Levomethadone hydrochloride molteni

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levomethadone Hydrochloride Molteni, 2.5 mg/mL, oral solution
For use in adults
Levomethadoni hydrochloridum
Before using this medicine, read the entire leaflet carefully, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If any of the side effects worsens or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Levomethadone Hydrochloride Molteni is and what it is used for
2. Important information before taking Levomethadone Hydrochloride Molteni
3. How to take Levomethadone Hydrochloride Molteni
4. Possible side effects
5. How to store Levomethadone Hydrochloride Molteni
6. Contents of the pack and other information

1. What Levomethadone Hydrochloride Molteni is and what it is used for

Levomethadone Hydrochloride Molteni contains the active substance levomethadone hydrochloride. It belongs to a group of medicines that act on the patient's nervous system.
Levomethadone Hydrochloride Molteni is used in the treatment of adults addicted to substances known as "opioids" or "opioid analgesics" – such as heroin and morphine. It acts as a substitute for the addictive substances.

2. Important information before using Levomethadone Hydrochloride Molteni

When not to use Levomethadone Hydrochloride Molteni:

• if the patient is allergic to levomethadone or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking antidepressant medicines called "MAO inhibitors" (monoamine oxidase inhibitors) or has taken them within the last 2 weeks (see "Other medicines and Levomethadone Hydrochloride Molteni");
• if the patient is taking medicines used to treat addiction or strong painkillers (see "Other medicines and Levomethadone Hydrochloride Molteni");
• if the patient has severe breathing difficulties or lung problems;
• the patient is addicted to non-opioid substances;
• the patient is under 18 years of age.

Do not take Levomethadone Hydrochloride Molteni if any of the above
apply to the patient. If the patient has any doubts, they should consult a doctor or pharmacist before
using Levomethadone Hydrochloride Molteni.
Warnings and precautions
Before starting to take Levomethadone Hydrochloride Molteni, consult a doctor or
pharmacist if the patient:

• does not feel alert or fully awake (has "reduced levels of consciousness");
• has low blood pressure;
• has previously had heart problems, including heart disease or heart rhythm disorders. This medicine may affect the electrical signals that control the heartbeat, especially at high doses. Therefore, inform the doctor if the patient has previously had heart problems;
• has previously had breathing or lung problems, such as asthma or chronic obstructive pulmonary disease (COPD);
• has difficulty passing urine;
• has prostate problems;
• has gallbladder or bile duct problems;
• has inflammation of the pancreas;
• has intestinal function disorders;
• has hypothyroidism;
• has increased intracranial pressure;
• has adrenal gland problems – hyperactivity or a type of tumour called a pheochromocytoma;
• has been informed by a doctor of having electrolyte imbalance disorders, such as hypokalaemia.

If any of the above apply to the patient (or if the patient is uncertain), they should discuss this with a doctor or
pharmacist before starting to take Levomethadone Hydrochloride Molteni.
Contact a doctor or pharmacist if any of the following symptoms occur while taking Levomethadone
Hydrochloride Molteni:

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

Long-term use of opioid painkillers may lead to decreased levels of
sex hormones and increased levels of the hormone prolactin. Contact a doctor or
pharmacist if symptoms such as reduced libido, impotence, or absence of menstruation occur.
Exercise caution when taking Levomethadone Hydrochloride Molteni

• Levomethadone Hydrochloride Molteni is approximately twice as potent as methadone. The correct dosage is provided in section 3 "How to take Levomethadone Hydrochloride Molteni".
• Levomethadone Hydrochloride Molteni must not be injected – it is intended for oral use only. Injecting this medicine is dangerous and may cause serious complications. It may lead to systemic infection, painful and swollen veins, or blockage of a blood vessel in the lungs.

Tolerance, dependence and compulsive use
This medicine contains levomethadone, 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, known as "tolerance"). Repeated use of Levomethadone Hydrochloride Molteni may also
lead to abuse, dependence and compulsive use, which may result in life-threatening overdose.
Dependence or compulsive use may make the patient feel they have no control over the amount
of medicine taken or the frequency of administration.
The risk of developing dependence or abuse varies among different patients.
The patient may be at higher risk of developing abuse or dependence on
Levomethadone 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 Levomethadone Hydrochloride Molteni, the patient notices any of the
following symptoms, this may indicate the development of dependence or abuse.

• The patient feels the need to take the medicine 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 the medicine again ("withdrawal symptoms").

If the patient notices any of the above symptoms, they should speak
with their doctor and discuss the best treatment approach, including the appropriate timing and safe method of discontinuing treatment (see section 3, Discontinuing Levomethadone
Hydrochloride Molteni).
Sleep-related breathing disorders
Levomethadone Hydrochloride Molteni may cause sleep-related breathing disorders, such
as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels
in the blood). Symptoms may include pauses in breathing 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.
Use of Levomethadone Hydrochloride Molteni may lead to positive results in sports doping tests. Do not use Levomethadone Hydrochloride
Molteni as a doping agent – it may seriously harm health.
Levomethadone Hydrochloride Molteni and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines the patient plans to take. This includes medicines available without a prescription
and herbal medicines. This is important because Levomethadone Hydrochloride Molteni may affect
the action of certain medicines. Likewise, certain other medicines may affect the action of Levomethadone
Hydrochloride Molteni.
Do not take Levomethadone Hydrochloride Molteni and inform the doctor or pharmacist
if the patient is taking any of the following medicines:

• antidepressant medicines called MAO inhibitors (monoamine oxidase inhibitors), including if the patient has taken them within the last 2 weeks – such as moclobemide, phenelzine and tranylcypromine;
• medicines used to treat addiction – such as buprenorphine. At least 20 hours must elapse after stopping Levomethadone Hydrochloride Molteni before starting buprenorphine;
• strong painkillers – such as morphine, butorphanol, nalbuphine and pentazocine.

If any of the above apply to the patient (or if the patient is uncertain), they should not
take Levomethadone Hydrochloride Molteni and should inform the doctor or pharmacist.
Before starting to take Levomethadone Hydrochloride Molteni, consult a doctor or pharmacist
if the patient is taking any of the following medicines:

• medicines used to treat severe mental disorders called "psychoses", such as chlorpromazine;
• medicines that cause sedation, including:
• other antidepressants – such as amitriptyline and clomipramine;
• sleeping medicines – including anaesthetics;
• medicines used to treat high blood pressure – such as reserpine, clonidine, urapidil and prazosin;
• spironolactone – a diuretic;
• medicines used to treat fungal infections – such as fluconazole, itraconazole, voriconazole and ketoconazole;
• medicines used to treat heart conditions – such as quinidine, verapamil and diltiazem;
• cimetidine – used to treat peptic ulcer disease;
• rifampicin – an antibiotic;
• macrolide antibiotics, e.g. clarithromycin, telithromycin and erythromycin;
• medicines used to treat certain bacterial infections – such as ciprofloxacin, fusidic acid;
• herbal medicines containing St John's wort (Hypericum perforatum);
• antiviral medicines, including some used to treat HIV, e.g. amprenavir, nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquinavir, abacavir, delavirdine, didanosine and stavudine;
• oral contraceptives ("the pill");
• antiepileptic medicines, including barbiturates – such as phenytoin and carbamazepine;
• 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;
• metamizole, a medicine used to treat pain and fever;
• sedative medicines called benzodiazepines – such as diazepam and flunitrazepam.
  Concomitant use of Levomethadone Hydrochloride Molteni and sedatives such as benzodiazepines or medicines with similar effects increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use should only be considered if no other treatment options are available. If a doctor prescribes Levomethadone Hydrochloride Molteni together with sedatives, the doctor should also limit the dose and duration of concomitant treatment. Inform the doctor about all sedative medicines the patient is taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives so they are aware of the possibility of the above-mentioned signs and symptoms. If any of the above symptoms occur, contact a doctor. If any of the above apply to the patient (or if the patient is uncertain), discuss this with a doctor or pharmacist before starting Levomethadone Hydrochloride Molteni.

The risk of adverse effects increases if the patient takes levomethadone simultaneously
with antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine,
fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine,
nortriptyline). Contact a doctor if the following symptoms occur:

• Mental state changes (e.g. agitation, hallucinations, coma);
• Rapid heartbeat, unstable blood pressure, fever;
• Exaggerated reflexes, impaired coordination, muscle stiffness;
• Gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

Levomethadone Hydrochloride Molteni and alcohol
Do not drink alcohol while taking Levomethadone Hydrochloride Molteni, as alcohol may
exacerbate the adverse effects of this medicine and lead to severe poisoning with symptoms such as drowsiness,
shallow and weak breathing, and coma, which may be fatal.
Pregnancy, breastfeeding and fertility
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 using this medicine.
Pregnancy

• Levomethadone Hydrochloride Molteni may be used during pregnancy only after careful consideration by the doctor of the benefit-risk ratio, preferably under supervision in a specialist medical centre. Due to metabolic changes occurring during pregnancy, the number of doses may need to be increased to twice daily to maintain treatment effectiveness. The doctor may also recommend dividing the daily dose.
• Prolonged use during pregnancy may lead to the foetus becoming accustomed to and dependent on levomethadone, as well as withdrawal symptoms in the newborn, which often require hospital treatment.

Breastfeeding
Levomethadone passes into human milk. If the patient is breastfeeding or plans to breastfeed
while taking levomethadone, she should consult a doctor, as this may affect the
child. The decision on whether the patient may breastfeed while taking Levomethadone
Hydrochloride Molteni is made by the doctor. The patient should monitor the child for
unusual objective and subjective symptoms, such as increased sleepiness (more than
usual), breathing difficulties or floppiness. Seek immediate medical advice if
any of these symptoms are observed.
Fertility
There have been reports that methadone may cause problems with male fertility during
maintenance treatment.
Driving and operating machinery
While taking Levomethadone Hydrochloride Molteni, do not drive, use tools or operate
machinery, as the patient may feel drowsy and have reduced alertness
during treatment and sometimes also after discontinuation.
The patient may drive, use tools or operate machinery only after prior approval
from the doctor.
Levomethadone Hydrochloride Molteni contains methyl parahydroxybenzoate (E218)
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Levomethadone Hydrochloride Molteni (Brand Name)

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult your
doctor or pharmacist.

Recommended dose
Your doctor will determine the dose based on:

• your individual needs;
• the speed at which withdrawal symptoms occur.

Always take the dose prescribed by your doctor:

• do not take more or less of this medicine than the prescribed dose;
• do not take this medicine more or less frequently than recommended.

Initial dose:

• The usual starting dose is 6 to 8 mL of oral solution per day in the morning (i.e. 15 to 20 mg of levomethadone hydrochloride).
• If needed, the patient may receive a second dose of 4 to 10 mL of oral solution in the evening (i.e. 10 to 25 mg of levomethadone hydrochloride).

Dose escalation:

• Your doctor will usually increase the dose over 1 to 6 days until the appropriate dose for you is established.
• The dose may be increased by 2 to 4 mL per day (i.e. 5 to 10 mg of levomethadone hydrochloride), depending on how the medicine affects you.
• The usual maintenance dose may reach up to 24 mL of oral solution per day (i.e. up to 60 mg of levomethadone hydrochloride). In certain cases, your doctor may prescribe a higher dose.

Please note that Levomethadone Hydrochloride Molteni is approximately twice as potent as
methadone – meaning that the dose required is lower than with methadone.

Elderly patients, or those with kidney or liver problems, or severely ill patients
For patients over 65 years of age, those in very poor general health, or those with severe kidney or severe, chronic liver impairment, the dose may be reduced. In such cases, your doctor may wish to monitor you more closely.

How to take the medicine

• Levomethadone Hydrochloride Molteni is intended for oral use only.
• This medicine may be taken as supplied or diluted with water or non-alcoholic beverages – such as orange juice.
• Your prescribed dose will be measured and administered by your doctor or pharmacist.

Taking more Levomethadone Hydrochloride Molteni than prescribed
If you take more Levomethadone Hydrochloride Molteni than you should, seek immediate medical advice from a doctor or go to hospital. Take the medicine pack with you. The following symptoms of overdose may occur:

• breathing difficulties;
• extreme drowsiness, near loss of consciousness ("unresponsiveness"), or coma;
• pinpoint pupils;
• cold and clammy skin;
• very slow heart rate;
• muscle weakness;
• low blood sugar levels;
• brain dysfunction (known as toxic leukoencephalopathy).
  In extreme cases, respiratory or cardiac arrest and heart attack may occur.

If you miss a dose of Levomethadone Hydrochloride Molteni
If you forget to take a dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Levomethadone Hydrochloride Molteni treatment
Do not stop taking Levomethadone Hydrochloride Molteni without first discussing it with your doctor. Abruptly stopping this medicine may cause unwanted effects. If it becomes necessary to discontinue treatment with Levomethadone Hydrochloride Molteni, your doctor will gradually taper the dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur, you should
inform your doctor:
Adverse effects are more likely to occur at the beginning of treatment:

• feeling of restlessness, depression, irritability or drowsiness;
• loss of appetite (anorexia), weight loss or general malaise (nausea);
• stomach or intestinal cramps, diarrhoea or vomiting;
• fever, alternating chills and hot flushes, yawning, goosebumps, runny nose, sneezing;
• uncoordinated and rapid movements or tremors (shaking);
• rapid heartbeat (tachycardia);
• pinpoint pupils;
• body aches;
• weakness or motor restlessness;
• excessive sweating or tearing of the eyes.

Other adverse effects include:
Uncommon (may affect up to 1 in 100 people) to common (may affect up to 1 in 10 people):

• slow or shallow breathing;
• headache or visual disturbances;
• weakness, dizziness, fainting, confusion or disorientation;
• excessive drowsiness or insomnia;
• agitation or depression;
• palpitations or reduced heart rate;
• decreased sexual drive;
• reduced libido or difficulty achieving and maintaining erection in men;
• increased sweating;
• skin rash, including urticaria and other types of itchy rash;
• dry mouth;
• loss of appetite, nausea or vomiting;
• constipation;
• fluid retention (oedema), biliary spasms which may cause pain in the upper abdomen or back;
• urinary disorders, including reduced urine output.

Rare (may affect up to 1 in 1,000 people) to very rare (may affect up to 1 in 10,000 people):

• skin redness and sensation of warmth (hot flushes);
• internal bleeding;
• respiratory arrest;
• drop in blood pressure upon sudden change from lying to sitting or standing position (orthostatic hypotension);
• cardiac arrest, heart attack, circulatory disturbances, occurrence of shock.

Frequency not known:

• low blood sugar levels;
• sleep apnoea (breathing interruptions during sleep);
• dependence on Levomethadone Hydrochloride Molteni may develop in the patient.

It should be noted that the severity of some adverse effects decreases over time. However,
constipation and excessive sweating tend to persist. You should talk to your doctor or pharmacist about
treatment to help relieve these adverse effects.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse effects allows for the collection of further information on the safety of the medicine.

5. How to store Levomethadone Hydrochloride Molteni

• Keep this medicine out of sight and reach of children. This medicine should be stored in a secure place to which others do not have access. Taking this medicine by people for whom it has not been prescribed may lead to severe harm or death.
• Do not use this medicine after the expiry date stated on the outer carton and label following EXP. The expiry date refers to the last day of the stated month.
• This medicine does not require any special storage conditions.
• Shelf life (60 mL, 100 mL, 1000 mL bottles, oral solution): 12 weeks after first opening.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levomethadone Hydrochloride Molteni contains

• The active substance is levomethadone hydrochloride. Each millilitre (mL) of oral solution contains 2.5 milligrams (mg) of levomethadone hydrochloride.
• The other ingredients are methyl parahydroxybenzoate (E218), betaine hydrochloride, glycerol, caramel (E150C), purified water.

What Levomethadone Hydrochloride Molteni looks like and contents of the pack

• Levomethadone Hydrochloride Molteni 2.5 mg/mL oral solution is a clear, light amber-coloured liquid.
• It is available in the following pack sizes:
• 5, 10 or 20 mL single-dose bottles with child-resistant closure.
• 60 or 100 mL multi-dose bottles with child-resistant closure and adapter (pipette adapter). A 5 mL pipette, graduated from 0.25 mL to 5 mL in 0.25 mL increments, is supplied with the bottle.
• 1000 mL amber-coloured PVC bottle closed with a plastic screw cap and inner seal. The pack includes a dosing cup graduated from 1 mL to 6 mL.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.,
Strada Statale 67, Loc. Granatieri
50018 Scandicci (Firenze),
Italy

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Molteni Farmaceutici Polska Sp. z o.o
Tel.: +48 (12) 653 15 71
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Germany: Levomethadon Molteni 2.5 mg/mL Lösung zum Einnehmen
Italy: Ellepalmiron 2.5 mg/mL soluzione orale
Poland: Levomethadone Hydrochloride Molteni 2.5 mg/mL oral solution