- lidocaine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 02848/0001.
Lidocaine Hydrochloride Injection BP 0.5% w/v,1.0% w/v and 2.0% w/v glass ampoules
Package leaflet: Information for the patient
Lidocaine Hydrochloride 0.5% w/v Solution for Injection
Lidocaine Hydrochloride 1% w/v Solution for Injection
Lidocaine Hydrochloride 2% w/v Solution for Injection
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
The product is referred as above but for ease it has been mentioned as Lidocaine hydrochloride throughout the leaflet.
What is in this leaflet
1. What Lidocaine Hydrochloride is and what it is used for
2. What you need to know before you are given Lidocaine Hydrochloride
3. How Lidocaine Hydrochloride is given to you
4. Possible side effects
5. How to store Lidocaine Hydrochloride
6. Contents of the pack and other information
1. WHAT LIDOCAINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Lidocaine Hydrochloride is a local anaesthetic and belongs to a class of drugs called amide type local anaesthetics. It produces loss of feeling or sensation confined to one part of the body.
Lidocaine Hydrochloride 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 HYDROCHLORIDE
You should not be given this medicine:
Speak to your doctor if one of these applies to you before you are given this medicine.
Warnings and precautions
Talk to your doctor or nurse before you are given Lidocaine Hydrochloride if:
Use in children
Lidocaine injection is not recommended for use in neonates (less than a month old).
Other medicines and Lidocaine Hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
A large number of drugs can interact with Lidocaine Hydrochloride which can significantly alter their effects. These drugs include:
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 already taking one of these medicines, speak to your doctor before you receive Lidocaine Hydrochloride.
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 for advice before taking this medicine.
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.
Lidocaine Hydrochloride contain sodium
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
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 at: 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 container 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.
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This leaflet was last revised in April 2019.
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