ELLEPALMIRON

Package leaflet: Information for the patient

Ellepalmiron 5 mg/ml oral solution

Levomethadone hydrochloride
Equivalent medicine
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ellepalmiron is and what it is used for

Ellepalmiron contains the active substance levomethadone hydrochloride. It belongs to a group of medicines
that act on your nervous system.
Ellepalmiron is used to treat adults who are dependent on drugs known as "opioids" or "narcotic analgesics" – such as heroin and morphine. It works as a substitute for the addictive drugs.

2. What you need to know before taking Ellepalmiron

Do not take Ellepalmiron if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• you are taking medicines for depression called "MAOIs" (monoamine oxidase inhibitors) or have taken them within the last 2 weeks (see "Other medicines and Ellepalmiron")
• you are taking medicines for addiction treatment or strong painkillers (see "Other medicines and Ellepalmiron")
• you have serious breathing or lung problems
• you are not opioid-dependent.

Children and adolescents under 18 years of age must not take this medicine.
Do not take Ellepalmiron if any of the conditions listed above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Ellepalmiron.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ellepalmiron if:

• you do not feel alert or fully awake (you have a "low level of consciousness")
• you have low blood pressure
• you have had heart problems, including heart disease or irregular heartbeat
• you have had breathing or lung problems, such as asthma or "COPD" (chronic obstructive pulmonary disease)
• you are unable to urinate
• you are a man with prostate problems
• you have gallbladder or bile duct problems
• you have inflammation of the pancreas
• you have intestinal problems
• you have underactive thyroid gland
• you have increased pressure inside the skull
• you have adrenal gland problems – either an overactive adrenal gland or a type of tumor (called "pheochromocytoma")
• your doctor has diagnosed you with an electrolyte imbalance such as "hypokalemia"

If any of the conditions listed above apply to you (or if you are unsure), talk to your doctor or pharmacist before taking Ellepalmiron.

When using levometadone, it is important to note that it is approximately twice as potent as methadone (see also section 3 "How to take Ellepalmiron").

Ellepalmiron is for oral use only and must not be injected. Injecting this medicine is dangerous and can seriously harm your health: you may develop infections in the body, veins may become painful and swollen, or you may experience blockage of a blood vessel in the lungs.

Effects on anti-doping tests

For individuals engaged in sports, using Ellepalmiron without therapeutic need constitutes doping and may result in a positive anti-doping test. Do not use Ellepalmiron as a performance-enhancing substance – it may seriously harm your health.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Other medicines and Ellepalmiron

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines obtained without a prescription and herbal medicines. This is because Ellepalmiron may affect how some medicines work, or other medicines may affect how Ellepalmiron works.

Do not take Ellepalmiron and consult your doctor or pharmacist if you are taking any of the following medicines:

• antidepressant medicines called MAOIs (monoamine oxidase inhibitors), or if you have taken them within the last 2 weeks – this includes moclobemide, phenelzine, and tranylcypromine
• medicines used to treat addiction – such as buprenorphine. You must wait at least 20 hours after stopping Ellepalmiron before starting buprenorphine
• strong painkillers – such as morphine, butorphanol, nalbuphine, and pentazocine.

If any of the conditions listed above apply to you (or if you are unsure), do not take Ellepalmiron and consult your doctor or pharmacist.

Tell your doctor or pharmacist before taking Ellepalmiron if you are taking any of the following medicines:

• medicines for a serious mental health condition called "psychosis", such as chlorpromazine
• medicines that dull your senses, including:
• other antidepressants – such as amitriptyline and clomipramine
• medicines that help you sleep – including anesthetics
• medicines that calm you called benzodiazepines – such as diazepam and flunitrazepam
• medicines for high blood pressure – such as reserpine, clonidine, urapidil, and prazosin
• antifungal medicines – such as fluconazole, itraconazole, and ketoconazole
• medicines for heart problems – such as quinidine, verapamil, and diltiazem
• cimetidine – used to treat stomach ulcers
• rifampicin – an antibiotic
• oral contraceptives ("the pill")
• medicines for epilepsy, including barbiturates – such as phenytoin and carbamazepine
• medicines that calm you called benzodiazepines – such as diazepam and flunitrazepam

The concomitant use of Ellepalmiron and sedative medicines such as benzodiazepines or related substances increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should be considered only when no other treatment options are available. However, if your doctor prescribes Ellepalmiron together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the symptoms listed above. Contact your doctor if you experience any of these symptoms.

If any of the conditions listed above apply to you (or if you are unsure), do not take Ellepalmiron and consult your doctor or pharmacist.

Ellepalmiron with food, drinks, and alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase the undesirable effects of Ellepalmiron.

Pregnancy, breastfeeding, and fertility

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking Ellepalmiron.
• Ask your doctor for advice before taking Ellepalmiron if you are breastfeeding. Small amounts may pass into your breast milk and this may affect your baby.

Driving and using machines

Do not drive or operate tools or machinery while taking Ellepalmiron.

This is because you may feel drowsy and less alert both during treatment and for some time after stopping the medicine.

You may only drive or operate tools or machinery if your doctor confirms that it is safe for you to do so.

Ellepalmiron contains methyl 4-hydroxybenzoate (E218)

This may cause allergic reactions (including delayed reactions).

3. How to take Ellepalmiron

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

How much to take

Your dose is determined by your doctor:

• It is individually tailored for you
• It is based on how early your dependence symptoms appear

Always take the dose prescribed by your doctor:

• Do not take more or less of this medicine than prescribed
• Do not take this medicine more or less frequently than prescribed

Initial dose:

• The usual starting dose is 3 or 4 ml of oral solution daily (equivalent to 15 or 20 mg of levometadone hydrochloride).

Dose increase:

• Your doctor may increase your dose by 1 or 2 ml daily (equivalent to 5 or 10 mg of levometadone hydrochloride), depending on how the medicine affects you.
• The usual dose can be up to 12 ml of oral solution daily (equivalent to 60 mg of levometadone hydrochloride). In some cases, your doctor may instruct you to take a higher dose.

Elderly patients and severely ill patients
Your dose may be reduced if you are over 65 years of age. It may also be reduced if you are in poor general health or have severe kidney problems or long-standing severe liver problems. In such cases, your doctor may decide to monitor you more closely.

Method of administration

• Ellepalmiron is a liquid for oral use only.
• You may take this medicine undiluted or diluted with water or non-alcoholic drinks – such as orange juice.
• Your dose is measured and administered by your doctor or pharmacist.

If you take more Ellepalmiron than you should
If you take more Ellepalmiron than prescribed, speak to a doctor or go to hospital immediately. Take the medicine pack with you. The following effects may occur:

• Breathing difficulties
• Extreme drowsiness, near-fainting ("unconscious state") or coma
• Very small pupils in your eyes
• Cold and clammy skin
• Very low pulse
• Muscle weakness

In extreme cases, your breathing or blood circulation may stop, and you may have a heart attack.

If you forget to take Ellepalmiron
If you forget a dose, skip the missed dose and take the next one at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Ellepalmiron
Do not stop taking Ellepalmiron without first discussing it with your doctor, as you may experience unwanted effects. If you need to stop taking Ellepalmiron, your doctor will gradually discontinue it.

If you have any questions about how to use 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.
Tell your doctor if you notice any of the following side effects:
Side effects that occur more commonly at the beginning of treatment:

• feeling anxious, depressed, irritable or drowsy
• loss of appetite (anorexia), weight loss or feeling unwell (nausea)
• cramps in the stomach or intestines, diarrhoea or vomiting
• fever, chills alternating with hot flushes, yawning, goosebumps, runny nose, sneezing
• sudden, rapid movements or tremor
• increased heart rate (tachycardia)
• very small pupils in your eyes
• widespread body pain
• feeling weak or tired
• excessive sweating or watery eyes.

Other side effects include:
From uncommon (may affect up to 1 in 100 people) to common (may affect up to 1 in 10):

• slow or shallow breathing
• headache or vision problems
• feeling weak, dizzy, lethargic, confused or disoriented
• feeling very sleepy or unable to sleep
• feeling “high” or feeling “low”
• palpitations or reduced heart rate
• reduced sexual desire
• decreased libido or difficulty achieving and maintaining an erection in men
• sweating
• skin rashes, including urticaria and other types of itchy rash
• dry mouth
• loss of appetite, nausea or vomiting
• constipation
• fluid retention (‘oedema’), ‘biliary colic’ which may cause pain in the upper abdomen or back
• urinary problems including reduced urine output

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

• skin flushing and feeling of warmth (“hot flushes”)
• slow internal bleeding
• breathing stoppage
• low blood pressure when standing up quickly or sitting up
• absent heartbeats, heart attack, problems with pumping blood around the body, going into ‘shock’.

You may notice that some side effects become less intense over time. However, constipation and excessive sweating do not tend to improve. Consult your doctor or pharmacist about treatment to help relieve symptoms of these side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 Ellepalmiron

• 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 label and the carton after "Exp.". The expiry date refers to the last day of that month.
• Store below 25°C.
• Once the bottle has been opened, use the oral solution within 12 weeks.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ellepalmiron contains

• The active substance is levomethadone hydrochloride. Each millilitre (ml) of oral solution contains 5 milligrams (mg) of levomethadone hydrochloride.
• The other components are methyl 4-hydroxybenzoate (E218), betaine hydrochloride, glycerol, purified water.

Description of the appearance of Ellepalmiron and contents of the pack

• Ellepalmiron is a clear, colourless oral solution.
• It is available in packs of 100 ml, 3x100 ml and 500 ml.
• It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67, Frazione. Granatieri
50018 Scandicci (Florence)
Italy
This medicinal product is authorised in the European Economic Area countries under the
following names:
Germany L-Polaflux
Italy Ellepalmiron
Poland Levomethadone Hydrochloride Molteni
Spain Levometadona Hidrocloruro Molteni
Patient Information Leaflet

Ellepalmiron 2.5 mg/ml oral solution

For use in adults
Levomethadone hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ellepalmiron is and what it is used for

Ellepalmiron contains the active substance levomethadone hydrochloride. It belongs to a group of medicines
that act on your nervous system.
Ellepalmiron is used to treat adults who are dependent on drugs known as "opioids" or "narcotic analgesics" – such as heroin and morphine. It works as a substitute for the addictive drugs.

2. What you need to know before taking Ellepalmiron

Do not take Ellepalmiron if:

• you are allergic to levomethadone or to any of the other ingredients of this medicine (listed in section 6)
• you are taking medicines for depression called "MAOIs" (monoamine oxidase inhibitors), or have taken them within the last 2 weeks (see "Other medicines and Ellepalmiron")
• you are taking medicines for addiction treatment or strong painkillers (see "Other medicines and Ellepalmiron")
• you have serious breathing or lung problems
• you are dependent on non-opioid substances
• you are under 18 years of age.

Do not take Ellepalmiron if any of the conditions listed above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Ellepalmiron.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ellepalmiron if:

• you do not feel alert or fully awake (you have a "low level of consciousness")
• you have low blood pressure
• you have had heart problems, including heart disease or irregular heartbeat
• you have had breathing or lung problems, such as asthma or chronic obstructive pulmonary disease ("COPD")
• you are unable to pass urine
• you are a man with prostate problems
• you have gallbladder or bile duct problems
• you have inflammation of the pancreas
• you have intestinal problems
• you have underactive thyroid gland
• you have high pressure inside the skull
• you have adrenal gland problems – either an overactive adrenal gland or a type of tumor (called "pheochromocytoma")
• your doctor has diagnosed you with an "electrolyte imbalance" such as "hypokalemia"

If any of the conditions listed above apply to you (or if you are unsure), talk to your doctor or pharmacist before taking Ellepalmiron.
Be careful when using Ellepalmiron
Ellepalmiron is approximately twice as potent as methadone. See section 3 "How to take Ellepalmiron" for correct dosing.
Do not inject Ellepalmiron – use it only orally. Injecting it is dangerous and can seriously harm you. It may cause infection in the body, painful and swollen veins, or blockage of a blood vessel in the lungs.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Ellepalmiron
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This includes medicines obtained without a prescription and herbal medicines. This is because Ellepalmiron can affect how some medicines work. Also, other medicines can affect how Ellepalmiron works.
Do not take Ellepalmiron and consult your doctor or pharmacist if you are taking any of the following medicines:

• medicines for depression called MAOIs (monoamine oxidase inhibitors), or if you have taken them within the last 2 weeks – this includes moclobemide, phenelzine, and tranylcypromine
• medicines for treating addiction – such as buprenorphine. You must wait at least 20 hours after stopping Ellepalmiron before starting buprenorphine
• strong painkillers – such as morphine, butorphanol, nalbuphine, and pentazocine. If any of the conditions listed above apply to you (or if you are unsure), do not take Ellepalmiron and consult your doctor or pharmacist.

Tell your doctor or pharmacist before taking Ellepalmiron if you are taking any of the following medicines:

• medicines for a serious mental health condition called "psychosis", such as chlorpromazine
• medicines that dull your senses, including:
• other medicines for depression – such as amitriptyline and clomipramine
• medicines that help you sleep – including anesthetics
• medicines for high blood pressure – such as reserpine, clonidine, urapidil, and prazosin
• medicines for fungal infections – such as fluconazole, itraconazole, and ketoconazole
• medicines for heart problems – such as quinidine, verapamil, and diltiazem
• cimetidine – for treating stomach ulcers
• rifampicin – an antibiotic
• oral contraceptives ('the pill')
• medicines for epilepsy, including barbiturates – such as phenytoin and carbamazepine
• medicines that calm you, called benzodiazepines – such as diazepam and flunitrazepam

Concomitant use of Ellepalmiron and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not possible. However, if your doctor prescribes Ellepalmiron together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and follow the doctor's dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms. If any of the conditions listed above apply to you (or if you are unsure), do not take Ellepalmiron and consult your doctor or pharmacist.

Ellepalmiron and alcohol
Do not drink alcohol while taking this medicine. Alcohol may increase the undesirable effects of Ellepalmiron.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy

• Ellepalmiron may be used during pregnancy after careful risk-benefit assessment by a doctor, preferably under supervision in a specialized medical center.

The dose may need to be increased up to twice daily to maintain treatment effectiveness due to metabolic changes during pregnancy.

• Chronic use during pregnancy may lead to fetal dependence on levomethadone and postnatal withdrawal symptoms, which often require hospital treatment.

Breastfeeding
Levomethadone is excreted in breast milk. Your doctor will decide whether you can breastfeed during replacement treatment with Ellepalmiron.
Fertility
It has been reported that methadone may cause sexual dysfunction in male patients during maintenance treatment.
Driving and using machines
Do not drive or operate machinery while taking Ellepalmiron.
This is because you may feel drowsy and less alert both while taking the medicine and for some time after stopping it.
You may drive or operate machinery only if your doctor tells you it is safe to do so.
Ellepalmiron contains methyl 4-hydroxybenzoate (E218)
This may cause allergic reactions (including delayed reactions).

3. How to take Ellepalmiron

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
How much to take
Your dose will be decided by your doctor:

• it is individually tailored for you
• it is based on how soon your withdrawal symptoms appear. Always take the dose prescribed by your doctor:
• do not take more or less of this medicine than prescribed
• do not take this medicine more or less often than prescribed. Initial dose:
• The usual initial dose is 6 to 8 ml of oral solution once daily in the morning (equivalent to 15–20 mg of levomethadone hydrochloride).
• If necessary, a second dose of 4 to 10 ml of oral solution may be administered in the evening (equivalent to 10–25 mg of levomethadone hydrochloride). Dose increase:
• Your doctor will usually increase your dose over a period of 1 to 6 days until the appropriate dose for you is reached.
• Your doctor may increase your dose by 2 or 4 ml daily (equivalent to 5 or 10 mg of levomethadone hydrochloride), depending on how the medicine affects you.
• The usual dose can be up to 24 ml of oral solution daily (equivalent to 60 mg of levomethadone hydrochloride). In some cases, your doctor may instruct you to take a higher dose. Remember that Ellepalmiron is approximately twice as potent as methadone – this means you will take less of it compared to methadone.

If you are elderly, have kidney or liver problems, or are seriously ill
Your dose may be reduced if you are over 65 years of age, in poor general health, or have severe or long-standing kidney or liver problems. In such cases, your doctor may decide to monitor you more closely.
How to take Ellepalmiron

• Ellepalmiron is for oral use only.
• You may take this medicine as it is or diluted with water or non-alcoholic drinks – such as orange juice.
• Your dose will be measured and administered by your doctor or pharmacist. If you take more Ellepalmiron than you should If you take more Ellepalmiron than prescribed, speak to a doctor or go to hospital immediately. Take the medicine package with you. The following effects may occur:
• breathing difficulties
• extreme drowsiness, near-unconsciousness, or coma
• very small pupils
• cold and clammy skin
• very slow heartbeat
• muscle weakness. In extreme cases, your breathing or blood circulation may stop and you may suffer a heart attack. If you forget to take Ellepalmiron If you miss a dose, skip the missed dose and take the next one at your usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Ellepalmiron Do not stop taking Ellepalmiron without first discussing it with your doctor, as you may experience unwanted effects. If you need to stop taking Ellepalmiron, your doctor will gradually taper off the treatment. If you have any questions about using 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.
Tell your doctor if you notice any of the following side effects:

Side effects that occur more frequently at the beginning of treatment:

• feeling anxious, depressed, irritable or drowsy
• loss of appetite (anorexia), weight loss or feeling unwell (nausea)
• stomach or intestinal cramps, diarrhoea or vomiting
• fever, chills alternating with hot flushes, yawning, goosebumps, runny nose, sneezing
• sudden, rapid movements or trembling (tremor)
• increased heart rate (tachycardia)
• very small pupils in your eyes
• widespread body pain
• feeling weak or fatigued
• excessive sweating or watery eyes

Other side effects include:

From uncommon (may affect up to 1 in 100 people) to common (may affect up to 1 in 10):

• slow or shallow breathing
• headache or vision problems
• feeling weak, dizzy, faint, confused or disoriented
• feeling very drowsy or unable to sleep
• feeling “high” or feeling “low”
• palpitations or reduced heart rate
• reduced sexual desire
• decreased sexual drive or difficulty achieving and maintaining an erection in men
• sweating
• skin rashes, including hives and other types of itchy rash
• dry mouth
• loss of appetite, nausea or vomiting
• constipation
• fluid retention (‘oedema’), ‘biliary colic’ which may cause pain in the upper abdomen or back
• urinary problems including reduced urine output

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

• skin redness and feeling of warmth (“flushes”)
• slow internal bleeding
• respiratory arrest
• low blood pressure when standing up quickly or sitting up
• absent heartbeats, heart attack, problems with pumping blood around the body, going into ‘shock’

You may notice that some side effects become less intense over time. However, constipation and excessive sweating do not tend to improve. Consult your doctor or pharmacist about treatment to relieve symptoms of these side effects.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco).
Website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ellepalmiron

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Once a multidose bottle (60, 100 or 1000 ml) is opened, use the oral solution within 12 weeks.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ellepalmiron 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 4-hydroxybenzoate (E218), betaine hydrochloride, glycerol, caramel (E150C), purified water.

Description of the appearance of Ellepalmiron and contents of the pack

• Ellepalmiron 2.5 mg/ml oral solution is a slightly amber-coloured, clear liquid.
• It is available in the following pack sizes:
• single-dose bottles of 5, 10 or 20 ml, closed with a child-resistant cap;
• multiple-dose bottles of 60 or 100 ml, closed with a child-resistant cap and an insert (pipette adapter). A 5 ml pipette, graduated from 0.25 to 5 ml in 0.25 ml increments, is supplied with the bottle;
• amber PVC bottle of 1000 ml, closed with a plastic screw cap and an inner seal. A dosing cup from 1 to 6 ml is supplied. 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 – Tosco Romagnola
50018 Scandicci (Florence)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Levomethadon Hexal 2.5 mg/ml solution for oral intake
Italy Ellepalmiron 2.5 mg/ml oral solution
Poland Levomethadone Hydrochloride Molteni 2.5 mg/ml oral solution