Methadone Hidrohloride Molteni

Leaflet attached to the packaging: patient information

Methadone Hydrochloride Molteni

5 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. Contents of the packaging and other information

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

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

Indications:

treatment of withdrawal syndrome (a state after stopping drugs, characterized by, among others, headaches, muscle pain, fatigue, and irritability);
substitution treatment for people addicted to morphine and heroin.

2. IMPORTANT INFORMATION BEFORE TAKING METHADONE HYDROCHLORIDE MOLTENI

When not to take Methadone Hydrochloride Molteni

if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). In case of suspected allergy, consult a doctor;
in children and adolescents under 18 years of age;
if the patient has had or has respiratory disorders, such as respiratory failure and chronic obstructive pulmonary disease (COPD) (difficult airflow in the airways, whose symptoms include, among others: shortness of breath even at rest, persistent cough, wheezing), as the medicine may exacerbate the symptoms of these diseases;
if the patient has had or has asthma attacks;
during childbirth as an anesthetic;
if the patient has kidney function disorders;
if the patient has liver function disorders;
if the patient has organic heart disease (heart rhythm disorders);
if the patient has cor pulmonale (right ventricular hypertrophy due to chronic lung disease);
if the patient has diabetes;
if the patient has low blood pressure (hypotension);
if the patient has recently suffered head injuries;
if the patient has increased intracranial pressure;
if the patient has porphyria (a congenital or acquired disorder of enzyme function involved in the production of heme (red blood pigment));
if the patient has oligemia (reduced blood volume in blood vessels).

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 action 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.
Dependence or addictive use can make the patient feel that they have no control over the amount of medicine taken or the frequency of taking it.
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 ("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, while taking Methadone Hydrochloride Molteni, the patient notices any of the following symptoms, it may indicate the development of dependence or abuse:

• The patient feels the need to take the medicine for longer than prescribed by the doctor.
• The patient feels the need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those for which it was prescribed, for example, "to calm down" or "to be able to sleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has 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 right 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 this 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 (decreased potassium levels in the blood, decreased magnesium levels in the blood);
• is being treated with drugs that prolong the QT interval visible in an electrocardiogram called EKG (e.g., atazanavir, azithromycin);
• is being treated with drugs that may cause electrolyte disturbances (e.g., hydrochlorothiazide);
• is being treated with such drugs as ketoconazole, erythromycin;
• is being treated with metamizole, a drug 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 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 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 heartbeat, 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). Concomitant 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. Therefore, their concomitant 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 concomitant 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 symptoms and signs mentioned above. If the above symptoms occur, consult a doctor; strong painkillers (morphine, butorphanol, nalbuphine, pentazocine); substances that reduce urine pH (ammonium chloride); medicines used in heart and blood vessel diseases (quinidine, verapamil); naloxone and naltrexone (medicines used to treat addiction to morphine and heroin); octreotide (used to treat certain cancers).

Methadone Hydrochloride Molteni with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not take Methadone Hydrochloride Molteni during pregnancy. The medicine may harm the unborn child.
Women who are breastfeeding should consult their doctor before taking any medicine.
Do not take Methadone Hydrochloride Molteni while breastfeeding. The medicine passes into breast milk and may cause dependence in the baby.
Consult your doctor if you are breastfeeding or plan to breastfeed while taking methadone, as the medicine may affect the baby. Monitor the breastfed baby for unusual 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 hazardous tools while taking Methadone Hydrochloride Molteni. The medicine has a negative impact 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. 4 ml of syrup contains 1.6 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 their doctor before taking this medicine.

• The medicine contains glycerol - the medicine may cause headache, gastrointestinal disorders, 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 unit of volume, which is equivalent to 0.08% v/v. The amount of alcohol in a 2 ml volume 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

Take this medicine always 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 on your own.
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 5 mg of the active substance (methadone hydrochloride).

Addiction

The usual initial dose is 3 to 4 ml of syrup(15 mg to 20 mg of methadone hydrochloride) once a day.
In the case of addiction to large doses of drugs, the doctor may increase the dose. In the treatment of heroin and morphine addiction, the doctor should combine dosing with a detoxification program (removal of toxins) and adjust the dose according to the patient's degree of addiction.
Do not exceed the dose prescribed by your doctor.

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 disorders (decreased breathing rate, decreased amount of inhaled air);
deep sleep turning into coma;
pupil constriction;
cold and sweaty skin;
muscle weakness;
very slow heartbeat; 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:
if there is a lot of time left until the next dose, take the missed dose. In this case, change the time of taking the next dose;
if there is not much time left until the next dose, skip the missed dose and wait until the next dose. Continue treatment as recommended by your doctor.
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,
restlessness, agitation, difficulty concentrating,
muscle tremors, muscle and joint pain,
tearfulness, pupil dilation, yawning,
feeling of increased heart rate (palpitations),
headache,
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, 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 placing the patient in a lying position.
Other side effects:

Very common:occur in more than 1 in 10 patients

• nausea and vomiting

Common:occur in no more than 1 in 10 patients

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

Uncommon:occur in no more than 1 in 100 patients

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

Rare:occur in no more than 1 in 1000 patients

• tachycardia or bradycardia, extrasystoles, and arrhythmias. 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 you experience any side effects, including any side effects not listed in this leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 this 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 given month.
Shelf life after opening the 1000 ml bottle: 1 year.
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. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Methadone Hydrochloride Molteni contains
The active substance of the medicine is methadone hydrochloride.
1 ml of syrup contains 5 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 packaging contains

The medicine is a clear, colorless or slightly yellowish syrup with a citric flavor.
The medicine is available in two types of packaging:
A 20 ml or 1000 ml bottle.
A brown glass bottle with an HDPE cap with a child-resistant closure in a cardboard box with a leaflet (20 ml).
A PVC bottle with a PP cap with a tamper-evident closure and a polystyrene measuring cup (1000 ml). The bottle is packed in a cardboard box with a leaflet.

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, contact 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 revision of the leaflet: