Package leaflet: Information for the patient

Lefisyo 5 mg/ml oral solution
Levomethadoni hydrochloridum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Lefisyo is and what it is used for
Important information before taking Lefisyo
How to take Lefisyo
Possible side effects
How to store Lefisyo
Contents of the pack and other information

1. What Lefisyo is and what it is used for

Levomethadone hydrochloride, the active substance in Lefisyo, is a medicine belonging to the group of opioids.
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),
and as a bridging substitution therapy, for example during hospitalization.

2. 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 (MAO inhibitors), medicines used in the treatment of 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. However, these medicines may be used in the treatment of Lefisyo overdose.

Warnings and precautions
Levomethadone may be used only in opioid-dependent patients by physicians authorized to conduct substitution treatment, as standard doses used in substitution therapy may cause severe poisoning or even lead to death in patients without opioid tolerance.
Before starting Lefisyo, discuss with your doctor or pharmacist if any of the following situations apply to the patient. The doctor will initiate treatment only if necessary. This particularly applies to the following cases:

Pregnancy and breastfeeding
Impaired consciousness
Concomitant use of this medicine with other medicines that suppress certain brain functions (such as control of breathing) (see section "Lefisyo with other medicines" and "Lefisyo with alcohol")
Concurrent use of Lefisyo with sedatives or sleeping tablets (such as benzodiazepines and related medicines): This may lead to drowsiness, shallow and weakened breathing, coma, and may also lead to death (see also section "Lefisyo with other medicines")
Diseases in which respiratory depression should be avoided, such as:
- Asthma
- Lung diseases with chronic airway obstruction
- Heart failure caused by severe lung disease
- Moderate to severe respiratory depression (slow or shallow, ineffective breathing leading to increased carbon dioxide levels and decreased oxygen levels in the body) and dyspnea (feeling of breathlessness)
- Low blood oxygen levels
- Increased carbon dioxide levels in the blood
  In these conditions, breathing may be impaired or respiratory arrest may occur, even with standard doses of Lefisyo. Worsening of pre-existing asthma or skin rashes and blood count abnormalities may occur, especially if the patient has a tendency to allergies.
Increased intracranial pressure: May be further increased
Low blood pressure caused by dehydration
Enlarged prostate with incomplete bladder emptying
Pancreatitis
Biliary tract disorders
Intestinal obstruction and inflammatory bowel diseases
Pheochromocytoma, i.e. a hormone-secreting adrenal gland tumor
Hypothyroidism (a condition in which the thyroid gland does not produce enough hormones)
Suicide risk: In patients taking opioids, especially in combination with certain antidepressants, alcohol, and other substances such as benzodiazepines, suicide attempts may be a clinical sign of substance dependence. If the patient cannot stop using such substances concurrently, this should be discussed with a doctor or specialist clinic.
Severe abdominal disorders: Treatment with Lefisyo may also mask serious abdominal conditions. If initial symptoms of abdominal disorders occur, regular monitoring of the patient should be initiated until the exact cause is determined.
Cardiac arrhythmia (heart rhythm disorders) or prolonged ventricular repolarization, known as QT interval prolongation, or electrolyte imbalances, especially low blood potassium levels. Some opioids may affect cardiac conduction (prolongation of the QT interval on ECG). This may cause dangerous heart rhythm disturbances (too fast, irregular heartbeat; "torsade de pointes"). If the patient experiences irregular heartbeat or fainting, inform the doctor immediately.
Treatment with antiarrhythmic medicines of class I and III
Slowed heart rate

Dosage should be reduced in elderly patients and in patients with kidney disease, severe chronic liver disease, or poor general condition.
Before starting Lefisyo, discuss with your doctor or pharmacist if the patient has adrenal disorders. Treatment should be conducted with caution.
Talk to your doctor or pharmacist if, during treatment with Lefisyo, the patient experiences any of the following symptoms: weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms of insufficient cortisol hormone production by the adrenal glands, and the patient may require hormonal supplementation.
Long-term use of opioids may lead to decreased levels of sex hormones and increased levels of the hormone prolactin. If symptoms such as reduced sexual drive, impotence, or amenorrhea occur, contact your doctor.
Breathing disorders during sleep
Lefisyo may cause breathing disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, contact the doctor. The doctor may consider reducing the dose.
Tolerance, dependence, and compulsive use
This medicine contains levomethadone, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to the medicine's effect, known as "tolerance"). Repeated use of Lefisyo may also lead to dependence, abuse, and compulsive use, which may result in life-threatening overdose.
Dependence or compulsive use may make the patient feel they have no control over the amount or frequency of medicine intake.
The risk of developing dependence or abuse varies among patients. The patient may have a higher 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 ("addiction").
The patient smokes cigarettes.
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, during treatment with Lefisyo, the patient notices any of the following symptoms, this may indicate the development of dependence or abuse:

The patient feels a need to take the medicine longer than prescribed by the doctor.
The patient feels a need to take a higher dose than recommended.
The patient uses the medicine for reasons other than those for which it was prescribed, e.g., "to calm down" or "to be able to sleep."
The patient has repeatedly made unsuccessful attempts to stop or control medicine use.
After stopping the medicine, the patient feels unwell and feels better after resuming the medicine ("withdrawal symptoms").

If the patient notices any of the above symptoms, they should talk to their doctor and discuss the best treatment approach, including the appropriate time to stop treatment and a safe way to discontinue treatment (see section 3, "Stopping treatment with Lefisyo").
Additional information
Long-term and repeated use of levomethadone may lead to physical and psychological dependence and habituation with loss of effectiveness, known as tolerance. Stopping treatment after repeated use or in opioid dependence, or administering an opioid antagonist (a substance that may block the effect of opioids), may trigger withdrawal syndrome.
Taking Lefisyo by individuals not accustomed to repeated and regular opioid use poses a life-threatening risk and may lead to death due to respiratory arrest.
Lefisyo is intended for oral use only. Misuse of Lefisyo by intravenous injection leads to overdose and life-threatening adverse effects, such as blood infection, vein inflammation, and pulmonary embolism due to blood clots.
Drug and narcotic abuse during substitution treatment may lead to life-threatening incidents and must be strictly avoided.
The doctor will perform regular urine tests to check whether the patient is concurrently using narcotics.
When using levomethadone, it is important to remember that its potency is approximately twice that of racemic methadone (see also section 3, "How to take Lefisyo").
Effects of misuse for doping purposes
Taking Lefisyo may lead to positive results in anti-doping control tests. Moreover, inappropriate use of Lefisyo as a doping agent may pose health risks.
Lefisyo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking other medicines may affect the required daily dose of Lefisyo. If the patient notices any symptoms of intensified effect or withdrawal symptoms of Lefisyo, inform the doctor.
Do not take Lefisyo simultaneously with the following medicines:

Monoamine oxidase inhibitors: Medicines used in the treatment of depression or Parkinson's disease. These medicines must be discontinued at least 14 days before starting treatment with Lefisyo. Otherwise, life-threatening respiratory and circulatory suppression or stimulation may occur.
Pentazocine, buprenorphine: Medicines used in the treatment of severe pain. If these medicines are taken simultaneously with Lefisyo, withdrawal symptoms may occur. Do not take buprenorphine earlier than 20 hours after stopping Lefisyo. In exceptional cases, these medicines may be taken simultaneously with this medicine if used to treat Lefisyo overdose.

Tell your doctor if the patient is taking any of the following medicines, as they may alter the effect of Lefisyo:

Other medicines that suppress certain brain functions (e.g., control of breathing), such as
- Strong painkillers (including opioids)
- Certain medicines used to treat psychiatric disorders, whose active substance names usually end in "-azine", such as phenothiazine
- Sleeping tablets
- Antiepileptic medicines, such as barbiturates, whose active substance names usually end in "-tal", such as phenobarbital
- Narcotic medicines
- Certain medicines used to treat depression, known as tricyclic antidepressants (e.g., trimipramine and doxepine)

When these medicines are taken simultaneously with Lefisyo, they may mutually intensify their effects on brain functions and thus cause, for example, drowsiness or shallow and weakened breathing (see section "Warnings and weakened breathing"). Follow the doctor's dosage instructions precisely.

Sedatives and sleeping tablets known as benzodiazepines (usually ending in "-zepam", such as diazepam, flunitrazepam) and related medicines (such as zolpidem). Concurrent use of Lefisyo and sedatives, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should be considered only if other treatment options are not possible. However, if the doctor has prescribed Lefisyo together with sedative medicines, the dose and duration of concurrent use should be limited. Inform the doctor about all sedative medicines being taken and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives so they are aware of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact the 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 gastric acid production
Medicines used to treat fungal infections (such as itraconazole, ketoconazole, voriconazole, fluconazole)
Medicines used to treat heart rhythm disorders (e.g., antiarrhythmic 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 seizures)
Gabapentin and pregabalin (medicines used to treat epilepsy, neuropathic pain, or anxiety), which may increase the risk of opioid overdose, respiratory depression (breathing difficulties), and may be life-threatening
Medicines used to treat certain bacterial infections, such as rifampicin, macrolide antibiotics, ciprofloxacin, fusidic acid
St. John's wort (Hypericum perforatum)
Spironolactone (a diuretic)
Medicines inhibiting HIV replication (such as efavirenz, nevirapine, nelfinavir, ritonavir, amprenavir, didanosine, stavudine, zidovudine)

The risk of adverse effects increases when levomethadone is taken simultaneously with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Contact your doctor if symptoms such as the following occur:

Mental status changes (e.g., agitation, hallucinations, coma)
Rapid heartbeat, unstable blood pressure, fever
Exaggerated reflexes, coordination disturbances, muscle stiffness
Gastrointestinal symptoms (such as nausea, vomiting, diarrhea)

Lefisyo with alcohol
Do not drink alcohol while taking Lefisyo. Alcohol may unpredictably intensify the medicine's effect and cause severe poisoning with subjective and objective symptoms such as drowsiness, shallow and weakened breathing, and coma, in some cases even leading to death.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Levomethadone crosses the placenta and enters the fetal bloodstream. Lefisyo may be used during pregnancy after careful consideration by the doctor of the benefit-risk ratio, preferably under supervision in a specialized medical center.
Due to metabolic changes occurring during pregnancy, an increase in dose may be necessary. For the fetus's well-being, the doctor may also recommend dividing the daily dose.
Chronic use during pregnancy may lead to fetal habituation and dependence on levomethadone, as well as withdrawal symptoms in the newborn, which often require hospital treatment. Additionally, taking levomethadone before and during delivery may lead to breathing problems in the newborn.
Breastfeeding
Consult your doctor if the patient is breastfeeding or considering breastfeeding while taking levomethadone, as the medicine may affect the child. Monitor the child for abnormal subjective and objective symptoms, such as increased drowsiness (more than usual), breathing difficulties, and floppiness. If these symptoms are noticed, contact the doctor immediately.
Fertility
It has been reported that methadone in maintenance treatment causes sexual dysfunction in male patients.
Driving and operating machinery
This medicine, even when used as intended, may alter the patient's reactions in a way that impairs the ability to drive and operate machinery. This is particularly important when taken concurrently with alcohol and certain other medicines (see also section "Lefisyo with other medicines").
The decision on the ability to drive is made on a case-by-case basis by the treating doctor, taking into account the patient's individual response and specific 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, meaning the medicine is considered "sodium-free".

3. How to take Lefisyo

Levomethadone hydrochloride substitution therapy should be administered by a physician experienced in the treatment of opioid addiction, preferably in specialized centers for opioid addiction treatment.
The potency of levomethadone is approximately twice that of racemic methadone. Evidence indicates that the metabolism of levomethadone is enhanced following administration of racemic methadone, so this ratio may vary. This should be taken into account when determining dosage.
This medicine should always be taken as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.

Recommended doses
The dose is determined based on the presence of withdrawal symptoms and must be individualized according to the patient's specific circumstances. Generally, after dose adjustment, the goal is to administer the lowest possible maintenance dose.

To prevent overdose, the initial dose on the first day is 15 to 20 mg of levomethadone hydrochloride (corresponding to 3 to 4 ml of solution), taken in the morning. Depending on subjective and objective effects, an additional dose of 10 to 25 mg of levomethadone hydrochloride (2 to 5 ml of solution) may be taken in the evening of the first day.
For 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 solution).

After 1 to 6 days, the daily dose is administered once daily in the morning. The transition to a single daily morning dose is usually performed gradually using increments of 5 mg of levomethadone hydrochloride (1 ml of solution).

If efficacy is insufficient (withdrawal symptoms occur), the physician may increase the daily dose by 5 to 10 mg of levomethadone hydrochloride (1 to 2 ml of solution).
The maintenance dose is usually reached within 1 to 6 days. This dose may reach up to 60 mg of levomethadone hydrochloride (12 ml of solution), and in individual justified cases may be significantly higher. Doses exceeding 50 to 60 mg of levomethadone hydrochloride should only be used in justified individual cases and only if concomitant use of any other psychoactive substances has been ruled out.

Note
Daily requirements for levomethadone may be increased due to interactions with other medicines or increased metabolism of Lefisyo caused by certain other drugs (see also section 2 "Lefisyo and other medicines"). Therefore, even in patients receiving a stable dose, potential withdrawal symptoms should be monitored and the dose adjusted if necessary.

Elderly patients and patients with renal or hepatic impairment
Dosage should be reduced in elderly patients and in patients with kidney disease, severe chronic liver disease, or poor general condition.

Children and adolescents
Data on the use of this medicine in children and adolescents under 18 years of age are not available. Therefore, the use of Lefisyo in children and adolescents is not recommended.

Method of administration
Lefisyo is intended for oral use only.
It is ready for use and may be taken mixed with drinking water or beverages such as orange juice or raspberry syrup.

When Lefisyo is administered as a ready-to-use solution, it should be swallowed under medical supervision. The patient receives the required dose from the physician or a person designated by the physician and takes it immediately. The required amount is measured exclusively by the physician or an authorized person.

A prescription for a specific quantity of this medicine for self-administration by the patient, as a prescription for home use, must be issued by a physician. In this case, the patient takes the prescription to the pharmacy and receives Lefisyo divided into daily doses. The doses should be taken according to the physician's instructions.

Lefisyo is intended for oral use only.
Abuse of Lefisyo by intravenous injection may lead to overdose and life-threatening adverse effects such as:

Blood infection
Phlebitis (vein inflammation)
Pulmonary embolism (blockage of blood vessels in the lungs by a blood clot)

Duration of treatment
The duration of treatment depends, within the context of the overall therapeutic program, on the patient's progress in substitution therapy and individual response. The goal of treatment is to achieve abstinence from narcotics. The duration of Lefisyo use may range from short-term (e.g., substitution in drug-dependent patients during hospital treatment) to long-term.

Taking more than the recommended dose of Lefisyo
In case of suspected overdose, contact your doctor immediately!
Keep this package leaflet at hand to show it to the doctor for information. The doctor will provide immediate medical assistance without delay.

Symptoms of overdose include:

Euphoria ("feeling high")
Impaired concentration
Drowsiness
Dizziness upon standing
Cold, clammy skin
Low blood sugar levels
Reduced rate and depth of breathing, possibly leading to cyanosis (bluish discoloration of the lips)
Slowed heart rate and low blood pressure
Constricted pupils
Flaccidity of skeletal muscles
Deep drowsiness progressing to loss of consciousness and even coma
Brain dysfunction (known as toxic leukoencephalopathy)
Severe poisoning may lead to respiratory arrest, circulatory failure, cardiac arrest, and death.

Administration of Lefisyo to individuals not accustomed to it may result in death due to respiratory arrest. This applies to the following patient groups:

Children under 5 years of age from a dose of 0.5 mg levomethadone hydrochloride
Older children from a dose of 1.5 mg levomethadone hydrochloride
Adults not accustomed to opioids from a dose of 10 mg levomethadone hydrochloride

Never give Lefisyo to anyone else!

Missed dose of Lefisyo
A missed dose should be taken on the same day only if the patient has taken less Lefisyo than prescribed and is experiencing withdrawal symptoms. Under no circumstances should the prescribed daily dose be increased. If no withdrawal symptoms occur after taking a lower amount, the patient should inform the doctor so that the daily dose can be adjusted.

Levomethadone withdrawal
If the prescribed levomethadone dose is too low, withdrawal symptoms (e.g., nasal congestion, abdominal pain, diarrhea, muscle pain, anxiety) may occur within the 24-hour interval between doses. The treating physician should be aware that dose adjustment may be necessary if the patient reports withdrawal symptoms.

Stopping treatment with Lefisyo
Do not abruptly stop or discontinue treatment if the medicine has been taken for a long time. Abrupt discontinuation of Lefisyo may lead to severe, even life-threatening, withdrawal symptoms. Discontinuation of long-term treatment should be done slowly and gradually.

Any changes the patient wishes to make to their treatment should be discussed with the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The withdrawal symptoms listed below occur frequently at the beginning of treatment (may affect up to 1 in 10 people):

Anxiety
Loss of appetite
Involuntary muscle twitching
Depression
Intestinal spasms, stomach cramps
Nausea, vomiting
Diarrhea
Fever, alternating chills and hot flushes
Yawning
Goosebumps
Weight loss
Rapid heartbeat
Nasal congestion, sneezing
Dilated pupils
Irritability
Drowsiness
Physical pain
Fainting
Excessive sweating
Increased tearing
Restlessness and tremor

Other possible adverse reactions
Frequent (may affect up to 1 in 10 people) to not very frequent (may affect up to 1 in 100 people):

Shallow and weakened breathing
Nausea, vomiting, constipation, biliary spasm
Palpitations, slower heartbeat
Confusion, disorientation
Dizziness, sedation
Hives and other types of rash, itching
Decreased libido and/or impotence
Reduced urine volume, urinary disturbances
Fluid retention in tissues
Insomnia, restlessness
Loss of appetite, fatigue, weakness
Excitement and depression
Sweating, dry mouth
Blurred vision
Headache

Rare (may affect up to 1 in 1,000 people) to very rare (may affect up to 1 in 10,000 people):

Skin flushing and sensation of warmth
Respiratory arrest
Cardiac arrest
Drop in blood pressure upon standing (orthostatic hypotension)
Circulatory disturbances
Brief episodes of fainting due to irregular heartbeat
Shock
Bleeding

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

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

Note
After reaching a regular daily dose, adverse reactions may diminish within a few weeks. Constipation and increased sweating often persist and can be alleviated by taking appropriate measures. Please consult your doctor.

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 of the 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 Lefisyo

Keep this medicine out of sight and reach of children. This medicine should be stored in a safe place inaccessible to others. Taking this medicine by people for whom it has not been prescribed may lead to severe harm or death.
Do not use this medicine after the expiry date stated on the carton and label following:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special temperature storage requirements apply.
Store in the original packaging to protect from light.
After first opening of the immediate packaging: 90 days, provided it has been stored below 25°C in the original packaging to protect from light.
After first opening of the immediate packaging: 28 days, provided it has been stored below 25°C in the original packaging to protect from light (10 ml).
Diluted solutions mixed 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 have been stored below 25°C.
Solutions diluted with drinking water or preserved, viscous diluents for home use are suitable for use within 3 months, provided they have been stored below 25°C. Medicinal product for home use should be kept out of reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the package and other information

What Lefisyo contains

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

What Lefisyo looks like and contents of the pack
Lefisyo is a clear, colourless oral solution.
The cardboard pack contains a brown glass bottle (type III), closed with a child-resistant cap (PP) with a polyethylene insert and a tamper-evident ring.
Pack sizes:
100 ml, 500 ml and 1000 ml oral solution
The cardboard pack contains a brown glass bottle (type III), closed with a GL 18 cap with a polyethylene insert and a tamper-evident ring.
Pack size:
10 ml oral solution
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
INN-FARM d.o.o.
Maleševa ulica 14
1000 Ljubljana
Slovenia
Tel.: +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

Information intended exclusively for medical professionals:

Pharmacist's note:
The prescribed preparation intended for home use can be prepared by diluting Lefisyo with drinking water in a 1:2 ratio (one part Lefisyo and two parts water) or with preserved, viscous diluents in a 1:1 ratio.
In the case of a prescription for a medication intended for home use, Lefisyo is divided into portions according to the prescribed daily dose and labeled. These daily portions are dispensed to the patient.

Physician guidance for treatment of overdose:
Immediate medical intervention must be initiated in an emergency department or, if necessary, in an intensive care unit (e.g., intubation and ventilation). Specific opioid receptor antagonists (e.g., naloxone) may be used to treat poisoning symptoms. Individual opioid receptor antagonists differ in dosage requirements (refer to manufacturer's information!). It is particularly important to note that levomethadone may exert prolonged respiratory depressant effects (up to 75 hours), whereas opioid receptor antagonists have a significantly shorter duration of action (1 to 3 hours). Therefore, after the antagonist effect wears off, repeated injections may be necessary. Measures to prevent hypothermia and to restore blood volume may also be required.

In cases of oral levomethadone poisoning, gastric lavage may only be performed after administration of an antagonist. Airway protection via intubation is essential both during gastric lavage and prior to antagonist administration (due to the risk of vomiting).

Alcohol, barbiturates, bemegride, phenothiazines, and scopolamine must not be used in the treatment of poisoning. Levomethadone is not dialyzable.