)corresponding to 8.11 mg of lidocaína.

Each 5 ml of injectable solution contains 50 mg ofhydrochloride of lidocaína.

Each 10 ml of injectable solution contains 100 mg ofhydrochloride of lidocaína.

Each 20 ml of injectable solution contains 200 mg ofhydrochloride of lidocaína.

• The other components are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injectable preparations.

Appearance of Lidocaína Kabi and packaging content

Lidocaína Kabi is a transparent and colorless aqueous solution, practically free of visible particles.

Lidocaína Kabiis available inlow-density polyethylene vials with a medium-turn cap opening system (“twist-off”).

Packaging sizes

Vials of 5 ml in packs of 5, 10, 20, 50 or 100.

Vials of 10 ml in packs of 5, 10, 20, 50 or 100.

Vials of 20 ml in packs of 5, 10, 20, 50 or 100.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible:

Marketing authorization holder

Fresenius Kabi España, S.A.U.

C/Marina 16-18

08005 Barcelona

Spain

Manufacturer responsible

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 - Santiago de Besteiros

Portugal

This medicinal product is authorized in the member states of the European Economic Area under the following names:

This leaflet was revised in:May 2018.

<------------------------------------------------------------------------------------------------------------------------>

This information is intended solely for medical professionals or healthcare professionals:

Special precautions

Lidocaína Kabi injectable solution is not recommended for use in neonates. In this age group, the optimal serum concentration of lidocaína required to avoid toxicity, such as convulsions and cardiac arrhythmias, is unknown.

Handling and compatibility

Lidocaína Kabi injectable solution may be diluted in sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solutions.

The diluted solution must be visually inspected and not used if it presents opalescence, visible particles or precipitates.

If diluted in sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solutions under strict aseptic conditions, the solution should also be used within 12 hours.

Lidocaína is incompatible with solutions containing amphotericin B, sodium sulfadiazine, methohexital sodium, cefazolin sodium, phenytoin, glyceryl trinitrate and other alkaline solutions. Therefore, it is not advisable to mix Lidocaína Kabi with other agents.

Stable drugs in acidic medium such as hydrochloride ofadrenaline, noradrenaline tartrate or isoprenaline may deteriorate after being mixed with lidocaína hydrochloride and lidocaína solutions may elevate the pH above the maximum pH for their stability.

Residual waste disposal

All unused product or waste material must be disposed of in accordance with local requirements.