Methadone hydrochloride molteni

Package leaflet: Information for the patient

Methadone Hydrochloride Molteni
1 mg/ml, syrup
Methadoni hydrochloridum
Please read the entire leaflet carefully before starting to use the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet :

1. What Methadone Hydrochloride Molteni is and what it is 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 pack and other information

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

Methadone Hydrochloride Molteni is an opioid analgesic (it acts on opioid receptors that influence pain perception). It acts on the central nervous system in a manner similar to morphine.
Methadone Hydrochloride Molteni is available as a syrup and should be administered orally only.

Indications:

• treatment of withdrawal syndrome (a condition following narcotic discontinuation characterized by, among others, headache, muscle pain, fatigue, and irritability);
• substitution treatment in individuals addicted to morphine and heroin;
• relief of severe pain, particularly occurring in cancer diseases and after surgical procedures.

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 currently has respiratory disorders, such as respiratory insufficiency or chronic obstructive pulmonary disease (COPD) (obstructed airflow in the airways, symptoms of which include, among others: shortness of breath even at rest, persistent cough, wheezing), because the medicine may worsen symptoms of these conditions;
• if the patient has had or currently has asthma attacks;
• during childbirth as an anesthetic;
• if the patient has impaired kidney function;
• if the patient has impaired liver function;
• if the patient has organic heart disease (cardiac arrhythmias);
• if the patient has cor pulmonale (right ventricular hypertrophy due to chronic lung disease);
• if the patient has diabetes;
• if the patient has low arterial blood pressure (hypotension);
• if the patient has recently suffered head trauma;
• if the patient has increased intracranial pressure;
• if the patient has porphyria (inherited or acquired disorder characterized by impaired function of enzymes involved in heme formation (blood pigment));
• if the patient has oligemia (reduced circulating blood volume).

Warnings and precautions
Tolerance, dependence and abuse
This medicine contains methadone, which is an opioid medicine. Repeated use of opioids may
lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to the
medicine's action, known as "tolerance"). Repeated use of Methadone Hydrochloride Molteni
may also lead to dependence, abuse and addictive use, which may result in life-threatening
overdose. The risk of adverse effects may increase with higher doses and longer duration of use.
Dependence or addictive use may cause the patient to feel a lack of control over the amount or
frequency of medicine intake. When used in pain treatment, the patient may feel the need to
continue taking the medicine, even if it no longer relieves pain.
The risk of developing dependence or abuse varies among patients. The patient may be at higher
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 medicines or illegal drugs ("addiction");
• the patient smokes cigarettes;
• 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 symptoms
listed below, this 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, e.g., "to calm down" or "to be able to sleep".
• The patient has repeatedly made unsuccessful attempts to stop or control medicine use.
• After stopping the medicine, the patient feels unwell and feels better after resuming the medicine ("withdrawal symptoms").

If the patient notices any of the above symptoms, they should talk to their doctor and discuss the
best treatment approach, including the appropriate time to stop treatment and a safe way to
discontinue treatment (see section 3, Discontinuation of Methadone Hydrochloride Molteni).

Important information before taking Methadone Hydrochloride Molteni
Sleep-related breathing disorders
Methadone Hydrochloride Molteni may cause sleep-related breathing disorders, such as sleep
apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness,
difficulty maintaining sleep or excessive daytime sleepiness. If the patient or another person notices
such symptoms, contact a doctor. The doctor may consider reducing the dose.
Before starting Methadone Hydrochloride Molteni, discuss this with your doctor or pharmacist.
The medicine should be used with caution, especially if the patient:

• is elderly (over 65 years of age);
• is debilitated;
• has hypothyroidism;
• has Addison's disease (adrenal insufficiency);
• has benign prostatic hyperplasia;
• has urethral stricture;
• has severe constipation;
• has cardiac conduction disorders;
• has advanced heart disease, including ischemic heart disease;
• has liver disease;
• has a family history of sudden deaths;
• has electrolyte imbalances (low blood potassium levels, low blood magnesium levels);
• is concurrently treated with medicines that prolong the QT interval visible on electrocardiogram (ECG), such as atazanavir, azithromycin;
• is concurrently treated with medicines that may cause electrolyte imbalances (e.g., hydrochlorothiazide);
• is concurrently treated with medicines such as ketoconazole, erythromycin;
• is being treated with metamizole, a medicine used to treat pain and fever.

If any of the following symptoms occur during treatment with 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 insufficient cortisol, and hormone replacement may be necessary.

Do not take the medicine if any of the above warnings apply or have applied to the patient in the past.
If in doubt, contact a doctor or pharmacist before taking the medicine.
Long-term use may lead to decreased levels of sex hormones and increased prolactin levels. If
symptoms such as low libido, impotence or absence of menstruation occur, contact a doctor.
Children and adolescents
Do not use in children and adolescents under 18 years of age.
Methadone Hydrochloride Molteni and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used or planned
to be used.
Inform your doctor if the patient is taking any of the following medicines:

• cannabidiol (a medicine used to treat epileptic seizures);
• 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 life-threatening. These medicines may influence the occurrence of adverse effects of Methadone Hydrochloride Molteni.

Do not use Methadone 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);
• antidiarrheal medicines (diphenoxylate, loperamide);
• antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). The risk of adverse effects increases when methadone is used concomitantly with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). If any of the following symptoms occur, contact a doctor:
• changes in mental state (e.g., agitation, hallucinations, somnolence);
• rapid heartbeat, unstable blood pressure, fever;
• exaggerated reflexes, coordination disturbances, muscle stiffness;
• gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea);
• sedatives and hypnotics (including barbiturates, benzodiazepine derivatives). Concurrent use of Methadone Hydrochloride Molteni and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concurrent use should only be considered when no other treatment options are available. If a doctor prescribes Methadone Hydrochloride Molteni together with sedatives, the doctor should also limit the dose and duration of concurrent treatment. Inform the doctor about all sedative medicines the patient is taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or family members so they are aware of the possible signs and symptoms listed above. If the above symptoms occur, contact a doctor;
• strong analgesics (morphine, butorphanol, nalbuphine, pentazocine);
• substances reducing urine pH (ammonium chloride);
• medicines used for heart and blood vessel diseases (quinidine, verapamil);
• naloxone and naltrexone (medicines used in the treatment of morphine and heroin addiction);
• octreotide (used in the treatment of certain tumour diseases).

Methadone Hydrochloride Molteni with food and drink
Do not drink alcohol while taking this medicine. Alcohol may worsen adverse effects such as
respiratory disturbances and decreased arterial blood pressure.
Do not drink grapefruit juice while taking Methadone Hydrochloride Molteni.
Grapefruit juice may alter the effect of this medicine.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant or plans to become
pregnant, she should consult a doctor or pharmacist before taking this medicine.
Do not use Methadone Hydrochloride Molteni during pregnancy. The medicine may harm the
developing 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 infant.
Consult your doctor if a woman is breastfeeding or considering breastfeeding while taking
methadone, as the medicine may affect the infant. Monitor the breastfed infant for abnormal
symptoms such as increased sleepiness (more than usual), breathing difficulties or floppiness. If
any of these symptoms are observed, inform the doctor immediately.
Driving and operating machinery

Do not drive, operate machinery or use dangerous tools while taking Methadone Hydrochloride
Molteni. The medicine negatively affects the mental and physical abilities required 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 certain sugars, the patient should contact a doctor before taking this medicine.
The medicine contains glycerol – the medicine may cause headache, gastrointestinal disturbances 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, meaning the medicine is considered "sodium-free".
• This medicine contains 0.8 mg of alcohol (ethanol) per unit volume, equivalent to 0.08% w/v. The amount of alcohol in 10 ml 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 cause noticeable effects.

3. HOW TO TAKE METHADONE HYDROCHLORIDE MOLTENI

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure,
you should consult your doctor or pharmacist.
Do not change the prescribed dose on your own.
Do not use the medicine for longer than prescribed by your doctor.
This medicine is intended for oral use only. The medicine is ready for direct use.
1 ml of syrup contains 1 mg of the active substance (methadone hydrochloride).
Before starting treatment and regularly during therapy, your doctor will discuss with you what
to expect from taking Methadone Hydrochloride Molteni, when and for how long to take it, when
to contact your doctor, and when to stop taking the medicine (see also "Stopping Methadone
Hydrochloride Molteni").

Addiction
The usual starting dose is 15 to 20 ml of syrup (15 mg to 20 mg of methadone hydrochloride)
once daily.
In cases of addiction to high doses of narcotics, your doctor may increase the dose.
In the treatment of heroin and morphine addiction, your doctor should combine dosing with a
detoxification program (toxin removal) and adjust the dose according to the patient's level of
addiction.
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.
Your doctor should adjust the dosing according to the severity of pain and the patient's
response.

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

Taking more Methadone Hydrochloride Molteni than prescribed
If you take more medicine than prescribed, you should seek immediate medical help or go
to a hospital. Take the medicine packaging with you.
The following symptoms of overdose may occur:
respiratory depression (reduced breathing rate, decreased volume of inhaled air);
deep drowsiness progressing to coma;
pupil constriction (miosis);
cold and clammy skin;
muscle weakness;
very slow heart rate; decreased blood pressure;
impaired brain function (known as toxic leukoencephalopathy).
In severe cases of overdose, respiratory arrest, sudden cardiac arrest, and death may occur.
Taking a higher dose of Methadone Hydrochloride Molteni than recommended may result in
low blood sugar levels.

Missing a dose of Methadone Hydrochloride Molteni
If you miss a dose:
if there is still plenty of time before the next dose, take the missed dose. In this case, adjust the
timing of the next dose accordingly;
if it is almost time for the next dose, skip the missed dose and wait until the next scheduled
dose. Continue treatment as prescribed by your doctor.
Do not take a double dose to make up for a missed dose.

Stopping Methadone Hydrochloride Molteni
Do not stop treatment suddenly without consulting your doctor. Abrupt discontinuation 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, restlessness, difficulty concentrating;
muscle tremors, muscle and joint pain;
lacrimation, pupil dilation, yawning;
sensation of increased heart activity (palpitations);
headache;
sweating;
nausea, vomiting, loss of appetite, diarrhea;
pallor.
If your doctor decides that Methadone Hydrochloride Molteni can be discontinued, they will
advise you on how to gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most significant adverse effects of methadone are: respiratory depression, circulatory collapse,
respiratory arrest, shock, and cardiac arrest.
The most commonly observed adverse reactions are a feeling of emptiness in the head, dizziness
(aggravated upon standing), sedation, nausea, vomiting, sweating, and low blood pressure
(particularly upon assuming an upright position). Some of these effects, more frequently observed
in outpatients, may be reduced by placing the patient in a lying position.

Other adverse reactions
Very common: occurs in more than 1 in 10 patients

• nausea and vomiting

Common: occurs in up to 1 in 10 patients

• fatigue
• euphoria, dysphoria, insomnia, restlessness, disorientation
• miosis (pupil constriction), visual disturbances
• constipation

Uncommon: occurs in up to 1 in 100 patients

• headache, transient loss of consciousness
• respiratory depression
• hypotension
• dryness of the oral mucosa
• pruritus, urticaria, other skin reactions, edema, and more rarely hemorrhagic urticaria
• urinary retention and difficulty in urination, antidiuretic effect
• biliary tract spasms
• decreased libido, impotence

Rare: occurs in up to 1 in 1000 patients

• tachycardia or bradycardia, extrasystoles and cardiac arrhythmias. With high doses, torsade de pointes arrhythmias may occur.

Frequency unknown: frequency cannot be estimated from available data

• anorexia, hypoglycemia
• sleep apnea (pauses in breathing during sleep)
• dependence on Methadone Hydrochloride Molteni may develop in the patient (for further information, see section 2 "Warnings and precautions"). Other adverse reactions not listed in this leaflet may occur in some patients during treatment with Methadone Hydrochloride Molteni. If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE METHADONE HYDROCHLORIDE MOLTENI

Keep this medicine out of the sight and reach of children.
This medicine must be stored in a secure place inaccessible to others.
Taking this medicine by people for whom it has not been prescribed may result in severe harm or death.
Keep 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 specified month.
Storage period after first opening the bottle: 2 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Methadone Hydrochloride Molteni contains

• The active substance is methadone hydrochloride. 1 ml of syrup contains 1 mg of methadone hydrochloride.
• The other ingredients are: sucrose, glycerol (E 422), sodium benzoate (E 211), lemon flavouring agent, citric acid monohydrate, purified water.

What Methadone Hydrochloride Molteni looks like and contents of the pack
Methadone Hydrochloride Molteni is a clear, colourless or slightly yellow lemon-flavoured syrup.
The medicine is available in bottles with a capacity of 10 ml, 20 ml, 60 ml, 100 ml or 1000 ml.
The 10 ml or 20 ml bottle is made of amber glass, closed with an HDPE cap with child-resistant closure and packaged in a cardboard box.
The 60 ml bottle is made of transparent amber PVC, closed with an aluminium cap with a polyethylene seal and packaged in a cardboard box, or made of amber glass, closed with an aluminium cap with a polyethylene seal and packaged in a cardboard box.
The 100 ml bottle is made of amber glass with a child-resistant polyethylene (HDPE/LDPE) cap and a polyethylene (LDPE) pipette adapter, packaged in a cardboard box. A 5 ml polypropylene/polyethylene (HDPE) measuring pipette is included in the package.
The 1000 ml bottle is made of transparent amber PVC, closed with a polypropylene cap with a polyethylene seal and packaged in a cardboard box, or made of amber glass, closed with a polypropylene cap with a polyethylene seal and packaged in a cardboard box.

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.,
Strada Statale 67, Località Granatieri, 50018 Scandicci (Florence), Italy.
For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Molteni Farmaceutici Polska Sp. z o.o.,
ul. Józefa Korzeniowskiego 39, 30–214 Kraków,
tel.: (12) 653 15 71 or 72