Levomethadone Hidrohloride Molteni

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Levomethadone Hydrochloride Molteni, 2.5 mg/mL, oral solution

For use in adults
Levomethadone hydrochloride

Before taking the medicine, carefully read the contents of the entire leaflet, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Levomethadone Hydrochloride Molteni and what is it used for
• 2. Important information before taking Levomethadone Hydrochloride Molteni
• 3. How to take Levomethadone Hydrochloride Molteni
• 4. Possible side effects
• 5. How to store Levomethadone Hydrochloride Molteni
• 6. Package contents and other information

1. What is Levomethadone Hydrochloride Molteni and what is it used for

Levomethadone Hydrochloride Molteni contains the active substance levomethadone hydrochloride. It belongs to
a group of medicines that act on the patient's nervous system.
Levomethadone Hydrochloride Molteni is used to treat adults addicted to substances called "opioids" or "opioid analgesics" – such as heroin and morphine. It acts as a substitute for addictive substances.

2. Important information before taking Levomethadone Hydrochloride Molteni

When not to take Levomethadone Hydrochloride Molteni:

• 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 medicines for depression called "MAO inhibitors" (monoamine oxidase inhibitors) or has taken them in the last 2 weeks (see "Other medicines and Levomethadone Hydrochloride Molteni");
• if the patient is taking medicines used to treat addiction or strong painkillers (see "Other medicines and Levomethadone Hydrochloride Molteni");
• if the patient has severe breathing difficulties or lung problems;
• if the patient is addicted to non-opioid substances;
• if the patient is under 18 years of age.

Levomethadone Hydrochloride Molteni should not be taken if any of the above information applies to the patient. If the patient has any doubts, they should ask their doctor or pharmacist before taking Levomethadone Hydrochloride Molteni.

Warnings and precautions

Before starting to take Levomethadone Hydrochloride Molteni, the patient should consult their doctor or
pharmacist if they:

• do not feel alert or fully awake (have "reduced levels of consciousness");
• have low blood pressure;
• have had heart problems in the past, including heart disease or arrhythmias. This medicine may affect the electrical signals that control the heartbeat, especially at high doses. Therefore, the patient should tell their doctor if they have had heart problems in the past;
• have had breathing or lung problems in the past, such as asthma or chronic obstructive pulmonary disease (COPD);
• have difficulty urinating;
• have prostate problems;
• have gallbladder or bile duct problems;
• have pancreatitis;
• have bowel disorders;
• have hypothyroidism;
• have increased intracranial pressure;
• have adrenal problems - hyperfunction or a type of tumor called pheochromocytoma;
• have been informed by their doctor that they have electrolyte imbalance disorders, such as hypokalemia.

If any of the above information applies to the patient (or if they are unsure), before starting to take Levomethadone Hydrochloride Molteni, the patient should discuss this with their doctor or pharmacist.
The patient should consult their doctor or pharmacist if they experience any of the following symptoms while taking Levomethadone Hydrochloride Molteni:

• weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms indicating that the adrenal glands are producing too little cortisol hormone and hormone replacement may be necessary.

Long-term use of opioid painkillers may lead to decreased levels of sex hormones and increased levels of prolactin hormone. The patient should consult their doctor or pharmacist if they experience symptoms such as decreased libido, impotence, or absence of menstruation.

When taking Levomethadone Hydrochloride Molteni, caution should be exercised

• Levomethadone Hydrochloride Molteni is about twice as potent as methadone. The correct dosage is given in section 3 "How to take Levomethadone Hydrochloride Molteni".
• Levomethadone Hydrochloride Molteni should not be injected - it is intended for oral administration only. Injection is dangerous and may cause serious complications in the patient. It may cause infection of the entire body, veins may become painful and swollen, and it may also cause blockage of a blood vessel in the lungs.

Tolerance, dependence, and addictive use

This medicine contains levomethadone, which is an opioid medicine. Repeated use of opioids may lead to
decreased efficacy of the medicine (the patient's body gets used to the effect of the medicine, which is called "tolerance"). Repeated use of Levomethadone Hydrochloride Molteni may also lead to abuse, dependence, and addictive use, which may result in life-threatening overdose.
Dependence or addictive use may cause the patient to feel that they have no control over the amount of medicine they take or the frequency of taking it.
The risk of developing dependence or abuse varies from patient to patient.
The patient may be at greater risk of developing abuse or dependence on Levomethadone Hydrochloride Molteni if:

• the patient or a family member has ever abused alcohol or been addicted to alcohol, prescription medicines, or illegal drugs ("addiction");
• 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 Levomethadone Hydrochloride Molteni, 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 failed.
• After stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal symptoms").

If the patient notices any of the above symptoms, they should talk to their doctor and discuss the best treatment option for them, including the right time to stop treatment and a safe way to stop treatment (see section 3, Stopping Levomethadone Hydrochloride Molteni).

Sleep apnea

Levomethadone Hydrochloride Molteni may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (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 consult their doctor. The doctor may consider reducing the dose.
Taking Levomethadone Hydrochloride Molteni may lead to positive results in sports doping tests. Levomethadone Hydrochloride Molteni should not be used as a doping agent - it can seriously harm health.

Levomethadone Hydrochloride Molteni 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. This includes medicines available without a prescription and herbal medicines. This is important because Levomethadone Hydrochloride Molteni may affect the action of some medicines. Also, some other medicines may affect the action of Levomethadone Hydrochloride Molteni.

Do not take Levomethadone Hydrochloride Molteni and inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines for depression called MAO inhibitors (monoamine oxidase inhibitors), including moclobemide, phenelzine, and tranylcypromine, even if taken in the last 2 weeks;
• medicines used to treat addiction, such as buprenorphine. Before starting buprenorphine, the patient should wait at least 20 hours after stopping Levomethadone Hydrochloride Molteni;
• strong painkillers, such as morphine, butorphanol, nalbuphine, and pentazocine.

If any of the above information applies to the patient (or if they are unsure), they should not take Levomethadone Hydrochloride Molteni and should inform their doctor or pharmacist.

Before starting Levomethadone Hydrochloride Molteni, the patient should consult their doctor or pharmacist

if they are taking any of the following medicines:

• medicines used to treat severe mental disorders called "psychoses", such as chlorpromazine
• medicines that dull the senses, including:
• other antidepressants, such as amitriptyline and clomipramine
• sleeping pills, including anesthetics
• medicines used to treat high blood pressure, such as reserpine, clonidine, urapidil, and prazosin
• spironolactone - a diuretic
• medicines used to treat fungal infections, such as fluconazole, itraconazole, voriconazole, and ketoconazole
• medicines used to treat heart diseases, such as quinidine, verapamil, and diltiazem
• cimetidine - used to treat stomach ulcers
• rifampicin - an antibiotic
• macrolide antibiotics, such as clarithromycin, telithromycin, and erythromycin
• medicines used to treat certain bacterial infections, such as ciprofloxacin, fusidic acid
• herbal medicines containing St. John's Wort (Hypericum perforatum)
• antiviral medicines, including some medicines used to treat HIV, such as amprenavir, nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquinavir, abacavir, delavirdine, didanosine, and stavudine
• oral contraceptives ("the pill")
• antiepileptic medicines, including barbiturates, such as phenytoin and carbamazepine
• cannabidiol (a medicine used to treat seizures)
• gabapentin and pregabalin (medicines used to treat epilepsy, neuralgia, or anxiety), may increase the risk of opioid overdose, respiratory depression (breathing difficulties), and may be life-threatening
• metamizole, a medicine used to treat pain and fever
• sedatives called benzodiazepines, such as diazepam and flunitrazepam. Concurrent use of Levomethadone Hydrochloride Molteni and sedatives, such as benzodiazepines or medicines with similar effects, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, their concurrent use can only be considered when other treatment options are not available. If the doctor prescribes Levomethadone Hydrochloride Molteni together with sedatives, the doctor should also limit the dose and duration of concurrent treatment. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives so that they are aware of the possibility of the above symptoms. In case of the above symptoms, the patient should consult their doctor. If any of the above information applies to the patient (or if they are unsure), before starting Levomethadone Hydrochloride Molteni, they should discuss this with their doctor or pharmacist.

The risk of side effects increases if the patient takes levomethadone with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). The patient should consult their doctor if they experience symptoms such as:

• Changes in mental state (e.g., agitation, hallucinations, coma)
• Rapid heartbeat, unstable blood pressure, fever
• Excessive reflexes, disturbed coordination, muscle stiffness
• Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Levomethadone Hydrochloride Molteni and alcohol

The patient should not drink alcohol while taking Levomethadone Hydrochloride Molteni, as alcohol may enhance the side effects of this medicine and lead to severe poisoning with symptoms such as drowsiness, shallow and weak breathing, and coma, which can be fatal.

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 Hydrochloride Molteni may be used during pregnancy after careful consideration by the doctor of the benefit-to-risk ratio, preferably under the supervision of a specialized medical center. Due to metabolic changes during pregnancy, it may be necessary to increase the number of doses to two per day to maintain the effectiveness of the treatment. The doctor may also recommend dividing the daily dose.
• Long-term use during pregnancy may lead to the fetus becoming accustomed to and dependent on levomethadone, as well as to the occurrence of withdrawal symptoms in the baby after birth, which often requires hospital treatment.

Breastfeeding
Levomethadone passes into human milk. If the patient is breastfeeding or plans to breastfeed while taking levomethadone, they should consult their doctor, as this may affect the baby. The decision to breastfeed while taking Levomethadone Hydrochloride Molteni is made by the doctor. The patient should observe the baby to detect any unusual objective and subjective symptoms, such as increased sleepiness (more than usual), breathing difficulties, or limpness. The patient should consult their doctor immediately if any of these symptoms are noticed.
Fertility
There are reports that methadone causes problems with male fertility during maintenance treatment.

Driving and using machines

The patient should not drive vehicles, use tools, or operate machines while taking Levomethadone Hydrochloride Molteni, as they may feel drowsy and have reduced alertness during treatment with this medicine and sometimes also after stopping it.
The patient may drive vehicles, use tools, or operate machines after consulting their doctor.

Levomethadone Hydrochloride Molteni contains methyl parahydroxybenzoate (E218)

The medicine may cause allergic reactions (possible late-type reactions).

3. How to take Levomethadone Hydrochloride Molteni

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

The doctor will determine the dose for the patient:

• according to the patient's individual needs;
• based on the rate of occurrence of withdrawal symptoms. The patient should always take the dose prescribed by the doctor:
• not more or less of this medicine than the prescribed dose;
• not more or less frequently than prescribed.

Initial dose:

• The usual initial dose is 6 to 8 mL of oral solution per day in the morning (i.e., 15 to 20 mg of levomethadone hydrochloride).
• If necessary, the patient may receive a second dose of 4 to 10 mL of oral solution in the evening (i.e., 10 to 25 mg of levomethadone hydrochloride).

Dose increase:

• The doctor will usually increase the dose within 1 to 6 days until the appropriate dose for the patient is established.
• The doctor may increase the dose by 2 to 4 mL per day (i.e., 5 to 10 mg of levomethadone hydrochloride). This will depend on how the medicine affects the patient.
• The usual dose may be up to 24 mL of oral solution per day (i.e., up to 60 mg of levomethadone hydrochloride). In some cases, the doctor may prescribe a higher dose.

Remember that Levomethadone Hydrochloride Molteni is about twice as potent as methadone –

which means that the patient takes a smaller dose than they would with methadone.

Elderly patients, those with kidney or liver problems, or those who are severely ill

In patients over 65 years of age, those in very poor health, or those with severe kidney or liver dysfunction, the dose may be reduced. In these cases, the doctor may want to monitor the patient more closely.

How to take the medicine

• Levomethadone Hydrochloride Molteni is intended for oral administration only.
• This medicine can be taken as is or diluted with water or non-alcoholic beverages - such as orange juice.
• The patient's dose will be measured and administered by the doctor or pharmacist.

Taking a higher dose of Levomethadone Hydrochloride Molteni than prescribed

If the patient takes more Levomethadone Hydrochloride Molteni than they should, they should immediately consult their doctor or go to the hospital. They should take the medicine package with them.
The following overdose symptoms may occur:

• breathing difficulties;
• feeling very drowsy, almost loss of consciousness ("unconsciousness") or coma;
• pupils become very small;
• cold and sweaty skin;
• very slow heartbeat;
• muscle weakness;
• low blood sugar levels;
• brain disorders (known as toxic leukoencephalopathy). In severe cases, respiratory arrest or cardiac arrest may occur.

Missing a dose of Levomethadone Hydrochloride Molteni

If the patient misses a dose, they should skip the missed dose and take their usual dose when it is time for their next dose. They should not take a double dose to make up for the missed dose.

Stopping Levomethadone Hydrochloride Molteni

The patient should not stop taking Levomethadone Hydrochloride Molteni without first talking to their doctor. Stopping the medicine abruptly may cause side effects. If it is necessary to stop taking Levomethadone Hydrochloride Molteni, the doctor will gradually stop the treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should inform their doctor:

Side effects are more likely to occur at the beginning of treatment:

• feeling anxious, depressed, irritable, or drowsy;
• loss of appetite (anorexia), weight loss, or malaise (nausea);
• stomach or intestinal cramps, diarrhea, or vomiting;
• fever, chills, and sweating;
• uncoordinated and rapid movements or tremors (shakes);
• rapid heartbeat (tachycardia);
• very small pupils;
• body aches;
• weakness or restlessness;
• excessive sweating or tearing.

Other side effects include:

Uncommon (may affect up to 1 in 100 people) to common (may affect up to 1 in 10 people):

• slow or shallow breathing;
• headache or vision disturbances;
• weakness, dizziness, fainting, confusion, or disorientation;
• feeling very drowsy or insomnia;
• excitement or depression;
• palpitations or low heart rate;
• decreased sex drive;
• decreased libido or difficulty achieving or maintaining an erection in men;
• increased sweating;
• skin rash, including hives and other types of itchy rash;
• dry mouth;
• loss of appetite, nausea, or vomiting;
• constipation;
• fluid retention (edema), bile duct spasms, which can cause pain in the upper abdomen or back;
• urinary disorders, including difficulty urinating.

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

• flushing and feeling hot (hot flashes);
• slow bleeding inside the body;
• respiratory arrest;
• drop in blood pressure when changing position from lying down to sitting or standing;
• cardiac arrest, heart attack, circulatory disorders, or shock.

Frequency not known:

• low blood sugar levels;
• sleep apnea (pauses in breathing during sleep);
• the patient may develop dependence on Levomethadone Hydrochloride Molteni.

It is worth noting that the severity of some side effects decreases over time. However, constipation and increased sweating persist. The patient should talk to their doctor or pharmacist about treating these side effects.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Levomethadone Hydrochloride Molteni

• The medicine should be stored out of sight and reach of children. This medicine should be stored in a safe place, inaccessible to other people. Taking the medicine by people for whom it was not prescribed may lead to serious harm and death.
• The medicine should not be used after the expiration date stated on the carton and label after EXP. The expiration date refers to the last day of the specified month.
• This medicine does not require any special storage conditions.
• Shelf life (60 mL, 100 mL, 1000 mL bottles, oral solution): 12 weeks after first opening.
• 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. Package contents and other information

What Levomethadone Hydrochloride Molteni contains

• The active substance is levomethadone hydrochloride. Each milliliter (mL) of oral solution contains 2.5 milligrams (mg) of levomethadone hydrochloride. The other ingredients are methyl parahydroxybenzoate (E218), betaine hydrochloride, glycerol, caramel (E150C), and purified water.

What Levomethadone Hydrochloride Molteni looks like and what the package contains

• Levomethadone Hydrochloride Molteni 2.5 mg/mL oral solution is a clear, light amber liquid.
• It is available in the following packages:
• 5, 10, or 20 mL single-dose bottles, with a child-resistant closure.
• 60 or 100 mL multi-dose bottles, with a child-resistant closure and an adapter (pipette insert). A 5 mL pipette is calibrated from 0.25 mL to 5 mL with 0.25 mL graduations and is supplied with the bottle.
• 1000 mL PVC amber-colored bottle, closed with a plastic cap and an inner seal. The package includes a measuring cup with graduations from 1 to 6 mL.

Not all package types may be marketed.

Marketing authorization holder and manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Loc. Granatieri 50018 Scandicci (Firenze), Italy

For more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Molteni Farmaceutici Polska Sp. z o.o
Tel.: +48 (12) 653 15 71
e-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
Levomethadon Molteni 2.5 mg/mL Lösung zum Einnehmen
Italy
Ellepalmiron 2.5 mg/mL soluzione orale
Poland
Levomethadone Hydrochloride Molteni 2.5 mg/mL roztwór doustny

Date of last revision of the leaflet: