EPTADONE 5 mg/ml ORAL SOLUTION

2. What you need to know before you take Eptadone 5 mg/ml 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 have an addiction to medicines that are not like morphine or heroin (non-opioid medicines).
• If you have had breathing or lung problems, now or in the past.
• If you are about to give birth.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Eptadone:

• If you have kidney problems.
• If you have liver problems.
• If you have had a severe headache or a recent head injury.
• If you have been diagnosed with high intracranial pressure.
• If you have heart problems, such as heart 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 are often unwell.

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

• Weakness, tiredness, loss of appetite, nausea, vomiting, or low blood pressure. This may be a sign that your adrenal glands are not producing enough of the hormone cortisol, so you may need to take a hormone supplement.

Long-term use can cause a decrease in sex hormone levels and an increase in prolactin hormone. Talk to your doctor if you get symptoms such as decreased sex drive, impotence, or absence of menstruation (amenorrhea).

Tolerance, dependence, and addiction

This medicine contains an opioid medicine called methadone. Repeated use of opioids can reduce the effectiveness of the medicine (your body gets used to the medicine, this 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 medicine 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 greater risk of becoming dependent or addicted to Eptadone if:

• You or a family member have a history of alcohol, prescription medicine, or illicit substance abuse (addiction).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist 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 more doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to calm down" or "to help you sleep".
• You have made repeated attempts to stop or control the use of the medicine without success.
• You do not feel well 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 address the most appropriate treatment strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 "If you stop taking Eptadone").

Sleep-related breathing disorders

Eptadone can cause sleep-related breathing disorders, 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, nighttime awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Children and adolescents

This medicine is contraindicated in children.

Use in athletes:

This medicine contains methadone, which can produce a positive result in doping tests.

Other medicines and Eptadone

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Eptadone can affect the way some medicines work. Also, other medicines can affect the way Eptadone works.

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

• Medicines for depression called MAOIs (monoamine oxidase inhibitors) or have taken them in 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 diarrhea such as loperamide or co-phenotrope.
• Medicines that acidify the urine such as ammonium chloride.
• Medicines used to counteract 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 counteract the effects of opioid medicines.
• Octreotide used to treat some 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 can increase the risk of opioid overdose, respiratory depression (breathing difficulties), 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, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Eptadone with sedative medicines, your doctor should limit the dose and duration of concomitant treatment. Tell your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding the dose carefully. 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 such symptoms.

The risk of side effects increases if methadone is taken at the same time as antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Talk to your doctor if you get symptoms such as:

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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Eptadone.

Using Eptadone with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

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

Breastfeeding:

• Talk to your doctor if you are breastfeeding or thinking of breastfeeding while taking methadone, as it could affect your baby. Small amounts may pass into breast milk.
• Monitor your baby for any unusual symptoms, such as increased sleepiness (more than usual), breathing difficulties, or floppiness. See a doctor immediately if you notice any of these symptoms.

Driving and using machines:

• Do not drive or use machines when taking Eptadone. Your ability to operate this machinery will be affected. This will happen while you are taking it, and also for some time after.
• Start driving or using tools or machines only when your doctor tells you to.

Eptadone contains:

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

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

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, talk to your doctor or pharmacist.

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

• Do not take more or less than the dose you have been told to take.
• Do not take it more or less often than you have been told to take it.
• Do not take it for longer than your doctor has told you to take it.
• Take this medicine by mouth.
• The concentration of this liquid is 5 milligrams per milliliter.

If you think the effect of Eptadone is too strong or too weak, tell 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 medicine affects you.
• The maintenance dose is around 60/100mg 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, contact the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

The following effects may occur:

• breathing problems
• feeling drowsy, almost unconscious, or loss of consciousness
• pupils of the eyes very small
• cold and sweaty skin
• very slow heartbeat
• muscle weakness
• a brain disorder (known as toxic leukoencephalopathy)

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

A low blood sugar level may occur.

If you forget to take Eptadone

If you forget 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 forgotten doses.

If you stop taking Eptadone

Do not stop taking Eptadone without talking to your doctor first

You may get side effects. If you need to stop taking Eptadone, your doctor will do it gradually.

If you have any other 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 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 the available data)

The following side effects may occur with this medicine:

Common(may affect up to 1 in 10 people)

• breathing problems
• headache, feeling weak, drowsy, confused, difficulty sleeping, feeling nervous or irritable or mood changes, feeling empty-headed
• vision problems or pupils becoming smaller (miosis)
• feeling sick (nausea), vomiting, constipation, dry mouth, or loss of appetite
• slow heartbeat or irregular heartbeats (palpitations)
• difficulty urinating
• loss of sex drive or impotence
• excessive sweating, flushing of the face, or itching and edema

Uncommon(may affect up to 1 in 100 people)

• low blood pressure and feeling dizzy (especially when standing up)

• fainting

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

• extreme weakness that causes the heart to stop
• changes in a test called an electrocardiogram or ECG
• internal bleeding
• high levels of a hormone called prolactin in the blood
• respiratory arrest
• hemorrhagic urticaria
• shock

Frequency not known(cannot be estimated from the available data)

• low blood sugar
• you may become dependent on Eptadone (for more information, see section 2 "Warnings and precautions")
• sleep apnea (pauses in breathing during sleep)

You may find that some of the side effects decrease in intensity over time.

Reporting of side effects

If you experience 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 to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Eptadone 5mg/ml Oral Solution

Keep the bottle in the original packaging.

• Keep out of sight and reach of children. Keep this medicine in a safe place, protected from others. It can cause serious harm and be fatal to people who have not been prescribed it.
• Do not use this medicine after the expiry date which is stated on the packaging after EXP.
• Once the bottle is opened, it must be used within 12 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Eptadone Composition

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

Product Appearance and Packaging Contents:

Eptadone 5 mg/ml oral solution is a clear, lemon-flavored liquid presented in a 1000 ml multidose bottle, for oral administration only.

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

Marketing Authorization 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 on this medicinal product, please contact the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo nº 29

08022 Barcelona

Phone: 93 205 86 86

Date of the last revision of this leaflet:

May 2023

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/)