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LIDOCAINE HYDROCHLORIDE INJECTION BP 2% W/V

Active substance(s): LIDOCAINE HYDROCHLORIDE

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Patient Information Leaflet

hameln

Lidocaine Hydrochloride Injection 2%
Lidocaine Hydrochloride

Important information about your medicine
Your doctor or nurse will give you the injection
► If this injection causes you any problems talk to your doctor, nurse or pharmacist
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine
► Please tell your doctor or pharmacist, if you are taking any other medicines


• Read all of this leaflet carefully before you start using this medicine because
it contains important information for you. In some circumstances this may not be
possible and this leaflet will be kept in a safe place should you wish to read it.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• 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 Hydrochloride Injection 2% is and what it is used for
2. What you need to know before you use Lidocaine Hydrochloride Injection 2%
3. How to use Lidocaine Hydrochloride Injection 2%
4. Possible side effects
5. How to store Lidocaine Hydrochloride Injection 2%
6. Contents of the pack and other information

1. What Lidocaine Hydrochloride Injection
2% is and what it is used for
Lidocaine Hydrochloride Injection 2% is a local
anaesthetic. It is used to:
• produce local anaesthesia (numb a specific
area) and stop pain being felt in the area of
the body where it is administered.
• control fast or abnormal heart beats that you
might experience after a heart attack.

2. What you need to know before you use
Lidocaine Hydrochloride Injection 2%
Do NOT use Lidocaine Hydrochloride
Injection 2%:
• if you are sensitive or allergic to Lidocaine

Hydrochloride or any of the other ingredients in
this injection (listed in section 6). Tell your doctor
if you ever had an allergic or bad reaction,
for example, skin rash or breathlessness, to
any local anaesthetic medicines.
• if you have certain heart disorders. Tell
your doctor if you have any heart problems
particularly where your heart may pump blood
less efficiently, may beat irregularly, or may
beat more slowly.
• if you suffer from a state of decreased blood
volume (hypovolaemia)
• if you suffer from Porphyria – a disorder of
the blood. Tell your doctor if you have any
blood disorders.

Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Lidocaine Hydrochloride
Injection 2%:
• if you suffer from a heart or a breathing









disorder.
if you have kidney or liver disease.
if you are feeling unwell or run down for any
reason.
if you suffer from epilepsy or have fits.
if you have myasthenia gravis (a condition
causing weakness of your muscles).
if you are in shock.
if you have a blood disorder or an
imbalance in the constituents of your
blood.
if you have inflammation or infection in the
area to be injected.

Other
medicines
and
Hydrochloride Injection 2%:

Lidocaine

Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any
other medicines, including medicines obtained
without a prescription. This is especially important
with the following medicines as they may interact
with your Lidocaine Hydrochloride Injection 2%:
• Acetazolamide (used to reduce pressure
within the eye).
• Cimetidine (for stomach ulcer or heartburn).
• Dolasetron (used to prevent / treat nausea
and vomiting) .
• Quinupristin and dalfopristin (antibiotics).
• Beta-blockers, e.g. propranolol, (for angina,
high blood pressure or other heart problems)
• Calcium Channel Blockers e.g. Verapamil,
(for angina and high blood pressure).
• Diuretics (water tablets).
• Anti-virals – medicines used to treat
infections caused by viruses (e.g. HIV).
• Anti-arrhythmics - medicines used to
regulate the rhythm of your heart. (e.g.
Amiodarone, mexiletine).
• Anti-psychotics – medicines used to treat
certain psychiatric conditions (e.g. Pimozide,
Sertindole).
• Muscle relaxants (e.g. Suxamethonium).

• Opioids – strong pain relieving medicines
(e.g. Fentanyl)
• Oral contraceptives or oral HRT (Hormone
Replacement Therapy)

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
taking this medicine.

Driving and using machines:

Depending on where and how lidocaine
hydrochloride is used, it may affect your ability
to drive or operate machinery. Ask your doctor
about when it would be safe to drive or operate
machines.
You should not drive or use machinery if you
are affected by the administration of Lidocaine
Hydrochloride Injection 2%.

3. How to use Lidocaine Hydrochloride
Injection 2%
Your nurse or doctor will give you the
injection.
Your doctor will decide the correct dosage for
you and how and when the injection will be
given.

If you use more Lidocaine Hydrochloride
Injection 2% than you should
Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much.

If you think you have been given too much,
or you begin to experience lightheadedness,
numbness of your tongue or a ringing in
your ears you must tell the person giving you the
injection immediately

Lidocaine Hydrochloride Injection 2% is NOT
intended for use in the eye.

4. Possible side effects
Like all medicines, Lidocaine Hydrochloride
Injection 2% can cause side effects, although not
everybody gets them.

Allergic reactions:

• Allergic reactions to lidocaine hydrochloride are
rare, but tell your doctor immediately if you get
any difficulty with your breathing, a rash or
itchy skin.

Nervous and psychiatric disorders:
• Dizziness
or
lightheadedness,
drowsiness, tremor, your tongue going
numb – sometimes these symptoms may
indicate that you have been given too much
lidocaine.
• Convulsions (seizures).

Eye disorders:
• Blurred or double vision.
Ear disorders:
• Tinnitus (a ringing in your ears).
• Hyperacusis (you are more sensitive to
everyday sounds).

Heart disorders:

• Increased or decreased blood pressure.
• Slowing and stopping of your heart.
• Changes in the rhythm of your heart.

Breathing disorders:

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

Gastrointestinal disorders:
• Nausea (feeling sick) and vomiting (being
sick).

Skin disorders:
• 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.

Blood disorders

may
experience
a
blueish
discolouration to your skin, a headache,

• You

breathlessness and fatigue as a result of
abnormal amounts of methaemoglobin (a form
of haemoglobin) in your blood

After spinal injection of lidocaine, you
should tell your doctor if you experience
any of the following side effects:

• 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.
If you think this injection is causing you any
problems, or you are at all worried, talk to
your doctor, nurse 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. By reporting side effects you can
help provide more information on the safety of this
medicine.

5. How to store Lidocaine Hydrochloride
Injection 2%
Keep this medicine out of the sight and reach of
children.
Your injection will be stored at less than 25°C and
protected from light.
Do not use this medicine after the expiry date
which is stated on the label and carton after “Exp.
date”. The expiry date refers to the last day of that
month.

6. Contents of
information

the

pack

and

other

What Lidocaine Hydrochloride Injection
2% contains:

The active substance is lidocaine hydrochloride. In
Lidocaine Hydrochloride Injection 2% each ml of
solution contains 20 mg of lidocaine hydrochloride
in a sterile solution for injection.
The other ingredients are hydrochloric acid,
sodium hydroxide and water for injections.

What Lidocaine Hydrochloride Injection
2% looks like and contents of the pack:
Lidocaine Hydrochloride Injection 2% is a clear,
colourless, sterile solution in a clear glass
ampoule containing 2, 5, 10 or 20 ml. Not all
ampoule sizes may be marketed.
The marketing authorisation number of this
medicine is: PL 01502/0021R

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder
This leaflet was last approved April 2015.

44178/23/16

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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