Eptadone 20 mg oral solution

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Eptadone 20 mg oral solution

Methadone hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Eptadone 20 mg oral solution is and what it is used for
2. What you need to know before taking Eptadone 20 mg oral solution
3. How to take Eptadone 20 mg oral solution
4. Possible side effects
5. Storage of Eptadone 20 mg oral solution
6. Contents of the pack and other information

1. What Eptadone 20 mg oral solution is and what it is used for

Eptadone contains a medicine called methadone, which belongs to a group of medicines that act on the nervous system, such as morphine and diamorphine (also known as heroin). These are sometimes referred to as "opioids". Eptadone is a liquid medicine for oral intake only and must be taken by mouth.

Eptadone is used:

• to treat addiction to drugs such as morphine or heroin (opioids). It acts as a substitute for addictive substances, but is less addictive
• to treat severe pain

2. What you need to know before taking Eptadone 20 mg oral solution

Do not take Eptadone:

• If you are allergic to methadone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you are addicted to medicines that are not opioids, such as morphine or heroin ("opioid" medicines).
• If you have had respiratory or lung problems, now or in the past.
• If you are expecting to go into labour.

Warnings and precautions

Talk to your doctor or pharmacist before starting Eptadone:

• If you have kidney problems.
• If you have liver problems.
• If you have a severe headache or have recently had a head injury.
• If you have been diagnosed with increased intracranial pressure.
• If you have heart problems, such as irregular heartbeat.
• If you have low blood pressure.
• If you have been diagnosed with underactive thyroid gland.
• If you have been diagnosed with overactive adrenal glands.
• If you are a man with prostate problems.
• If you are over 65 years old.
• If you regularly feel unwell.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Eptadone:

• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be signs that your adrenal glands are producing very low levels of the hormone cortisol, and you may need to take a hormonal supplement.

• Pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increase in the dose of the medicine.

Long-term use may lead to decreased levels of sex hormones and increased levels of the hormone prolactin. Consult your doctor if you experience symptoms such as reduced libido, impotence, or absence of menstruation (amenorrhea).

Contact your doctor if you experience severe pain in the upper abdomen that may radiate to the back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary system.

Tolerance, dependence and addiction

This medicine contains an opioid medicine called methadone. Repeated use of opioids may reduce the effectiveness of the medicine (your body becomes used to the medicine, known as tolerance). Repeated use of Eptadone may also cause dependence, abuse, and addiction, which may lead to potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often. When used to treat pain, you may feel that you need to keep taking the medicine even when it no longer helps relieve your pain.

The risk of becoming dependent or addicted varies from person to person. You may be at higher risk of becoming dependent or addicted to Eptadone if:

• You or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction").
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

If you notice any of the following signs while taking Eptadone, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than prescribed, for example, "to calm down" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to discuss the most appropriate treatment strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 “If you stop taking Eptadone”).

Sleep-related breathing disorders

Eptadone may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

Children and adolescents

This medicine is contraindicated in children.

Use in athletes:

This medicine contains methadone, which may result in a positive doping test.

Other medicines and Eptadone

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Eptadone may affect how some medicines work. In addition, other medicines may affect how Eptadone works.

Do not take this medicine and consult your doctor if you are taking:

• Medicines for depression called MAOIs (monoamine oxidase inhibitors) or have taken them within the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine, and tranylcypromine.

Talk to your doctor if you are taking any of the following medicines:

• Medicines for fungal infections such as fluconazole, itraconazole, or ketoconazole.
• Medicines for epilepsy such as barbiturates, phenytoin, or carbamazepine.
• Medicines for diarrhoea such as loperamide or co-phenotrope.
• Medicines that acidify the urine such as ammonium chloride.
• Medicines used to block the effects of opioids such as naltrexone.
• Medicines used to treat addiction such as buprenorphine.
• Medicines for depression such as fluoxetine, paroxetine, sertraline, nefazodone, or fluvoxamine.
• Medicines for HIV such as nevirapine, delavirdine, didanosine, stavudine, zidovudine, ritonavir, abacavir, or efavirenz.
• Antibiotics such as rifampicin, clarithromycin, or erythromycin.
• Strong painkillers such as morphine, butorphanol, nalbuphine, pentazocine.
• Naloxone used to reverse the effects of opioid medicines.
• Octreotide used to treat certain types of cancer and to reduce secretions.
• Verapamil used for heart problems.
• "Cannabinoids" used for pain, such as dronabinol and nabilone.
• Metamizole, a medicine used to treat pain and fever.
• Cannabidiol (a medicine used to treat seizures).
• Gabapentin and pregabalin (medicines used to treat epilepsy, nerve pain, or anxiety). These may increase the risk of opioid overdose, respiratory depression (difficulty breathing), and can be potentially fatal.
• Medicines to calm you down, called benzodiazepines, such as diazepam or flunitrazepam. The concomitant use of Eptadone and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Eptadone together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment. 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 who are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

The risk of side effects increases if methadone is taken simultaneously with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Consult your doctor if you experience symptoms such as:

• changes in mental state (such as restlessness, hallucinations, coma)
• rapid pulse, unstable blood pressure, fever
• overactive reflexes, lack of coordination, muscle stiffness
• gastrointestinal symptoms (such as nausea, vomiting, diarrhoea)

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking Eptadone.

Use of Eptadone with food, drinks and alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase the side effects of methadone. Do not drink grapefruit juice while taking this medicine. Grapefruit juice may alter the effect of methadone.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

• Do not take Eptadone if you are about to go into labour.

Some studies have reported congenital malformations or neurodevelopmental problems (problems related to early development) in children born to mothers who used methadone during pregnancy to treat opioid addiction. However, it is not possible to determine whether this is due to methadone use or other factors, such as maternal health and social and environmental conditions associated with opioid addiction.

Breastfeeding:

• Talk to your doctor if you are breastfeeding or planning to breastfeed while taking methadone, as it may affect your baby. Small amounts may pass into breast milk.
• Monitor your baby for any abnormal signs or symptoms, such as increased drowsiness (more than usual), difficulty breathing, or floppiness. Seek immediate medical attention if you observe any of these symptoms.

Driving and using machines:

• You must not drive or operate machinery when taking Eptadone. Your ability to handle such machinery will be impaired. This will occur while you are taking it, and also for some time afterwards.
• Only resume driving or using tools or machinery when your doctor advises you to do so.

Eptadone contains:

• This medicine contains 0.1% ethanol (alcohol); this small amount corresponds to 0.001 ml per mg.
• This medicine may cause headache, stomach discomfort, and diarrhoea because it contains glycerol.
• This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. Diabetic patients should be aware that this medicine contains 40 g of sucrose per 100 ml.

3. How to take Eptadone 20 mg oral solution

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The dosage must be individually determined, so your doctor will establish the appropriate dose for you and make any necessary adjustments.

• Do not take more or less than the prescribed dose.
• Do not take it more or less frequently than instructed.
• Do not take it for longer than prescribed by your doctor.
• Take this medicine by mouth.
• The concentration of this liquid is 1 mg (milligram) per millilitre.

If you feel that the effect of Eptadone is too strong or too weak, inform your doctor or pharmacist.

For substance dependence

• The usual dose is initially 10 to 30 mg (10 to 30 ml) daily, increasing as needed to 40–60 mg (40–60 ml) per day over the course of 1 to 2 weeks. This will depend on how the medicine affects you.
• The maintenance dose is typically around 60/100 mg per day.
• Always take the dose prescribed by your doctor.

For severe pain

• The usual dose is 5 to 10 mg (5 to 10 ml), every 6–8 hours.
• Your doctor may adjust the amount you should take each day. This will depend on how the medicine affects you.
• Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using Eptadone, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop taking Eptadone”).

If you take more Eptadone than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount taken.

The following effects may occur:

• breathing difficulties
• drowsiness, being almost unconscious, or even loss of consciousness
• very small pupils
• cold and clammy skin
• very slow pulse
• muscle weakness
• a brain disorder (known as toxic leukoencephalopathy)

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

Low blood sugar levels may occur.

If you forget to take Eptadone

If you miss a dose, do not take the medicine when you remember.

Wait until it is time for your next dose and take only one dose.

Do not take a double dose to make up for missed doses.

If you stop taking Eptadone

Do not stop taking Eptadone without first consulting your doctor.

You may experience side effects. If you need to discontinue Eptadone, your doctor will gradually reduce your dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following classification has been used for the frequency of adverse reactions:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Frequency not known (cannot be estimated from available data)

The following adverse effects may occur with this medicine:

Common (may affect up to 1 in 10 people)

• breathing problems
• headache, feeling of weakness, drowsiness, confusion, difficulty sleeping, feeling nervous or irritable, or mood changes, sensation of emptiness in the head
• vision problems or pupils becoming smaller (miosis)
• dizziness (nausea), vomiting, constipation, dry mouth, or loss of appetite
• slower heart rate or irregular heartbeat (palpitations)
• difficulty urinating
• loss of sexual desire or sexual impotence
• excessive sweating, facial flushing, itching, and edema

Uncommon (may affect up to 1 in 100 people)

• low blood pressure and dizziness (especially when standing up)
• fainting (syncope)

Rare (may affect up to 1 in 1,000 people)

• extreme weakness leading to cardiac arrest
• changes in a test called electrocardiogram or ECG
• internal bleeding
• high levels in the blood of a hormone called prolactin
• respiratory arrest
• hemorrhagic urticaria
• shock

Frequency not known (cannot be estimated from available data)

• low blood sugar levels
• you may become dependent on Eptadone (for further information, see section 2 “Warnings and precautions”)
• sleep apnea (breathing pauses during sleep)
• symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary system (a condition affecting the intestinal valve known as Oddi sphincter dysfunction), for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

You may notice that some of these adverse effects decrease in intensity over time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eptadone 20 mg oral solution

Keep the bottle in the outer packaging.

• Keep out of the sight and reach of children. Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
• Do not use this medicine after the expiry date stated on the packaging after EXP.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Eptadone

• The active substance is methadone hydrochloride. Each ml of Eptadone contains 1 mg of methadone hydrochloride.
• The other components (excipients) are sucrose, glycerol, citric acid monohydrate, lemon flavour (containing citropten, citral and ethanol), sodium benzoate and purified water.

Appearance of the product and contents of the pack:

Eptadone 20 mg oral solution is a lemon-flavoured, clear liquid supplied in a 20 ml single-dose bottle for oral administration only.

Each bottle contains 20 mg of methadone hydrochloride.

Marketing Authorisation Holder and Manufacturer:

• Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.

SS67 Fraz. Granatieri

50018 Scandicci (Florence)

Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo nº 29

08022 Barcelona

Tel.: 93 205 86 86

Date of the most recent review of this leaflet:

April 2026

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)