METADONE 1 mg /Ml Syrup

Зміст інструкції

1. METADONE CLORIDRATO MOLTENI 1 mg/ml oral solution, 5 mg/ml oral solution
   1. What is METADONE CLORIDRATO MOLTENI and what is it used for
   2. What you need to know before taking METADONE CLORIDRATO MOLTENI
2. METADONE HYDROCHLORIDE MOLTENI can also cause dependence and abuse, which can lead to a
   1. How to take METADONE HYDROCHLORIDE MOLTENI
   2. Possible side effects
   3. How to store METADONE CLORIDRATO MOLTENI
   4. Package contents and other information

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

Generic medicine

Read this leaflet carefully before taking this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• the treatment of severe pain, which does not respond to other pain relievers;
• the treatment of opioid substance dependence (for example heroin) and for maintenance therapy. Detoxification treatment and maintenance treatment must be carried out under medical supervision.

2. What you need to know before taking METADONE CLORIDRATO MOLTENI

Do not take METADONE CLORIDRATO MOLTENI

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

The use of methadone is not indicated during pregnancy, during breastfeeding and in the treatment of labor pains
because its long duration of action increases the probability 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 CLORIDRATO MOLTENI.
Tolerance and dependence
This medicine contains methadone, which is an opioid medicine. Repeated use of opioids can cause
the drug to become less effective (you become accustomed to it, a phenomenon known as tolerance). Repeated use of

METADONE HYDROCHLORIDE MOLTENI can also cause dependence and abuse, which can lead to a

potentially lethal overdose. The risk of these undesirable effects may increase with a higher dose and a longer duration of use.
Dependence can cause you to lose control over how much medicine you take or how often you take it.
When the medicine is used for the treatment of pain, you may feel that you need to continue taking it even when it does not help to relieve the pain.
The risk of becoming dependent varies from person to person. You may be at greater risk of becoming dependent on METADONE HYDROCHLORIDE MOLTENI if:

• You or someone in your family has ever abused or been addicted to alcohol, prescription medications, or illegal drugs (“addiction”).
• You smoke.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of these 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, such as to “stay calm” or “help you sleep”
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine you feel sick and feel better when you resume taking the medicine (“withdrawal effects”).

If you notice any of these signs, see your doctor and discuss the best way to treat you, including when it is appropriate to stop it and how to stop it safely (see paragraph 3 If you stop treatment with METADONE HYDROCHLORIDE MOLTENI).
Sleep-Related Breathing Disorders
METADONE HYDROCHLORIDE MOLTENI can cause sleep-related breathing disorders 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 labored breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or another person observes these symptoms, see your doctor, who may consider a dose reduction.
Take particular care when using methadone and inform your doctor:

• if you are taking medications that affect the central nervous system (narcotic analgesics, general anesthetics, antipsychotics (phenothiazines), other sedative hypnotic tranquilizers, tricyclic antidepressants), or even substances such as alcohol because they can cause depression, deep sedation, or coma;
• if anxiety states occur during treatment. This medicine has no anti-anxiety action, so higher doses should not be used;
• if you have acute abdominal problems;
• if you have a low blood volume (hypovolemia) or are being treated with phenothiazine or anesthetics because you may experience a severe drop in blood pressure;
• if you feel dizzy when you get up, due to a rapid drop in pressure (orthostatic hypotension);
• if you are elderly or debilitated;
• if you have a thyroid malfunction (hypothyroidism);
• if you have a disease of the adrenal glands (Addison's disease);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have difficulty urinating due to a narrowing of the urethra;
• if you have head injuries (cranial injuries) and increased intracranial pressure;
• if you suffer from heart disease that may alter heart rate (prolongation of the QT interval) or are being treated with medications that can cause this.

See your doctor or pharmacist if you experience any of the following symptoms while taking METADONE HYDROCHLORIDE MOLTENI:
weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. This may be a symptom that the adrenal glands are producing too little of the hormone cortisol and you may need to take a hormone supplement.
Long-term use can 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).
If you have a physical dependence on narcotics, the administration of antagonists must be done with caution because it can trigger withdrawal syndrome.
If you are an athlete, taking METADONE HYDROCHLORIDE MOLTENI may result in a positive doping test.

Children
The use of this medicine for the treatment of pain 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 medicine.
Methadone can affect how some medicines work and some medicines can interfere with the functioning 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 drugs (e.g. dexamethasone);
• metamizole, a medicine used to treat pain and fever;
• preparations based on St. John's wort (hypericum perforatum), used for anxiety and depression;
• diuretics (e.g. spironolactone);
• medicines used to acidify the urine, such as ammonium chloride.

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

• medicines used to regulate the heartbeat (quinidine);
• medicines to lower blood pressure (verapamil);
• other medicines for heart and 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 for the treatment of fungal infections, such as itraconazole and fluconazole;
• gabapentin and pregabalin (medicines used to treat epilepsy, neuropathic pain or anxiety) can increase the risk of opioid overdose, respiratory depression (difficulty breathing) and can be potentially fatal.

Methadone can interfere with the activity of other medicines, tell your doctor if you are taking:

• medicines for AIDS therapy such as didanosine, stavudine and zidovudine;
• medicines that affect cardiac conduction or that can affect blood salt concentration;
• medicines for controlling heart rhythm such as sotalol, amiodarone and flecainide, antidepressants such as paroxetine and sertraline and some antibiotics (erythromycin and clarithromycin), because they can cause heart problems;
• opioid antagonists, naloxone and naltrexone, used for drug and alcohol addiction;
• opioid analgesics, such as butorphanol, nalbuphine, pentazocine;
• medicines that exert a depressant effect on the CNS such as other analgesics, tranquilizers;
• medicines used in the treatment of diarrhea such as diphenoxylate and loperamide;
• medicines based on octreotide used for the treatment of some tumors;
• antimuscarinic medicines;
• medicines used for depression, such as monoamine oxidase inhibitors (MAO) and desipramine.

The risk of side effects increases if you use methadone in combination with sedatives such as benzodiazepines or medicines related to them, increasing the risk of drowsiness, difficulty breathing (respiratory depression), coma and can 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 sedatives, the dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or family to pay attention to the above signs and symptoms.
See your doctor if you experience these symptoms.

METADONE HYDROCHLORIDE MOLTENI with drinks and alcohol
During treatment with methadone, do not drink alcoholic beverages, which can cause drowsiness, and avoid taking grapefruit juice, which interacts with the activity of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Methadone is contraindicated in pregnancy, for possible effects on fetal development, and during breastfeeding.
However, your doctor may decide to carry out maintenance treatment with methadone if there is an evident inability to stop using heroin.
Any discontinuation of treatment must take place under the control of the doctor and must be carried out no earlier than the 14th week of gestation and no later than the 32nd to avoid, respectively, the risk of abortion and preterm labor.
Talk to your doctor if you are breastfeeding or are planning to breastfeed while taking methadone as this can harm the baby. Monitor your baby for signs and symptoms such as increased sleepiness (more than usual), difficulty breathing, or weakness. Consult your doctor immediately if you notice any of these symptoms.

Driving and using machines
METADONE HYDROCHLORIDE MOLTENI can alter your ability to drive and operate machinery.

METADONE HYDROCHLORIDE MOLTENI contains sucrose, glycerol and sodium benzoate
This medicine contains 0.5 mg of sodium benzoate per ml. Sodium benzoate can 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 can cause headache, stomach upset and diarrhea.
Sucrose: if your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this medicine. The maximum daily dose (120 ml, equal to 120 mg of methadone hydrochloride) contains 48 g of sucrose. This should be taken into consideration 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 some sugars, contact him before taking this medicine.
The maximum daily dose (24 ml, equal to 120 mg of methadone hydrochloride) contains 9.6 g of sucrose. This should be taken into consideration 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 following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what
you might expect from the use of METADONE HYDROCHLORIDE MOLTENI, when and for how long
you should take it, when to contact your doctor and when you should stop it (see also If you stop taking
METADONE HYDROCHLORIDE MOLTENI).
This medicine is a solution to be taken by mouth (orally), do not use it for injection.
The dosage will be appropriately adjusted by your doctor depending on 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 for one or more administrations per day, as directed by your doctor.
Sometimes, in cases of exceptionally intense pain or in cases where the usual dose proves to be ineffective, your
doctor may prescribe a higher dose.

Treatment of opioid dependence
The medicine will be administered to you daily according to your doctor's opinion and the treatment plan.
A detoxification treatment cycle will not exceed 21 days and cannot be repeated before 4 weeks after the conclusion of the previous cycle.
Normally, an initial dose of 15-20 mg per day can counteract withdrawal crises. This dose may
be increased by your doctor, usually to 40 mg per day, in single or divided doses, for subjects
dependent on high amounts of opioids.
The dose will be stable for 2-3 days and 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 therapy can abolish the compulsive search for heroin (craving) and dominate the anxious state
of the drug addict.
The recommended doses range from 50 to 120 mg per day depending on the degree of tolerance and the ability to
metabolize the drug.

Use in the elderly:
In elderly patients, methadone must be administered with caution and the initial dose must be reduced.
Instructions for packs with a child-resistant closure
To open: press and simultaneously rotate counterclockwise.
To close: press and simultaneously rotate clockwise.

If you take more METADONE HYDROCHLORIDE MOLTENI than you should
In case of accidental ingestion/administration of an excessive dose of METADONE HYDROCHLORIDE
MOLTENI, immediately notify your doctor or go to the nearest hospital.
Overdose manifests with the following symptoms:

• difficulty breathing (irregular and shallow breathing, bluish discoloration of the skin due to lack of oxygen)
• extreme drowsiness leading to stupor or coma
• constriction of the pupils (miosis)
• cold and clammy skin
• muscle flaccidity
• slowed heartbeat (bradycardia)
• low blood pressure (hypotension);
• a brain disorder (known as toxic leukoencephalopathy).

It can cause low blood sugar.
In severe overdose, especially intravenously, the following may occur:

• cessation of breathing (apnea)
• circulatory collapse
• cardiac arrest
• death

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

If you stop taking METADONE HYDROCHLORIDE MOLTENI
Abruptly stopping treatment with this medicine can cause unwanted, even serious, effects.
Carefully follow your doctor's instructions on how to gradually reduce the use of this medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the side effects of metadone hydrochloride. Sufficient data are not available
to establish the frequency of the individual effects listed.
The main risks of methadone are represented by:

• serious breathing problems (respiratory depression and respiratory arrest);
• serious problems with circulation (circulatory depression);
• serious problems with the heart (shock and cardiac arrest);
• heart diseases that can alter the heart rate (prolongation of the QT interval and torsade de pointes);
• sleep apnea (pauses in breathing during sleep);
• may become dependent on METADONE HYDROCHLORIDE MOLTENI (for more information see section 2 Warnings and precautions).

Other side effects observed are:

• feeling of emptiness in the head, dizziness and drowsiness;
• nausea, vomiting, sweating;
• feeling of dizziness when getting up due to a drop in pressure (orthostatic hypotension);
• mood disorders (euphoria, dysphoria);
• weakness, headache, insomnia, agitation;
• disorientation and visual disturbances;
• dry mouth, loss of appetite (anorexia), constipation and gallbladder problems;
• facial flushing, slowing of the heartbeat (bradycardia), perception of the heartbeat (palpitations);
• feeling of fainting 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;
• swellings due to fluid accumulation (edema). Frequency not known: low blood sugar

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: 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 CLORIDRATO MOLTENI

Keep this medicine out of the sight and reach of children. Store this medicine in a
secure location, inaccessible to others. It may cause serious harm and be fatal to people
to whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.

METADONE CLORIDRATO MOLTENI 1 mg/ml oral solution
After the first opening of the multidose bottles of 100 ml, 500 ml or 1000 ml, the medicine must be
used within 2 months .After this period, any remaining medicine must be discarded.

METADONE CLORIDRATO MOLTENI 5 mg/ml oral solution
After the first opening of the multidose bottles of 60 ml, 100 ml or 1000 ml, 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What METADONE HYDROCHLORIDE MOLTENI contains

• The active ingredient is methadone hydrochloride. Each ml of solution contains 1 or 5 mg of methadone hydrochloride
• The other ingredients are sucrose, glycerol, sodium benzoate, lemon aroma, citric acid, purified water (see paragraph 2. METADONE HYDROCHLORIDE MOLTENI contains sucrose,glycerol and sodium benzoate)

Description of the appearance of METADONE HYDROCHLORIDE MOLTENI and package contents
METADONE HYDROCHLORIDE MOLTENI 1 mg/ml oral solution
Bottles of 5 mg, 10 mg, 20 mg, 40 mg, 60 mg;
Multidose bottles of 100 ml, 500 ml, 1000 ml
The 100 ml multidose pack with child-resistant closure is equipped with a graduated pipette.

METADONE HYDROCHLORIDE MOLTENI 5 mg/ml oral solution
Bottles of 25 mg, 50 mg, 100 mg;
Multidose bottle of 60 ml, 100 ml, 1000 ml
The 60 ml and 100 ml multidose packs are equipped with a graduated pipette.
Packs subject to special medical prescription are equipped with a child-resistant closure.

Marketing Authorisation 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, limited to the 5 ml, 10 ml, 20 ml and 40 ml bottles:
ISTITUTO DE ANGELI s.r.l. Loc. Prulli, Reggello (FI)