Lidocaine Kabi 20 mg/ml injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lidocaine Kabi 20 mg/ml injection solutionEFG

Lidocaine hydrochloride (as monohydrate)

Read all of 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, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Lidocaine Kabi is and what it is used for
2. What you need to know before using Lidocaine Kabi
3. How to use Lidocaine Kabi
4. Possible adverse reactions
5. How to store Lidocaine Kabi
6. Contents of the pack and other information

1. What Lidocaine Kabi is and what it is used for

Lidocaine Kabi is a local anaesthetic. It is used to:

• produce local numbing (anaesthesia) and relieve pain in the area of the body where it is administered.

2. What you need to know before using Lidocaína Kabi

Do not use Lidocaína Kabi:

• if you are allergic to lidocaine hydrochloride, to other amide-type local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).
• if your blood volume is reduced (hypovolemia).
• if you have certain heart problems (irregular or slow heart rhythm).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Lidocaína Kabi:

• if you have ever had an allergic reaction or a serious reaction, for example, skin rash or difficulty breathing, to any local anaesthetic medicine.
• if you have a heart disorder, especially one affecting heart rate.
• if you are taking medicines to treat irregular heartbeats, such as amiodarone.
• if you are in shock.
• if you have a lung or respiratory disorder.
• if you suffer from seizures or have epilepsy.
• if you have muscle weakness (loss of muscle function, called myasthenia gravis).
• if you have a bleeding disorder and are receiving treatment with blood-thinning medicines.
• if you are elderly or in a generally weakened condition.
• 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 the components of your blood, particularly low potassium levels in the blood, which may cause muscle cramps and constipation (hypokalemia).
• if you have been told that you have too much acid in your blood and tissues (acidosis), or that you lack sufficient oxygen.
• if you have recently had vomiting, diarrhoea, or bleeding, or if you have not been drinking normal amounts of fluids.
• if you have a rare inherited blood pigment disorder affecting the skin and nervous system called porphyria, or if anyone in your family has it.
• if you have inflammation or infection at the injection site.
• if you are pregnant, likely to become pregnant, or are breastfeeding.

Children

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

Using Lidocaína Kabi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Medicines used to treat high blood pressure, such as diuretics (medicines that increase urine production), beta-blockers such as propranolol, timolol, and calcium channel blockers such as verapamil, prenylamine.
• Medicines used to treat irregular heartbeats, such as amiodarone, mexiletine, phenytoin.
• Medicines used to stimulate the heart and treat shock, such as dopamine.
• Medicines used to treat heart failure and shock, such as dopamine.
• Medicines used to prevent blood clotting (anticoagulants), such as heparin.
• Medicines used to treat stomach ulcers, such as cimetidine, ranitidine.
• Medicines used to treat infections, such as quinupristin, dalfopristin.
• Medicines used to treat viral infections, such as amprenavir, atazanavir, darunavir, lopinavir.
• Medicines for relief of severe pain, such as fentanyl, codeine, and meperidine.
• Medicines used to treat migraine, such as ergotamine.
• Medicines used to relax muscles, such as suxamethonium.
• Medicines used to treat certain types of muscle spasms (such as serotonin).
• Medicines used to treat mental disorders, such as sertindole, pimozide, fluvoxamine, olanzapine, quetiapine, zotepine.
• Medicines used to treat nausea and vomiting, such as dolasetron, tropisetron.
• Medicines used to reduce pressure inside the eye, such as acetazolamide.
• Oral contraceptives or oral hormone replacement therapy.

If adrenaline (epinephrine) is to be added to your lidocaine injection, you should also inform your doctor if you have high blood pressure, reduced blood supply to the brain, an overactive thyroid gland, or if you are taking antidepressant medicines. If you are to receive a strong anaesthetic to render you unconscious, inform your doctor if you have already received a lidocaine injection containing adrenaline (epinephrine).

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

Pregnancy and breastfeeding

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

Your doctor will only administer this medicine during pregnancy or breastfeeding if considered necessary.

Driving and using machines

Depending on where and how this medicine is used, it may affect your ability to drive or operate machinery. Your doctor will advise you whether you can drive or operate machinery.

You must not drive or operate machinery if you are under the influence of Lidocaína Kabi.

Lidocaína Kabi 20 mg/ml solution for injection contains sodium

This medicine contains 32 mg (approximately 1.39 mmol) of sodium (the main component of table salt) per dose. This is equivalent to 1.6% of the maximum daily dietary intake of 2 g of sodium recommended by the WHO for an adult.

3. How to use Lidocaine Kabi

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

If you are given more Lidocaine Kabi than you should

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

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

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Tell your doctor or nurse immediately if you experience an allergic reaction, including:

• swelling of the hands, feet, face, lips, tongue or throat
• difficulty breathing
• severe skin itching (with rash)
• fever
• drop in blood pressure and shock

Other possible adverse 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
• Increase in blood pressure
• Vomiting (feeling sick)

Uncommon (may affect up to 1 in 100 people)

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

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

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

Not known (frequency cannot be estimated from available data)

• You may experience bluish discoloration of the skin, headache, difficulty breathing and fatigue due to abnormally high levels of methaemoglobin (a form of haemoglobin with reduced oxygen-binding capacity) in the blood
• Agitation (restlessness)
• Unconsciousness
• Tinnitus (a ringing in the ears)
• Hyperacusis (increased sensitivity to everyday sounds)
• You may find it more difficult to breathe or your breathing may stop

After 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 bowels
• Feeling weak or dizzy
• Slow heart rate or pulse

For patients returning home before the numbness or loss of sensation caused by a local anaesthetic has worn off:

While you still feel numb in the injected area, serious injuries may occur without your awareness. To avoid injury, take special care until the anaesthesia wears off or sensation and touch return.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Human Medicines Pharmacovigilance System at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine Kabi

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

This medicine does not require any special storage conditions.

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

Do not use if the ampoule is damaged or broken.

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

However, if the diluted solution is not used immediately, it must not be stored for longer than 12 hours under strict aseptic conditions and below 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lidocaine Kabi

• The active substance is lidocaine hydrochloride (as monohydrate).

Lidocaine Kabi 20 mg/ml injection solution:

Each ml of injection solution contains 20 mg of lidocaine hydrochloride (as monohydrate), equivalent to 16.22 mg of lidocaine.

Each 5 ml of injection solution contains 100 mg of lidocaine hydrochloride.

Each 10 ml of injection solution contains 200 mg of lidocaine hydrochloride.

Each 20 ml of injection solution contains 400 mg of lidocaine hydrochloride.

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

Appearance of Lidocaine Kabi and contents of the pack

Lidocaine Kabi is a clear, colourless aqueous solution, practically free from visible particles.

Lidocaine Kabi is available in low-density polyethylene vials with a half-turn opening system (“twist-off” cap).

Pack sizes

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

C/Marina 16-18

08005 Barcelona

Spain

Manufacturer

Labesfal – Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 - Santiago de Besteiros

Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:

This leaflet was last reviewed in: May 2018.

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This information is intended only for healthcare professionals:

Special precautions

Lidocaína Kabi injectable solution is not recommended for use in neonates. In this age group, the optimal serum concentration of lidocaine required to avoid toxicity, such as seizures 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 should be inspected visually and must not be used if cloudiness, visible particles or precipitates are present.

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

Lidocaine is incompatible with solutions containing amphotericin B, sodium sulfadiazine, sodium methohexital, sodium cefazolin, phenytoin, glyceryl trinitrate and other alkaline solutions. Therefore, mixing Lidocaína Kabi with other agents is not recommended.

Drugs stable in an acidic medium, such as adrenaline hydrochloride, noradrenaline acid tartrate or isoprenaline, may deteriorate after mixing with lidocaine hydrochloride, as lidocaine solutions may raise the pH above the maximum pH for their stability.

Disposal of waste

Any unused product or waste material should be disposed of in accordance with local requirements.