Levomethadone Hidrohloride Molteni

Leaflet attached to the packaging: information for the user

Levomethadone Hydrochloride Molteni, 5 mg/mL, oral solution

Levomethadone hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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 "pain-relieving opioids" - 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 pain-relieving medicines (see "Other medicines and Levomethadone Hydrochloride Molteni");
• if the patient has breathing difficulties or lung problems;
• if the patient is not addicted to opioid substances.

This medicine should not be used in children and adolescents under 18 years of age. Do not take this medicine if any of the above information applies to you. If you are in doubt, consult your doctor or pharmacist before taking Levomethadone Hydrochloride Molteni.

Warnings and precautions

Before starting to take Levomethadone Hydrochloride Molteni, you should consult a doctor or pharmacist if you:

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

If any of the above information applies to you (or you are not sure), before starting to take Levomethadone Hydrochloride Molteni, you should discuss it with your doctor or pharmacist. You should consult a doctor or pharmacist if you 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 pain-relieving medicines may lead to a decrease in hormone levels and an increase in prolactin hormone levels. You should consult a doctor or pharmacist if you experience symptoms such as decreased libido, impotence, or absence of menstruation.

When levomethadone is used, it is very important to consider that it has about twice the potency of methadone

(see also section 3 "How to take Levomethadone Hydrochloride Molteni").
Levomethadone Hydrochloride Molteni is intended for oral use only and should not be injected. Injection use is dangerous and can cause serious complications in the patient: the patient may develop a systemic infection, the veins may become painful and swollen, or the patient may experience a 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 can lead to reduced 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 can result in life-threatening overdose. Dependence or addictive use can make the patient feel that they have no control over the amount of medicine they take or how often they take 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 you experience any of the following symptoms while taking Levomethadone Hydrochloride Molteni, it may indicate that you have developed dependence or abuse:

• You feel the need to take the medicine for longer than your doctor recommended.
• You feel the need to take a higher dose than recommended.
• You use the medicine for reasons other than the one for which it was prescribed, such as "to calm down" or "to be able to sleep".
• You have repeatedly tried to stop or control the use of the medicine but failed.
• After stopping the medicine, you feel unwell and feel better after taking it again ("withdrawal symptoms").

If you experience any of the above symptoms, you should talk to your doctor and discuss the best treatment option for you, including the appropriate 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 you or someone else notices such symptoms, you should consult a doctor. The doctor may consider reducing the dose.

Effect on test results

Taking Levomethadone Hydrochloride Molteni may lead to positive results in sports tests (anti-doping tests). Do not use Levomethadone Hydrochloride Molteni as a doping agent - it can seriously harm your health.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Levomethadone Hydrochloride Molteni and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription, including herbal medicines. This is important because Levomethadone Hydrochloride Molteni may affect the action of some medicines, and 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), or if you have taken them in the last 2 weeks - including moclobemide, phenelzine, and tranylcypromine;
• medicines used to treat addiction - such as buprenorphine. You should wait at least 20 hours after stopping Levomethadone Hydrochloride Molteni before starting to take buprenorphine;
• strong pain-relieving medicines - such as morphine, butorphanol, nalbuphine, and pentazocine.

If any of the above information applies to you (or you are not sure), do not take Levomethadone Hydrochloride Molteni and inform your doctor or pharmacist. You should tell your doctor or pharmacist before starting to take Levomethadone Hydrochloride Molteni if you are taking any of the following medicines:

• medicines used to treat severe mental disorders called "psychoses", such as chlorpromazine;
• medicines that weaken the perception of stimuli, 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 rhythm disorders - 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 ("birth control pills");
• medicines used to treat epilepsy, 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 or 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. For this reason, their concurrent use can only be considered if other treatment options are not available. If your doctor prescribes Levomethadone Hydrochloride Molteni together with sedatives, the doctor should also limit the dose and duration of concurrent treatment. You should inform your doctor about all sedatives you are taking and strictly follow the doctor's instructions regarding the dose. It may be helpful to inform friends or relatives so that they are aware of the possibility of the above symptoms. If the above symptoms occur, you should consult a doctor.

The risk of side effects increases if you take levomethadone together with antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). You should consult a doctor if you experience symptoms such as:

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

If any of the above information applies to you (or you are not sure), before starting to take Levomethadone Hydrochloride Molteni, you should discuss it with your doctor or pharmacist.

Levomethadone Hydrochloride Molteni and alcohol

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

Pregnancy, breastfeeding, and fertility

Before taking Levomethadone Hydrochloride Molteni, you should consult a doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Before starting to take this medicine, you should discuss it with your doctor or pharmacist. 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.
• Chronic use during pregnancy may lead to the fetus becoming accustomed to and dependent on levomethadone, as well as to the occurrence of withdrawal symptoms after birth, which often requires hospital treatment.

Breastfeeding

• Levomethadone passes into breast milk. Before taking Levomethadone Hydrochloride Molteni, if you are breastfeeding or plan to breastfeed during levomethadone treatment, you should consult a doctor, as it may affect the baby. The decision to breastfeed during substitution treatment with Levomethadone Hydrochloride Molteni is made by the doctor. You should observe the baby to detect any unusual objective and subjective symptoms, such as increased sleepiness (more than usual), breathing difficulties, or floppiness. You should consult a 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

Do not drive or operate tools or machines while taking Levomethadone Hydrochloride Molteni, as you may feel drowsy and have reduced alertness while taking this medicine and sometimes also after stopping it. You may drive or operate tools or machines after consulting your doctor.

Levomethadone Hydrochloride Molteni contains methyl parahydroxybenzoate (E218)

It may cause allergic reactions (possibly delayed).

3. How to take Levomethadone Hydrochloride Molteni

This medicine should always be taken according to the doctor's instructions. If you are in doubt, consult your doctor or pharmacist.

Recommended dose

The doctor will determine the dose for you:

• according to your individual needs;
• based on the rate of occurrence of withdrawal symptoms.

Always take the dose prescribed by your doctor:

• do not take more or less of this medicine than the prescribed dose;
• do not take this medicine more or less frequently than prescribed.

Initial dose:

• The usual initial dose is 3 to 4 mL of oral solution per day (i.e., 15 to 20 mg of levomethadone hydrochloride).

Dose increase:

• The doctor may increase the dose for you by 1 to 2 mL per day (i.e., 5 to 10 mg of levomethadone hydrochloride). This will depend on how the medicine affects you.
• The usual dose may be increased to 12 mL of oral solution per day (i.e., 60 mg of levomethadone hydrochloride). In exceptional cases, the doctor may recommend a higher dose for you.

Elderly and severely ill patients

The dose may be reduced if you are over 65 years old. The dose may also be reduced if you are in severe general condition or have severe kidney or liver function disorders. In such cases, the doctor may want to monitor you more frequently.

Method of administration

• Levomethadone Hydrochloride Molteni is a liquid for oral use only.
• You can take this medicine undiluted or diluted with water or non-alcoholic beverages - such as orange juice.
• The dose for you will be measured and administered by your doctor or pharmacist.

Taking a higher dose of Levomethadone Hydrochloride Molteni than recommended

If you take more Levomethadone Hydrochloride Molteni than you should, you should talk to a doctor or go to the hospital immediately. You should take the medicine packaging with you. The following overdose symptoms may occur:

• breathing difficulties;
• feeling very drowsy, almost loss of consciousness ("unconsciousness") or coma;
• pupil constriction;
• 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 and heart attack may occur.

Missing a dose of Levomethadone Hydrochloride Molteni

If you forget to take a dose, you should skip the missed dose and take your usual dose when it is time for your next dose. Do not take a double dose to make up for the missed dose.

Stopping Levomethadone Hydrochloride Molteni

Do not stop taking Levomethadone Hydrochloride Molteni without first talking to your doctor. Stopping the medicine suddenly may cause side effects. If necessary, your doctor will gradually stop the treatment with Levomethadone Hydrochloride Molteni. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, you should inform your 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 nausea (vomiting);
• fever, alternating chills and hot flashes, yawning, goosebumps, runny nose, sneezing;
• uncoordinated and rapid movements or shivering (shivers);
• rapid heartbeat (tachycardia);
• very small pupils;
• general body pain;
• weakness or restlessness;
• excessive sweating or tearfulness.

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 disorders;
• weakness, dizziness, fainting, confusion, or disorientation;
• feeling very drowsy or insomnia;
• euphoric-dysphoric mood;
• palpitations or slower heartbeat;
• decreased sex drive;
• decreased libido or difficulty achieving and 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"), "biliary colic", which can cause pain in the upper abdomen or back;
• urination disorders, including reduced urine output.

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

• red skin and feeling of heat ("hot flashes");
• internal bleeding;
• respiratory arrest;
• low blood pressure occurring after rapid change of position to 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. You should talk to your doctor or pharmacist about treatment to relieve these side effects.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl. By reporting side effects, you 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, to which other people do not have access. Taking the medicine by people for whom it was not prescribed may lead to serious harm and death.
• Do not use this medicine after the expiry date stated on the label and carton after: "EXP". The expiry date refers to the last day of the given month.
• Store at a temperature below 25°C.
• Shelf life (oral solution): 12 weeks after first opening
• Medicines should not be disposed of via wastewater or household waste. You should ask your 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 5 milligrams (mg) of levomethadone hydrochloride.
• The other ingredients are: methyl parahydroxybenzoate (E218), betaine hydrochloride, glycerol, purified water.

What Levomethadone Hydrochloride Molteni looks like and what the package contains

• Levomethadone Hydrochloride Molteni is a clear and colorless oral solution.
• It is available in pack sizes of: 100 mL, 3 x 100 mL, 500 mL, and 1000 mL. The 100 mL package: a brown glass bottle with a child-resistant closure and an adapter for a pipette. A 5 mL pipette is calibrated from 0.25 mL to 5 mL with a scale every 0.25 mL and is supplied with the bottle.
• Not all pack sizes 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 on this medicine, you 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 Levomethadone Molteni Italy Ellepalmiron Poland Levomethadone Hydrochloride Molteni Spain Levometadona Molteni

Date of last revision of the leaflet: 04/07/2024