Package leaflet: Information for the patient

Lidocaine 10 mg/ml solution for injectionLidocaine 20 mg/ml solution for injection

lidocaine hydrochloride

Read all of this leaflet carefully before you are given 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.

What is in this leaflet: 1. What Lidocaine is and what it is used for 2. What you need to know before you are given Lidocaine 3. How Lidocaine is given 4. Possible side effects 5. How to store Lidocaine 6. Contents of the pack and other information

1. What Lidocaine is and what it is used for

Lidocaine is a local anaesthetic and belongs to a class of medicines called amide type local anaesthetics. 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 (anaesthesia) by injection of the solution into or around the area of operation. It may also be used to produce local anaesthesia 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 Lidocaine must not be given - if you are allergic to lidocaine hydrochloride, to local anaesthetics of the amide

type or any of the other ingredients of this medicine (listed in section 6); - if you have very low blood pressure, or if you have lost too much blood or other

body fluids or your heart is unable to pump enough blood for other reasons, you should not get Lidocaine injected into your spine.

Warnings and precautionsTalk to your doctor before having Lidocaine injection if: - 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 (tired). - 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).

ChildrenThe dose of Lidocaine should be reduced in children.This medicine is not recommended for use in neonates (less than a month old).

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

A large number of medicines can interact with Lidocaine Hydrochloride which can significantly alter their effects. These medicines 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, - 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 medicines) - 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,) - 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 medicines. If you are about to receive a strong anaesthetic 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.

Lidocaine with food, drink and alcohol Alcohol, especially chronic abuse, can decrease the effect of local anaesthetics.

Pregnancy and breast-feedingIf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. Lidocaine should only be used during pregnancy and breast-feeding if absolutely necessary.

Driving and using machinesCertain 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.

Lidocaine solution for injection contains sodiumThis medicine contains sodium (28 mg) per dose, i.e. essentially sodium free.

3. How Lidocaine is given

The site of injection will depend on the area to be numbed. It will be given to you as an injection into a vein, a muscle, under the skin, or into the epidural space near the spinal cord.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.

The recommended maximum dose for a healthy adult is 400 mg.

Use in childrenThere is limited experience in children below 1 year of age. The maximum dosage for children (1 to 12 years of age) is 5 mg/kg. The dose should be individualized according to the age and weight.

If you have been given too much Lidocaine than you shouldThe doctor treating you is trained to deal with serious side effects from getting too much Lidocaine.The first signs of being given too much Lidocaine are usually as follows: - convulsions, - restlessness, - feeling dizzy or light-headed, - nausea,- numbness or tingling sensations of the lips and around the mouth,- problems with sight.

If any of these happen to you, or you think you have received too much Lidocaine, tell your doctor immediately.

The following information is intended for medical or healthcare professionals only:

Qualitative and quantitative compositionEach ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 10 mg of lidocaine hydrochloride anhydrous (100 mg per 10 ml ampoule).

Excipients: Sodium (as sodium chloride) 28 mg/ampoule (2.8 mg/ml)

Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 20 mg of lidocaine hydrochloride anhydrous (200 mg per 10 ml ampoule and 100 mg per 5 ml ampoule).

Excipients: Sodium (as sodium chloride) 10,4 mg/per 5 ml ampoule (2.08 mg/ml) Sodium (as sodium chloride) 20.8 mg per 10 ml ampoule (2.08 mg/ml)

Pharmaceutical form

Solution for injectionA clear, colourless or slightly yellowish liquid, free from visible particles.The pH of solution is 5.0 - 7.0Osmolality of solution is 250 - 350 mOsmol/kg H

2O

PosologyLidocaine Accord should only be used by, or under the supervision of, doctors with experience of regional anaesthesia and resuscitative skills. Facilities for resuscitation should be available when administering local anaesthetics. The lowest possible dose producing the required effect should be given.

The table may serve as a guide for adults having a body weight of about 70 kilograms. The dose should be adjusted according to age, weight and condition of the patient.

The recommended maximum single dose of lidocaine hydrochloride should not exceed 400 mg.

Paediatric populationThe doses are reduced to children and patients with poor general condition.Special care has to be exercised when treating children below 4 years. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The anaesthesia technique should be selected carefully. Painful anaesthesia techniques should be avoided. The behaviour of the child during treatment has to be monitored carefully.

The average dose to be used is in the range of 20 mg to 30 mg lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride which can be administered in children may alternatively be calculated from the expression: child’s weight (in kilograms) x 1.33. Do not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight.

Lidocaine Injection is not recommended for use in neonates (see section 5.2). The optimum serum concentration of lidocaine required to avoid toxicity, such as convulsions and cardiac arrhythmias, in this age group is not known.

Special populationThe doses should be reduced in patients with renal impairment, hepatic impairment and the elderly, commensurate with age and physical status (see section 4.4).

Method of administrationThe method of administration of lidocaine varies according to the procedure.Lidocaine may be administered by intravenous, intramuscular, subcutaneous or epidural injection.

DilutionTo prepare a solution of 1.5% lidocaine hydrochloride, 2% lidocaine hydrochloride should be diluted in a syringe with 0.9% sodium chloride: 3 units (ml) 2% lidocaine hydrochloride with 1 unit (ml) chloride sodium 0.9%. The diluted solution must be prepared immediately before use.To prepare a solution of 0.5% lidocaine hydrochloride, 1% lidocaine hydrochloride should be diluted in a syringe with 0.9% sodium chloride: 1 unit (ml) 1% lidocaine hydrochloride with 1 unit (ml) of sodium chloride 0.9%. The diluted solution must be prepared immediately before use.

IncompatibilitiesThis product should not be mixed with other medicinal products.

Lidocaine 10 mg/ml solution for injection Review - 1

PIL Size: 121 x 850 mm, Pantone BlackDate: 23/03/17

Front Side

More serious side effects from being given too much Lidocaine may follow, such as balance and coordination disorders, auditory changes, euphoria, confusion, problems with your speech, paleness, sweating, trembling, convulsions, effects on your heart and blood vessels, loss of consciousness, coma and stopping breathing for a short while (apnoea).

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

Rare (may affect up to 1 in 1,000 people):Severe allergic reactions are rare. If you have a severe allergic reaction, tell your doctor immediately. The signs may include: - swelling of your face, lips, tongue or throat; this may make it difficult to swallow, - severe or sudden swelling of your hands, feet and ankles, - difficulty breathing, - severe itching of the skin (with raised lumps), - fever, - fall in blood pressure.

Other possible side effects:

Very common (may affect more than 1 in 10 people) - Low blood pressure - Nausea

Common (may affect up to 1 in 10 people) - Pins and needles - Dizziness - Slow heart beat - High blood pressure - Vomiting

Uncommon (may affect up to 1 in 100 people) - Convulsions - Numbness of the tongue or tingling sensations around the mouth - Ringing in the ears or being sensitive to sound - Visual disturbances - Loss of consciousness - Tremor - Drowsiness - Light-headedness - Tinnitus - Feeling of intoxication - Difficulty in speaking

Rare (may affect up to 1 in 1,000 people) - Hypersensitive reactions such as hives (urticaria), rash, angioedema and in

severe cases anaphylactic shock - Changes in sensations or muscle weakness (neuropathy) - Inflammation of a membrane surrounding the spinal cord (arachnoiditis) which

can cause pain in the lower back, or pain, numbness or weakness in the legs - Double vision - Irregular or stopped heart beat - Slowed or stopped breathing

Reporting of side effectsIf 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 MHRA Yellow Card Sceme, Wesbtie: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lidocaine

Keep this medicine out of the sight and reach of children.It does not require any special storage conditions.Do not refrigerate or freeze.Do not use this medicine after the expiry date which is stated on the label.The expiry date refers to the last day of that month.

This medicine is for single use only.Discard any unused contents.

The solution should be visually inspected before use. Use only if solution is clear and free from visible particles.

6. Contents of the pack and other information What Lidocaine contains - The active substance is lidocaine hydrochloride. - The other ingredients are sodium chloride and water for injection.

What Lidocaine looks like and contents of the packA clear, colourless or slightly yellowish liquid, free from visible particles.

Lidocaine 10 mg/ml solution for injection:Each 1 ml of solution contains 10 mg of lidocaine hydrochloride.

Lidocaine 20 mg/ml solution for injection:Each 1 ml of solution contains 20 mg of lidocaine hydrochloride.

Type I transparent glass ampoules with an approximate total capacity of 5 ml or 10 ml. 5 ampoules are packed in trays covered with a foil and inserted in cardboard cartons.

Pack sizes: 10 mg/ml: 100 x 10 ml20 mg/ml: 100 x 5 ml, 100 x 10 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authoristation Holder:Amneal Pharma Europe Ltd70 Sir John Rgerson’s QuayDublin 2Ireland

Manufacturer:LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was last revised in March 2017

Route of administration Recommended doses of Lidocaine hydrochlorideor procedure Concentration Volume (ml) Total dose (mg) (mg/ml)Infiltration anaesthesia:Small procedures 10 mg/ml 2-10 ml 20-100 mgLarge procedures 10 mg/ml 10-20 ml 100-200 mg 20 mg/ml 5-10 ml 100-200 mgIntravenous regional anaesthesia:Arm 10 mg/ml 10-20 ml 100-200 mg 20 mg/ml 5-10 ml 100-200 mgLeg 10 mg/ml 20 ml 200 mg 20 mg/ml 10 ml 200 mgNerve blocks 10 mg/ml 2-20 ml 20-200 mg 20 mg/ml 1-10 ml 20-200 mgEpidural anaesthesia:Lumbar analgesia 10 mg/ml 25-40 ml 250-400 mg 20 mg/ml 12.5-20 ml 250-400 mgThoracic anaesthesia 10 mg/ml 20-30 ml 200-300 mg 20 mg/ml 10-15 ml 200-300 mgSacral surgery analgesia 10 mg/ml 40 ml 400 mg 20 mg/ml 20 ml 400 mgSacral obstetric analgesia 10 mg/ml 20-30 ml 200-300 mg 20 mg/ml 10-15 ml 200-300 mg

Package leaflet: Information for the patient

Lidocaine 10 mg/ml solution for injectionLidocaine 20 mg/ml solution for injection

lidocaine hydrochloride

Read all of this leaflet carefully before you are given 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.

What is in this leaflet: 1. What Lidocaine is and what it is used for 2. What you need to know before you are given Lidocaine 3. How Lidocaine is given 4. Possible side effects 5. How to store Lidocaine 6. Contents of the pack and other information

1. What Lidocaine is and what it is used for

Lidocaine is a local anaesthetic and belongs to a class of medicines called amide type local anaesthetics. 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 (anaesthesia) by injection of the solution into or around the area of operation. It may also be used to produce local anaesthesia 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 Lidocaine must not be given - if you are allergic to lidocaine hydrochloride, to local anaesthetics of the amide

type or any of the other ingredients of this medicine (listed in section 6); - if you have very low blood pressure, or if you have lost too much blood or other

body fluids or your heart is unable to pump enough blood for other reasons, you should not get Lidocaine injected into your spine.

Warnings and precautionsTalk to your doctor before having Lidocaine injection if: - 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 (tired). - 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).

ChildrenThe dose of Lidocaine should be reduced in children.This medicine is not recommended for use in neonates (less than a month old).

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

A large number of medicines can interact with Lidocaine Hydrochloride which can significantly alter their effects. These medicines 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, - 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 medicines) - 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,) - 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 medicines. If you are about to receive a strong anaesthetic 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.

Lidocaine with food, drink and alcohol Alcohol, especially chronic abuse, can decrease the effect of local anaesthetics.

Pregnancy and breast-feedingIf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. Lidocaine should only be used during pregnancy and breast-feeding if absolutely necessary.

Driving and using machinesCertain 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.

Lidocaine solution for injection contains sodiumThis medicine contains sodium (28 mg) per dose, i.e. essentially sodium free.

3. How Lidocaine is given

The site of injection will depend on the area to be numbed. It will be given to you as an injection into a vein, a muscle, under the skin, or into the epidural space near the spinal cord.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.

The recommended maximum dose for a healthy adult is 400 mg.

Use in childrenThere is limited experience in children below 1 year of age. The maximum dosage for children (1 to 12 years of age) is 5 mg/kg. The dose should be individualized according to the age and weight.

If you have been given too much Lidocaine than you shouldThe doctor treating you is trained to deal with serious side effects from getting too much Lidocaine.The first signs of being given too much Lidocaine are usually as follows: - convulsions, - restlessness, - feeling dizzy or light-headed, - nausea,- numbness or tingling sensations of the lips and around the mouth,- problems with sight.

If any of these happen to you, or you think you have received too much Lidocaine, tell your doctor immediately.

The following information is intended for medical or healthcare professionals only:

Qualitative and quantitative compositionEach ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 10 mg of lidocaine hydrochloride anhydrous (100 mg per 10 ml ampoule).

Excipients: Sodium (as sodium chloride) 28 mg/ampoule (2.8 mg/ml)

Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 20 mg of lidocaine hydrochloride anhydrous (200 mg per 10 ml ampoule and 100 mg per 5 ml ampoule).

Excipients: Sodium (as sodium chloride) 10,4 mg/per 5 ml ampoule (2.08 mg/ml) Sodium (as sodium chloride) 20.8 mg per 10 ml ampoule (2.08 mg/ml)

Pharmaceutical form

Solution for injectionA clear, colourless or slightly yellowish liquid, free from visible particles.The pH of solution is 5.0 - 7.0Osmolality of solution is 250 - 350 mOsmol/kg H

2O

PosologyLidocaine Accord should only be used by, or under the supervision of, doctors with experience of regional anaesthesia and resuscitative skills. Facilities for resuscitation should be available when administering local anaesthetics. The lowest possible dose producing the required effect should be given.

The table may serve as a guide for adults having a body weight of about 70 kilograms. The dose should be adjusted according to age, weight and condition of the patient.

The recommended maximum single dose of lidocaine hydrochloride should not exceed 400 mg.

Paediatric populationThe doses are reduced to children and patients with poor general condition.Special care has to be exercised when treating children below 4 years. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The anaesthesia technique should be selected carefully. Painful anaesthesia techniques should be avoided. The behaviour of the child during treatment has to be monitored carefully.

The average dose to be used is in the range of 20 mg to 30 mg lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride which can be administered in children may alternatively be calculated from the expression: child’s weight (in kilograms) x 1.33. Do not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight.

Lidocaine Injection is not recommended for use in neonates (see section 5.2). The optimum serum concentration of lidocaine required to avoid toxicity, such as convulsions and cardiac arrhythmias, in this age group is not known.

Special populationThe doses should be reduced in patients with renal impairment, hepatic impairment and the elderly, commensurate with age and physical status (see section 4.4).

Method of administrationThe method of administration of lidocaine varies according to the procedure.Lidocaine may be administered by intravenous, intramuscular, subcutaneous or epidural injection.

DilutionTo prepare a solution of 1.5% lidocaine hydrochloride, 2% lidocaine hydrochloride should be diluted in a syringe with 0.9% sodium chloride: 3 units (ml) 2% lidocaine hydrochloride with 1 unit (ml) chloride sodium 0.9%. The diluted solution must be prepared immediately before use.To prepare a solution of 0.5% lidocaine hydrochloride, 1% lidocaine hydrochloride should be diluted in a syringe with 0.9% sodium chloride: 1 unit (ml) 1% lidocaine hydrochloride with 1 unit (ml) of sodium chloride 0.9%. The diluted solution must be prepared immediately before use.

IncompatibilitiesThis product should not be mixed with other medicinal products.

Lidocaine 10 mg/ml solution for injection Review - 1

PIL Size: 121 x 850 mm, Pantone BlackDate: 23/03/17

Back Side

More serious side effects from being given too much Lidocaine may follow, such as balance and coordination disorders, auditory changes, euphoria, confusion, problems with your speech, paleness, sweating, trembling, convulsions, effects on your heart and blood vessels, loss of consciousness, coma and stopping breathing for a short while (apnoea).

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

Rare (may affect up to 1 in 1,000 people):Severe allergic reactions are rare. If you have a severe allergic reaction, tell your doctor immediately. The signs may include: - swelling of your face, lips, tongue or throat; this may make it difficult to swallow, - severe or sudden swelling of your hands, feet and ankles, - difficulty breathing, - severe itching of the skin (with raised lumps), - fever, - fall in blood pressure.

Other possible side effects:

Very common (may affect more than 1 in 10 people) - Low blood pressure - Nausea

Common (may affect up to 1 in 10 people) - Pins and needles - Dizziness - Slow heart beat - High blood pressure - Vomiting

Uncommon (may affect up to 1 in 100 people) - Convulsions - Numbness of the tongue or tingling sensations around the mouth - Ringing in the ears or being sensitive to sound - Visual disturbances - Loss of consciousness - Tremor - Drowsiness - Light-headedness - Tinnitus - Feeling of intoxication - Difficulty in speaking

Rare (may affect up to 1 in 1,000 people) - Hypersensitive reactions such as hives (urticaria), rash, angioedema and in

severe cases anaphylactic shock - Changes in sensations or muscle weakness (neuropathy) - Inflammation of a membrane surrounding the spinal cord (arachnoiditis) which

can cause pain in the lower back, or pain, numbness or weakness in the legs - Double vision - Irregular or stopped heart beat - Slowed or stopped breathing

Reporting of side effectsIf 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 MHRA Yellow Card Sceme, Wesbtie: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lidocaine

Keep this medicine out of the sight and reach of children.It does not require any special storage conditions.Do not refrigerate or freeze.Do not use this medicine after the expiry date which is stated on the label.The expiry date refers to the last day of that month.

This medicine is for single use only.Discard any unused contents.

The solution should be visually inspected before use. Use only if solution is clear and free from visible particles.

6. Contents of the pack and other information What Lidocaine contains - The active substance is lidocaine hydrochloride. - The other ingredients are sodium chloride and water for injection.

What Lidocaine looks like and contents of the packA clear, colourless or slightly yellowish liquid, free from visible particles.

Lidocaine 10 mg/ml solution for injection:Each 1 ml of solution contains 10 mg of lidocaine hydrochloride.

Lidocaine 20 mg/ml solution for injection:Each 1 ml of solution contains 20 mg of lidocaine hydrochloride.

Type I transparent glass ampoules with an approximate total capacity of 5 ml or 10 ml. 5 ampoules are packed in trays covered with a foil and inserted in cardboard cartons.

Pack sizes: 10 mg/ml: 100 x 10 ml20 mg/ml: 100 x 5 ml, 100 x 10 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authoristation Holder:Amneal Pharma Europe Ltd70 Sir John Rgerson’s QuayDublin 2Ireland

Manufacturer:LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was last revised in March 2017