Prilotekal

Package leaflet: Information for the user

Prilotekal
20 mg/ml, solution for injection
Prylocaine hydrochloride
Read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
 Keep this leaflet for future reference.
 Consult your doctor or pharmacist if you have any further questions.
 If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents:

1. What Prilotekal is and what it is used for
2. Important information before using 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 solution for injection is a type of medicine called a local anaesthetic, belonging to the amide group, and is supplied as a solution for injection. Prilotekal solution for injection is used to numb specific parts of the body and to prevent pain during surgical procedures in adults.
Prilotekal is injected into the lower part of the patient's spine. It helps rapidly block pain from the waist downwards for a limited period (short-term surgical procedures).

2. Important information before administering Prilotekal to the patient

When not to use Prilotekal
 if the patient is allergic (hypersensitive) to prilocaine hydrochloride, other amide-type local anaesthetics, or to any of the other components of this medicine (listed in section 6),
 if the patient has severe conduction disorders of the heart,
 if the patient has acute anaemia,
 if the patient has uncontrolled heart failure,
 if the patient has hypovolemic or cardiogenic shock,
 if the patient has congenital or acquired methemoglobinemia,
 if the patient has general or specific contraindications to the technique of spinal anaesthesia.

Prilotekal must not be injected into a blood vessel.
Prilotekal must not be used in children under 6 months of age.

Warnings and precautions
The patient should inform the doctor before receiving this medicine if any of the following conditions apply:
 if the patient has ever previously experienced an adverse reaction to a local anaesthetic,
 if the patient has a skin infection at or near the proposed injection site,
 if the patient suffers from any of the following conditions:

• central nervous system disorders, such as meningitis, poliomyelitis, or spinal cord problems due to anaemia,
• severe headache,
• brain or spinal tumours, or any other tumours,
• spinal tuberculosis,
• recent spinal cord injury,
• very low blood pressure or low blood volume,
• blood clotting disorders,
• acute porphyria,
• fluid in the lungs,
• sepsis (blood poisoning).
   if the patient has heart disease (including complete or partial heart block, uncontrolled heart failure, arrhythmia)
   if the patient has liver or kidney disease
   if the patient has a neurological disorder, such as multiple sclerosis, hemiplegia, paraplegia, or neuromuscular disorders
   if the patient has general physical weakness.

Spinal anaesthesia should only be administered by a physician with the necessary knowledge and experience. The physician is responsible for taking all necessary steps to avoid intravascular injection and for having the skills to recognize and manage adverse reactions.

Children and adolescents
The use of Prilotekal is not recommended in children and adolescents. The efficacy and safety of Prilotekal in children and adolescents have not been established. Data in this regard are not available.
The use of Prilotekal in children under 6 months of age is contraindicated due to the higher risk of developing methemoglobinemia.

Prilotekal with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription. This is particularly important when using antiarrhythmic drugs (class III) and pain-relieving medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, who will decide whether she should receive Prilotekal injection.
Do not administer prilocaine for local or regional anaesthesia during labour and delivery.
It is not known whether prilocaine passes into breast milk. Breastfeeding may be resumed 24 hours after administration of the medicine.

Driving and operating machinery
Do not drive or operate any tools or machinery, as Prilotekal may temporarily affect reactions and muscle coordination.

Prilotekal contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose corresponding to 4 ml of Prilotekal injection solution), meaning the medicine is considered "sodium-free".

3. How to use Prilotekal

This medicine is administered to the patient by a doctor, who will determine the appropriate dose for the patient. Usually,
the dose used 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).
The doctor injects Prilotekal into the lower part of the spine, with the patient in a sitting or lying position.
Prilotekal is not recommended for use in children and adolescents. The safety and efficacy of Prilotekal
in children and adolescents have not been established. The use of Prilotekal in children under 6 months of age is
contraindicated due to the higher risk of developing methemoglobinemia.
In patients with poor general condition and concomitant diseases (e.g. vascular occlusion, vascular atherosclerosis, diabetic polyneuropathy, and impaired liver or
kidney function), a reduced dose is recommended.
Lower doses are recommended in patients with impaired kidney or liver function.
Prilotekal is administered intrathecally.
Equipment, medications, and personnel capable of managing emergencies must be immediately available. In rare cases, severe reactions have been reported after administration of local anesthetics, even in the absence of a history of hypersensitivity in the individual patient.
Accidental overdose of Prilotekal
It is unlikely that a patient will receive too much Prilotekal if it is administered by a doctor experienced in the use of spinal local anesthetics. However, if a dose is accidentally injected directly into the bloodstream, the patient may rapidly develop visual or hearing disturbances, muscle twitching, tremors, seizures, convulsions, and loss of consciousness. In every case where the patient is receiving Prilotekal, appropriate equipment for treatment must be readily available in case of overdose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Prilotekal may cause adverse reactions, although not everyone will experience them.
As with all local anaesthetic medicines, decreased blood pressure and slower heart rate may commonly occur.
The patient may feel nauseous, have low blood pressure or a slow heartbeat. Other possible adverse reactions include: postoperative headache, vomiting, and difficulty in urinating.

Possible adverse reactions:

Very common: may affect more than 1 in 10 people
Low blood pressure, nausea.

Common: may affect up to 1 in 10 people
Paresthesia, dizziness, vomiting.

Uncommon: may affect up to 1 in 100 people
Seizures, perioral paresthesia, loss of consciousness, tremor, numbness of the tongue, speech difficulties, hearing problems, tinnitus, visual disturbances, back pain, transient muscle weakness. Slow heartbeat, elevated arterial blood pressure.

Rare: may affect up to 1 in 1,000 people
Methemoglobinemia, cyanosis, anaphylactic shock, anaphylactic reactions, allergic reactions, itching.
Meningitis, neuropathy, peripheral nerve abnormalities.
Double vision. Cardiac arrest, irregular heartbeat. Respiratory depression.

It is unlikely that Prilotekal injection solution will cause severe adverse reactions unless accidentally administered incorrectly or used concomitantly with other local anaesthetic agents. In such cases, symptoms such as tongue numbness, confusion, dizziness, tremors, and seizures may occur. In very rare cases, the use of prilocaine may lead to: myocardial infarction, breathing difficulties, loss of sensation in the lower parts of the body, and allergic reactions causing rashes, swelling, or very low blood pressure.

A rare but serious adverse reaction associated with spinal anaesthesia is high or total spinal block, resulting in circulatory and respiratory depression.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Prilotekal

Keep the medicine out of the sight and reach of children.
Do not use Prilotekal after the expiry date stated on the vials and outer packaging. The expiry date (EXP) refers to the last day of the specified month.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Store in the original packaging to protect from light.
Use immediately after first opening.
Do not use Prilotekal if the solution is not clear and free from particles.
Any unused product or waste material must be disposed of according to local regulations. Due to restricted hospital use, disposal of residual medicine is carried out directly by the hospital. This will help protect the environment.

6. Contents of the pack and other information

What Prilotekal contains
The active substance is prilocaine hydrochloride.
1 ml of injection solution contains 20 mg of prilocaine hydrochloride (equivalent to 2%).
1 vial with 5 ml of solution contains 100 mg of prilocaine hydrochloride.
The other ingredients are: anhydrous glucose or monohydrate glucose, water for injections, sodium
hydroxide 1N (for pH adjustment).

What Prilotekal looks like and contents of the pack
Injection solution. A clear, colourless solution.
Prilotekal is supplied in vials made of colourless type I glass.
Pack: carton containing 10 vials, each containing 5 ml of injection solution.

Marketing Authorisation Holder
B.Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany

Manufacturer:
Sirton Pharmaceuticals SPA
Piazza XX Settembre 2
22079 Villa Guardia (CO)
Italy
Sintetica GmbH
Albersloher Weg 11
48155 - Münster
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:

The following information is intended solely for healthcare professionals:
{ SmPC is attached at the end of the printed leaflet, as a detachable section. }