Leaflet: information for the user

Levometadone Molteni 5mg/ml oral solution

Levometadone, hydrochloride

Read this leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1.What is Levometadone Molteni and what it is used for

2.What you need to know before starting to take Levometadone Molteni

3.How to take Levometadone Molteni

4.Possible side effects

5.Storage of Levometadone Molteni

6.Contents of the pack and additional information

Levometadona Molteni contains the active ingredient levometadone hydrochloride. This belongs to a group of medicines that act on the nervous system.

Levometadona Molteni is used to treat adults who are addicted to substances called «opioids» or «narcotic analgesics», such as heroin or morphine. It acts as a substitute for the addictive drugs.

Do not take Levometadona Molteni if:

• You are allergic to levometadone hydrochloride or any of the other components of this medication (listed in section 6)
• You are taking medications for depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks (see "Taking Levometadona Molteni with other medications")
• You are taking medications for addiction or strong pain medications (see "Taking Levometadona Molteni with other medications")
• You have severe respiratory or pulmonary problems
• You are not addicted to opioid medications or drugs.

Children and adolescents under 18 years of age should not take this medication.

Do not take this medication if you meet any of the above circumstances. If you are unsure, consult your doctor or pharmacist before starting to take Levometadona Molteni.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if:

• You do not feel alert or fully awake (have "low levels of consciousness")
• You have low blood pressure
• You have had heart problems, including heart disease or problems with heart rhythm.This medication may affect the electrical signals that control your heart's contractions, particularly at high doses. Therefore, inform your doctor if you have a history of heart problems.
• You have had respiratory or pulmonary problems such as asthma or "COPD" (chronic obstructive pulmonary disease)
• You cannot urinate
• You are a man with prostate problems
• You have problems with your gallbladder or bile duct
• You have an inflamed pancreas
• You have intestinal problems
• Your thyroid gland is underactive
• You have high pressure inside your skull
• You have problems with your adrenal glands, either an overactive adrenal gland or a type of tumor (called "pheochromocytoma")
• Your doctor has told you that you have an "electrolyte imbalance" such as "hypokalemia".

If you meet any of the above circumstances (or are unsure), consult your doctor or pharmacist before starting to take Levometadona Molteni.

Consult your doctor or pharmacist if you experience any of the following symptoms while taking Levometadona Molteni:

• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. This may be a sign that your adrenal glands are producing very little cortisol hormone, and you may need to take a hormone supplement.

The prolonged use of opioids may cause a decrease in sex hormone levels and an increase in prolactin hormone levels. Contact your doctor if you experience symptoms such as decreased libido, impotence, or absence of menstruation (amenorrhea).

• When taking levometadone, it is essential to note that it is approximately twice as active as methadone(see also section 3 "How to take Levometadona Molteni").
• This medication is only for oral use and should not be injected. Using it by injection is hazardous and may seriously harm your health: you may have a body infection, your veins may become painful and swollen, or you may have a blockage of a blood vessel in your lungs.

Tolerance, dependence, and addiction

This medication contains an opioid called levometadone. The repeated use of opioids may reduce the effectiveness of the medication (your body becomes accustomed to the medication, which is known as tolerance). The repeated use of Levometadona Molteni may also cause dependence, abuse, and addiction, which may lead to a potentially fatal overdose.

Dependence or addiction may make you feel that you no longer have control over the amount of medication you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may be at a higher risk of becoming dependent or addicted to Levometadona Molteni if:

• You or a family member has a history of alcohol, prescription medication, or illicit substance abuse ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking Levometadona Molteni, it could be a sign that you have become dependent or addicted:

• You need to take the medication for a longer period than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medication for reasons other than those prescribed, such as "to calm down" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop or control your use of the medication.
• You do not feel well when you stop taking the medication and feel better when you take it again ("abstinence symptoms").

If you notice any of these signs, talk to your doctor to address the most suitable treatment strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 "If you interrupt treatment with Levometadona Molteni").

Respiratory problems related to sleep

Levometadona Molteni may cause respiratory problems related to sleep such as, for example, 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, nocturnal awakenings due to lack of breath, difficulties maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Effects on analytical test results

The use of this medication may lead to positive results in drug tests in sports (anti-doping tests). Do not use Levometadona Molteni as a doping medication, as it may cause serious harm to your health.

Children and adolescents

Children and adolescents under 18 years of age should not take this medication.

Taking Levometadona Molteni with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This includes over-the-counter medications and herbal medications. This is because Levometadona may affect how some medications work. Additionally, some medications may affect how Levometadona works.

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

• Medications for depression called MAOIs (monoamine oxidase inhibitors), or have taken them in the last 2 weeks. This includes moclobemide, phenelzine, and tranylcypromine.
• Medications for addiction, such as buprenorphine. You should wait at least 20 hours after stopping Levometadona Molteni before starting buprenorphine.
• Strong pain medications, such as morphine, butorphanol, nalbuphine, and pentazocine.

If you meet any of the above circumstances (or are unsure), do not take Levometadona Molteni and consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take Levometadona Molteni if you are taking any of the following:

• Medications for a serious mental health problem called "psychosis", such as chlorpromazine
• Medications that dull your senses, including:

- Other medications for depression, such as amitriptyline and clomipramine

- Medications to help you sleep, including anesthetics

• Medications for high blood pressure, such as reserpine, clonidine, urapidil, and prazosin
• Spironolactone - a diuretic
• Medications for fungal infections, such as fluconazole, itraconazole, voriconazole, and ketoconazole
• Medications for heart problems, such as quinidine, verapamil, and diltiazem
• Cimetidine, to treat stomach ulcers
• Rifampicin, an antibiotic
• Macrolide antibiotics, for example clarithromycin, telithromycin, and erythromycin
• Medications for certain bacterial infections, such as ciprofloxacin, fusidic acid
• Herbal medications containing St. John's Wort (Hypericum perforatum)
• Antiviral medications, including some medications used to treat HIV, such as amprenavir, nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquinavir, abacavir, delavirdine, didanosine, and stavudine
• Oral contraceptives ("the pill")
• Medications for epilepsy, including barbiturates, such as phenytoin and carbamazepine.
• Cannabidiol (a medication used to treat seizures)
• Gabapentin and pregabalin (medications used to treat epilepsy, nerve pain, or anxiety). These may increase the risk of opioid overdose, respiratory depression (difficulty breathing), and may be potentially fatal.
• Metamizole, a medication used to treat pain and fever
• Medications to calm you down, called benzodiazepines, such as diazepam or flunitrazepam
  The concomitant use of Levometadona Molteni and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, it should only be considered when other treatment options are not possible.
  However, if your doctor prescribes Levometadona Molteni along with sedatives, your doctor should limit the dose and duration of concomitant treatment.
  Inform your doctor about all the sedatives you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

The risk of adverse effects increases if you use levometadone at the same time as antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Contact your doctor if you experience symptoms such as:

• Mental state changes (e.g., agitation, hallucinations, coma)
• Fast heart rate, unstable blood pressure, fever
• Exaggerated reflexes, altered coordination, muscle rigidity
• Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)

If you meet any of the above circumstances (or are unsure), consult your doctor or pharmacist before starting to take this medication.

Taking Levometadona Molteni with alcohol

Do not consume alcohol while taking this medication. This is because alcohol may increase the adverse effects of this medication and cause a severe intoxication with symptoms such as drowsiness, shallow and weak breathing, and coma, which may be fatal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

• Levometadona Molteni can be used during pregnancy after a careful benefit-risk assessment by a doctor, preferably under supervision in a specialized medical center. You may need to increase the dose to twice a day to maintain the effectiveness of the treatment due to changes in metabolism during pregnancy. Your doctor may also recommend dividing the daily dose.
• Long-term use during pregnancy may lead to fetal habituation and addiction to levometadone, as well as postnatal withdrawal symptoms, which often require hospital treatment.

Breastfeeding

• Levometadone is excreted in breast milk. Consult your doctorif you are breastfeeding or are thinking of breastfeeding while on levometadone treatment, as it may affect your baby.Your doctor will decide if breastfeeding is allowed during Levometadona Molteni treatment. Monitor your baby for any abnormal signs and symptoms, such as increased drowsiness (more than usual), breathing difficulties, or flaccidity. Contact your doctor immediately if you notice any of these symptoms.

Fertility

• It has been reported that methadone causes sexual dysfunction in male patients undergoing maintenance treatment.

Driving and using machines

Do not drive or use any tools or machines while taking Levometadona Molteni.

This is because you may feel drowsy and less alert while taking the medication and for some time after stopping it.

You can only drive or use tools or machines if your doctor tells you to.

Levometadona Molteni contains parahydroxybenzoic acid methyl ester (E218)

This may cause allergic reactions (possibly delayed).

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

How much to take

Your dose will be decided by your doctor:

• it is chosen individually for you
• it is based on how quickly your withdrawal symptoms start.

Take always the dose that your doctor tells you:

• do not take more or less of this medication than what has been told to you
• do not take this medication more or less frequently than what has been told to you.

Initial dose:

• The usual initial dose is between 3 and 4ml of the oral solution per day (equivalent to between 15 and 20mg of levomethadone hydrochloride).

Dose increase:

• Your doctor may increase your dose between 1 and 2ml per day (equivalent to between 5 and 10mg of levomethadone hydrochloride).This will depend on how the medication affects you.
• The usual dose may be up to 12ml of the oral solution per day (equivalent to 60mg of levomethadone hydrochloride). In some cases, your doctor may indicate that you take a higher dose.

Patients over 65 years old and severely ill people

Your dose may be reduced if you are over 65 years old. It may also be reduced if you have a very poor health status or if you have severe kidney problems or severe and long-term liver problems. In these cases, your doctor may want to monitor you more closely.

Administration form

• Levometadona Molteni is a solution for exclusive use byoral route.
• You can take this medication on its own or diluted with water or non-alcoholic beverages, such as orange juice.
• Your doctor or pharmacist will measure and administer your dose.

If you take more Levometadona Molteni than you should

In case of overdose or accidental ingestion, consult your doctor immediately or go to the hospital immediately. You can also consult your pharmacist or the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Carry the packaging of the medication with you. The following effects may appear:

• respiratory problems
• feeling very drowsy, on the verge of fainting («unconscious») or entering a coma
• very small pupils in the eyes
• cool and sticky skin
• very slow pulse
• muscle weakness
• low blood sugar level
• a brain disorder (known as toxic leukoencephalopathy).

In extreme cases, your breathing or blood flow may stop and you may suffer a heart attack.

If you forgot to take Levometadona Molteni

If you forget a dose, skip the missed dose and take your next dose normally.Do not take a double dose to compensate for a missed dose.

If you interrupt the treatment with Levometadona Molteni

Do not stop taking Levometadona Molteni without first consulting your doctor. This is because you may experience adverse effects. If you need to stop taking Levometadona Molteni, your doctor will gradually withdraw the medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor if you notice any of the following side effects:

Side effects that may occur more frequently at the beginning of treatment:

• feeling of anxiety, depression, irritability, or drowsiness
• loss of appetite (anorexia), weight loss, or feeling unwell (nausea)
• stomach or intestinal cramps, diarrhea, or discomfort (vomiting)

• fever, alternating chills and sweats, yawning, goosebumps, nasal discharge, sneezing

• rapid, spasmodic, and trembling movements (tremor)
• increased heart rate (tachycardia)
• very small pupils in the eyes
• general body pain
• feeling of weakness or restlessness
• excessive sweating or tearing of the eyes

Other side effects include:

Between infrequent (may affect up to 1 in 100 people) and frequent (may affect up to 1 in 10 people):

• slow or shallow breathing
• headache or vision problems
• feeling of weakness, dizziness, fainting, confusion, or disorientation
• feeling extremely sleepy or unable to sleep
• feeling of euphoria or depression
• palpitations or decreased heart rate
• decreased libido or difficulty achieving and maintaining an erection in men
• sweating
• skin eruptions, including urticaria and other types of skin eruptions with itching
• dry mouth
• loss of appetite, nausea, or vomiting
• constipation
• fluid retention («edema»), «biliary colic» that may cause pain in the upper abdomen or back
• urinary problems, including urinating very little

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

• red skin and feeling of heat («flushing»)
• reducing bleeding within the body
• stopping breathing
• low blood pressure when standing up or sitting quickly
• absence of heartbeats, heart attack, problems with blood circulation throughout the body, entering «shock».

Unknown frequency::

• low blood sugar level
• sleep apnea (pauses in breathing during sleep)
• you may become dependent on Levometadona Molteni (for more information, see section 2 “Warnings and precautions”).

You may notice that some side effects become less intense over time. However, it is unlikely that constipation or excessive sweating will improve. Consult your doctor or pharmacist about treatment to alleviate symptoms of these side effects.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children. Store this medication in a safe and protected place where other people cannot access it. It can cause serious harm and be fatal to people who have not been prescribed it.
• Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.
• Store below 25°C.
• Once the bottle is opened, use the oral solution within 12 weeks.
• Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of Levometadona Molteni

• The active ingredient is levometadone hydrochloride. Each milliliter (ml) of oral solution contains 5milligrams (mg) of levometadone hydrochloride
• The other components are methyl parahydroxybenzoate (E218), betaína chloride, glycerol, purified water.

Appearance of the product and contents of the packaging

• Levometadona Molteni is a transparent and colorless oral solution.
• It is available in packaging sizes of 100ml, 3x100ml, 500ml (clinical packaging) and 1000 ml (clinical packaging).

Size of 100ml: glass vial with a safety cap and anadapterfor pipette. Includes a graduated dosing pipette of 0.25 to 5 ml,divided into 0.25 ml.
Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.

Strada Statale 67, Loc. Granatieri

50018 Scandicci (Florence)

Italy

Responsible manufacturer:

L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.

Strada Statale 67, Loc. Granatieri

50018 Scandicci (Florence)

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona – Spain

Phone: 93 205 86 86

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyLevomethadon Molteni

ItalyEllepalmiron

PolandLevomethadone Hydrochloride Molteni

SpainLevometadona Molteni

Last review date of this leaflet:July 2024