EPTADONE 100 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Eptadone 100 mg Oral Solution

Methadone Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Eptadone 100 mg Oral Solution is and what it is used for
2. What you need to know before you take Eptadone 100 mg Oral Solution
3. How to take Eptadone 100 mg Oral Solution
4. Possible side effects

5 Storage of Eptadone 100 mg Oral Solution

1. Contents of the pack and further information

1. What Eptadone 100 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 like morphine and diamorphine (also known as heroin). They are sometimes known as "opioids". Eptadone is a liquid medicine that should only be taken by mouth.

Eptadone is used:

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

2. What you need to know before you take Eptadone 100 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 have 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 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 problems with your heart rhythm.
• 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 producing very low levels 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 libido, 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 have 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 medicines, or illicit substances ("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 treatment with 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 sleepiness during the day. If you or someone else notices 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 may produce a positive result in doping tests.

Other medicines and Eptadone

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. Eptadone may affect the way some medicines work. Also, other medicines may affect the way Eptadone works.

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

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

Consult 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.
• Potent painkillers such as morphine, butorphanol, nalbuphine, pentazocine.
• Naloxone used to counteract 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 (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 must limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding the dose carefully. It may be useful 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). Consult your doctor if you get symptoms such as:

• changes in mental state (such as restlessness, hallucinations, coma)
• fast heart rate, 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, consult your doctor or pharmacist before taking Eptadone.

Using 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 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 may affect your baby. Small amounts may pass into breast milk.
• Monitor your baby for signs and symptoms such as increased sleepiness (more than usual), breathing difficulties, or weakness. Contact your 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 0.0002 ml 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 be aware that this medicine contains 40 g of sucrose per 100 ml.

3. How to take Eptadone 100 mg Oral Solution

Follow exactly the administration instructions of this medicine given 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 the 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 your doctor prescribes.
• Take this medicine by mouth.
• The concentration of this liquid is 5 mg (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 the course of 1 to 2 weeks. This will depend on how the medicine 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 Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

The following effects may appear:

• breathing problems
• feeling of drowsiness, almost unconscious or even loss of consciousness
• pupils of the eyes very small
• cold and sweaty 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.

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 treatment with Eptadone

Do not stop taking Eptadone without consulting your doctor first

You may have side effects. If you need to stop taking Eptadone, your doctor will gradually reduce the dose.

If you have any further questions on 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 adverse reactions may appear 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, feeling of empty head
• vision problems or pupils become smaller (miosis)
• feeling of nausea, vomiting, constipation, dry mouth, or loss of appetite
• slow heart rate or irregular heartbeats (palpitations)
• difficulty urinating
• loss of sexual desire or sexual 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 of dizziness (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 in the blood of a hormone called prolactin
• respiratory arrest
• hemorrhagic urticaria
• shock

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

• low blood sugar level
• 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storage of Eptadone 100 mg 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 carton after EXP.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Packaging Content 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 Content:

Eptadone 100 mg oral solution is a clear, lemon-flavored liquid presented in a single-dose vial for oral administration only.

Each vial contains 100 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/)