Prospect:Information for the Patient

Eptadone 5 mg/ml Oral Solution

Methadone Hydrochloride

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others, 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 not listed in this prospect. See section 4.

1.What is Eptadone 5 mg/ml Oral Solution and for what it is used

2.What you need to know before starting to take Eptadone 5 mg/ml Oral Solution

3.How to take Eptadone 5 mg/ml Oral Solution

4.Possible adverse effects

5Storage of Eptadone 5 mg/ml Oral Solution

6.Contents of the package and additional information

Eptadone contains a medicine called methadone, which belongs to a group of medicines that act on the nervous system like morphine and diamorphine (also known as heroin). Sometimes they are known as “opioids”. Eptadone is a liquid drinkable medicine that should only be taken orally.

Eptadone is used:

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

Do not take Eptadone:

• If you are allergic to hydrochloride of metadone or to any of the other components of this medication (including those listed in section 6).
• If you have addiction to medications that are not like morphine or heroin (opioid medications).
• If you have had respiratory or pulmonary problems, now or in the past.
• If you are expecting to give birth.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eptadone:

• If you have kidney problems.
• If you have liver problems.
• If you have a severe headache or have had a head injury recently.
• If you have been diagnosed with high intracranial pressure.
• If you have heart problems, such as rhythm problems.
• If you have low blood pressure.
• If you have been diagnosed with low thyroid function.
• If you have been diagnosed with high adrenal function.
• If you are a man with prostate problems.
• If you are over 65 years old.
• If you usually 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. This may be a sign that your adrenal glands are producing very low levels of cortisol, so you may need to take a hormone supplement.

Long-term use may cause a decrease in sex hormone levels and an increase in prolactin levels. Consult your doctor if you experience symptoms such as decreased libido, impotence, or absence of menstruation (amenorrhea).

Tolerance, dependence, and addiction

This medication contains an opioid medication called metadone. Repeated use of opioids can reduce the effectiveness of the medication (your body gets used to the medication, this is what is known as tolerance). Repeated use of Eptadone can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose.

Dependence or addiction can make you feel like you no longer have control over the amount of medication you need to take or how often you need to take it.

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

• You or a family member have a history of abuse or dependence on alcohol, prescription medications, or illicit substances (addiction).
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

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 medication for a longer period than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medication for reasons other than those prescribed, such as "to calm down" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop or control the use of the medication.
• You do not feel well when you stop taking the medication and feel better when you take it again (abstinence symptoms).

If you notice any of these signs, talk to your doctor to address the most appropriate therapeutic strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 "If you interrupt treatment with Eptadone").

Respiratory problems related to sleep

Eptadone can cause respiratory problems related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Children and adolescents

This medication is contraindicated in children.

Use in athletes:

This medication contains Metadone, which can produce a positive result in doping tests.

Other medications and Eptadone

Inform your doctor or pharmacist if you are using or have recently usedor may need to use any other medication. Eptadone may affect the way some medications work. Additionally, other medications may affect the way Eptadone works.

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

• Depression medications called IMAO (monoamine oxidase inhibitors) or have taken them in the last 2 weeks. IMAO medications are medications such as moclobemide, phenelzine, and tranylcypromine.

Consult your doctor if you are taking any of the following medications:

• Fungal infection medications such as fluconazole, itraconazole, or ketoconazole.
• Epilepsy medications such as barbiturates, phenytoin, or carbamazepine.
• Diarhea medications such as loperamide or co-phenotrope.
• Medications that acidify the urine such as ammonium chloride.
• Medications used to stop the action of opioids such as naltrexone.
• Medications used to treat addiction such as buprenorphine.
• Depression medications such as fluoxetine, paroxetine, sertraline, nefazodone, or fluvoxamine.
• Medications for HIV such as nevirapine, delavirdine, didanosine, stavudine, zidovudine, ritonavir, abacavir, or efavirenz.
• Antibiotics such as rifampicin, clarithromycin, or erythromycin.
• Potent analgesics such as morphine, butorphanol, nalbuphine, pentazocine.
• Naloxone used to counteract the effects of opioid medications.
• Octreotide used to treat certain types of cancer and to reduce secretions.
• Verapamil used to treat heart problems.
• "Cannabinoids" used to treat pain, such as dronabinol and nabilone.
• Metamizol, a medication used to treat pain and fever.
• Cannabidiol (a medication used to treat seizures).
• Gabapentin and pregabalin (medications used to treat epilepsy, nerve pain, or anxiety). These may increase the risk of opioid overdose, respiratory depression (difficulty breathing), and may be potentially fatal.
• Medications to calm you down, called benzodiazepines, such as diazepam or flunitrazepam.
  The concomitant use ofEptadoneand sedatives such as benzodiazepines or related medications increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and may be potentially fatal.Therefore, it should only be considered when other treatment options are not possible.
  However, if your doctor prescribesEptadonealong with sedatives, your doctor should limit the dose and duration of concomitant treatment.
  Inform your doctor about all sedatives you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

The risk of side effects increases if metadone is consumed 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)
• Fast pulse, unstable blood pressure, fever
• Increased reflexes, discoordination, muscle rigidity
• Gastrointestinal symptoms (such as nausea, vomiting, diarrhea)

If you are unsure if 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 medication. Alcohol may increase the side effects of metadone. Do not drink grapefruit juice while taking this medication. Grapefruit juice may alter the effect of metadone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

• Do not take Eptadone if you are expecting to give birth.

Lactation:

• Talk to your doctor if you are breastfeeding or planning to do so while taking metadone, as it may affect your baby. Small amounts may pass into breast milk.Monitor your baby for any abnormal signs and symptoms, such as excessive sleepiness, difficulty breathing, or weakness. Immediately contact your doctor if you observe any of these symptoms.

Driving and using machines:

• You should not drive or use machines while taking Eptadone. Your ability to operate this equipment will be affected. This will occur while you are taking it, and also for some time afterwards.
• Only start driving or using tools or machines when your doctor tells you to.

Eptadone contains:

• 0.1% ethanol (alcohol), this small amount corresponds to 0.0002ml per mg.
• This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. Patients with diabetes should note that this medication contains 40g of saccharose per 100ml.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

• Do not take more or less than the dose indicated.
• Do not take it more or less frequently than indicated.
• Do not take it for longer than prescribed by your doctor.
• Take this medication orally.
• The concentration of this liquid is 5 milligrams per milliliter.

If you estimate that the action 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 (2 to 6 ml) per day, increasing to 40-60 mg (8-12 ml) per day as needed over 1 to 2 weeks. This will depend on how the medication affects you.
• The maintenance dose is around 60/100 mg per day.
• Always take the dose prescribed by your doctor.

If you take more Eptadone than you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount taken.

The following effects may appear:

• Respiratory problems
• Sensation of drowsiness, almost unconscious or even loss of consciousness
• Very small pupils in the eyes
• Cold and moist 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 have a heart attack.

It may cause a low level of blood sugar.

If you forgot to take Eptadone

If you forget a dose, do not take the medication when you remember.

Wait until it's time for your next dose and take only one dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eptadone

Do not stop taking Eptadone without consulting your doctor first

You may experience side effects. If you need to stop taking Eptadone, your doctor will make you stop gradually.

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

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

The following criteria have been used to classify 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 side effects may occur with this medicine:

Common(may affect up to 1 in 10 people)

• Respiratory problems
• Headache, feeling of weakness, drowsiness, confusion, difficulty sleeping, feeling of nervousness or irritability, or mood changes, feeling of empty-headedness
• Visual problems or constricted pupils (miosis)
• Feeling of dizziness (nausea), vomiting, constipation, dry mouth, or loss of appetite
• Slower heart rate or irregular heartbeats (palpitations)
• Difficulty urinating
• Loss of sexual desire or impotence
• Excessive sweating, facial flushing, or itching and edema

Uncommon(may affect up to 1 in 100 people)

• Low blood pressure and feeling of dizziness (especially when standing up)

• Syncope

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

• Extreme weakness causing heart stoppage
• Changes in an electrocardiogram (ECG) test
• Internal bleeding
• High levels of a hormone called prolactin in the blood
• 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 more information, see section 2 “Warnings and precautions”)
• Sleep apnea (pauses in breathing during sleep)

You may notice that some side effects decrease in intensity over time.

Reporting of side effects

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

Keep the bottle in its original packaging.

• Keep out of the sight and reach of children..Store this medication in a safe and secure location where others cannot access it. It may cause severe harm and be fatal to individuals who have not been prescribed it.
• Do not use this medication after the expiration date appearing on the packaging after CAD.
• Once the bottle is opened, use it within 12 months.

Medications should not be disposed of through drains or trash. If unsure, ask your pharmacist how to dispose of unused packaging and medication. This will help protect the environment..

Composition of Eptadone

• The active principle is hydrochloride of methadone. Each ml of Eptadone contains 5 mg of hydrochloride of methadone.
• The other components (excipients) are sucrose, glycerol, citric acid monohydrate, lemon aroma (includes citropten, citral and ethanol), sodium benzoate and purified water.

Appearance of the product and contents of the packaging:

Eptadone 5 mg/ml oral solution is a transparent lemon-flavored liquid that is presented in a multi-dose bottle of 1000 ml, for oral administration only.

It contains a dosing cup. Each bottle contains 5000 mg of methadone hydrochloride.

Holder of the marketing authorization and responsible for manufacturing:

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

SS67 Fraz. Granatieri

50018 Scandicci (Florence)

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo nº 29

08022 Barcelona

Tel.: 93 205 86 86

Date of the last review of this leaflet:

May 2023

Other sources of information

The detailed information about this medication is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)