Patient leaflet - Lidocaine Hydrochloride 0.5% w/v solution for injection
1. WHAT LIDOCAIN
Lidocaine Hydrochloride is type local anaesthetics. It p body. Lidocaine Hydroch (anaesthesia) by injection o used to produce local ana conduction is to be cut administering the solution i means of a tourniquet (ba pressure).
2. WHAT YOU NE
You should not be given
hloride is and what it is used for before you are given Lidocaine Hydr hloride is given to you
Hydrochloride
nd other information
ochloride
T IT IS USED FOR
lass of drugs called amide onfined to one part of the roduce local numbness f operation. It may also be lose to the nerves whose r the spinal cord, or by ted from the circulation by from vessel by applying
IVEN LIDOCAINE
E HYDROCHLORIDE IS AND WHA
a local anaesthetic and belongs to a c roduces loss of feeling or sensation c loride Injection may be used to p f the solution into or around the area o esthesia by injection of the solution c off, or into the epidural space nea nto a vein in a limb that has been isola ndage that stops the flow of blood
ED TO KNOW BEFORE YOU ARE G
HYDROCHLORIDE
this medicine:
- if you are allergic to lid medicine (listed in sectio
- if you suffer from state o
- if you suffer from abnor blood pressure, slow he
- If the solution also conta into a vein or used in a supply to these areas mi Speak to your doctor if one Warnings and precaution
Lidocaine Hydrochloride is
- if the anterior part (anter
- if you have a history of a Talk to your doctor or nurs
- you suffer from any hear
- you suffer from fits (epile
- you have low concentrat constipation (hypokalae
- you ever had an allergic or collapse
you have had recent vo normal amounts of fluid
ocaine hydrochloride, to any of the n 6) or to other similar amide type an f decreased blood volume (hypovola mality of impulse propagation in the art rate (complete heart block) ins adrenaline, lidocaine hydrochlori reas such as fingers, toes, ears, nos ght become inadequate.
of these applies to you before you a s
not recommended:
ior chamber) of your eye is shallow cute increase of eye pressure (acute e before you are given Lidocaine Hyd t problem, particularly if it affects the psy)
ion of potassium in the blood causin mia)
reaction to local anaesthetic e.g. a sk
miting, diarrhoea or bleeding, or if you
other ingredients of this aesthetics
emia)
heart causing decreased
de should not be injected e or penis, as the blood
re given this medicine.
narrow angle glaucoma). rochloride if:
heart rate
g muscle cramps,
in rash or breathlessness
have not been drinking
- you are feeling ill and ru
- you have been told that enough oxygen
- you suffer from any liver
- you have porphyria (a ra
- you have an infection of
- you have problems with
you are pregnant, likely
- you suffer from loss of m Use in children
Lidocaine injection is not r Other medicines and Lid
Tell your doctor or pharma medicines.
A large number of drugs ca alter their effects. These dr
- medicines used to tre betablockers, e.g. tim verapamil, prenylamine
- medicines used in the tr
dopamine used to stimu
n down
you have too much acid in your bloo
disease or kidney problems re inherited disease that affects the s the skin with pus at or near the site to your breathing
to become pregnant or breast-feedin uscle function and weakness (myast
ecommended for use in neonates (les ocaine Hydrochloride
cist if you are taking, have recently tak
n interact with Lidocaine Hydrochlori ugs include:
at high blood pressure such as olol and propranolol and calcium
eatment of stomach ulcers (e.g. raniti late the heart and to treat shock
d and tissues, or not
kin and nervous system) be injected
g
henia gravis).
s than a month old).
en or might take any other
de which can significantly
diuretics (water tablets) channel blockers, e.g.
dine, cimetidine)
- strong pain relieving m drugs)
- medicines used to tr 5- hydroxytryptamine)
- medicines used to trea lopinavir)
- medicines used to treat
- medicines used to treat
- medicines used to treat zotepine)
- medicines used to treat If adrenaline (epinephrine) your doctor if you suffer fro an overactive thyroid gland If you are already taking receive Lidocaine Hydroc Pregnancy and breast-fe
If you are pregnant or brea a baby, ask your doctor for Lidocaine Hydrochloride s absolutely necessary.
edicines such as codeine and pethi
eat certain types of muscle jerk
t viral infection (e.g. amprenavir, a
irregular heart beat (mexiletine, amio infections (quinupristin/dalfopristin) mental disorders (pimozide, sertindol
nausea and vomiting (tropisetron, dol is to be added to your lidocaine inje m high blood pressure, shortage of or if you are taking antidepressant d one of these medicines, speak to y hloride.
eding:
st-feeding, think you may be pregna advice before taking this medicine. hould only be used during pregnan
dine (Narcotics or opioid
ing (e.g. Serotonin or
tazanavir, darunavir and
darone)
e, olanzapine, quetiapine,
asetron).
ction, you should also tell blood supply to the brain, rugs.
our doctor before you
nt or are planning to have
cy and breast feeding if
AMS Component No.: LF-122555-01 Product Description: Lidocaine HCL 1.0% w/v 10ml x 10 amp UK,0.5% w/v 10ml x 10amp UK,1.0% w/v 20ml x 10 amp UK, 2.0% w/v 20ml x 10 amp UK,1.0% w/v 2ml x 10 amp UK, 2.0% w/v 2ml x 10 amp UK, 2.0% w/v 5ml x 10 amp
UK,1.0% w/v 5ml x 10 amp UK
Component: Leaflet
Product Code: 100455,100456, 100457,100458, 100459,100460, 100461,100462 Country: UK
Revision Date: 26-May-2021 Revised by: ADK
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.
Information on Sodium content:
This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially ‘sodium-free’.
3. HOW LIDOCAINE HYDROCHLORIDE IS GIVEN TO YOU
The site of injection will depend on the area to be numbed. It will be administered by a trained healthcare professional. The maximum dose for a healthy adult is 200mg. 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, Lidocaine Hydrochloride can cause side effects, although not everyone gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. Lidocaine may result in abnormal amount of methemoglobin (a form of hemoglobin in blood) which may cause bluish discoloration of skin, headache, shortness of breath, malaise and fatigue.
Other serious side effects are also rare, but may occur if too much Lidocaine Hydrochloride is given or if the drug is unintentionally injected into a blood vessel. Such side effects may occur with certain frequency, which is defined as follows: Not known: frequency cannot be estimated from the available data
- changes in the rhythm and speed of the heart
- low blood pressure
- slow heart rate (less than 60 beats/minute)
- cessation of normal circulation of blood due to failure of the heart
- pain at the injection site, or numbness or loss of power after the effects of the injection should have worn off
- temporary pain sensation at the lower back, buttocks, legs which resolves within a few days
- numbness or tingling/paralysis of legs after administration of lidocaine in the spine
- difficulty in passing water, problems with the frequency, consistency and/or ability to control your bowel movements (bowel dysfunction)
- loss of balance, pins and needles around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, restless or twitching, changes in your normal mood or behaviour, involuntary rhythmic muscular contractions, fits or seizures, profound state of unconsciousness (coma)
- allergic reaction to local anaesthetic e.g. a skin rash or breathlessness or collapse
- feelings of anxiety or fear
- blurred vision, double vision or transient visual loss
- feeling sick (nausea) or being sick (vomiting)
- breathlessness
- cessation of breathing (respiratory arrest)
- feeling drowsy or faint
- involuntary rhythmic muscle movement (tremor).
Note : If you are having a blood test, tell your doctor, as injection of lidocaine into a muscle can increase the blood levels of an enzyme marker for muscle damage. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell 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.
Do not use this medicine after the expiry date which is stated on the carton and ampoule label after ‘Exp’. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the ampoule in the outer carton in order to protect from light.
The solution should not be used if it is discoloured in any way.
This medicine should not be mixed with any other drugs.
If only part of an ampoule is used, the remaining solution should be discarded.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lidocaine Hydrochloride Contains
The active substance is lidocaine hydrochloride.
Lidocaine Hydrochloride Injection BP 0.5% w/v, each 1ml of which contains 5mg of active ingredient.
Lidocaine Hydrochloride Injection BP 1% w/v, each 1ml of which contains 10mg of active ingredient.
Lidocaine Hydrochloride Injection BP 2% w/v, 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 Hydrochloride looks like and contents of the pack
Lidocaine Hydrochloride is a clear colourless, sterile solution for injection. Lidocaine Hydrochloride Injection BP 0.5% w/v is available in 10ml clear glass ampoules, packed in boxes of 10 ampoules.
Lidocaine Hydrochloride Injection BP 1% w/v is available in 2ml, 5ml, 10ml and 20ml clear glass ampoules, packed in boxes of 10 ampoules.
Lidocaine Hydrochloride Injection BP 2% w/v is available in 2ml, 5ml, 10ml and 20ml clear glass ampoules, packed in boxes of 10 ampoules.
Not all pack sizes may be marketed.
Marketing authorisation holder
Mercury Pharmaceuticals Limited
Capital House, 85 King William Street, London, EC4N 7BL, UK
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in May 2021.
LF-122555-01
AMS Component No.: LF-122555-01 Product Description: Lidocaine HCL 1.0% w/v 10ml x 10 amp UK,0.5% w/v 10ml x 10amp UK,1.0% w/v 20ml x 10 amp UK, 2.0% w/v 20ml x 10 amp UK,1.0% w/v 2ml x 10 amp UK, 2.0% w/v 2ml x 10 amp UK, 2.0% w/v 5ml x 10 amp
UK,1.0% w/v 5ml x 10 amp UK
Component: Leaflet
Product Code: 100455,100456, 100457,100458, 100459,100460, 100461,100462 Country: UK
Revision Date: 26-May-2021 Revised by: ADK