Methadone hydrochloride molteni

Package leaflet: Information for the patient

Methadone Hydrochloride Molteni
5 mg/ml, syrup
Methadoni hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Methadone Hydrochloride Molteni is and what it is used for
2. What you need to know 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 which influence pain perception). It affects the central nervous system in a manner similar to morphine.
Methadone Hydrochloride Molteni is available as a syrup and should be taken orally only.
Indications:
Treatment of opioid withdrawal syndrome (a condition following opioid discontinuation characterized by, among others, headache, muscle pain, fatigue, and irritability);
Substitution treatment in individuals dependent on 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 to any of the other ingredients of this medicine
(listed in section 6). If an allergic reaction is suspected, 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), as the medicine may worsen symptoms of these diseases;
if the patient has had or currently has asthma attacks;
during childbirth as an anesthetic agent;
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 blood pressure (hypotension);
if the patient has recently suffered head injuries;
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 (the red pigment in blood));
if the patient has oligemia (reduced volume of circulating blood in blood vessels).

Warnings and precautions
Tolerance, dependence, and compulsive use
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 compulsive use, which may result in life-threatening overdose.
Dependence or compulsive use may cause the patient to feel they have no control over the amount or frequency of medicine intake.
The risk of developing dependence or abuse varies among patients. The patient may have a 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 the patient notices any of the symptoms listed below while taking Methadone Hydrochloride Molteni, 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 the use of the medicine.
• After stopping the medicine, the patient feels unwell and feels better after taking it again ("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 discontinue treatment and the safest way to stop treatment (see section 3, Discontinuing 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 oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, 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.
Discuss this with your doctor or pharmacist before starting Methadone Hydrochloride Molteni.
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 diseases;
has a family history of sudden deaths;
has electrolyte imbalances (low potassium levels in blood, low magnesium levels in blood);
is being treated simultaneously with medicines that prolong the QT interval visible on electrocardiogram (ECG) (e.g., atazanavir, azithromycin);
is being treated simultaneously with medicines that may cause electrolyte imbalances (e.g., hydrochlorothiazide);
is being treated simultaneously 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 supplementation may be necessary. Do not take the medicine if any of these 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 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 simultaneously 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, coma)
• rapid heartbeat, unstable blood pressure, fever
• exaggerated reflexes, coordination disorders, 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. For this reason, 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 sedatives 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 potential signs and symptoms listed above. If the above symptoms occur, contact a doctor; strong analgesics (morphine, butorphanol, nalbuphine, pentazocine); substances that reduce urine pH (ammonium chloride); medicines used for heart and blood vessel diseases (quinidine, verapamil); naloxone and naltrexone (medicines used to treat morphine and heroin addiction); octreotide (used to treat 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
breathing disorders and decreased 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 or breastfeeding, suspects she may be pregnant, or is planning to have a
child, 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 drowsiness (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 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. 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 certain sugars, the patient should consult 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 2 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 have any doubts, consult your doctor or pharmacist.
Do not change the prescribed dose on your own.
Do not use the medicine for longer than your doctor has instructed.
This medicine is intended for oral use only. The syrup is ready for immediate use.
1 ml of syrup contains 5 mg of active substance (methadone hydrochloride).

Addiction
The usual starting dose is 3 to 4 ml of syrup (15 mg to 20 mg of methadone hydrochloride) once daily.
If addiction involves 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 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 more Methadone Hydrochloride Molteni than you should
If you take more medicine than prescribed, you must immediately contact your doctor 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;
cold and clammy skin;
muscle weakness;
very slow heart rate; reduced arterial blood pressure;
brain dysfunction (known as toxic leukoencephalopathy).
In severe cases of overdose, respiratory arrest, sudden cardiac arrest, and death may occur.
Taking more Methadone Hydrochloride Molteni than recommended may result in low blood sugar levels.

If you forget to take Methadone Hydrochloride Molteni
If you miss a dose of the medicine:
if there is still plenty of time before the next dose, take the missed dose. In this case, adjust the time of the next dose accordingly;
if there is only a short time left before the next dose, skip the missed dose and wait for 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 swings, depression,
insomnia, difficulty falling asleep,
nervousness, restlessness, difficulty concentrating,
tremor, muscle and joint pain,
lacrimation, pupil dilation, yawning,
palpitations (sensation of rapid heartbeat),
headache,
sweating,
nausea, vomiting, loss of appetite, diarrhoea,
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 experiences 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
dizziness, vertigo (worsening upon standing), sedation, nausea, vomiting,
sweating and low blood pressure (especially after assuming an upright position). Some of these effects,
which occur more frequently 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

• weakness
• 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
• itching, urticaria, other skin reactions, oedema, and rarely haemorrhagic urticaria
• urinary retention and difficulty in urination, antidiuretic effect
• biliary colic
• decreased libido, impotence

Rare: occurs in up to 1 in 1000 patients

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

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

• anorexia, hypoglycaemia
• sleep apnoea (pauses in breathing during sleep)
• dependence on Methadone Hydrochloride Molteni may develop in the patient (for more information, see section 2 "Warnings and precautions").

Other adverse reactions 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 doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 authorisation holder.
Reporting adverse reactions enables better assessment of the benefit-risk balance of the medicine.

5. HOW TO STORE METHADONE HYDROCHLORIDE MOLTENI

Keep this medicine out of sight and reach of children.
This medicine must be stored in a secure place inaccessible to others.
Taking this medicine by persons to whom it has not been prescribed may result in severe harm or 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 specified month.
Storage period after first opening of the 1000 ml bottle: 1 year.
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 5 mg of methadone hydrochloride.
The other ingredients are: sucrose, glycerol (E 422), sodium benzoate (E 211), lemon flavouring agent, monohydrate citric acid, 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 two types of packaging:

• 20 ml or 1000 ml bottle.
• 20 ml amber glass bottle closed with an HDPE cap with child-resistant closure, packed in a cardboard box with the leaflet.
• 1000 ml PVC bottle closed with a PP cap with tamper-evident seal made of PE, together with a polystyrene measuring cup. The bottle is packed in a cardboard box with the leaflet.

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 Marketing Authorisation Holder:
Molteni Farmaceutici Polska Sp. z o.o.,
Józefa Korzeniowskiego 39 Street, 30–214 Kraków, Poland
Tel.: (12) 653 15 71 or 72