SUMMARY CMI

PRILOTEKAL

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I being given PRILOTEKAL?

PRILOTEKAL contains the active ingredient prilocaine hydrochloride. PRILOTEKAL is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery in adults.

For more information, see Section 1. Why am I being given PRILOTEKAL? in the full CMI.

2. What should I know before being given PRILOTEKAL?

You must not be given PRILOTEKAL if you have ever had an allergic reaction to prilocaine hydrochloride or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before being given PRILOTEKAL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PRILOTEKAL and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is PRILOTEKAL given?

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).

More instructions can be found in Section 4. How is PRILOTEKAL given? in the full CMI.

5. What should I know while being given PRILOTEKAL?

For more information, see Section 5. What should I know while being given PRILOTEKAL? in the full CMI.

6. Are there any side effects?

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. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

PRILOTEKAL

Active ingredient: prilocaine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about PRILOTEKAL. You should also speak to your doctor or healthcare professional if you would like further information or if you have any concerns or questions about being given PRILOTEKAL.

Where to find information in this leaflet:

1. Why am I being given PRILOTEKAL?
2. What should I know before being given PRILOTEKAL?
3. What if I am taking other medicines?
4. How is PRILOTEKAL given?
5. What should I know while being given PRILOTEKAL?
6. Are there any side effects?
7. Product details

1. Why am I being given PRILOTEKAL?

PRILOTEKAL contains the active ingredient prilocaine hydrochloride. PRILOTEKAL is a local anaesthetic.

PRILOTEKAL is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery in adults.

PRILOTEKAL is injected into the 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 should I know before being given PRILOTEKAL?

Warnings

You must not be given PRILOTEKAL if:

• you are allergic to prilocaine hydrochloride, other amide-type local anaesthetics or any of the ingredients listed at the end of this leaflet (always check the ingredients to make sure you can use this medicine),
• you have serious problems with cardiac conduction,
• you suffer from severe anaemia,
• you have a decompensated cardiac insufficiency,
• you have cardiogenic and hypovolemic shock,
• you have a problem with your blood called methemoglobinemia,
• you have general or specific contraindications for the technique of subarachnoid (spinal) anaesthesia.

You must not be given PRILOTEKAL into a blood vessel. PRILOTEKAL must not be used in children.

Check with your doctor if you:

• have any other medical conditions such as:
  - 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)
• take any medicines for any other condition
• have ever had a bad reaction to an anaesthetic in the past
• have a skin infection at or near the proposed site of the injection
• have a heart condition (e.g. total or partial heart block, cardiac decompensation, arrhythmia)
• have any liver or kidney problems
• suffer from neurological disorder, such as multiple sclerosis, hemiplegia, paraplegia or neuromuscular disorders
• 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 into a blood vessel and to know how to recognize and treat undesirable effects.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known whether prilocaine hydrochloride passes into breast milk. Breast-feeding can be resumed approximately 24 hours after treatment.

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 developing methemoglobinemia.

PRILOTEKAL contains sodium

• This medicine contains less than 1 mmol sodium (23 mg) per dose (maximum dose equal to 4 mL of PRILOTEKAL solution for injection).

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

In particular, if you are taking any medicines for irregular heartbeat (class III antiarrhythmics agents) and for pain relief.

Tell your doctor if you are taking blood thinning tablets e.g. aspirin, warfarin.

Some medicines may interfere with PRILOTEKAL and affect how it works.

Some medicines may interfere with PRILOTEKAL and increase the risk of methemoglobinemia (a blood disorder in which too little oxygen is delivered to your cells). Types of medicines are antibiotics (sulfonamides) and some drugs for treating malaria, blood pressure (sodium nitroprusside) and heart conditions (nitroglycerine).

Medicines that may increase the effect of PRILOTEKAL include:

• other anesthetics
• those for irregular heartbeat (antiarrhythmics), such as lidocaine and mexiletine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PRILOTEKAL.

4. How is PRILOTEKAL given?

How much is given

• 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).

When is PRILOTEKAL used

• PRILOTEKAL is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery in adults.

How is PRILOTEKAL given

• The doctor will give you PRILOTEKAL into the lower part of your spine while you are in a seated position or lying down.
• PRILOTEKAL is not recommended for the use in children and adolescents. The safety and efficacy of PRILOTEKAL in the paediatric population have not been established. The use of PRILOTEKAL in children younger than 6 months is contraindicated due to a higher risk of developing methemoglobinemia.
• For patients in a compromised general condition and with established concomitant disorders (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy), a reduced dose is indicated.
• In the case of compromised liver or kidney function a lower dosage range is recommended.
• PRILOTEKAL 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 individual hypersensitivity in the patient's case history.

If you have been given too much PRILOTEKAL

If you are given too much PRILOTEKAL, you may need urgent medical attention.

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 into the 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.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while being given PRILOTEKAL?

Remind any doctor, nurse or pharmacist you visit that you were given PRILOTEKAL.

Things you should not do

• Do not drink alcohol while you are being given PRILOTEKAL.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PRILOTEKAL affects you.

PRILOTEKAL may temporarily interfere with your reactions and muscular coordination.

Drinking alcohol

Tell your doctor if you drink alcohol.

Do not drink alcohol while you are being given PRILOTEKAL.

If you drink alcohol while you are being given PRILOTEKAL your blood pressure may drop making you feel dizzy and faint.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

How to store PRILOTEKAL

• Store PRILOTEKAL below 25°C.
• Do not refrigerate or freeze.
• Use immediately after first opening.

Follow the instructions in the carton on how to take care of the medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight.

Keep it where young children cannot reach it.

When to discard PRILOTEKAL

Do not use PRILOTEKAL after the expiry date which is stated on the ampoules and the outer carton.

Getting rid of any unwanted medicine

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.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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 heartbeat. Other possible effects are headache after surgery, vomiting and difficulty in passing urine.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

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 undesirable effect of spinal anaesthesia is a high or total spinal block, with consequent cardiovascular and respiratory depression.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What PRILOTEKAL contains

Do not take this medicine if you are allergic to any of these ingredients.

What PRILOTEKAL looks like

PRILOTEKAL is a clear, colourless solution for injection.

PRILOTEKAL comes in Type I clear colourless glass ampoules.

Box of 10 ampoules each containing 5 mL of solution for injection.

AUST R 376271

Who distributes PRILOTEKAL

B. Braun Australia Pty Ltd
Level 5, 7-9 Irvine Place
Bella Vista NSW 2153
Australia

Toll free number: 1800 251 705

This leaflet was prepared in March 2023.

Published by MIMS December 2023

1 Name of Medicine

Prilocaine hydrochloride.

2 Qualitative and Quantitative Composition

The active ingredient in Prilotekal is prilocaine hydrochloride.
Prilotekal solution for intrathecal injection contains the following inactive ingredients: glucose sodium hydroxide 1N (for pH adjustment), water for injections.

3 Pharmaceutical Form

Solution for injection. Clear, colourless solution.
The pH is between 4.0 and 6.0.
The solution is hyperbaric with osmolality comprised between 490 and 540 mOsm/kg.

4 Clinical Particulars

4.1 Therapeutic Indications

Prilotekal is indicated in adults for spinal anaesthesia in short-term surgical procedures.

4.2 Dose and Method of Administration

Prilotekal is only to be used for spinal anaesthesia.
The product contains no antimicrobial preservative. An ampoule should be used on one patient on one occasion only. Solutions showing discolouration and unused portions of solutions from ampoules should be discarded. The medicinal product has to be visually inspected prior to use. Only clear solutions practically free from particles should be used.
The safety and effectiveness of Prilotekal depend on proper dosage, correct technique and adequate precautions.
The equipment, drugs and personnel capable of dealing with an emergency, e.g. maintaining the patency of the airways and administering oxygen, must be immediately available, since in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient's case history.
Because of the possibility of hypotension and bradycardia, an IV cannula should be inserted before the local anaesthetic is injected.
If signs of acute systemic toxicity or total spinal block are observed, the injection of the local anaesthetic must be stopped immediately (see Section 4.4 Special Warnings and Precautions for Use).

Dosage.

Note.

i. Recommended doses.

ii. Hypotension.

Method of administration.

4.3 Contraindications

Prilotekal is contraindicated for techniques of regional anaesthesia requiring continuous administration.
Prilotekal must not be used in patients with:
Hypersensitivity to prilocaine hydrochloride, other amide-type local anaesthetics or to any of the excipients listed in Section 6.1 List of Excipients. Detection of suspected sensitivity by skin testing is of limited value.
Serious problems with cardiac conduction including complete heart block.
In patients with hypoxemia e.g. as a result of severe anaemia, cardiac insufficiency etc, large doses of prilocaine may produce methaemoglobinaemia.
Decompensated cardiac insufficiency.
In patients with uncorrected hypotension including cardiogenic and hypovolemic shock.
Congenital or idiopathic acquired methaemoglobinemia.
Concomitant anticoagulant therapy general and specific contraindications for the technique of subarachnoid anaesthesia.
The use of Prilotekal in children younger than 6 months is contraindicated due to a higher risk of developing methaemoglobinemia. The intravascular injection of Prilotekal is contraindicated. Prilotekal must not be injected into infected areas. Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

4.4 Special Warnings and Precautions for Use

Due to the glucose content Prilotekal is only to be used for spinal anaesthesia. It is not for use in epidural anaesthesia.
Prilocaine may potentiate the formation of methaemoglobin by medicinal products known to induce methaemoglobin (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
It is essential for the doctor to recognize and be ready to treat undesirable effects, systemic toxicity and other complications. If signs of acute systemic toxicity or total spinal block are observed, the injection of the local anaesthetic must be stopped immediately (see Section 4.9 Overdose). Delay in proper management of dose-related toxicity, under-ventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and death.
The most effective prophylactic measures are scrupulous compliance with the recommended dose for Prilotekal, with it being essential for the doctor to check its action (visual and verbal contact with the patient), as well as careful aspiration prior to injecting the solution.
Some patients require special attention in order to reduce the risk of serious undesirable effects, even when locoregional anaesthesia constitutes the optimum choice for the surgical intervention:
Patients treated with class III antiarrhythmic agents (e.g. amiodarone). These patients should be subjected to careful observation and ECG monitoring, since cardiac effects may be added (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
In patients with acute porphyria, Prilotekal should only be administered when there is a compelling indication for its use, as Prilotekal may potentially precipitate porphyria. Appropriate precautions should be taken in all patients with porphyria.
Ensuring the presence of reliable venous access and the availability of vasopressor drugs and oxygen is recommended. As with all local anaesthetics, a drop in arterial pressure may occur and cardiac frequency may slow.
A serious, undesirable effect of spinal anaesthesia is high or total spinal block, with consequent cardiovascular and respiratory depression. Cardiovascular depression is induced by an extended block of the sympathetic nervous system, which may induce severe hypotension and bradycardia to the point of cardiac arrest. Respiratory depression is induced by the block of the respiratory musculature and the diaphragm.
Rarely, neurological damage may occur after spinal anaesthesia, manifesting as paresthesia, loss of sensitivity, motor weakness and paralysis. Occasionally these symptoms persist.
Local anaesthetics should be given with great caution (if at all) to patients with pre-existing abnormal neurological conditions.
Careful evaluation of the risk-benefit ratio is recommended prior to treatment.
Local anaesthetics react with certain metals and cause the release of their respective ions which, if injected, may cause severe irritation. Adequate precautions should be taken to avoid prolonged contact between Prilotekal solutions and metal surfaces such as metal bowls, cannulae and syringes with metal parts.

Methaemoglobinemia.

Management of methaemoglobinemia.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. Methaemoglobinemia.

2. Anti-arrhythmic drugs.

3. Cardiovascular system and CNS.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Depending on dosage local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.
Patients should be warned of this possibility and advised not to drive a motor vehicle or operate machinery if affected.

4.8 Adverse Effects (Undesirable Effects)

The possible undesirable effects due to the use of Prilotekal are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the amide group.
The undesirable effects include the physiological effects of the nerve block (e.g. reduction in arterial pressure, bradycardia, temporary urine retention).
The effects of the spinal insertion technique should be distinguished (e.g. spinal hematoma, post-spinal headache, meningitis).
The frequency of onset of undesirable effects is classified as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. See Table 2.
Adverse effects may be due to high plasma levels as a result of excessive dosage, rapid absorption, delayed elimination or metabolism, or inadvertent intravascular injection. Pronounced acidosis or hypoxia may increase the risk and severity of toxic reactions.
These undesirable effects mainly manifest as symptoms affecting the central nervous and cardiovascular system.
Mild undesirable effects (feeling dizzy or dazed) can be attributed to moderate overdose and generally resolve rapidly after reducing the dose or halting administration of Prilotekal.
Serious undesirable effects are attributable to significant overdose and/or accidental injection of local anaesthetic into a blood vessel. They manifest as symptoms affecting the central nervous system (restlessness, speech problems, disorientation, dizziness, muscle contractions, cramps, vomiting, loss of consciousness, respiratory arrest and mydriasis) and the cardiocirculatory system (raised arterial pressure and pulse frequency, arrhythmia, drop in arterial pressure, asystole) following irritation and/or depression of the cerebral cortex and the cerebral marrow (see Section 4.9).
In addition, following inhibition or block of the cardiac conduction system, cardiac frequency may slow down and myocardial depression may occur.
Any problems relating to metabolism (liver) or excretion (kidney) of Prilotekal should also be considered as other possible causes of undesirable effects.

Post marketing data.

Reporting suspected adverse effects.

4.9 Overdose

It is unlikely that Prilotekal, at the recommended dose, will induce plasma levels capable of inducing systemic toxicity. After intrathecal administration, systemic toxicity is expected to be low, due to the low dose administered.

High or total spinal block.

Acute systemic toxicity.

a) Symptoms affecting the central nervous system.

b) Cardiovascular symptoms.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glucose, sodium hydroxide 1N (for pH adjustment), water for injections.

6.2 Incompatibilities

Dilution or infusion of the injection is not recommended. Incompatibilities have not been assessed.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Do not refrigerate or freeze.
The medicinal product has to be used immediately after first opening. Restricted to hospital use only.

6.5 Nature and Contents of Container

Type I clear colourless glass ampoule.
Box of 10 ampoules each containing 5 mL of solution for injection. 1 ampoule with 5 mL solution, contains 100 mg of prilocaine hydrochloride [1 mL of solution for injection contains 20 mg of prilocaine hydrochloride (equivalent to 2%)].

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Pharmacotherapeutic group: anaesthetics, local; amides ATC code: N01BB04.
The chemical name for prilocaine hydrochloride is 2-propylamino propiono-o-toluidide hydrochloride; also known as propitocaine hydrochloride.
Prilocaine hydrochloride has a pKa of 7.89. Prilocaine base, which has a molecular weight of 220.3, is only slightly soluble in water. Prilocaine hydrochloride is soluble 1:5 in water.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes