LIDOCAINE HYDROCHLORIDE 2% W/V SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

3. How to use Lidocaine

4. Possible side effects

1. what lidocaine is and what it is used for

Lidocaine is a local anaesthetic. It is used to:

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

2. what you need to know before you are using lidocaine

Do not use Lidocaine:

• – if you are allergic to lidocaine hydrochloride, to other similar amide type anaesthetics or any of the other ingredients of this medicine (listed in section 6).

• – if you suffer from a state of decreased blood volume (hypovolaemia).

• – if you have certain heart disorders (irregular or slow heart beat).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lidocaine: – if you ever had an allergic or bad reaction, for example, skin rash or breathlessness, to any local anaesthetic medicines.

• – if you suffer from a heart disorder, particularly if it affects the heart rate.

• – if you are taking medicines to treat irregular heart beat such as amiodarone.

• – if you are in shock.

• – if you suffer from lung or breathing disorder.

• – if you suffer from fits or have epilepsy.

• – if you suffer from loss of muscle function (weakness of your

muscles, called myasthenia gravis).

if you suffer from a bleeding disorder and are treated medicines preventing your blood from clotting.

if you are elderly or in a generally debilitated condition.

if you are feeling unwell or run down for any reason.

if you have kidney or liver disease.

if you have a blood disorder or any imbalance in constitutents of your blood, particularly if you have

concentration of potassium in the blood causing muscle cramps and constipation (hypokalaemia).

if you have been told that you have too much acid in your blood and tissues, or not enough oxygen.

if you have had recent vomiting, diarrhoea or bleeding, or if you have not been drinking normal amounts of fluid.

if you have a rare inherited disease of the blood pigment that affects the skin and nervous sytem called porphyria, or 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 breastfeeding.

Children

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

Other medicines and Lidocaine

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

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

• – Medicines used to treat high blood pressure such as diuretics (water tablets), beta blocker such as propanolol, timolol and calcium channel blockers such as verapamil, prenylamine.

• – Medicines used to treat irregular heart beat such as amiodarone, mexiletine, phenytoin.

• – Medicines used to stimulate the heart and to treat shock such as dopamine.

• – Medicines to treat cardiac failure and states of shock such as dopamine.

• – Medicines used to prevent your blood from clotting (anticoagulants) such as heparin.

• – Medicines used in the treatment of stomach ulcers such as cimetidine, ranitidine.

• – Medicines to treat infections such as quinupristin, dalfopristin.

• – Medicines to treat viral infection such as amprenavir, atazanavir, darunavir, lopinavir.

• – Medicines for the relief of strong pain such as fentanyl, codeine, pethidine.

• – Medicines to treat migraine, ergotamine.

• – Medicines used to relax muscles such as suxamethonium.

• – Medicines used to treat certain types of muscle twitching (such as serotonin).

• – Medicines to treat mental disorders such as sertindole, pimozide, fluvoxamine, olanzapine, quetiapine, zotepine.

• – Medicines to treat nausea and vomitting such as dolasetron, tropisetron.

• – Medicines used to reduce pressure within the eye such as acetazolamide.

• – Oral contraceptive or oral hormone replacement therapy.

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

Seek immediately medical help if you have an allergic reaction causing:

• – swelling of the hands, feet, face, lips, mouth, tongue or throat.

• – difficulties in breathing.

• – itchy skin rash.

• – fever.

• – drop in blood pressure and shock.

Other possible side effects are:

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

• – Decreased blood pressure

• – Nausea (feeling sick)

Common (may affect up to 1 in 10 people)

• – Paraesthesia (tingling, numbness)

• – Dizziness

• – Slow heart rate

• – Increased blood pressure

• – Vomiting (being sick)

Uncommon (may affect up to 1 in 100 people)

• – Convulsions (seizures)

• – Lightheadedness, drowsiness, loss of consciousness, tremor, your tongue going numb, difficulty in 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 hives (urticaria), skin rash, rapid swelling of subcutaneous tissue and mucous membrane, difficulties in breathing, and in severe cases drop in blood pressure and shock

• – 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

• – Impaired balance and coordination (peripheral nerve injuries)

• – Inflammatory condition of the membranes surrounding the nerves (arachnoiditis)

• – Blurred or double vision

• – Transient vision loss (amaurosis)

• – Changes in the rhythm of your heart

• – Stopping your heart (cardiac arrest)

Not known (frequency cannot be estimated from the available data)

• – You may experience a blueish discolouration to your skin, headache, breathlessness and fatigue as a result of abnormal amounts of methaemoglobin (a form of haemoglobin which has a decreased ability to bind oxygen) in your blood

• – Flurry (nervousness)

• – Unconsciousness

• – Tinnitus (a ringing in your ears)

• – Hyperacusis (you are more sensitive to everyday sounds)

• – You may find it more difficult to breathe or your breathing may stop

After spinal injection of Lidocaine, you should tell your doctor if you experience any of the following symptoms:

• – 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.

For patients going home before the numbness or loss of feeling caused by a local anaesthetic wears off:

During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anaesthetic wears off or feeling returns to the area.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:

United Kingdom

Yellow Card Scheme

Website: or search for MHRA Yellow

Card in the Google Play or Apple App Store

For IE: via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +3531 6764971; Fax: +353 1 676 2517. Web­site:www,hpra­.ie: Email:

5. How to store Lidocaine

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

Pregnancy and breast-feeding

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

This medicine should only be used during pregnancy and breastfeeding if absolutely necessary.

Driving and using machines

Depending on where and how this medicine is used, it is likely to affect your ability to drive or operate machines. Ask your doctor about when it would be safe to drive or operate machines.

You should not drive or use machines if you are affected by the administration of Lidocaine.

Lidocaine 1% w/v Solution for Injection contains sodium

This medicine contains 85 mg (approximately 3.72 mmol) sodium (main component of cooking/table salt) in each dose. This is eguivalent to 4.25 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicinal product does not require any specific storage conditions.

Upon opening of the ampoules, use immediately and discard any unused solution.

Do not use if the ampoule is damaged or broken.

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

However, if the diluted solution is not used immediately, do not store 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 label and carton after „EXP“. The expiry date refers to the last day of that month.

Do not throw away any medicine 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 contains- the active substance is lidocaine hydrochloride (as monohydrate).

Lidocaine 1% w/v Solution for Injection:

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

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

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

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

Lidocaine 2% w/v Solution for Injection:

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

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

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

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

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

What Lidocaine looks like and contents of the pack

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

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

For Ireland:

Fresenius Kabi Deutschland GmbH

Else-Kroener Strasse 1,

Bad Homburg v.d.H. 61352, Germany

For UK:

Fresenius Kabi Ltd

Cestrian Court

Eastgate Way, Manor Park

Runcorn, Cheshire

WA71NT

Manufacturer:

Labesfal – Laboratorios Almiro, S.A

Zona Industrial do Lagedo

Santiago de Besteiros

Portugal

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in August 2018

The following information is professionals only:

Special warnings

Lidocaine solution for injection is not recommended for use in neonates. The optimum serum concentration of lidocaine required to avoid toxicity, such as convulsions and cardiac arrhythmias, in this age group is not known.

Handling and Compatibility

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

The diluted solution should be visually inspected and should not be used in the presence of opalescence, visible particles or precipitate.

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

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

Acid stable drugs such as adrenaline hydrochloride, noradrenaline acid tartrate, or isoprenaline may deteriorate after mixture with lidocaine hydrochloride and the lidocaine solutions may raise the pH above the maximum pH for their stability.

Disposal

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

FRESENIUS KABI _