Methadone hydrochloride Molteni

Italy
Brand name Methadone hydrochloride Molteni
Form solution, oral
Active substance / Dosage
METHADONE HYDROCHLORIDE
Prescription type Prescription only – special ministerial triplicate form required
ATC code
N07BC02
Registration number 029610
Manufacturer L. MOLTENI & C. DEI F.LLI ALITTI SOCIETA' DI ESERCIZIO S.P.A.
Methadone hydrochloride Molteni solution, oral

Table of Contents

Patient Information Leaflet

METADONE HYDROCHLORIDE MOLTENI 1 mg/ml oral solution, 5 mg/ml oral solution

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What METADONE HYDROCHLORIDE MOLTENI is and what it is used for
  2. What you need to know before taking METADONE HYDROCHLORIDE MOLTENI
  3. How to take METADONE HYDROCHLORIDE MOLTENI
  4. Possible side effects
  5. How to store METADONE HYDROCHLORIDE MOLTENI
  6. Contents of the pack and other information

1. What METADONE CLORIDRATO MOLTENI is and what it is used for

METADONE CLORIDRATO MOLTENI contains the active substance methadone hydrochloride, which belongs to a group of medicines that act on the Nervous System, the opioid analgesics.
This medicine is used for:

  • the treatment of severe pain that does not respond to other pain-relieving medicines;
  • the treatment of opioid drug addiction (for example, heroin) and for maintenance therapy. Detoxification treatment and maintenance treatment must be carried out under medical supervision.

2. What you should know before taking METADONE HYDROCHLORIDE MOLTENI

Do not take METADONE HYDROCHLORIDE MOLTENI

  • if you are allergic to methadone or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from severe constipation;
  • if you have heart problems (organic cardiopathies);
  • if you have severe liver or kidney problems;
  • if you suffer from fluctuations in blood glucose levels (uncompensated diabetes);
  • if you have porphyria (a rare blood disorder);
  • if you have low blood pressure (hypotension);
  • if you have high pressure inside the skull (intracranial hypertension);
  • if you have head injuries (cranioencephalic trauma);
  • if you suffer from acute asthma attacks or other lung diseases (chronic obstructive bronchopulmonary diseases);
  • if you have respiratory problems (respiratory failure);
  • if you have an enlarged heart due to lung disease (pulmonary heart);
  • if you have a low volume of circulating blood (hypovolemia).

The use of methadone is not indicated during pregnancy, during breastfeeding, or for the treatment of labour pain, as its long duration of action increases the likelihood of respiratory problems in the newborn. Furthermore, the use of this medicine is not indicated in children.

Warnings and precautions

Talk to your doctor or pharmacist before taking METADONE HYDROCHLORIDE MOLTENI.

Tolerance and dependence

This medicine contains methadone, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you become accustomed to it, a phenomenon known as tolerance). Repeated use of METADONE HYDROCHLORIDE MOLTENI may also lead to dependence and abuse, which can result in a potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence may cause you to lose control over how much medicine you take or how often you take it. When the medicine is used for pain treatment, you might feel that you need to continue taking it even when it no longer helps relieve your pain.

The risk of becoming dependent varies from person to person. You may have a higher risk of becoming dependent on METADONE HYDROCHLORIDE MOLTENI if:

  • You or someone in your family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
  • You smoke.
  • You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking METADONE HYDROCHLORIDE MOLTENI, it could be a sign that you have become dependent:

  • You need to take the medicine for longer than recommended by your doctor.
  • You need to take a higher dose than recommended.
  • You are using the medicine for reasons other than those for which it was prescribed, for example, to "stay calm" or "help you sleep".
  • You have made repeated unsuccessful attempts to stop or control the use of the medicine.
  • You feel unwell when you stop taking the medicine and feel better when you restart it ("withdrawal effects").

If you notice any of these signs, talk to your doctor and discuss the best treatment approach for you, including when it is appropriate to stop and how to stop safely (see section 3 If you stop taking METADONE HYDROCHLORIDE MOLTENI).

Sleep-related breathing disorders

METADONE HYDROCHLORIDE MOLTENI may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, talk to your doctor, who may consider reducing the dose.

Pay particular attention to the use of methadone and inform your doctor:

  • if you are taking medicines that act on the central nervous system (narcotic analgesics, general anaesthetics, antipsychotics (phenothiazines), other sedative tranquilizers or hypnotics, tricyclic antidepressants), or substances such as alcohol, as they may cause depression, profound sedation, or coma;
  • if anxiety states occur during treatment. This medicine does not have anti-anxiety effects, so higher doses should not be used;
  • if you have acute abdominal problems;
  • if you have a low volume of circulating blood (hypovolemia) or are being treated with phenothiazines or anaesthetics, as you may experience a severe drop in blood pressure;
  • if you feel dizzy when standing up, due to a rapid drop in blood pressure (orthostatic hypotension);
  • if you are elderly or debilitated;
  • if you have thyroid dysfunction (hypothyroidism);
  • if you have adrenal gland disease (Addison's disease);
  • if you have an enlarged prostate (prostatic hypertrophy);
  • if you have difficulty urinating due to urethral narrowing;
  • if you have head injuries (cranial lesions) and increased intracranial pressure;
  • if you suffer from heart diseases that may alter heart rate (QT interval prolongation) or are being treated with medicines that may cause this.

Talk to your doctor or pharmacist if you experience any of the following symptoms during treatment with METADONE HYDROCHLORIDE MOLTENI:
weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms that your adrenal glands are producing too little cortisol hormone, and you may need to take a hormonal supplement.

Long-term use 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 (amenorrhoea).

If you have physical dependence on narcotics, administration of antagonists must be done with caution, as it may trigger withdrawal symptoms.

If you are an athlete, taking METADONE HYDROCHLORIDE MOLTENI may result in a positive anti-doping test.

Children

The use of this medicine for pain treatment is contraindicated in children.

Other medicines and METADONE HYDROCHLORIDE MOLTENI

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Methadone may affect how some medicines work, and some medicines may interfere with the action of methadone.

Your doctor may decide to increase the dose of methadone to avoid withdrawal symptoms if you are taking other medicines such as:

  • medicines for epilepsy such as barbiturates (e.g. phenobarbital), carbamazepine, phenytoin;
  • medicines for the treatment of AIDS such as nevirapine and efavirenz, as well as amprenavir, nelfinavir, abacavir, lopinavir/ritonavir and ritonavir/saquinavir combinations;
  • medicines for tuberculosis such as rifampicin;
  • anti-inflammatory medicines (e.g. dexamethasone);
  • metamizole, a medicine used to treat pain and fever;
  • St. John's wort (Hypericum perforatum) preparations, used for anxiety and depression;
  • diuretics (e.g. spironolactone);
  • medicines used to acidify urine, such as ammonium chloride.

Your doctor may decide to reduce the dose of methadone if you are taking:

  • medicines used to regulate heart rhythm (quinidine);
  • medicines to lower blood pressure (verapamil);
  • other medicines for heart and blood pressure problems (calcium antagonists);
  • immunosuppressants (cyclosporine);
  • antibiotics such as clarithromycin, erythromycin, telithromycin, and ciprofloxacin;
  • cannabinoids;
  • cannabidiol (a medicine used to treat seizures);
  • medicines used for stomach problems such as cimetidine;
  • medicines for the treatment of AIDS such as delavirdine;
  • antidepressants such as nefazodone and selective serotonin reuptake inhibitors such as fluvoxamine and fluoxetine;
  • medicines used to treat fungal infections, such as itraconazole and fluconazole;
  • gabapentin and pregabalin (medicines used to treat epilepsy, neuropathic pain, or anxiety) which may increase the risk of opioid overdose, respiratory depression (difficulty breathing), and may be potentially fatal.

Methadone may interfere with the activity of other medicines. Inform your doctor if you are taking:

  • medicines for the treatment of AIDS such as didanosine, stavudine, and zidovudine;
  • medicines that affect cardiac conduction or may affect blood electrolyte concentrations;
  • medicines for controlling heart rhythm such as sotalol, amiodarone, and flecainide, antidepressants such as paroxetine and sertraline, and certain antibiotics (erythromycin and clarithromycin), as they may cause heart problems;
  • opioid antagonists, naloxone and naltrexone, used for drug and alcohol dependence;
  • opioid analgesics such as butorphanol, nalbuphine, pentazocine;
  • medicines that exert a depressant action on the CNS, such as other analgesics, tranquilizers;
  • medicines used to treat diarrhoea such as diphenoxylate and loperamide;
  • octreotide-based medicines used to treat certain tumours;
  • antimuscarinic medicines;
  • medicines used for depression, such as monoamine oxidase inhibitors (MAOIs) and desipramine.

The risk of side effects increases if methadone is used concomitantly with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline).

Contact your doctor if you experience symptoms such as:

  • changes in mental state (e.g. agitation, hallucinations, coma)
  • tachycardia, blood pressure instability, fever
  • exaggerated reflexes, impaired coordination, muscle stiffness
  • gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea)

Concomitant use of METADONE HYDROCHLORIDE MOLTENI and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes METADONE HYDROCHLORIDE MOLTENI together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.

Talk to your doctor if you experience such symptoms.

METADONE HYDROCHLORIDE MOLTENI with food and alcohol

During treatment with methadone, do not drink alcoholic beverages, as they may cause drowsiness, and avoid consuming grapefruit juice, as it may interact with the activity of this medicine.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Methadone is contraindicated during pregnancy due to possible effects on fetal development, and during breastfeeding.

However, your doctor may decide to initiate methadone maintenance treatment if there is clear evidence of inability to discontinue heroin use.

Any discontinuation of treatment must occur under medical supervision and should not occur before the 14th week or after the 32nd week of gestation, to avoid, respectively, the risk of abortion and preterm delivery.

Talk to your doctor if you are breastfeeding or planning to breastfeed while taking methadone, as it may harm the baby. Monitor your baby for unusual signs and symptoms such as increased drowsiness (more than usual), breathing difficulties, or weakness. Contact your doctor immediately if you notice any of these symptoms.

Driving and using machines

METADONE HYDROCHLORIDE MOLTENI may affect your ability to drive vehicles and operate machinery.

METADONE HYDROCHLORIDE MOLTENI contains sucrose, glycerol, and sodium benzoate

This medicine contains 0.5 mg of sodium benzoate per 1 ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age (see section "Pregnancy and breastfeeding").

This medicine contains less than 1 mmol per dose, i.e., essentially "sodium-free".

METADONE HYDROCHLORIDE MOLTENI 1 mg/ml oral solution contains:

Glycerol: which may cause headache, gastric disturbances, and diarrhoea.

Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. The maximum daily dose (120 ml, equivalent to 120 mg of methadone hydrochloride) contains 48 g of sucrose. This should be considered if you have problems with unstable blood glucose levels (diabetes mellitus).

The medicine may be harmful to teeth.

METADONE HYDROCHLORIDE MOLTENI 5 mg/ml oral solution contains:

Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

The maximum daily dose (24 ml, equivalent to 120 mg of methadone hydrochloride) contains 9.6 g of sucrose. This should be considered if you have problems with unstable blood glucose levels (diabetes mellitus).

The medicine may be harmful to teeth.

3. HOW TO TAKE METADONE HYDROCHLORIDE MOLTENI

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using METADONE HYDROCHLORIDE MOLTENI, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "If you stop taking METADONE HYDROCHLORIDE MOLTENI").

This medicine is an oral solution to be taken by mouth (oral route); do not use it for injection.
The dosage will be appropriately adjusted by your doctor according to the severity of your condition and your response to therapy. The recommended dosages are reported below.

Pain relief
The average dose ranges from 5 to 20 mg, taken once or several times daily, according to your doctor's instructions.
Occasionally, in cases of exceptionally severe pain or when the usual dose proves ineffective, your doctor may prescribe a higher dose.

Treatment of opioid addiction
The medicine will be administered daily according to your doctor’s advice and the treatment program. A detoxification treatment cycle must not exceed 21 days and cannot be repeated until at least 4 weeks after completion of the previous cycle.
Typically, an initial daily dose of 15–20 mg can counteract withdrawal symptoms. This dose may be increased by your doctor, usually up to 40 mg per day, administered as a single dose or divided doses, for individuals dependent on high amounts of opioids.
The dose should be kept stable for 2–3 days, then the amount of methadone will be gradually reduced.

Maintenance treatment
Your doctor may decide to administer methadone for more than three weeks as maintenance therapy.
Methadone treatment may eliminate the compulsive craving for heroin and control the anxiety state of the opioid-dependent patient.
Recommended doses range from 50 to 120 mg per day, depending on the degree of tolerance and the individual's ability to metabolize the drug.

Use in elderly patients:
Methadone should be administered with caution in elderly patients, and the initial dose should be reduced.

Instructions for packages with child-resistant closures
To open: press down and turn counterclockwise at the same time.
To close: press down and turn clockwise at the same time.

If you take more METADONE HYDROCHLORIDE MOLTENI than you should
In case of accidental ingestion or overdose of METADONE HYDROCHLORIDE MOLTENI, contact your doctor immediately or go to the nearest hospital.
Overdose symptoms include:

  • breathing difficulties (irregular and shallow breathing, bluish skin discoloration due to lack of oxygen)
  • extreme drowsiness progressing to stupor or coma
  • pinpoint pupils (miosis)
  • cold and clammy skin
  • muscle flaccidity
  • slowed heart rate (bradycardia)
  • low blood pressure (hypotension)
  • a brain disorder (known as toxic leukoencephalopathy)

It may cause low blood sugar (hypoglycemia).
In severe overdose, especially following intravenous administration, the following may occur:

  • respiratory arrest (apnea)
  • circulatory collapse
  • cardiac arrest
  • death

If you forget to take METADONE HYDROCHLORIDE MOLTENI
Do not take a double dose to make up for the missed dose.

If you stop taking METADONE HYDROCHLORIDE MOLTENI
Stopping treatment with this medicine abruptly may cause unwanted, even serious, side effects.
Carefully follow your doctor’s instructions on how to gradually reduce the use of this medicine.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Below are the side effects associated with hydrochloride methadone. There are insufficient data available to determine the frequency of the individual side effects listed.
The main risks of methadone are:

  • serious breathing problems (respiratory depression and respiratory arrest);
  • serious circulatory problems (circulatory depression);
  • serious heart problems (shock and cardiac arrest);
  • heart diseases that may alter heart rate (QT interval prolongation and torsades de pointes);
  • sleep apnoea (pauses in breathing during sleep);
  • you may become dependent on METADONE HYDROCHLORIDE MOLTENI (for further information see section 2 Warnings and precautions).

Other observed side effects are:

  • lightheadedness, dizziness and drowsiness;
  • nausea, vomiting, sweating;
  • dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
  • mood disturbances (euphoria, dysphoria);
  • weakness, headache, insomnia, agitation;
  • disorientation and visual disturbances;
  • dry mouth, loss of appetite (anorexia), constipation and gallbladder problems;
  • facial flushing, slowed heart rate (bradycardia), awareness of heartbeat (palpitations);
  • feeling faint and loss of consciousness (syncope);
  • urinary retention or difficulty urinating, fluid retention;
  • loss of sexual desire (libido) and/or sexual impotence;
  • itching, urticaria, other skin reactions;
  • swelling due to fluid accumulation (oedema).

Frequency not known: low blood sugar
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METADONE HYDROCHLORIDE MOLTENI

Keep this medicine out of the sight and reach of children. Store this medicine in a safe place, where other people cannot access it. It may cause serious harm and be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
METADONE HYDROCHLORIDE MOLTENI 1 mg/ml oral solution
After first opening of the 100 ml, 500 ml or 1000 ml multidose bottles, the medicine must be used within 2 months. After this period, any remaining medicine must be discarded.
METADONE HYDROCHLORIDE MOLTENI 5 mg/ml oral solution
After first opening of the 60 ml, 100 ml or 1000 ml multidose bottles, the medicine must be used within 8 months. After this period, any remaining medicine must be discarded.
Store in the original packaging, tightly closed, to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What METADONE CLORIDRATO MOLTENI contains

  • The active substance is methadone hydrochloride. Each ml of solution contains 1 or 5 mg of methadone hydrochloride.
  • The other components are sucrose, glycerol, sodium benzoate, lemon flavour, citric acid, purified water (see section 2. METADONE CLORIDRATO MOLTENI contains sucrose, glycerol and sodium benzoate).

Description of the appearance of METADONE CLORIDRATO MOLTENI and contents of the pack
METADONE CLORIDRATO MOLTENI 1 mg/ml oral solution
Bottles containing 5 mg, 10 mg, 20 mg, 40 mg, 60 mg;
Multiple-dose bottles of 100 ml, 500 ml, 1000 ml.
The 100 ml multiple-dose bottle with child-resistant closure is supplied with a graduated pipette.
METADONE CLORIDRATO MOLTENI 5 mg/ml oral solution
Bottles containing 25 mg, 50 mg, 100 mg;
Multiple-dose bottles of 60 ml, 100 ml, 1000 ml.
The 60 ml and 100 ml multiple-dose packs are supplied with a graduated pipette.
Packs subject to special medical prescription are equipped with child-resistant closure.

Marketing Authorization Holder
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.,
S.S. 67, Fraz. Granatieri, Scandicci (FI).

Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.,
S.S. 67, Fraz. Granatieri, Scandicci (FI).
or alternatively, solely for the 5 ml, 10 ml, 20 ml and 40 ml bottles:
ISTITUTO DE ANGELI s.r.l., Loc. Prulli, Reggello (FI).