Prilotekal

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prilotekal 20 mg/ml injectable solution

prilocaine hydrochloride
Read 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 doubts, consult your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet,
consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Prilotekal is and what it is used for
2. What you need to know before you are given Prilotekal
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 20 mg/ml injectable solution is a local anaesthetic belonging to the amide class
and is an injectable solution. Prilotekal injectable solution is used in adults to anaesthetize
(numb) specific parts of the body and to prevent pain during surgery.
Prilotekal is injected into the lower part of the spine. This rapidly blocks pain from the waist down for a limited period of time (short-duration surgical procedures).

2. WHAT YOU SHOULD KNOW BEFORE PRILOTEKAL IS ADMINISTERED TO YOU

PRILOTEKAL
You must not be given Prilotekal

• if you are allergic (hypersensitive) to prilocaine hydrochloride, to any other amide-type local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe cardiac conduction disorders,
• if you suffer from severe anaemia,
• if you have heart failure,
• if you have cardiogenic or hypovolemic shock,
• if you suffer from congenital or acquired methemoglobinemia,
• if you have general or specific contraindications to subarachnoid anaesthesia.
  Prilotekal must not be administered intravascularly.

Prilotekal must not be used in children under 6 months of age.
Warnings and precautions
If you suffer from any of the following conditions, discuss them with your doctor before this medicine is administered to you.

• If you have ever previously experienced an adverse reaction to an anaesthetic
• If you have a skin infection at or near the intended injection site
• If you suffer from any of the following disorders:
• diseases of the central nervous system, such as meningitis, poliomyelitis, or spinal cord disorders due to anaemia
• severe headache
• brain, spinal, or other tumours
• spinal tuberculosis
• recent vertebral trauma
• very low blood pressure or reduced blood volume
• coagulation disorders
• acute porphyria
• pulmonary edema (fluid in the lungs)
• sepsis (blood poisoning)
• If you have a heart condition (e.g.: partial or complete heart block, heart failure, arrhythmia)
• If you have liver or kidney problems
• If you suffer from neurological disorders such as multiple sclerosis, hemiplegia, paraplegia, or neuromuscular disorders
• If your general health condition is compromised.
  Spinal anaesthesia must be performed only by a physician with the necessary knowledge and experience. The physician in charge is responsible for taking the necessary measures to avoid intravascular injection and must be able to recognize and manage adverse effects.

Children and adolescents
The use of Prilotekal is not recommended in children and adolescents. The safety and efficacy of Prilotekal have not been established in the paediatric population. No data are available.
The use of Prilotekal is contraindicated in children under 6 months of age due to the high risk of developing methemoglobinemia.
Other medicines and Prilotekal
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription. In particular, inform your doctor if you are taking any medicines for irregular heartbeat (class III antiarrhythmics) or for pain relief.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, who will decide whether or not to administer injectable prilocaine to you. Prilocaine must not be administered for local or regional anaesthesia during childbirth.
It is not known whether prilocaine passes into breast milk. Breastfeeding may be resumed approximately 24 hours after treatment.
Driving and using machines
Do not drive or operate tools or machinery, as Prilotekal may temporarily interfere with your reactions and muscular coordination.
Prilotekal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose equal to 4 ml of Prilotekal injectable solution), i.e. essentially “sodium-free”.

3. HOW TO USE PRILOTEKAL

This medicine will be administered to you by a doctor, who will determine the appropriate dose for you. The
recommended dose in adults is 40–60 mg of prilocaine hydrochloride (2–3 ml of Prilotekal); the maximum dose is
80 mg of prilocaine hydrochloride (4 ml of Prilotekal).
Your doctor will administer Prilotekal into the lower part of your spinal column, while you are sitting or lying down.
The use of hyperbaric prilocaine hydrochloride is not recommended in children and adolescents. The safety and
efficacy of Prilotekal in the pediatric population have not been established.
The use of Prilotekal is contraindicated in children under 6 months of age due to the high risk of developing
methemoglobinemia.
A reduced dose is recommended in patients with compromised general conditions and concomitant
established diseases (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy, impaired liver or
renal function).
In case of impaired liver and kidney function, a lower dosing interval is recommended.
Hyperbaric prilocaine hydrochloride is administered by spinal injection.
Equipment, medications, and personnel capable of managing an emergency must be immediately available.
Severe reactions have been reported rarely following the use of local anesthetics, even in the absence of
individual hypersensitivity in the patient's medical history.
If you receive more Prilotekal than you should
The doctor administering Prilotekal will be experienced in the use of spinal local anesthetics, so it is
unlikely that you will receive an excessive dose. However, if the dose is accidentally injected directly into
the bloodstream, transient visual or auditory disturbances, muscle spasms, tremors, chills, seizures
(convulsions), and loss of consciousness may occur. Equipment to manage overdose must be available
every time Prilotekal is administered.
If you have any doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Prilotekal can cause adverse reactions, although not everyone experiences them.
As with all local anaesthetics, a sudden drop in blood pressure and a slowing of heart rate may occur.
You may experience nausea, low blood pressure, or slow heart rate. Other possible effects include headache after surgery, vomiting, and difficulty urinating.
The possible adverse reactions listed below are reported as follows:
Very common: may affect more than 1 in 10 people
Lowering of blood pressure, feeling unwell (nausea)
Common: may affect up to 1 in 10 people
Paresthesia, dizziness, vomiting
Uncommon: may affect up to 1 in 100 people
Seizures, circumoral paresthesia, loss of consciousness, agitation, tongue numbness, speech disturbances, hearing problems, tinnitus, visual disturbances, back pain, temporary muscle weakness, slow heart rate, increased blood pressure.
Rare: may affect up to 1 in 1,000 people
Methemoglobinemia, cyanosis. Anaphylactic shock, anaphylactic reactions, allergic reactions, pruritus.
Arachnoiditis, neuropathy, peripheral nerve injury.
Diplopia. Cardiac arrest, irregular heartbeat. Respiratory depression.
It is unlikely that Prilotekal injection solution will cause serious adverse reactions, except if accidentally administered by an incorrect route or used together with other local anaesthetics. If this occurs, symptoms such as tongue numbness, dizziness, dizziness, tremors, and seizures may appear. In extremely rare cases, prilocaine has been associated with heart attacks, breathing difficulties, loss of sensation in the lower part of the body, and allergic reactions, which may cause skin rashes, swelling, or very low blood pressure.
A rare but serious adverse effect of spinal anaesthesia is high or total spinal block, resulting in cardiovascular and respiratory depression.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PRILOTEKAL

Keep this medicine out of the sight and reach of children.
Do not use Prilotekal after the expiry date stated on the vial label and outer carton, following "Exp." The expiry date refers to the last day of that month.
Do not store Prilotekal above 25°C. Do not refrigerate. Store in the original packaging to protect the medicine from light.
The medicine should be used immediately after first opening.
Do not use Prilotekal if you notice that the solution is not clear or contains particles in suspension.
Any unused medicinal product or waste material must be disposed of properly. Since this medicine is intended for hospital use only, the disposal of unused portions will be carried out directly by the hospital. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Prilotekal contains
The active substance is prilocaine hydrochloride.
1 ml of injectable solution contains 20 mg of prilocaine hydrochloride (equivalent to 2%).
One 5 ml vial of solution contains 100 mg of prilocaine hydrochloride.
The other components are:
Anhydrous glucose
Sodium hydroxide 1 N (for pH adjustment)
Water for injections

Description of the appearance of Prilotekal and contents of the pack
Injectable solution. A clear, colourless solution.
Prilocaine hydrochloride 2% hyperbaric is available in clear, colourless, type I glass vials.
Pack: 10 vials, each containing 5 ml of injectable solution.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße, 1
34212 Melsungen
Germany

Sirton Pharmaceuticals S.P.A.
Piazza XX Settembre 2
22079 Villa Guardia
Italy

Sintetica GmbH
Albersloher Weg 11
48155 - Münster
Germany

This medicinal product is authorised in the EEA Member States under the following names:

The following information is intended exclusively for healthcare professionals.

The SmPC is included at the end of the printed PI as a detachable section.