LIDOCAINE 20 MG / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Lidocaine 10 mg/ml Solution for injection

Read all of this leaflet carefully before you start taking 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 or pharmacist.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

• 1. What Lidocaine solution for injection is and what it is used for

• 2. What you need to know before you are given Lidocaine solution for injection

• 3. How to be given Lidocaine solution for injection

• 4. Possible side effects

• 5. How to store Lidocaine solution for injection

• 6. Contents of the pack and other information

1. what lidocaine solution for injection is and what it is used for

Lidocaine Hydrochloride is a local anesthetic and belongs to a class of drugs called amide type local anesthetics. It produces loss of feeling or sensation confined to one part of the body. Lidocaine solution for injection may be used to produce local numbness (anesthesia) by injection of the solution into or around the area of operation. It may also be used to produce local anesthesia by injection of the solution close to the nerves whose conduction is to be cut off, or into the epidural space near the spinal cord, or by administering the solution into a vein in a limb that has been isolated from the circulation by means of a tourniquet (bandage that stops the flow of blood from vessel by applying pressure).

2. what you need to know before you are given lidocaine solution for injectiondo not be given this medicine if you know you are allergic to lidocaine hydrochloride, to any of the other ingredients (see section 6 of this leaflet) of this medicine or to other similar amide type anesthetics.

• if you suffer from state of decreased blood volume (hypovolaemia).
• if you suffer from abnormality of impulse propagation in the heart causing decreased blood pressure, slow heart rate (complete heart block)

If the solution also contains adrenaline, lidocaine hydrochloride should not be injected into a vein or used in areas such as fingers, toes, ears, nose or penis, as the blood supply to these areas might become inadequate.

Speak to your doctor if one of these applies to you before you are given this medicine.

Warning and precautions:

• you suffer from any heart problem, particularly if it affects the heart rate.
• you suffer from fits (epilepsy).
• you have low concentration of potassium in the blood causing muscle cramps, constipation (hypokalaemia).
• you ever had an allergic reaction to local anesthetic e.g. a skin rash or breathlessness or collapse.
• you have had recent vomiting, diarrhea or bleeding, or if you have not been drinking normal amounts of fluid.
• you are feeling ill and run down.
• you have been told that you have too much acid in your blood and tissues, or not enough oxygen.
• you suffer from any liver disease or kidney problems.
• you have porphyria (a rare inherited disease that affects the skin and nervous system).
• you have an infection of the skin with pus at or near the site to be injected.
• you have problems with your breathing.
• you are pregnant, likely to become pregnant or breast-feeding.
• you suffer from loss of muscle function and weakness (myasthenia gravis).

Lidocaine solution for injection is not recommended for use in neonates (less than a month old).

Other medicines and Lidocaine solution for injection

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

A large number of drugs can interact with Lidocaine Hydrochloride which can significantly alter their effects. These drugs include:

• medicines used to treat high blood pressure such as diuretics (water tablets), betablockers, e.g. timolol and propranolol and calcium channel blockers, e.g. verapamil, prenylamine.
• medicines used in the treatment of stomach ulcers (e.g. ranitidine, cimetidine).
• dopamine used to stimulate the heart and to treat shock.
• strong pain relieving medicines such as codeine and pethidine (narcotics or opioid drugs).
• medicines used to treat certain types of muscle jerking (e.g. serotonin or 5– hydroxytryptamine)
• medicines used to treat viral infection (e.g. amprenavir, atazanavir, darunavir and lopinavir).
• medicines used to treat irregular heart beat (mexiletine, amiodarone).
• medicines used to treat infections (quinupristin/dal­fopristin).
• medicines used to treat mental disorders (pimozide, sertindole, olanzapine, quetiapine, zotepine).
• medicines used to treat nausea and vomiting (tropisetron, dolasetron).

If adrenaline (epinephrine) is to be added to your lidocaine injection, you should also tell your doctor if you suffer from high blood pressure, shortage of blood supply to the brain, an overactive thyroid gland or if you are taking antidepressant drugs. If you are about to receive a strong anesthetic to put you to sleep, you should tell your doctor if you have already received an injection of lidocaine containing adrenaline (epinephrine).

If you are already taking one of these medicines, speak to your doctor before you receive Lidocaine Hydrochloride.

Lidocaine solution for injection contains approximately 300mg of sodium per maximum dose. This should be taken into consideration by patients on a controlled sodium diet and in cases where fluid restriction is required.

Pregnancy and breastfeeding:

Tell your doctor before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breastfeeding. Lidocaine Hydrochloride should only be used during pregnancy and breast feeding if absolutely necessary.

Driving and using machines:

Certain areas of your body will be numb for about 2–4 hours after having this medicine. If this is likely to affect your ability to drive or use machinery you should wait for the effect to wear off. In general, it is wise to ask your doctor whether it is safe to drive.

• 3. How to be given Lidocaine solution for injection

The site of injection will depend on the area to be numbed. It will be administered by a trained healthcare professional. Your doctor will decide the most suitable dosage for your particular case according to your age and physical circumstances as well as the site of injection, the method used and your response to the injection. If you have any concerns or questions about how much of this medicine you have received, speak to your doctor immediately.

4. possible side effects

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

Seek immediate medical help if you have any of the following symptoms:

Allergic reactions causing

• Swelling of hands, feet, lips, mouth, tongue or throat
• Difficulties breathing
• Itchy skin rash
• Dizziness or lightheadedness, drowsiness, tremor, your tongue going numb – sometimes these symptoms may indicate that you have been given too much Lidocaine solution for injection.
• Convulsions (seizures).
• Blurred or double vision.
• Tinnitus (a ringing in your ears).
• Hyperacusis (you are more sensitive to everyday sounds).
• Increased or decreased blood pressure.
• Slowing and stopping of your heart.
• Changes in the rhythm of your heart.
• You may find it more difficult to breathe or your breathing may stop.
• Nausea (feeling sick) and vomiting (being sick).
• Rash, itching and swelling of the face.
• Pain, inflammation or numbness at the site of injection after the effects of the injection should have worn off.
• Pain or numbness in the back or lower legs.
• Difficulty in walking.
• Problems with controlling your bladder or bowels.
• Feeling faint or light headed.
• Slow heart rate or pulse rate.

5. how to store lidocaine solution for injection

Keep out of the sight and reach of children.

The solution should not be used after the expiry date printed on the ampoule and carton.

Do not store above 25°C. Do not refrigerate or freeze.

For single use only. Discard any unused contents.

The solution should not be used if it is discolored in any way.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat lidocaine solution for injection contains:the active substance is lidocaine hydrochloride.

Lidocaine 10mg/ml solution for injection, each 1ml of which contains 10mg of active ingredient.

Lidocaine 20mg/ml solution for injection, each 1ml of which contains 20mg of active ingredient.

The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

What Lidocaine solution for injection looks like and contents of pack

Lidocaine solution for injection is a clear colourless, sterile solution for injection.

Lidocaine 10mg/ml solution for injection is available in 2ml, 5ml, 10ml clear glass ampoules and 20ml clear glass vial. The 2ml and 5ml glass ampoules are available in pack of 5,10 and 25, 10ml ampoule available in pack of 5 and 10 and 20ml vial available in pack of 1 and 10.

Lidocaine 20mg/ml solution for injection is available in 2ml, 5ml clear glass ampoules and 20ml clear glass vial. The 2ml and 5ml glass ampoules are available in pack of 5,10 and 25 and 20ml vial available in pack of 1 and 10.

Not all pack sizes may be marketed.

Marketing authorization holder

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk IP24 3SE

United Kingdom

Manufacturer

Peckforton Pharmaceuticals Limited

The Granary, The Courtyard Barns,

Choke Lane, Cookham Dean, Maidenhead,

Berkshire, SL6 6PT,

United Kingdom.

Or

UAB Norameda

Meistru 8a, 02189,

Vilnius, Lithuania

Or

Bieffe Medital S.p.A.

Via Nuova Provinciale 23034

Grossotto (SO) Italy

This Leaflet was last revised in 01/2020.