Methadone Hidrohloride Molteni

Leaflet attached to the packaging: patient information

Methadone Hydrochloride Molteni

1 mg/ml, syrup

Methadone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS METHADONE HYDROCHLORIDE MOLTENI AND WHAT IS IT USED FOR

Methadone Hydrochloride Molteni is an opioid analgesic (it affects opioid receptors, which affect pain perception). It acts on the central nervous system in a similar way to morphine.
Methadone Hydrochloride Molteni is in the form of a syrup and should only be taken orally.

Indications for use:

• treatment of withdrawal syndrome (a state after stopping drugs characterized by, among other things, headaches, muscle pain, fatigue, and irritability);
• substitution treatment for people addicted to morphine and heroin;
• relief of severe pain, especially in cancer and after surgical operations.

2. IMPORTANT INFORMATION BEFORE TAKING METHADONE HYDROCHLORIDE MOLTENI

When not to take Methadone Hydrochloride Molteni

• in children and adolescents under 18 years of age;
• during childbirth as an anesthetic;

Warnings and precautions

Tolerance, dependence, and addictive use

This medicine contains methadone, 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 Methadone Hydrochloride Molteni can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. The risk of side effects may increase with the use of higher doses and longer treatment duration.
Dependence or addictive use can make the patient feel that they have no control over the amount of medicine taken or the frequency of its use. During pain treatment, the patient may feel that they need to continue taking the medicine, even if it does not help relieve the pain.
The risk of developing dependence or abuse is different for different patients. The patient may be at greater risk of developing abuse or dependence on Methadone Hydrochloride Molteni if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription drugs, or illegal drugs ("dependence");
• 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 Methadone Hydrochloride Molteni, it may indicate the development of dependence or abuse:

• The patient feels the need to take the medicine for longer than the doctor recommended.
• The patient feels the need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than the one 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 failed.
• After stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal symptoms").

If the patient notices any of these symptoms, they should talk to their doctor and discuss the best treatment option, including the appropriate time to stop treatment and a safe way to stop treatment (see section 3, Stopping Methadone Hydrochloride Molteni).
Important information before taking Methadone Hydrochloride Molteni

Sleep apnea

Methadone 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 contact their doctor. The doctor may consider reducing the dose.
Before starting Methadone Hydrochloride Molteni, discuss it with your doctor or pharmacist.

The medicine should be taken with caution, especially if the patient:

• is elderly (over 65 years old);
• is weakened;
• has hypothyroidism;
• has Addison's disease (adrenal insufficiency);
• has an enlarged prostate;
• has urethral stricture;
• has severe constipation;
• has conduction disorders in the heart;
• has advanced heart disease, including coronary artery disease;
• has liver disease;
• has a history of sudden deaths in the family;
• has electrolyte disturbances (low potassium levels in the blood, low magnesium levels in the blood);
• is being treated with medicines that prolong the QT interval visible in the electrocardiogram (ECG) (e.g., atazanavir, azithromycin);
• is being treated with medicines that may cause electrolyte disturbances (e.g., hydrochlorothiazide);
• is being treated with such medicines as ketoconazole, erythromycin;
• is being treated with metamizole, a medicine used to treat pain and fever.

If any of the following symptoms occur while taking Methadone Hydrochloride Molteni, consult a doctor or pharmacist:

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

Do not take the medicine if any of the above warnings have occurred or have occurred in the patient's history.
In case of doubts, consult a doctor or pharmacist before taking the medicine.
Long-term use may lead to a decrease in sex hormone levels and an increase in prolactin levels. If symptoms such as low libido, impotence, or amenorrhea occur, consult a doctor.

Children and adolescents

Do not use in children and adolescents under 18 years of age.

Methadone Hydrochloride Molteni and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Tell your doctor if you are taking any of the following medicines:

• cannabidiol (a medicine used to treat seizure disorders)
• gabapentin and pregabalin (medicines used to treat epilepsy, neuralgia, or anxiety), may increase the risk of opioid overdose, respiratory depression, and can be life-threatening. These medicines may affect the occurrence of side effects of Methadone Hydrochloride Molteni.

Do not takeMethadone Hydrochloride Molteni with the following medicines:

• antibiotics (rifampicin, clarithromycin, erythromycin);
• antifungal medicines (fluconazole, itraconazole, ketoconazole);
• antiviral medicines (delavirdine, nevirapine, didanosine, stavudine, zidovudine, ritonavir, efavirenz);
• antiepileptic medicines (barbiturates, carbamazepine, phenytoin);
• anti-diarrheal medicines (diphenoxylate, loperamide);
• antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). The risk of side effects increases when methadone and antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline) are used together. If the following symptoms occur, consult a doctor:
• changes in mental state (e.g., agitation, hallucinations, coma)
• rapid heart rate, unstable blood pressure, fever
• excessive reflexes, coordination disorders, muscle stiffness
• gastrointestinal disorders (e.g., nausea, vomiting, diarrhea);
• sedatives and hypnotics (e.g., barbiturates, benzodiazepine derivatives). The concurrent use of Methadone Hydrochloride Molteni and sedatives, such as benzodiazepines or similar medicines, increases the risk of somnolence, respiratory depression, and can be life-threatening. For this reason, their concurrent use can only be considered when other treatment options are not available. If the doctor prescribes Methadone 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 recommendations 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, consult a doctor;
• strong painkillers (morphine, butorphanol, nalbuphine, pentazocine); substances that reduce urine pH (ammonium chloride);
• medicines used to treat heart and blood vessel diseases (quinidine, verapamil);
• naloxone and naltrexone (medicines used to treat addiction to morphine and heroin); octreotide (used to treat certain types of cancer).

Methadone Hydrochloride Molteni with food and drink

Do not drink alcoholwhile taking this medicine. Alcohol may enhance the side effects, such as respiratory depression and decreased blood pressure.
Do not drink grapefruit juicewhile taking Methadone Hydrochloride Molteni.
Grapefruit juice may change the effect of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not use Methadone Hydrochloride Molteni during pregnancy. The medicine may harm the unborn child.
Breastfeeding women should consult a doctor before taking any medicine.
Do not use Methadone Hydrochloride Molteni in breastfeeding women. The medicine passes into breast milk and may cause dependence in the child.
Consult your doctor if you are breastfeeding or plan to breastfeed while taking methadone, as the medicine may affect the child. You should monitor the breastfed child for abnormal symptoms, such as increased sleepiness (more than usual), breathing difficulties, or limpness. If any of these symptoms are noticed, consult a doctor immediately.

Driving and using machines

Do notdrive vehicles, operate machines, or use dangerous tools while taking Methadone Hydrochloride Molteni. The medicine has a negative effect on the mental and physical abilities necessary to perform these activities.
Warnings regarding excipients

The medicine contains sucrose, glycerol, sodium benzoate (E 211)

1 ml of syrup contains 400 mg of sucrose. 15 ml of syrup contains 6 g of sucrose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking this medicine.
The medicine contains glycerol – the medicine may cause headache, stomach upset, and diarrhea.
The medicine contains sodium benzoate (E 211). This medicine contains 0.5 mg of sodium benzoate per 1 ml.

• Sodium - this medicine contains less than 1 mmol of sodium per ml, which means the medicine is considered "sodium-free".
• This medicine contains 0.8 mg of alcohol (ethanol) per ml, which is equivalent to 0.08% v/v. The amount of alcohol in a 10 ml dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. HOW TO TAKE METHADONE HYDROCHLORIDE MOLTENI

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Do not change the dose prescribed by your doctor yourself.
Do not take the medicine for longer than your doctor has prescribed.
The medicine is for oral use only. The medicine is ready for immediate use.
1 ml of syrup contains 1 mg of the active substance (methadone hydrochloride).
Before and regularly during treatment, your doctor will discuss with you what you can expect when taking Methadone Hydrochloride Molteni, when and for how long you should take it, when to contact your doctor, and when to stop taking the medicine (see also "Stopping Methadone Hydrochloride Molteni").

Dependence

The usual initial dose is 15 to 20 ml of syrup(15 mg to 20 mg of methadone hydrochloride) once a day.
In the case of dependence on large doses of drugs, the doctor may increase the dose.
In the treatment of dependence on heroin and morphine, the doctor should combine dosing with a detoxification program (removal of toxins) and adjust the dose according to the patient's degree of dependence.
Do not exceed the dose prescribed by your doctor.

Pain

2.5 ml to 10 ml of syrup(2.5 mg to 10 mg of methadone hydrochloride), the dose should be repeated as needed every 3 to 8 hours.
The doctor should adjust the dosing according to the severity of the pain and the patient's response.

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

Taking a higher dose of Methadone Hydrochloride Molteni than recommended

If a higher dose of the medicine is taken than recommended, immediatelyconsult a doctor or go to the hospital. Take the medicine packaging with you.
The following overdose symptoms may occur:
respiratory depression (decreased breathing rate, decreased amount of inhaled air);
deep sleepiness leading to coma;
pupil constriction;
cold and sweaty skin;
muscle weakness;
very slow heart rate; decreased blood pressure;
brain function disorders (known as toxic leukoencephalopathy).
In severe cases of overdose, respiratory arrest, cardiac arrest, and death may occur.
Taking a higher dose of Methadone Hydrochloride Molteni than necessary may result in low blood sugar levels.

Missing a dose of Methadone Hydrochloride Molteni

If a dose is missedat the right time:Do not take a double dose to make up for a missed dose of the medicine.

Stopping Methadone Hydrochloride Molteni

Do not stop treatment abruptly without consulting your doctor. Abrupt cessation may cause withdrawal symptoms (occurring after sudden cessation of Methadone Hydrochloride Molteni).
The following withdrawal symptoms may occur:
anxiety, sudden mood changes, depression;
insomnia, difficulty falling asleep;
nervousness, agitation, difficulty concentrating;
muscle tremors, muscle and joint pain;
tearfulness, pupil dilation, yawning;
feeling of increased heart rate (palpitations);
headaches;
sweating;
nausea, vomiting, loss of appetite, diarrhea;
pallor.
If the doctor decides that it is possible to stop Methadone Hydrochloride Molteni, they will inform you how to gradually reduce the dose.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most important side effects of methadone are respiratory depression, circulatory collapse, respiratory arrest, shock, and cardiac arrest.
The most commonly observed undesirable reactions are a feeling of emptiness in the head, dizziness (worsening when standing up), sedation, nausea, vomiting, sweating, and low blood pressure (especially when standing up). Some of these reactions, which occur more frequently in outpatients, may be reduced by lying the patient down.
Other side effects

• nausea and vomiting

Very common:occur in more than 1 in 10 patients

• weakness
• euphoria, dysphoria, insomnia, agitation, disorientation
• pupil constriction, vision disorders
• constipation

Common:occur in no more than 1 in 10 patients

• headache, transient loss of consciousness
• respiratory depression
• decreased blood pressure
• dryness of the mucous membranes
• itching, urticaria, other skin reactions, edema, and rare urticaria
• urinary retention and difficulty urinating, antidiuretic effect
• biliary colic
• decreased libido, impotence

Uncommon:occur in no more than 1 in 100 patients

• tachycardia or bradycardia, extrasystoles, and heart rhythm disorders. After large doses, torsades de pointes-type tachycardia may occur.

Frequency not known:frequency cannot be estimated from the available data

• anorexia, low blood sugar,
• sleep apnea (pauses in breathing during sleep)
• the patient may develop dependence on Methadone Hydrochloride Molteni (more information, see section 2 "Warnings and precautions"). In some patients, other side effects may occur during treatment with Methadone Hydrochloride Molteni. If any side effects occur, including any side effects not listed in the leaflet, consult a doctor or pharmacist.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE METHADONE HYDROCHLORIDE MOLTENI

Keep the medicine out of the sight and reach of children. This medicine should be stored in a safe place, inaccessible to other people. Taking the medicine by people it has not been prescribed for may lead to serious harm and death.
Store the medicine in its original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 2 months.
Medicines should not be disposed of via wastewater or household waste. 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 Methadone Hydrochloride Molteni contains

• The active substance of the medicine is methadone hydrochloride. 1 ml of syrup contains 1 mg of methadone hydrochloride.
• The other excipients are: sucrose, glycerol (E 422), sodium benzoate (E 211), flavor and aroma enhancer citric, citric acid monohydrate, purified water.

What Methadone Hydrochloride Molteni looks like and what the package contains

The medicine is a clear, colorless or slightly yellow syrup with a citric flavor.
The packaging of the medicine is a bottle with a capacity of 10 ml, 20 ml, 60 ml, 100 ml, or 1000 ml.
The bottle containing 10 ml or 20 ml of syrup is made of orange glass, closed with an HDPE cap with a child-resistant closure, and packed in a cardboard box.
The bottle containing 60 ml of syrup is made of amber, transparent PVC, closed with an aluminum cap with a polyethylene seal, and packed in a cardboard box or made of orange glass, closed with an aluminum cap with a polyethylene seal, and packed in a cardboard box.
The bottle containing 100 ml of syrup is made of orange glass with a child-resistant closure cap made of polyethylene (HDPE/LDPE) with a polyethylene nozzle (LDPE) for the pipette, packed in a cardboard box. A 5 ml measuring pipette made of polypropylene/polyethylene (HDPE) is attached to the packaging.
The bottle containing 1000 ml of syrup is made of amber, transparent PVC, closed with a polypropylene cap with a polyethylene seal, and packed in a cardboard box or made of orange glass, closed with a polypropylene cap with a polyethylene seal, and packed in a cardboard box.

Marketing authorization holder and manufacturer

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

To obtain more detailed information about this medicine, consult the representative of the marketing authorization holder:
Molteni Farmaceutici Polska Sp. z o.o.,
ul. Józefa Korzeniowskiego 39, 30 – 214 Kraków,
tel.: (12) 653 15 71 or 72

Date of the last update of the leaflet: