LIDOCAINE KABI 10 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Lidocaine Kabi 10 mg/ml Solution for InjectionEFG

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Lidocaine Kabi is and what it is used for
2. What you need to know before you use Lidocaine Kabi
3. How to use Lidocaine Kabi
4. Possible side effects
5. Storage of Lidocaine Kabi

Contents of the pack and further information

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

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

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

2. What you need to know before you use Lidocaine Kabi

Do not use Lidocaine Kabi:

• if you are allergic to lidocaine hydrochloride, to other similar anesthetics of the amide type, 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 heartbeat).

Warnings and precautions

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

• if you have ever had an allergic reaction or a severe reaction, for example, skin rash or difficulty breathing, to any local anesthetic.
• 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 have seizures or epilepsy.
• if you have muscle weakness (myasthenia gravis).
• if you have a bleeding disorder in your blood and are being treated with medicines that prevent blood clotting.
• if you are elderly or in a weakened state.
• if you feel unwell or tired 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 if you have low potassium levels in your blood, which can cause muscle cramps and constipation (hypokalemia).
• if you have been told 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 fluid.
• if you have a rare inherited blood pigment disorder that affects 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

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

Using Lidocaine Kabi with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Medicines used to treat high blood pressure, such as diuretics (medicines that promote urine production), beta blockers like propranolol, timolol, and calcium channel blockers like 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 for treating 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 for treating infections, such as quinupristin, dalfopristin.
• Medicines for treating viral infections, such as amprenavir, atazanavir, darunavir, lopinavir.
• Medicines for relieving severe pain, such as fentanyl, codeine, and pethidine.
• Medicines for treating migraines, ergotamine.
• Medicines used to relax muscles, such as suxamethonium.
• Medicines used to treat certain types of muscle spasms (such as serotonin).
• Medicines for treating mental disorders, such as sertindole, pimozide, fluvoxamine, olanzapine, quetiapine, zotepine.
• Medicines for treating 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 tell your doctor if you have high blood pressure, lack of blood supply to the brain, an overactive thyroid gland, or if you are taking antidepressant medicines. If you are going to receive a strong anesthetic to put you to sleep, you should tell your doctor if you have already received a lidocaine injection containing adrenaline (epinephrine).

If you are already taking one of these medicines, talk to your doctor before using Lidocaine Kabi.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Your doctor will only give you this medicine during pregnancy or breastfeeding if it is necessary.

Driving and using machines

Depending on where and how this medicine is used, it may affect your ability to drive or use machines. Your doctor will tell you if you can drive or use machines.

Do not drive or use machines if you are under the effects of Lidocaine Kabi.

Lidocaine 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) per 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.

3. How to use Lidocaine Kabi

Your doctor will decide 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 too much Lidocaine Kabi

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

However, if you think you have been given too much, or if you start to feel dizzy or lightheaded, numbness or tingling in the lips and around the mouth, or ringing in the ears, you should tell the person giving you the injection immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell 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.
• severe itching of the skin (with hives).
• fever.
• low blood pressure and shock.

Other possible side effects are:

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

• Low blood pressure
• Nausea

Common(may affect up to 1 in 10 people)

• Paresthesia (tingling, numbness)
• Dizziness
• Slow heart rate
• High blood pressure
• Vomiting (being sick)

Uncommon(may affect up to 1 in 100 people)

• Seizures
• Drowsiness, dizziness, loss of consciousness, tremors, numbness of the tongue, difficulty speaking (sometimes, these symptoms can indicate that you have been given too much lidocaine)

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

• Hypersensitivity reactions such as urticaria (hives), skin rash, rapid swelling of the tissue under the skin and mucous membranes, difficulty breathing, and, in severe cases, low 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
• Damage to the balance and coordination (peripheral nerve damage)
• Inflammation of the membranes surrounding the nerves (arachnoiditis)
• Blurred or double vision
• Temporary loss of vision (amaurosis)
• Changes in heart rhythm
• Cardiac arrest

Not known(cannot be estimated from the available data)

• You may experience a bluish discoloration of the skin, headache, difficulty breathing, and fatigue as a result of abnormal amounts of methemoglobin (a form of hemoglobin that has a lower ability to bind to oxygen) in the blood
• Agitation (nervousness)
• Unconsciousness
• Tinnitus (a ringing in the ears)
• Hyperacusis (increased sensitivity to everyday sounds)
• You may find it harder to breathe or your breathing may stop

After spinal injection of Lidocaine Kabi, you should tell 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 go 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 can occur without you realizing it. To avoid injuries, be careful until the anesthesia has worn off or sensation and touch have returned.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side 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 the 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 a glucose 50 mg/ml (5%) solution under 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 under strict aseptic conditions below 25°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lidocaine Kabi

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

Lidocaine Kabi 10 mg/ml solution for injection:

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

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

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

Each 20 ml of solution for injection contains 200 mg of lidocaine hydrochloride.

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

Appearance of Lidocaine Kabi and pack contents

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

Lidocaine Kabi is available in low-density polyethylene ampoules with a twist-off cap.

Pack sizes

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

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

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

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

This leaflet was last revised in:May 2018.

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

This information is intended only for healthcare professionals:

Special precautions

Lidocaine Kabi solution for injection 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 solution for injection 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 not used if it shows 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.

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

Drugs that are stable in acidic media, such as adrenaline hydrochloride, noradrenaline tartrate, or isoprenaline, may deteriorate after being mixed 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 should be disposed of in accordance with local requirements.