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1. Cos’è Levometadone cloridrato G.L. e a cosa serve
2. Cosa deve sapere prima di prendere Levometadone cloridrato G.L.
3. How to take Levometadone hydrochloride G.L.
4. Possible side effects
5. How to store Levometadone cloridrato G.L.
6. Content of the pack and other information

Levomethadone hydrochloride G.L. 2.5 mg tablets
Levomethadone hydrochloride G.L. 5 mg tablets
Levomethadone hydrochloride G.L. 10 mg tablets
Levomethadone hydrochloride G.L. 20 mg tablets
Levomethadone hydrochloride G.L. 30 mg tablets
Levomethadone hydrochloride

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levomethadone hydrochloride G.L. is and what it is used for
• 2. What you need to know before you take Levomethadone hydrochloride G.L.
• 3. How to take Levomethadone hydrochloride G.L.
• 4. Possible side effects
• 5. How to store Levomethadone hydrochloride G.L.
• 6. Contents of the pack and other information

1. Cos’è Levometadone cloridrato G.L. e a cosa serve

Levometadone cloridrato G.L. is a medicine belonging to the opioid group. The active ingredient is levometadone hydrochloride.
Levometadone cloridrato G.L. is used for substitution therapy for opioid dependence in
adults.
Substitution therapy, also called maintenance therapy, takes place under intensive
medical, social and psychosocial care.

2. Cosa deve sapere prima di prendere Levometadone cloridrato G.L.

Do not take Levometadone cloridrato G.L. if

• you are allergic to levometadone or any of the other ingredients of this medicine listed in section 6.
• you are currently using monoamine oxidase inhibitors (medicines for Parkinson's disease or depression) or have stopped taking them less than two weeks ago,
• you are using medicines that can reverse or influence the action of Levometadone cloridrato G.L., such as pentazocine and buprenorphine: however, these medicines can be used to treat an overdose of Levometadone cloridrato G.L..
• you suffer from respiratory depression.
• you have obstructive airway diseases.
• you are dependent on non-opioid substances.

Further information is available in section 2 “Other medicines and Levometadone cloridrato
G.L.”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levometadone cloridrato G.L. if any of the
following points apply to you. The doctor will only start treatment if it is essential. This is particularly
true for:

• pregnancy and breastfeeding
• impaired consciousness
• concomitant use of other medicines that inhibit certain brain functions (e.g. control of breathing) (see also “Other medicines and Levometadone cloridrato G.L.” and “Levometadone cloridrato G.L. with drinks and alcohol”)
• concomitant use of Levometadone cloridrato G.L. and sedative medicines such as benzodiazepines or related active ingredients which increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Levometadone cloridrato G.L. together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.
• diseases in which it is necessary to avoid respiratory impairment, such as
• asthma
• lung diseases with chronically narrowed airways
• heart failure due to severe lung disease
• moderate to severe respiratory impairment and shortness of breath
• low oxygen levels in the blood
• increased levels of carbon dioxide in the blood. With these diseases, even the usual doses of Levometadone cloridrato G.L. can make breathing more difficult to the point of respiratory arrest. In particular, if you are prone to allergies, existing asthma may worsen or skin rashes and changes in blood counts may occur.
• increased intracranial pressure: may be intensified.
• low blood pressure in case of dehydration
• enlarged prostate with incomplete emptying of the urinary bladder
• inflammation of the pancreas
• diseases of the bile ducts
• intestinal diseases with narrowing and inflammation of the intestine
• pheochromocytoma, a tumor of the adrenal gland that produces hormones
• hypothyroidism
• risk of suicide: Suicide attempts with opioids, especially in relation to some medicines for depression (tricyclic antidepressants), alcohol and other substances, are part of the clinical picture of substance dependence. If you are unable to stop taking these medicines, consult your doctor or a specialized counseling center.
• severe abdominal diseases: Treatment with Levometadone cloridrato G.L. can also mask severe abdominal diseases. When the first signs of an abdominal disease appear, you must undergo regular medical monitoring until the exact cause has been clarified.
• patients with cardiac arrhythmias or prolonged ventricular activity, known as QT prolongation, or irregularities in mineral balance, especially due to low potassium levels in the blood. Some opioids, such as levometadone, can affect cardiac conduction (QT prolongation on ECG). This can lead to a dangerous heart rhythm disorder (too fast heartbeat, “Torsades de Pointes”). If you experience an irregular heartbeat or fainting, inform your doctor immediately.
• treatment with antiarrhythmic medicines of classes I and III,
• slowed heartbeat.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking
Levometadone cloridrato G.L.:

• Weakness, fatigue, loss of appetite, nausea, vomiting or low blood pressure. This may be a symptom that the adrenal glands produce too little cortisol hormone, and you may need to take a hormone supplement.

Further information
Avoid the abuse of drugs, alcohol and medicines during treatment, as this can lead to potentially
life-threatening episodes. The doctor may perform urine tests to detect any
drug abuse. Do not give this medicine to anyone else. It may cause death or harm them in
other ways.
Levometadone cloridrato G.L. is for oral use only. Improper use by intravenous injection can
cause serious adverse effects that can be fatal, such as sepsis (a life-threatening condition that occurs when the body's response to infection causes injury to its own
tissues and organs), phlebitis (inflammation of the veins), pulmonary embolism (blockage of an artery in the
lungs due to the movement of material from other parts of the body through the bloodstream).
Levometadone cloridrato G.L. contains insoluble excipients in water that give rise to particles that
can cause life-threatening events in the case of intravenous administration.
Long-term use of opioids can cause a decrease in sex hormone levels and an
increase in prolactin hormone levels. Contact your doctor if you experience symptoms such as
decreased libido, impotence or absence of menstruation (amenorrhea).
Levometadone cloridrato G.L. can cause dependence with prolonged and repeated use. Physical and mental
dependence, as well as tolerance, occur.

Doping
For athletes: the use of Levometadone cloridrato G.L. without therapeutic necessity
constitutes doping and can still result in a positive doping test.
The use of Levometadone cloridrato G.L. as a doping agent can be harmful to health.

Other medicines andLevometadone cloridrato G.L.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The daily dose required of Levometadone cloridrato G.L. may vary following the intake of
other medicines. Contact your doctor if you notice signs of increased effect or withdrawal symptoms from
Levometadone cloridrato G.L..
For further information on these two aspects, see the penultimate section of paragraph 3 and the beginning
of paragraph 4.
The risk of adverse effects increases if you use levometadone in conjunction with antidepressants
(such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline,
venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Contact your doctor if you experience
symptoms such as:

• Changes in mental status (e.g. agitation, hallucinations, coma)
• Rapid heartbeat, unstable blood pressure, fever
• Exaggeration of reflexes, altered coordination, muscle rigidity
• Gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) The following medicines must not be taken in conjunction with Levometadone cloridrato G.L.:
• monoamine oxidase inhibitors: medicines for depression or Parkinson's disease.

These medicines must be stopped at least 14 days before treatment with
Levometadone cloridrato G.L.. Otherwise, potentially
lethal, depressive or irritating effects on breathing and circulation may occur.

• pentazocine, buprenorphine: medicines for severe pain. Withdrawal symptoms may occur when used in conjunction with Levometadone cloridrato G.L.. Buprenorphine should not be used for at least 20 hours after stopping treatment with Levometadone cloridrato G.L.. Exceptionally, these medicines may be used in conjunction with Levometadone cloridrato G.L. if they are used to treat an overdose of Levometadone cloridrato G.L.. Tell your doctor if you are taking any of the following substances as they may affect the effects of Levometadone cloridrato G.L.:
• other medicines that suppress certain brain functions (e.g. control of breathing), such as: o strong painkillers, including opioids; o some medicines for psychiatric disorders whose active ingredients usually end in "-azine" such as phenothiazine; o sedatives and sleeping pills, the so-called benzodiazepines whose active ingredients usually end in "-zepam" such as diazepam, flunitrazepam and other sleeping pills; o medicines for epilepsy, the so-called barbiturates, whose active ingredients usually end in "-tal", such as phenobarbital; o narcotics or o some medicines for depression, the so-called tricyclic antidepressants (e.g. trimipramine and doxepin). If used in conjunction, they may have a mutually enhancing effect on brain function, leading, for example, to drowsiness or shallow and weak breathing (see “Warnings and precautions”). Please follow your doctor's dosage recommendations exactly. o some medicines for depression, the so-called selective serotonin reuptake inhibitors (“SSRIs”, e.g. sertraline, fluvoxamine, fluoxetine and paroxetine); o medicines for high blood pressure (e.g. reserpine, clonidine, urapidil and prazosin); o cimetidine, a medicine to reduce stomach acid formation; o antifungal medicines (e.g. itraconazole, ketoconazole, voriconazole and fluconazole); o medicines for cardiac arrhythmias (e.g. class I and III such as amiodarone); o contraceptive pills; o carbamazepine and phenytoin, medicines for epilepsy; o medicines for some bacterial diseases, such as rifampicin, the so-called macrolide antibiotics, ciprofloxacin, fusidic acid; o St. John's wort preparations, Cannabis; o spironolactone, a diuretic (diuretic); o medicines that inhibit the proliferation of the human immunodeficiency virus (e.g. efavirenz, nevirapine, nelfinavir, ritonavir, amprenavir, didanosine, stavudine and zidovudine); o medicines that can attenuate the effect of opioids (such as naloxone, naltrexone, nalmefene, pentazocine, nalbufine, butorphanol, buprenorphine); o substances that can affect the ECG; o metamizole, a medicine used to treat pain and fever.

Levometadone cloridrato G.L. with drinks and alcohol
Do not drink alcohol and grapefruit juice during treatment with Levometadone cloridrato G.L..
Alcohol can unpredictably increase its effect and cause severe poisoning with signs
such as drowsiness, shallow and weak breathing and coma, with possible fatal outcome.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
Pregnancy
Levometadone cloridrato G.L. can be used during pregnancy after careful evaluation of the
risk-benefit ratio by a doctor, preferably under control in a specialized medical center.
Chronic use during pregnancy can lead to habituation and dependence on methadone in the
fetus, as well as withdrawal symptoms in the newborn after birth, which often require hospital treatment.
Breastfeeding
Talk to your doctor if you are breastfeeding or may be breastfeeding while taking levometadone, as this
may have effects on your baby. Check your baby for abnormal signs and symptoms such as
increased drowsiness (more than usual), difficulty breathing or weakness. Consult your doctor immediately if you notice any of these symptoms.
Fertility
Methadone has been reported to cause sexual dysfunction in male patients
in maintenance treatment.

Driving and using machines
Levometadone cloridrato G.L. impairs the ability to drive and use machines
because it causes drowsiness and reduces attention. Active participation in traffic is not
recommended at the beginning of treatment, during dose titration, if withdrawal symptoms occur or in case of co-administration of substances that impair cognitive function.
The doctor will decide whether you are allowed to drive vehicles, use machines or perform other dangerous activities.
He will take into account your reactivity and your dose of Levometadone cloridrato G.L..

Levometadone cloridrato G.L. contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Levometadone hydrochloride G.L.

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.
The dose is adjusted individually by the doctor and depends on your perception and your
particular situation. The doctor will also take into account national recommendations.
Unless otherwise prescribed by your doctor, the usual dose is:

• initial doseOn the morning of the first day, you will receive a dose of 15 to 20 mg of levometadone hydrochloride. Depending on the effect of this initial dose, you may receive an additional dose of 10 to 25 mg of levometadone hydrochloride in the evening of the first day.
• daily doseWithin 1-6 days, the initial dose will be changed to a daily dose to be taken once in the morning. This change occurs with increments of 5 mg of levometadone hydrochloride per day. If withdrawal symptoms occur, the doctor may increase the daily dose to 5 to 10 mg of levometadone hydrochloride. The daily dose can reach up to 60 mg of levometadone hydrochloride. In justified cases, the daily dose may be considerably higher. The aim should always be the lowest possible maintenance dose.
• discontinuation of treatment

Discontinuation of treatment must occur over several weeks or months. The dose
is reduced in the smallest possible steps. If necessary, a solution of
levometadone can be used to reduce therapy.

Elderly patients and patients with impaired renal and/or hepatic function
The doctor may reduce the dose.

Pregnant patients
The doctor may adjust the dose based on the effectiveness of this medicine as metabolism may
change during pregnancy.

Children and adolescents under 18 years of age
Due to the lack of sufficient data on the safety and efficacy of Levometadone hydrochloride
G.L. in children and adolescents, intake is not recommended.

Route of administration
Levometadone hydrochloride G.L. is for oral use.
The oral route is the only effective and safe route of administration for this medicine.
Take the prescribed dose immediately after receiving it with a glass of water.
Alternatively, the tablets can be easily dissolved in water, orange or apple juice. The
solution is intended to be taken immediately.
The tablets must only be removed from the blister immediately before use. The tablets
should not be removed prematurely from the packaging to be taken later.

Duration of treatment
The doctor will determine the duration of treatment. This depends on the course of therapy and your
perception and is therefore not limited in time. However, the goal of treatment is to abstain
completely from drug use.

If you take more Levometadone hydrochloride G.L. than you should
Contact the nearest doctor immediately in case of suspected overdose!
will immediately take emergency medical measures.
Signs of overdose include:

• “feeling strange”
• poor concentration
• drowsiness
• dizziness when getting up
• moist skin
• reduced breathing with lips that may turn blue
• slowed heartbeat and low blood pressure
• pinpoint pupils
• relaxation of skeletal muscles
• extreme drowsiness, ranging from altered consciousness to coma. It can cause a drop in blood sugar.

Significant poisoning can lead to respiratory arrest, circulatory failure, cardiac arrest and death.
Taking Levometadone hydrochloride G.L. by people who are not used to it can lead
to death from respiratory failure. This applies to:

• children up to 5 years of age with a dose of 0.5 mg of levometadone hydrochloride;
• older children with a dose of 1.5 mg of levometadone hydrochloride;
• opioid-naive adults with a dose of 10 mg of levometadone hydrochloride.

Never give Levometadone hydrochloride G.L. to other people!
If you forget to take Levometadone hydrochloride G.L.
Repeat the intake on the same day only if you have taken less Levometadone hydrochloride G.L. than
prescribed and withdrawal symptoms occur. Do not increase the daily dose in any case! Inform
the doctor if you have not developed withdrawal symptoms after taking a reduced amount of
Levometadone hydrochloride G.L. so that your daily dose can be adjusted.

If you stop taking Levometadone hydrochloride G.L.
Do not stop suddenly or discontinue treatment after prolonged use. Sudden discontinuation of Levometadone hydrochloride G.L. can lead to withdrawal symptoms from severe to life-threatening.
Long-term treatment must be discontinued slowly.
Talk to your doctor about any desired changes in treatment.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects appear commonlyat the beginning of therapy (may affect up to 1 in 10 people):

• states of anxiety
• loss of appetite
• involuntary muscle contractions
• depression
• intestinal spasms, abdominal cramps
• nausea, vomiting
• diarrhea
• fever, alternating chills and hot flushes
• yawning
• goosebumps
• weight loss
• fast heartbeat
• runny nose, sneezing
• dilated pupils
• irritability
• drowsiness
• physical pain
• fainting
• heavy sweating
• increased tear production
• restlessness and tremor.

Other possible side effects occur with the following frequencies:
From common(may affect up to 1 in 10 people) to uncommon(may affect up to 1 in 100 people):

• shallow and weak breathing
• nausea, vomiting, constipation, biliary tract cramps
• palpitations, slow heartbeat
• confusion, disorientation
• drowsiness, dampness
• urticaria and other skin rashes, itching
• decreased sexual desire and/or impotence
• decreased urination, bladder emptying disorders
• fluid retention in tissues
• insomnia, restlessness
• loss of appetite, fatigue, weakness
• feeling hyped up and feeling down
• profuse sweating, dry mouth
• visual disturbances
• headache
• weight gain.

From rare(may affect up to 1 in 1,000) to very rare(may affect up to 1 in 10,000)

• redness of the skin, including a feeling of warmth
• respiratory arrest
• cardiac arrest
• low blood pressure when standing up
• circulatory dysfunction
• short-term fainting due to irregular heartbeat
• shock
• bleeding.

Not known(frequency cannot be estimated from available data)

• low blood sugar levels. Note Once the regular daily dose is reached, side effects may decrease within a few weeks. Constipation and increased sweating often persist and can be relieved with appropriate measures. Consult your doctor about this.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levometadone cloridrato G.L.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, the label and the
pack after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Tablet container:
after first opening: do not use for more than 6 months.
Solutions of dissolved tablets are stable for up to 3 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Levometadone Hydrochloride G.L. contains

• The active ingredient is levometadone hydrochloride

Levometadone hydrochloride G.L. 2.5 mg tablets
1 tablet contains 2.5 mg of levometadone hydrochloride, equivalent to 2.237 mg of
levometadone.
Levometadone hydrochloride G.L. 5 mg tablets
1 tablet contains 5 mg of levometadone hydrochloride, equivalent to 4.473 mg of levometadone.
Levometadone hydrochloride G.L. 10 mg tablets
1 tablet contains 10 mg of levometadone hydrochloride, equivalent to 8.947 mg of levometadone.
Levometadone hydrochloride G.L. 20 mg tablets
1 tablet contains 20 mg of levometadone hydrochloride, equivalent to 17.893 mg of
levometadone.
Levometadone hydrochloride G.L. 30 mg tablets
1 tablet contains 30 mg of levometadone hydrochloride, equivalent to 26.840 mg of
levometadone.

• The other ingredients are: microcrystalline cellulose; pregelatinized corn starch; lactose monohydrate; sucrose; magnesium stearate.

Description of the appearance of Levometadone Hydrochloride G.L. and contents of the pack
Levometadone hydrochloride G.L. is available in the form of 2.5 mg, 5 mg, 10 mg, 20 mg,
30 mg tablets. The tablets are described below.
2.5 mg:
Round tablet, from white to off-white in color, convex on one side with the inscription “L2”
embossed on one side, score line on the other side, with a diameter of 7.1 ± 0.2 mm and a
thickness of 2.8 ± 0.5 mm. The tablet can be divided into equal doses.
5 mg:
Round tablet, from white to off-white in color, convex on one side with the inscription “L5”
embossed on one side, score line on the other side, with a diameter of 9.2 ± 0.2 mm and a
thickness of 3.9 ± 0.5 mm. The tablet can be divided into equal doses.
10 mg:
Oblong tablet, from white to off-white in color, biconvex with the inscription “L10” embossed in
relief on one side, score line on the other side, with a length of 13.5 ± 0.2 mm, a width
of 5.5 ± 0.2 mm and a thickness of 3.6 ± 0.5 mm. The tablet can be divided into equal doses.
20 mg:
Round tablet, from white to off-white in color, convex on one side with the inscription “L20”
embossed on one side, score line on the other side, with a diameter of 12.1 ± 0.2 mm and a
thickness of 4.8 ± 0.6 mm. The tablet can be divided into equal doses.
30 mg:
Oval tablet, from white to off-white in color, biconvex with the inscription “L30” embossed in
relief on one side, score line on the other side, with a length of 17.5 ± 0.2 mm, a width of 9.0
± 0.2 mm and a thickness of 6.2 ± 0.8 mm. The tablet can be divided into equal doses.
The tablets are packaged in opaque blisters or in opaque white HDPE containers
closed with a child-resistant and tamper-evident screw cap.
Levometadone hydrochloride G.L. 2.5 mg tablets/5 mg tablets:
Levometadone hydrochloride G.L. is available in packs of 7, 28, 30, 50, 56 and 98 tablets in blisters
in PVC/PVdC//Al and in packs of 50, 100 and 500 tablets in HDPE containers.
Levometadone hydrochloride G.L. 10 mg tablets:
Levometadone hydrochloride G.L. is available in packs of 7, 28, 30, 50, 56 and 98 in blisters in
PVC/PVdC//Al and in packs of 50 and 500 tablets in HDPE containers.
Levometadone hydrochloride G.L. 20 mg tablets/30 mg tablets:
Levometadone hydrochloride G.L. is available in packs of 7, 28, 30, 50, 56 and 98 in blisters in
PVC/PVdC//Al and in packs of 100 and 250 tablets in HDPE containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany Levomethadon G.L. Pharma 2,5 mg Tabletten
Levomethadon G.L. Pharma 5 mg Tabletten
Levomethadon G.L. Pharma 10 mg Tabletten
Levomethadon G.L. Pharma 20 mg Tabletten
Levomethadon G.L. Pharma 30 mg Tabletten
Italy Levometadone cloridrato G.L.
<--------------------------------------------------------------------------------------------------------------------------->

The following information is intended exclusively for physicians or healthcare professionals:
Substitution therapy with levometadone must be initiated by a physician experienced in the treatment of
opioid/opiate dependence. Levometadone hydrochloride G.L. is not suitable for acute withdrawal syndrome. Depending on national requirements, such treatment should preferably be administered
in specialized centers for the treatment of opioid/opiate dependence. The recommendations of national guidelines must also be taken into consideration.

Posology
Levometadone is approximately twice as potent as racemic methadone.
The dosage should be based on withdrawal symptoms and should be adjusted on a case-by-case basis, depending on
the individual patient's situation and their subjective experience of withdrawal. Substitution therapy with
levometadone should be initiated when patients are otherwise stable and medically fit. After dose stabilization, it is generally desirable to aim for the lowest effective maintenance dose, administered every 24 hours.
To avoid overdose, 15-20 mg of the initial dose of levometadone hydrochloride should be taken on
the first day in the morning. Depending on the subjective and objective effect, 10-25 mg
additional levometadone hydrochloride is administered in the evening on the first day. In patients with low or
unknown tolerance (e.g. after release from prison), the initial dose should not exceed 15 mg of
levometadone hydrochloride.
After 1-6 days, the daily dose is changed to a single morning dose. The switch to a single
morning dose is usually carried out in increments of 5 mg of levometadone hydrochloride.
In case of insufficient efficacy (appearance of withdrawal symptoms), the treating physician may increase the
dose by 5 to 10 mg of levometadone hydrochloride per day.
A dose higher than 50-60 mg of levometadone hydrochloride may only be administered in exceptional
cases of proven necessity, after excluding substance abuse for medical reasons.
Route of administration
Oral use. Physicians must warn patients that the oral route is the only effective and safe route of administration
for this medicine.
The tablets can be taken whole with sufficient liquid or can
be easily dissolved in water, orange or apple juice.
The solution is intended for immediate consumption.

Precautions
In general, it is recommended to perform an ECG before starting therapy and after two weeks of
treatment, as well as before increasing the dose and as an annual check-up, in order to check cardiac function for signs of cardiac arrhythmia.

Overdose
Even doses lower than those normally used as part of substitution treatment can
produce life-threatening poisoning, particularly in non-tolerant individuals (especially
children). This can occur in children up to 5 years of age from a dose of approximately 0.5 mg of
levometadone, in older children from a dose of approximately 1.5 mg of levometadone and in adults
non-tolerant to opioids from a dose of approximately 10 mg of levometadone.
A dose reduction is recommended in cases where patients show signs and symptoms of excessive
activity of levometadone characterized by malaise such as “feeling strange, poor concentration,
drowsiness and orthostatic dizziness.
Furthermore, overdose is characterized by respiratory depression (Cheyne-Stokes respiration,
cyanosis), extreme drowsiness progressing to stupor or coma, miosis, relaxation of skeletal muscles, moist skin and sometimes bradycardia and hypotension. Severe poisoning can cause respiratory arrest, circulatory collapse, cardiac arrest and death. Hypoglycemia has been reported.
Emergency measures or, if necessary, intensive care interventions (e.g. intubation and
ventilation) must be initiated immediately. Specific opioid antagonists (e.g. naloxone) can be used to treat the symptoms of poisoning. Individual opioid antagonists
differ in dosage (product information must be considered!). In particular, it should be noted that the respiratory depressant effect of levometadone can be prolonged (up to 75
hours), while opioid antagonists are substances of short duration of action (1 to 3 hours). Further injections may be necessary after the effect of the antagonist has subsided. Measures may be necessary
to prevent a drop in body temperature and a volume replacement therapy.
In case of oral poisoning with levometadone, gastric lavage should only be performed after
treatment with an antagonist.
Maintaining airway patency by intubation is of particular importance in case of
gastric lavage and before administration of antagonists (induction of emesis may be possible).
Alcohol, barbiturates, bemegride, phenothiazines and scopolamine should not be used in the therapy of
intoxications.
Levometadone cannot be dialyzed.