Lefisio

Leaflet accompanying the packaging: patient information

Lefisyo 5 mg/ml oral solution

Levomethadone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lefisyo and what is it used for
• 2. Important information before taking Lefisyo
• 3. How to take Lefisyo
• 4. Possible side effects
• 5. How to store Lefisyo
• 6. Contents of the packaging and other information

1. What is Lefisyo and what is it used for

Levomethadone hydrochloride, the active substance of Lefisyo, is a medicine belonging to the opioid group.
Lefisyo is used:
as part of substitution therapy in the treatment of opioid dependence in adults,
which includes medical, social, and psychological care (integrated treatment program).
as a bridging substitution therapy, for example, in the case of hospitalization.

2. Important information before taking Lefisyo

When not to take Lefisyo

• If the patient is allergic to levomethadone or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking monoamine oxidase inhibitors (MAOIs, medicines used to treat Parkinson's disease or depression) or if the patient has stopped taking them within the last two weeks.
• If the patient is taking medicines that may neutralize or alter the effect of Lefisyo, such as pentazocine and buprenorphine. Nevertheless, these medicines can be used in the treatment of Lefisyo overdose.

Warnings and precautions

Levomethadone may only be used in patients dependent on opioids (opioids)
by doctors authorized to conduct substitution treatment, as standard doses
used in substitution treatment may cause severe poisoning or even lead to
death in patients with opioid intolerance.
Before starting treatment with Lefisyo, the patient should discuss with their doctor or pharmacist if any of the following situations apply to them. The doctor will only start treatment if necessary. This applies in particular to the following cases:

• Pregnancy and breastfeeding
• Disorders of consciousness
• Taking this medicine at the same time as other medicines that inhibit some brain functions (such as respiratory control) (see "Lefisyo and other medicines" and "Lefisyo with alcohol")
• Taking Lefisyo at the same time as sedatives or sleeping pills (such as benzodiazepines and related medicines): This can lead to drowsiness, shallow breathing, and coma, and can also lead to death (see also "Lefisyo and other medicines")
• Diseases in which respiratory depression should be avoided, such as:
• Asthma
• Lung diseases with chronic obstruction of the airways
• Heart failure caused by severe lung disease
• Moderate to severe respiratory depression (slow or shallow breathing, leading to increased carbon dioxide levels and decreased oxygen levels in the body) and shortness of breath
• Low oxygen levels in the blood
• Increased carbon dioxide levels in the blood In the case of these diseases, breathing may be difficult or respiratory arrest may occur, even when using standard doses of Lefisyo. It is possible to exacerbate existing asthma or skin rashes and blood abnormalities, particularly if the patient has a tendency to allergies.
• Increased intracranial pressure: May increase further
• Low blood pressure due to dehydration
• Enlarged prostate with incomplete emptying of the bladder
• Pancreatitis
• Bile duct disorders
• Intestinal obstruction and inflammatory diseases
• Pheochromocytoma, i.e. adrenal gland cancer that produces hormones
• Hypothyroidism (a condition in which the thyroid gland does not produce enough hormones)
• Suicide risk: In the case of taking opioids, especially in combination with certain medicines used to treat depression (antidepressants), alcohol, and other substances, such as benzodiazepines, suicide attempts may be one of the clinical signs of substance dependence. If the patient cannot stop taking such substances, they should discuss it with their doctor or a specialist clinic.
• Severe abdominal conditions: Treatment with Lefisyo may also mask severe abdominal conditions. In the event of the first symptoms of abdominal disorders, regular monitoring of the patient's condition should be started until the exact cause is determined.
• Heart rhythm disturbances (arrhythmias) or prolongation of the QT interval, or mineral balance disorders, particularly in the case of low potassium levels in the blood. Some opioids may affect cardiac conduction (prolongation of the QT interval in the ECG). This can cause dangerous arrhythmias (too fast, irregular heartbeat; "torsades de pointes"). If the patient experiences irregular heartbeat or fainting, they should immediately tell their doctor.
• Treatment with anti-arrhythmic medicines of class I and III
• Slowed heart rate

In elderly patients and patients with kidney disease, severe chronic liver disease, or poor general condition, the dose should be reduced.
Before starting treatment with Lefisyo, the patient should discuss with their doctor or pharmacist if they have adrenal disorders. Treatment should be carried out with caution.
The patient should talk to their doctor or pharmacist if they experience any of the following symptoms while taking Lefisyo: weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms of the adrenal glands producing too little of the hormone cortisol, and the patient may need to take hormonal supplements.
Long-term use of opioids can lead to decreased levels of sex hormones and increased levels of the hormone prolactin. If the patient experiences symptoms such as decreased sex drive, impotence, or absence of menstruation, they should contact their doctor.
Sleep apnea
Lefisyo may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia related to sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should contact their doctor. The doctor may consider reducing the dose.
Tolerance, dependence, and addictive use
This medicine contains levomethadone, which is an opioid medicine. Repeated use of opioids can lead to reduced effectiveness of the medicine (the patient's body gets used to the effect of the medicine, which is called "tolerance"). Repeated use of Lefisyo can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose.
Dependence or addictive use can make the patient feel like they have no control over the amount of medicine they take or how often they take it.
The risk of developing dependence or abuse is different for different patients. The patient may be at greater risk of developing abuse or dependence on Lefisyo if:

• The patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("dependence").
• The patient smokes.
• The patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If the patient notices any of the following symptoms while taking Lefisyo, it may indicate that they have developed dependence or abuse.

• The patient feels the need to take the medicine for longer than prescribed by the doctor.
• The patient feels the need to take a higher dose than prescribed.
• The patient uses the medicine for reasons other than those for which it was prescribed, such as "to calm down" or "to be able to sleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has been unsuccessful.
• After stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal symptoms").

If the patient notices any of these symptoms, they should talk to their doctor and discuss the best treatment option for them, including the appropriate time to stop treatment and the safe way to stop treatment (see section 3, Stopping Lefisyo).

Additional information

Long-term and repeated use of levomethadone can lead to physical and psychological dependence and habituation with loss of effectiveness, known as tolerance. Stopping treatment after repeated use or in the case of opioid dependence, or administering an opioid antagonist (a substance that can block the effect of opioids), may cause withdrawal syndrome.
Taking Lefisyo by people who are not accustomed to repeated and regular use of opioids is life-threatening and can lead to death due to respiratory arrest.
Lefisyo is intended for oral use only.
Abuse of Lefisyo by injecting it into a vein can lead to overdose and life-threatening side effects, such as blood infection, vein inflammation, and blockage of blood vessels in the lungs by a blood clot.
Abuse of drugs and medicines during substitution treatment can lead to life-threatening incidents and should be avoided at all costs.
The doctor will regularly perform urine tests to check if the patient is not taking drugs at the same time.
When using levomethadone, it is essential to remember that the potency of levomethadone is approximately twice that of methadone racemate (see also section 3 "How to take Lefisyo").

Consequences of improper use for doping purposes

Taking Lefisyo can cause positive results in anti-doping tests. Furthermore, improper use of Lefisyo as a doping substance can pose health risks.

Lefisyo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking other medicines can affect the required daily dose of Lefisyo. If the patient notices any symptoms of increased effect or withdrawal symptoms of Lefisyo, they should tell their doctor.
The patient should not take Lefisyo at the same time as the following medicines:

• Monoamine oxidase inhibitors: Medicines used to treat depression or Parkinson's disease. The patient should stop taking these medicines at least 14 days before starting treatment with Lefisyo. Otherwise, life-threatening suppressive or stimulating effects on breathing and circulation may occur.
• Pentazocine, buprenorphine: Medicines used to treat severe pain. When taking these medicines with Lefisyo, withdrawal symptoms may occur. Buprenorphine should not be taken earlier than 20 hours after stopping Lefisyo. In exceptional cases, these medicines can be taken at the same time as Lefisyo if they are used to treat Lefisyo overdose.

The patient should tell their doctor if they are taking any of the following medicines, as they may alter the effect of Lefisyo:

• Other medicines that inhibit some brain functions (such as respiratory control), such as
• Strong painkillers (including opioids)
• Certain medicines used to treat psychiatric disorders, whose active substance name usually ends in "-azine", such as phenothiazine
• Sleeping pills
• Antiepileptic medicines, such as barbiturates, whose active substance name usually ends in "-tal", such as phenobarbital
• Narcotic medicines
• Certain medicines used to treat depression, known as tricyclic antidepressants (e.g. trimipramine and doxepin)

When taking these medicines with Lefisyo, they may enhance each other's effects on brain function and thereby cause, for example, drowsiness or shallow breathing (see also "Warnings and precautions").
The patient should carefully follow the doctor's instructions regarding dosage.

• Sedatives and sleeping pills known as benzodiazepines (usually ending in "-zepam", such as diazepam, flunitrazepam) and related medicines (such as zolpidem). Taking Lefisyo and sedatives, such as benzodiazepines or related medicines, at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concurrent use should only be considered when other treatment options are not possible. If the doctor has prescribed Lefisyo with sedatives, they should limit the dose and duration of concurrent use. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.
• Certain medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs), such as sertraline, fluvoxamine, fluoxetine, and paroxetine
• Medicines used to treat high blood pressure, such as reserpine, clonidine, urapidil, and prazosin
• Cimetidine, a medicine used to reduce stomach acid production
• Medicines used to treat fungal infections, such as itraconazole, ketoconazole, voriconazole, and fluconazole
• Medicines used to treat heart rhythm disorders, such as anti-arrhythmic medicines of class I and III, such as amiodarone
• Oral contraceptives
• Carbamazepine and phenytoin, medicines used to treat epilepsy
• Cannabidiol (a medicine used to treat seizure disorders)
• Gabapentin and pregabalin (medicines used to treat epilepsy, nerve pain, or anxiety), may increase the risk of opioid overdose, respiratory depression, and can be life-threatening
• Medicines used to treat certain bacterial infections, such as rifampicin, antibiotics known as macrolides, ciprofloxacin, and fusidic acid
• St. John's Wort
• Spironolactone (a diuretic)
• Medicines that inhibit the replication of the HIV virus (such as efavirenz, nevirapine, nelfinavir, ritonavir, amprenavir, didanosine, stavudine, and zidovudine).

The risk of side effects increases when levomethadone and antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, and nortriptyline) are taken at the same time. The patient should contact their doctor if they experience symptoms such as:

• Changes in mental state (e.g. agitation, hallucinations, coma)
• Accelerated heart rate, unstable blood pressure, fever
• Excessive reflexes, coordination disorders, muscle stiffness
• Gastrointestinal symptoms (such as nausea, vomiting, diarrhea)

Lefisyo and alcohol

The patient should not drink alcohol while taking Lefisyo. Alcohol can unpredictably enhance the effect of the medicine and cause severe poisoning with symptoms such as drowsiness, shallow breathing, and coma, and can even lead to death.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Levomethadone passes into the placenta and the blood of the unborn child. Lefisyo may be used during pregnancy after careful consideration by the doctor of the benefit-to-risk ratio, preferably under the supervision of a specialist medical center.
Due to metabolic changes during pregnancy, it may be necessary to increase the dose of the medicine. For the well-being of the fetus, the doctor may also recommend dividing the daily dose.
Chronic use during pregnancy may lead to habituation and dependence of the fetus on levomethadone, as well as the occurrence of withdrawal symptoms in the child after birth, which often requires hospital treatment. Additionally, taking levomethadone before and during delivery may lead to breathing problems in the newborn.
Breastfeeding
The patient should consult their doctor if they are breastfeeding or plan to breastfeed while taking levomethadone, as the medicine may affect the child. The child should be monitored for abnormal symptoms, such as increased sleepiness (more than usual), breathing difficulties, and limpness. If such symptoms are noticed, the patient should immediately contact their doctor.
Fertility
It has been noted that methadone in maintenance treatment causes sexual function disorders in male patients.

Driving and using machines

This medicine, even when used as intended, can affect the patient's reactions in a way that impairs their ability to drive vehicles and operate machines. This is particularly important when taking it with alcohol and certain other medicines (see also "Lefisyo and other medicines").
The decision to drive a vehicle is made in each individual case by the attending physician, taking into account the patient's individual response and prescribed dosage.

Lefisyo contains sodium benzoate

The medicine contains 0.3 mg of sodium benzoate per ml.

Lefisyo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How to take Lefisyo

Levomethadone hydrochloride substitution therapy should be administered by a doctor experienced in the treatment of opioid dependence, preferably in centers specializing in the treatment of opioid dependence.
The potency of levomethadone is approximately twice that of methadone racemate. There is evidence that the metabolism of levomethadone is increased after administration of methadone racemate, so this ratio may change. This should be taken into account when determining the dose.
This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended doses

The dose is determined based on the occurrence of withdrawal symptoms and must be adjusted to the patient, depending on their individual situation. Generally, after adjusting the dose, the goal is to administer the smallest possible maintenance dose.
To avoid overdose, the patient will receive an initial dose of 15 to 20 mg of levomethadone hydrochloride (corresponding to 3 to 4 ml of the solution) on the first day in the morning. Depending on the subjective and objective effect, an additional dose of 10 to 25 mg of levomethadone hydrochloride (2 to 5 ml of the solution) will be taken on the first day in the evening.
In patients with low or unknown tolerance threshold (e.g. after release from prison), the initial dose should not exceed 15 mg of levomethadone hydrochloride (3 ml of the solution).
After 1 to 6 days, the daily dose is administered once a day in the morning. The transition to a single daily dose administered in the morning is usually done gradually using 5 mg of levomethadone hydrochloride (1 ml of the solution).
If the effect is insufficient (occurrence of withdrawal symptoms), the doctor may increase the daily dose by 5 to 10 mg of levomethadone hydrochloride (1 to 2 ml of the solution).
The maintenance dose is usually achieved after 1 to 6 days. This dose may be up to 60 mg of levomethadone hydrochloride (12 ml of the solution), and in justified individual cases, it may be significantly higher. A dose higher than 50 to 60 mg of levomethadone hydrochloride may only be used in justified individual cases and only if the concurrent use of any other psychoactive substances has been ruled out.

Caution

The daily requirement for levomethadone may be increased due to interactions with other medicines or in the case of increased metabolism of Lefisyo due to the action of other medicines (see also section 2 "Lefisyo and other medicines"). For this reason, even in patients receiving a stable dose, attention should be paid to potential withdrawal symptoms and the dose should be adjusted if necessary.

Patient groups requiring dose adjustment

In elderly patients and patients with kidney disease, severe chronic liver disease, or poor general condition, the dose should be reduced.

Children and adolescents

Data on the treatment of children and adolescents under the age of 18 are not available. For this reason, the use of Lefisyo in children and adolescents is not recommended.

Method of administration

Lefisyo is intended for oral use only.
It is ready to use and can be taken after mixing with drinking water or beverages, such as orange juice and raspberry syrup.
In the case of taking Lefisyo ready for immediate use, it should be swallowed and taken under medical supervision. The patient will receive the required dose of the medicine from the doctor or a person designated by the doctor and will take it immediately. The required amount will be measured exclusively by the doctor or a person designated by them.
A prescription for a specified amount of this medicine for the patient to take at home, as a prescription for a medicine for home use, must be issued by the doctor. In this case, the patient will take the prescription to the pharmacy and receive Lefisyo there, divided into daily doses. The doses of the medicine should be taken according to the doctor's instructions.
Lefisyo is intended for oral use only.
Abuse of Lefisyo by injecting it into a vein can lead to overdose and life-threatening side effects, such as

• Blood infection
• Vein inflammation
• Blockage of blood vessels in the lungs by a blood clot

Duration of treatment

The duration of treatment depends on the progress of substitution treatment and the patient's individual feelings. The goal of treatment is to achieve abstinence from drugs. The duration of treatment may range from short-term (e.g. substitution in patients dependent on medicines during hospital treatment) to long-term.

Taking a higher dose of Lefisyo than prescribed

In case of suspected overdose, the patient should immediately contact their doctor!
The patient should have this leaflet accompanying the packaging to show it to the doctor for their information. The doctor will provide immediate medical assistance.
Overdose symptoms include:

• "Feeling of euphoria"
• Impaired ability to concentrate
• Drowsiness
• Dizziness when changing position to standing
• Cold, sweaty skin
• Low blood sugar levels
• Reduced frequency and depth of breathing, also causing cyanosis of the lips
• Slowed heart rate and low blood pressure
• Constricted pupils
• Muscle weakness
• Deep sleep progressing to loss of consciousness, and even coma
• Brain function disorders (known as toxic leukoencephalopathy) Severe poisoning can lead to respiratory arrest, circulatory failure, cardiac arrest, and death.

Taking Lefisyo by people who are not accustomed to it can lead to death due to respiratory arrest. This applies to the following patient groups:

• Children under the age of 5 from a dose of 0.5 mg of levomethadone hydrochloride
• Older children from a dose of 1.5 mg of levomethadone hydrochloride
• Adults who are not accustomed to taking opioids, from a dose of 10 mg of levomethadone hydrochloride

Never give Lefisyo to other people!

Missing a dose of Lefisyo

The patient should take the missed dose on the same day only if they have taken less Lefisyo than prescribed and are experiencing withdrawal symptoms. In no case should the prescribed dose for the day be increased.If the patient has not experienced any withdrawal symptoms after taking a smaller amount, they should tell their doctor so that they can adjust the daily dose.

Stopping levomethadone

If the prescribed dose of levomethadone is too small, withdrawal symptoms (nasal congestion, abdominal pain, diarrhea, muscle pain, anxiety) may occur within a 24-hour interval between doses. The attending physician should be aware that there may be a need to change the dose if the patient reports withdrawal symptoms.

Stopping Lefisyo

Do not stop treatment abruptly or discontinuein the case of long-term use. Abrupt discontinuation of Lefisyo may lead to severe, life-threatening withdrawal symptoms. The end of long-term treatment should be gradual and progressive.
The patient should discuss any changes they want to make to their treatment with their doctor.
In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lefisyo can cause side effects, although not everybody gets them.
The following withdrawal symptomsoccur frequentlyat the beginning of treatment (may occur in up to 1 in 10 people):

• Anxiety
• Loss of appetite
• Involuntary muscle twitching
• Depression
• Intestinal cramps, stomach cramps
• Nausea, vomiting
• Diarrhea
• Fever, alternating chills and heat
• Yawning
• Goosebumps
• Weight loss
• Accelerated heart rate
• Runny nose, sneezing
• Dilated pupils
• Irritability
• Drowsiness
• Physical pain
• Fainting
• Excessive sweating
• Increased tear production
• Restlessness and tremors

Other possible side effects

Frequently(may occur in up to 1 in 10 people) to infrequently(may occur in up to 1 in 100 people):

• Shallow breathing
• Nausea, vomiting, constipation, biliary colic
• Palpitations, slower heart rate
• Confusion, disorientation
• Dizziness, sedation
• Hives and other types of rash, itching
• Decreased sex drive and (or) impotence
• Decreased urine output, urinary disorders
• Water retention
• Insomnia, agitation
• Loss of appetite, fatigue, weakness
• Excitement and depression
• Sweating, dry mouth
• Blurred vision
• Headache

Rarely(may occur in up to 1 in 1,000 people) to very rarely(may occur in up to 1 in 10,000 people):

• Redness of the skin and feeling of heat
• Respiratory arrest
• Cardiac arrest
• Drop in blood pressure when changing position to standing
• Circulatory disorders
• Short periods of fainting due to irregular heartbeat
• Shock
• Bleeding

Unknown(frequency cannot be estimated from the available data):

• Low blood sugar levels
• The patient may develop dependence on Lefisyo (more information, see section 2 "Warnings and precautions")
• Sleep apnea (pauses in breathing during sleep)

Note
After achieving a regular daily dose, side effects may subside within a few weeks. Constipation and increased sweating often persist and can be alleviated by taking appropriate measures. The patient should ask their doctor about this.
If side effects occur, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lefisyo

The medicine should be stored in a place that is not visible and inaccessible to children. This medicine should be stored in a safe place to which other people do not have access. Taking this medicine by people who have not been prescribed it can lead to serious harm and death.
Do not use this medicine after the expiry date stated on the carton and label after: Expiry date (EXP). The expiry date refers to the last day of the specified month.
There are no special storage instructions for the medicine.
Store in the original packaging to protect from light.
After opening the immediate packaging 90 days, provided it was stored below 25°C in the original packaging to protect from light.
After opening the immediate packaging 28 days, provided it was stored below 25°C in the original packaging to protect from light (10 ml).
Diluted solutions with fruit juice (such as orange juice or raspberry syrup) or drinking water for immediate use are suitable for use within 7 days, provided they were stored below 25°C.
Solutions diluted with water or preserved and viscous diluents for home use are suitable for use within 3 months, provided they were stored below 25°C. The preparation for home use should be stored in a place inaccessible to children.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Lefisyo contain

• The active substance of Lefisyo is levomethadone hydrochloride.
• The other ingredients are: glycerol, sodium benzoate (E 211), citric acid monohydrate, and purified water.

What Lefisyo looks like and what the packaging contains

Lefisyo is a clear and colorless solution.
The carton contains a brown glass bottle (type III), closed with a child-resistant closure (PP) with a polyethylene plug and a ring that allows the detection of tampering.
Pack sizes:
100 ml, 500 ml, and 1000 ml oral solution
The carton contains a brown glass bottle (type III), closed with a GL 18 screw cap with a polyethylene plug and a ring that allows the detection of tampering.
Pack size:
10 ml oral solution
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

INN-FARM d.o.o.
Maleševa ulica 14
1000 Ljubljana
Slovenia
Phone: +386 70 390 711
Fax: +386 5191 116
e-mail: [email protected]

Manufacturer

Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče
Slovenia
Date of last revision of the leaflet:07/2024

Information intended for healthcare professionals only:

Note for the pharmacist:
The prescribed preparation for home use can be prepared by diluting Lefisyo with drinking water in a ratio of 1:2 (one part Lefisyo and two parts water) or preserved and viscous diluents in a ratio of 1:1.

In the case of a prescription for a medicine for home use, Lefisyo is divided into portions according to the established daily dose and labeled. These daily portions are issued to the patient.

Recommendation for the doctor regarding the treatment of overdose:
Immediate assistance should be provided in the emergency department or, if necessary, in the intensive care unit (e.g. intubation and ventilation). Specific opioid receptor antagonists (e.g. naloxone) can be used to treat symptoms of poisoning. Individual opioid receptor antagonists differ in terms of dosage (see the manufacturer's information!). In particular, it should be taken into account that levomethadone may have a long-lasting depressive effect on the respiratory system (up to 75 hours), while opioid receptor antagonists act much shorter (from 1 to 3 hours). Therefore, after the antagonistic effect has subsided, additional injections may be necessary. Measures to prevent hypothermia and replenish blood volume may be necessary.
In the case of oral levomethadone poisoning, gastric lavage can be performed only after administering an antagonist. It is particularly important to secure the airways by intubation during gastric lavage, as well as before administering antagonists (possible vomiting).
In the treatment of poisoning, alcohol, barbiturates, bemegride, phenothiazine, and scopolamine should not be used.
Levomethadone is not subject to dialysis.