Lidocaine Kabi 10 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lidocaine Kabi 10 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 side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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 side effects
5. How to store Lidocaine Kabi

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 similar amide-type local anesthetics, 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 severe reaction, for example, skin rash or difficulty breathing, to any local anesthetic medicine.
• if you have a heart disorder, especially if it affects your 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 medicines that prevent blood clotting.
• 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, or that you do not have enough oxygen.
• if you have recently had vomiting, diarrhea, or bleeding, or if you have not been drinking normal amounts of fluid.
• 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 in the area to be injected.
• 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).

Use of 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, tell 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 to treat heart failure and shock, such as dopamine.
• Medicines used to prevent blood clotting (anticoagulants), such as heparin.
• Medicines used in the treatment of 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 the relief of severe pain, such as fentanyl, codeine, and pethidine.
• Medicines to treat migraine, ergotamine.
• Medicines used to relax muscles, such as suxamethonium.
• Medicines used to treat certain types of muscle spasms (such as serotonin).
• Medicines to treat mental disorders, such as sertindole, pimozide, fluvoxamine, olanzapine, quetiapine, zotepine.
• Medicines 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 anesthetic to put you to sleep, you should 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 are planning 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 use machines.

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

Lidocaína Kabi 10 mg/ml solution for injection contains sodium

This medicine contains 85 mg (approximately 3.72 mmol) of sodium (the main component of table salt) in each dose. This is equivalent to 4.25% 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 everybody 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)

• Decrease in 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
• Confusion, drowsiness, loss of consciousness, tremors, numbness of the tongue, difficulty speaking (sometimes these symptoms may indicate that you have been given too much lidocaine)

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 the available data)

• You may experience bluish discoloration of the skin, headache, difficulty breathing and fatigue as a result of abnormal levels of methemoglobin (a form of hemoglobin with reduced ability to bind oxygen) in the blood
• Agitation (restlessness)
• Unconsciousness
• Tinnitus (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, you must 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 who are discharged before the numbness or loss of sensation caused by a local anesthetic has worn off:

While you still feel numb in the injected area, serious injuries may occur without your knowledge. To avoid injury, take special care until the anesthesia 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 sodium chloride 9 mg/ml (0.9%) solution or in a glucose 50 mg/ml (5%) solution 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 10 mg/ml solution for injection:

Each ml of injection solution contains 10 mg of lidocaine hydrochloride (as monohydrate), equivalent to 8.11 mg of lidocaine.

Each 5 ml of injection solution contains 50 mg of lidocaine hydrochloride.

Each 10 ml of injection solution contains 100 mg of lidocaine hydrochloride.

Each 20 ml of injection solution contains 200 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 ampoules with a half-turn cap opening system (“twist-off”).

Pack sizes

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:

This leaflet has been reviewed in: May 2018.

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

This information is intended for medical or healthcare professionals only:

Special precautions

Lidocaine Kabi injection 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

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

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

If diluted in sodium chloride 9 mg/ml (0.9%) solution 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 Lidocaine 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, and lidocaine solutions may raise the pH above the maximum pH for their stability.

Disposal of waste

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