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PRILOTEKAL

Active substance(s): PRILOCAINE HYDROCHLORIDE / PRILOCAINE HYDROCHLORIDE / PRILOCAINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Prilotekal®
20 mg/ml solution for injection
Prilocaine 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 or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Prilotekal is and what it is used for
2. What you need to know before Prilotekal is given to you
3. How to use Prilotekal
4. Possible side effects
5. How to store Prilotekal
6. Contents of the pack and other information
1. What Prilotekal is and what it is used for
Prilotekal solution for injection 20 mg/ml is a type of medicine called local anaesthetic, belonging
to the category of the amides, contains a medicine called prilocaine hydrochloride and is a
solution for injection. Prilotekal solution for injection is used to anaesthetise (numb) specific
parts of the body and prevent pain during surgery in adults.
Prilotekal is injected into lower part of your spine. This quickly stops pain from your waist down
for a limited period of time (short term surgical procedures).
2. What you need to know before Prilotekal is given to you
You must not be given Prilotekal
- if you are allergic (hypersensitive) to prilocaine hydrochloride, other amide-type local
anaesthetics or any of the other ingredients in this medicine (listed in section 6)
-

if you have serious problems with cardiac conduction,

-

if you suffer from severe anaemia,

-

if you have a decompensated cardiac insufficiency,

-

if you have cardiogenic and hypovolemic shock,

-

if you suffer from congenital or acquired methemoglobinemia

-

if you have general or
anaesthesia

specific contraindications for the technique of subarachnoid

You must not be given Prilotekal in a blood vessel.
Prilotekal must not be used in children younger than 6 months.

Warning and Precautions
If you suffer from any of these, you should discuss it with your doctor before being given this
medicine
– if you have ever had a bad reaction to an anaesthetic in the past,
– if you have a skin infection at or near the proposed site of the injection,
– if you are suffering from any of the following:
– diseases of the central nervous system such as meningitis, polio and problems with
your spinal cord due to anaemia,
– a severe headache,
– brain, spine or any other tumours,
– tuberculosis of the spine,
– recent trauma to your spine,
– very low blood pressure or low blood volume,
– problems with clotting of your blood,
- acute porphyria
– fluid in your lungs,
– septicaemia (blood poisoning),
– if you have a heart condition (e.g. total or partial heart block, cardiac decompensation,
arrhythmia).
– if you have any liver or kidney problems,
– if you suffer from neurological or neuromuscular disorders, such as multiple sclerosis,
hemiplegia, paraplegia or neuromuscular disorders.
– if you are in reduced general condition.
Spinal anaesthesia must only be administered by a doctor with the necessary knowledge and
experience. The doctor in charge is responsible for taking the measures needed to avoid
injection in a blood vessel and to know how to recognize and treat undesirable effects.
Children and adolescents
Prilotekal is not recommended for the use in children and adolescents. The safety and efficacy
of Prilotekal in paediatric population have not been established. No data are available.
The use of Prilotekal in children younger than 6 months is contraindicated due to a higher risk of
of developing methemoglobinemia.
Other medicines and Prilotekal
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription. In particular if you are taking any medicines
for an irregular heartbeat (class III antiarrhythmics agents) and for pain relief.
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 who will decide whether or not you should be given prilocaine injection.
Prilocaine should not be a administered for local or regional anaesthesia during childbirth.
It is not known whether prilocaine passes into breast milk. Breast-feeding can be resumed
approximately 24 hours after treatment.
Driving and using machines

Do not drive and do not use any tools or machines as Prilotekal may temporarily interfere with
your reactions and muscular coordination.
Prilotekal contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose (maximum dose
equal to 4 ml of Prilotekal solution for injection), so it is essentially “sodium-free”.
3. How to use Prilotekal
This medicine will be given to you by your doctor who will decide what dose is right for you. The
usual dose in adults is 40-60 mg of prilocaine hydrochloride (2-3 ml of Prilotekal); the maximal
dose is 80 mg of prilocaine hydrochloride (4 ml of Prilotekal).
The doctor will give you Prilotekal into the lower part of your spine while you are in a seated
position or lying down.
Prilocaine hydrochloride hyperbar is not recommended for use in children and adolescents. The
safety and efficacy of Prilotekal in paediatric population have not been established. The use of
Prilotekal in children younger than 6 months is contraindicated due to a higher risk of of
developing methemoglobinemia.
For patients in a compromised general condition and with established concomitant disorders
(e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy and compromised liver and
kidney function), a reduced dose is indicated.
In the case of compromised liver or kidney function a lower dosage range is recommended.
Prilocaine hydrochloride hyperbar is injected via spinal route.
Equipment, drugs and personnel capable of dealing with an emergency, must be immediately
available. Rare cases of severe reactions have been reported after using local anaesthetics, even
in the absence of individual hypersensitivity in the patient’s case history.
If you have been given too much Prilotekal
The doctor giving you Prilotekal will be experienced in the use of spinal local anaesthetics, so it
is unlikely that you will be given an overdose. However, if the dose is accidently injected directly
in to blood, you may develop problems for a short time with your sight or hearing, twitching of
your muscles, tremors, trembling, fits (seizures), and loss of consciousness. Whenever you are
given Prilotekal, equipment will be available to care for you if an overdose happens.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Prilotekal can cause side effects, although not everybody gets them.
As with all local anaesthetics, a drop in arterial pressure may occur and cardiac frequency may
decrease.
You may feel sick, have lowered blood pressure or a slow heart beat. Other possible effects are
headache after surgery, vomiting and difficulty in passing urine.
These are the possible side effects:

Very common: may affect more than 1 in 10 people
Lowered blood pressure, feeling sick (nausea)
Common: may affect up to 1 in 10 people
Paresthesia, dizziness, vomiting
Uncommon: may affect up to 1 in 100 people
Convulsions, circumoral paresthesia, loss of consciousness, shaking, feeling of numbness
affecting the tongue, speech problems, hearing problems, tinnitus, visual problems, back pain,
temporary muscle weakness. Slow heart beat, elevated blood pressure.
Rare: may affect up to 1 in 1,000 people
Methemoglobinemia, cyanosis. Anaphylactic shock, anaphylactic reactions, allergic reactions,
itching. Arachnoiditis, neuropathy, lesions of peripheral nerves.
Diplopia. Cardiac arrest, irregular heartbeat. Respiratory depression.
Prilotekal solution for injection is unlikely to cause serious side effects unless it is accidentally
injected in the wrong way or used together with other local anaesthetics. If this happens,
numbness of the tongue, light-headedness, dizziness, shakiness and fits may occur. In
extremely rare cases, prilocaine has been associated with heart attack, breathing difficulties,
loss of feeling in your lower body and allergic reactions, which may cause rashes, swelling or
very low blood pressure.
A rare, but serious undesiderable effects of spinal anaesthesia is a high or total spinal block,
with consequent cardiovascular and respiratory depression.
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 Prilotekal
Keep out of the reach and sight of children.
Do not use Prilotekal after the expiry date which is stated on the ampoules and the outer carton.
The expiry date refers to the last day of that month.
Do not store Prilotekal above 25°C. Do not refrigerate. Store in original package in order to
protect from light.
Use immediately after first opening.
Do not use Prilotekal if you notice that the solution is not clear and free from particles.
Any remaining product must be disposed of. As it is limited to hospital use the waste drug
elimination is carried out directly by the hospital. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Prilotekal contains:
The active substance is prilocaine hydrochloride.
1 ml of solution for injection contains 20 mg of prilocaine hydrochloride (equivalent to 2%).
1 ampoule with 5 ml solution, contains 100 mg of prilocaine hydrochloride.
The other ingredients are:
Glucose anhydrous
Sodium hydroxide 1N (for pH adjustment)
Water for injection
What Prilotekal looks like and contents of the pack
Solution for injection. Clear, colourless solution.
Prilotekal comes in Type I clear colourless glass ampoules.
Box of 10 ampoules each containing 5 ml of solution for injection
Marketing Authorisation Holder and Manufacturer:
Mercury Pharmaceuticals Ltd
No. 1 Croydon,
12-16 Addiscombe Road,
Croydon,
CR0 0XT, UK
This leaflet was last revised in April 2014
The following information is intended for medical and healthcare professionals only:
The SPC is added at the end of the printed PL as a tear-off section.

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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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