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PROCAINE HYDROCHLORIDE BP 2% W/V ISOTONIC INJECTION

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Procaine Hydrochloride BP 2% w/v Isotonic
Injection
Procaine Hydrochloride
(Referred to as Procaine Injection this leaflet)
Read all of this leaflet carefully before you are given
Procaine Injection
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor,
nurse or anaesthetist
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse
or anaesthetist

In this leaflet:
1. What Procaine Injection is and what it is used for
2. Before Procaine Injection is given
3. How Procaine Injection is given
4. Possible side effects
5. How to store Procaine Injection
6. Further information
This leaflet contains a summary of the information available for
this medicine. You should ask your doctor or nurse if you are
unsure about any aspect of this medicine.

1. What Procaine Injection is and what it is used
for
Procaine Injection is a local anaesthetic.
Procaine Injection is used before surgery to numb the area to be
operated on. It may also be used to numb deeper areas.

2. Before Procaine Injection is given
You should not be given Procaine Injection if:
• you are allergic (hypersensitive) to Procaine Hydrochloride or
other local anaesthetics, or to any of the other ingredients of
the injection listed in section 6 of this leaflet
• you have heart disease
• you have kidney problems
• your doctor has told you that you have low levels of
plasma-cholinesterase
• you have swelling at the site of injection.
Take special care with Procaine Injection
Tell your doctor if:
• you are elderly or ill
• you have epilepsy (fits)
• you have liver damage
• you are in shock
• you have a muscle disorder known as myasthenia gravis
• you have heart problems.
If any of the above applies to you, please tell your doctor or
nurse.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have
recently taken, any other medicines, including medicines
obtained without prescription.
Tell your doctor if you are taking any of the following:
• guanethidine (a medicine use to treat high blood pressure)
• monoamine oxidase inhibitors (MAOIs) such as moclobemide,
a type of medicine used to treat severe depression. Tell your
doctor if you are currently taking MAOIs or you have taken
them within the last two weeks
• beta-blockers (medicines used to treat high blood pressure),
such as propranolol and atenolol
• trichloroethylene, cyclopropane and halothane (drugs used
as general anaesthetics)
• tricyclics antidepressants (a type of medicine used to treat
depression), such as amitriptyline and imipramine
• phenothiazines (medicines used to treat serious mental
disorders), such as chlorpromazine and fluphenazine
• neostigmine (a medicine used to treat myasthenia gravis)
• neuromuscular blocking agents (medicines used to stop
movement during surgery), such as suxamethonium chloride
and atracurium
• strong painkillers (narcotic analgesics) such as morphine
• vasoconstrictors (drugs that narrow blood vessels), such as
ephedrine hydrochloride and noradrenaline/norepinephrine
• acetazolamide (a medicine used to treat sickness)
• sulphonamides (a type of medicine used to treat bacterial
infections), such as co-trimoxazole and sulfadiazine
• CNS depressants (medicines that act on the brain and can
cause drowsiness or sleepiness), such as temazepam and
promethazine hydrochloride.
Pregnancy and breast-feeding
Procaine Injection should only be used in pregnancy where
there is no safer alternative. Ask your doctor for advice before
you are given Procaine Injection if you are pregnant, trying for a
baby or breast-feeding.
Driving and using machines
Procaine Injection may affect your ability to drive or use
machines. If you feel it has affected you do not drive or use
machinery.

3. How Procaine Injection is given
This medicine is an injection which will be given to you by a
doctor. Your doctor will determine the dose you require. It will
be given under the skin.
Adults and the elderly:
For numbing on the surface of the skin:
• an initial dose of 250-600mg as a 0.25%, 0.5% or 1% solution
• the dose will then be adjusted to your needs. The total dose
will not be more than 1000mg.
To numb deeper areas:
• initial dose of 500mg as a 0.5%, 1% or 2% solution
• the dose will then be adjusted to your needs. The total dose
will not be more than 1000mg.
Children:
Not recommended.
If you are given too much Procaine Injection
This medicine will be given to you by your doctor so it is
unlikely you will receive too much. If you are concerned about
your treatment, please talk to your doctor.

4. Possible side effects
Like all medicines, Procaine Injection can cause side effects,
although not everybody gets them.
As can happen with any medicine, a few people may develop an
allergic reaction. If you experience the following, tell your
doctor or nurse immediately:
• sores, hives, swelling, itching
• a blocked nose, and breathing difficulties.
Other possible side effects include:
• dizziness
• low blood pressure
• a ring or buzzing in the ears (tinnitus)
• feeling nervous or worried
• blurred vision
• feeling sick
• twitching, shaking or convulsions (fits)
• excitement followed by drowsiness
• swelling of the lips, face, mouth, tongue and throat.
Rare side effects include
• a lowering of the blood supply from the heart.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

5. Storing Procaine Injection
Keep out of the reach and sight of children.
You should not be given this medicine if it has passed the expiry
date shown on the ampoule label. The expiry date refers to the
last day of that month. The doctor or nurse will check that the
product has not passed this date.
This medicine must be protected from light.

6. Further Information
What Procaine Injection contains:
Procaine Injection contains 2%w/v of the active substance
Procaine Hydrochloride.
The other ingredients are sodium chloride, sodium
metabisulphite, water for injections, hydrochloric acid and
sodium hydroxide.
What Procaine Injection looks like and contents of the pack:
Procaine Injection is supplied in clear glass ampoules, each
containing 2ml, 5ml or 10ml of the solution. Each pack contains
10 ampoules.
Product Licence Holder and Manufacturer:
Martindale Pharmaceuticals Ltd.,
Bampton Road,
Harold Hill,
Romford Essex RM3 8UG
Product licence numbers: PL 1883/6187R
Leaflet approved: 12/2008
If you would like any more information, or would like the
leaflet in a different format, please contact Medical
Information at the above address.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Expand Transcript

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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