Lidocaine Hydrochloride 2% w/v solution for injection – patient leaflet, side effects, dosage

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

Lidocaine Hydrochloride is a local anaesthetic. These are medicines which numb an area of the body. Lidocaine belongs to a group of medicine called amide type local anaesthetics. It produces a loss of feeling or sensation that is confined to one part of the body (local anaesthesia).

Lidocaine hydrochloride solution for injection is used to numb specific parts of the body and prevent pain during medicinal procedures or surgery.

2. What you need to know before you take Lidocaine hydrochloride

Do not take Lidocaine hydrochloride

• If you are hypersensitive (allergic) to lidocaine or local anesthetic of amide type or to any of the other ingredients present in this medicine. An allergic reaction may be recognized as a rash, itching, swollen face or lips, or shortness of breath.

Take special care with Lidocaine hydrochloride

• If you suffer from epilepsy
• If you have any heart problems, in particular a slow heartbeat
• If you have problems with your breathing
• If you suffer from any liver disorder
• If you have any inflammation or infection in the area to be injected

• If you have been told that you have reduced levels of the body chemicals dopamine and

  5-hydroxytryptamine (serotonin).

You should talk to your doctor if you think this could apply to you.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.

Taking other medicines

Please inform your doctor if you are taking any medicines, even those not prescribed. Taking some medicines together can be harmful. Remember that the doctor at the hospital may not have been informed if you have recently begun a course of treatment for another illness. In particular tell your doctor if you are taking

• other local anesthetics
• volatile anesthetics e.g. chloroform, halothane, cycloproprane, trichloroethylene or other related agents
• pethidine (strong pain reliever)
• cimetidine (for stomach problems)

• betablockers which are used to control your heart beat or to lower your blood pressure e.g.

  propranolol

• antidepressant drugs

If adrenaline (epinephrine) is to be added to your Lidocaine hydrochloride, you should 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.

Pregnancy and breast-feeding

If you are pregnant or you think you may be pregnant, you should inform your doctor who will decide whether or not you should be given Lidocaine hydrochloride. Ask your doctor or pharmacist for advice before taking any medicine.

Lidocaine hydrochloride may get into breast milk. If you are breast-feeding you should discuss options with your doctor. Ask your doctor or pharmacist for advise before taking any medicines.

Driving and using machines

Do not drive or use any tools or machines because Lidocaine hydrochloride may interfere with your ability to do so safely. Ask your doctor when it would be safe to resume these activities.

3. How to take Lidocaine Hydrochloride

Lidocaine solution for injection may be used to produce local anaesthesia by injection of the solution into or around a peripheral nerve or network of nerves. It may also be used to relieve pain by administering the solution into the epidural spaces, which is close to the spinal cord, or into a vein in a limb that has been isolated from the circulation by means of a tourniquet. If you are unsure why you have been given this product and how to use it, ask your doctor to explain.

Your doctor will decide what dose is right for you. The maximum dose for healthy adults should not exceed 200 mg. The dose will depend on your size, your state of health, the part of the body that the medicine is injected into and what the medicine is being used for. Smaller doses are used for elderly people, young children and people who are unwell, The dose for children should not exceed 5 mg per kg body weight.

For most procedures, one dose is enough but more doses may be needed of the procedure takes a ling time.

4. Possible side effects

Like all medicines, Lidocaine Hydrochloride can cause side effects.

Lidocaine hydrochloride is generally well tolerated. Serious side effects are rare and usually only occur with high blood levels of Lidocaine hydrochloride. Tell your doctor immediately if you notice any of the following

• Any signs of an allergic reaction such as skin rush, wheeziness, swelling of the tongue or lips, or feeling suddenly weak and unwell (allergic reactions to Lidocaine hydrochloride are rare)
• Numbness of tongue, feeling dizzy and light-headed, blurred vision, muscle twitching, drowsiness and occasionally loss of consciousness, fits, low blood pressure and slowed breathing or heart beat which may be life threatening (these symptoms are suggestive of too much Lidocaine hydrochloride entering the blood stream).
• Yellowing of the skin or the white of the eyes (signs of disturbed liver function, which are reversible, have been observed after repeated administration of Lidocaine hydrochloride).

Nerve damage can rarely occur with some types of nerve block and may result in localised areas of anaesthesia or paraesthesia (tingling or other odd sensations), loss of bladder control or loss of power on the legs. These effects may be permanent.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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 via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lidocaine Hydrochloride

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

This medicinal product does not require any special temperature storage condition. Keep ampoules or vials in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton and ampoule The product should be used immediately after opening.

This medicine should not be mixed with any other drugs.

Discard any unused contents.

The injection should not be used if there are particles present.

6. Contents of the pack and other information

What Lidocaine Hydrochloride Contains

The active substance is lidocaine hydrochloride.

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

What Lidocaine Hydrochloride looks like and contents of the pack

Lidocaine Hydrochloride is a clear, colourless or almost colourless solution for injection. Lidocaine Hydrochloride 1% w/v and 2% w/v Solution for injection is available in 2ml, 5ml, 10ml clear glass ampoules and 20ml clear glass vials with Rubber stopper and Flipp off seal. The ampoules are supplied in pack of 5, 10, 20 and 50 and the vials are supplied in pack of 1, 5, 10 and 20.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orbit Pharma Limited

128 City Road, London

United Kingdom, EC1V 2NX

Manufacturer

SCIOM Limited

Unit 4, Martinfield Business Centre

Martinfield, Welwyn Garden City

AL7 1HG

This leaflet was last revised in JAN 2026.

Information for healthcare professionals

The method of administration of lidocaine varies according to the procedure (infiltration anaesthesia, intravenous regional anaesthesia or nerve block).

The dosage should be adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the require effect should be given. The dosage varies depending on the area to be anaesthetised, vascularity of the tissues, number of neuronal segments to be blocked, individual tolerance and the anaesthetic technique. The lowest dosage needed to provide anaesthesia should be administered.

Unnecessarily high doses of local anaesthetics are to be avoided. In general, surgical anaesthesia (e.g. epidural administration) requires the use of higher concentrations and doses. When blocking smaller nerves, or when a less intense block is required, the use of a lower concentration is indicated. The volume of drug used will affect the extent and spread of anaesthesia. The maximum dose for healthy adults should not exceed 200 mg.

Care should be taken to prevent acute toxic reactions by avoiding intravascular injection. Careful aspiration before and during the injection is recommended. When a large dose is to be injected, e.g. in epidural block, a test dose of 3 – 5 ml of lidocaine containing adrenaline (epinephrine) is recommended. An accidental intravascular injection may be recognised by a temporary increase in heart rate. The main dose should be injected slowly while keeping in constant verbal contact with the patient. If toxic symptoms occur, the injection should be stopped immediately.

Children: The dosage should be calculated on a weight basis and should not exceed 5 mg/kg.

Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.