EPTADONE 10 mg /1 Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. EPTADONE 5 mg/20 ml syrup, 10 mg/20 ml syrup, 20 mg/20 ml syrup, 1 mg/ml syrup
   1. What is Eptadone and what is it used for?
   2. What you need to know before taking Eptadone
   3. How to take Eptadone
   4. Possible side effects
   5. How to store Eptadone
   6. Contents of the pack and other information
2. EPTADONE 10 mg/1 ml injectable solution
   1. What is Eptadone and what is it used for?
   2. What you need to know before using Eptadone
   3. How to use Eptadone
   4. Possible side effects
   5. How to store Eptadone
   6. Contents of the pack and other information

EPTADONE 5 mg/20 ml syrup, 10 mg/20 ml syrup, 20 mg/20 ml syrup, 1 mg/ml syrup

Methadone hydrochloride

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Eptadone and what is it used for?

Eptadone contains the active ingredient methadone hydrochloride, which belongs to a group of medicines that
act on the Nervous System, opioid analgesics.
This medicine is used for the treatment of severe pain, which does not respond to other pain-relieving
medicines.

2. What you need to know before taking Eptadone

Do not take Eptadone

• if you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe constipation;
• if you have heart problems (organic heart disease);
• if you have serious problems with your liver and kidneys;
• if you suffer from fluctuations in blood glucose levels (uncontrolled diabetes);
• if you suffer from porphyria (a rare blood disease);
• if you have low blood pressure (hypotension);
• if you have high pressure inside the skull (intracranial hypertension);
• if you have head injuries (cranioencephalic traumas);
• if you suffer from acute asthma attacks or other lung diseases (chronic obstructive bronchopneumopathies);
• if you have breathing problems (respiratory failure);
• if you have an enlarged heart due to lung disease (pulmonary heart);
• if you have a low blood volume (hypovolemia).

The use of methadone is not indicated during pregnancy, during breastfeeding and in the treatment of labor
pains, as its long duration of action increases the likelihood of breathing problems in the newborn.
Furthermore, the use of this medicine is not indicated in children.

Warnings and precautions
Talk to your doctor or pharmacist before taking Eptadone.
Methadone therapy can cause physical and mental dependence, and tolerance to the drug. This
means that the dose taken will be less effective. Therefore, it must be prescribed and taken with the same
caution as morphine.
Pay particular attention to the use of methadone and tell your doctor:

• if you are taking medicines that act on the central nervous system (narcotic analgesics, phenothiazines, other tranquilizers, hypnotic sedatives, tricyclic antidepressants), or even substances such as alcohol because they can cause breathing problems (respiratory depression), lowering of blood pressure (hypotension), deep sedation or coma;
• if anxiety states occur during treatment. This medicine has no anti-anxiety action, so avoid taking higher doses;
• if you have acute abdominal problems;
• if you have a low blood volume (hypovolemia) or are being treated with phenothiazine or anesthetics because it may have a severe drop in blood pressure;
• if you feel dizzy when you get up, due to a rapid drop in pressure (orthostatic hypotension);
• if you are elderly or debilitated;
• if you have a thyroid malfunction (hypothyroidism);
• if you have a disease of the adrenal glands (Addison's disease);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have difficulty urinating due to a narrowing of the urethra;
• if you suffer from or have suffered from heart rhythm disturbances (arrhythmias), serious heart disease, a lowered concentration of potassium and magnesium in the blood (hypokalemia and hypomagnesemia), have a family history of sudden death in young age, are being treated with sotalol, amiodarone, flecainide (antiarrhythmics), thioridazine, haloperidol, sertindole (antipsychotics) or erythromycin and clarithromycin (antibiotics), because they can alter the heart rate (prolongation of the QT interval).

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 symptom
that the adrenal glands are producing too little of the hormone cortisol and may require
hormonal supplementation.
Long-term use can cause a decrease in sex hormone levels and an increase in prolactin levels. Contact your doctor if you experience symptoms such as decreased libido, impotence or
absence of menstruation (amenorrhea).
If you have a physical dependence on narcotics, the administration of antagonists must be done with caution
because it can trigger a withdrawal crisis.
If you are an athlete, taking Eptadone may give a positive result to doping tests.

Children
The use of this medicine is contraindicated in children.

Other medicines and Eptadone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines, because Eptadone can affect how some
medicines work or because other medicines can affect how Eptadone works.
The concomitant use of Eptadone and sedatives such as benzodiazepines or related medicines
increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be
life-threatening. For this reason, concomitant use should only be considered when other
treatment options are not possible.
However, if your doctor prescribes Eptadone together with sedatives, the dose and duration of treatment
concomitantly must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to inform friends or family to pay attention to
the above-mentioned signs and symptoms. See your doctor if you experience these symptoms.
The risk of side effects increases if methadone is used in conjunction with antidepressants (such as
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine,
amitriptyline, clomipramine, imipramine, nortriptyline).
Contact your doctor if you experience symptoms such as:

• changes in mental status (e.g. agitation, hallucinations, coma)
• tachycardia, instability of pressure, fever
• exaggerated reflexes, impaired coordination, muscle rigidity
• gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea)

Your doctor may decide to increase the dose of methadone to avoid withdrawal symptoms if you are
taking other medicines such as:

• medicines for epilepsy such as barbiturates, carbamazepine, phenytoin, phenobarbital;
• medicines for the treatment of AIDS such as nevirapine and efavirenz;
• medicines for tuberculosis such as rifampicin;
• medicines used to acidify the urine such as ammonium chloride;
• medicines used for the treatment of inflammation and allergies such as dexamethasone;
• medicines for the treatment of depression such as hypericum perforatum (St. John's wort);
• metamizole, a medicine used to treat pain and fever. Your doctor may decide to decrease the dose of methadone if you are taking:
• medicines used to regulate the heartbeat (quinidine);
• medicines to lower blood pressure (verapamil);
• cannabinoids;
• antibacterial medicines such as clarithromycin, erythromycin and telithromycin;
• medicines for the treatment of AIDS such as delavirdine and ritonavir;
• antidepressants such as nefazodone, desipramine and selective serotonin reuptake inhibitors such as fluoxetine, fluvoxamine, paroxetine and sertraline;
• medicines used for the treatment of fungal infections, such as itraconazole, ketoconazole and fluconazole.

Methadone can interfere with the activity of other medicines, tell your doctor if you are taking:

• medicines for AIDS therapy such as didanosine, stavudine, zidovudine, amprenavir, nelfinavir, lopinavir/ritonavir and ritonavir /saquinavir;
• medicines that affect cardiac conduction or drugs that may affect the concentration of salts;
• opioid antagonists, naloxone and naltrexone, used for drug and alcohol dependence;
• medicines used in the treatment of pain such as butorphanol, nalbuphine, pentazocine;
• medicines that have a depressive effect on the CNS such as analgesics, tranquilizers;
• medicines used in the treatment of diarrhea such as diphenoxylate, loperamide and octreotide;
• antimuscarinic medicines;
• medicines used for depression such as monoamine oxidase inhibitors (MAO);
• medicines used for heart rhythm control such as sotalol, amiodarone, flecainide;
• medicines used for mental disorders (thioridazine, haloperidol, sertindole).

Eptadone with drinks and alcohol
During treatment with methadone, do not drink alcoholic beverages, which can cause drowsiness, and
avoid taking grapefruit juice, which interacts with the activity of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist before taking this medicine.
Methadone is contraindicated in pregnancy, for possible effects on fetal development, and during
breastfeeding.
Talk to your doctor if you are breastfeeding or planning to breastfeed while taking methadone
as this may harm the baby. Monitor your baby for signs and symptoms such as
increased drowsiness (more than usual), difficulty breathing or weakness. Consult your
doctor immediately if you notice any of these symptoms.

Driving and using machines
Eptadone can alter the ability to drive vehicles and operate machinery.

Eptadone contains sucrose, ethanol and para-hydroxybenzoates
Eptadone contains 13 g of sucrose per dose. This should be taken into consideration if you have problems with blood glucose instability (diabetes mellitus). The medicine may be harmful to teeth.
This medicine contains 12 vol% ethanol (alcohol), e.g. up to 1.9 g per dose, equivalent to 48 ml of
beer or 20 ml of wine per dose. It may be harmful to alcoholics. Take into consideration in
women who are pregnant or breastfeeding, children and high-risk groups such as people affected by
liver disease or epilepsy.
This medicine contains para-hydroxybenzoates which may cause allergic reactions (also delayed).

3. How to take Eptadone

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
This medicine is a solution to be taken by mouth (orally), do not use it for injection.
The dosage will be appropriately adjusted by the doctor depending on the severity of the pain and your response
to therapy.
The average dose ranges from 5 to 20 mg one or more times a day, as directed by your doctor. Sometimes,
in cases of exceptionally intense pain or in cases where the usual dose proves to be ineffective, your doctor
may prescribe a higher dose.
The packages are equipped with a child-resistant closure.
To open: press and simultaneously rotate counterclockwise.
To close: press and simultaneously rotate clockwise.

If you take more Eptadone than you should
In case of accidental ingestion/taking of an excessive dose of Eptadone, immediately notify your
doctor or go to the nearest hospital.
Overdose manifests with the following symptoms:

• difficulty breathing (irregular and shallow breathing, bluish discoloration of the skin due to lack of oxygen)
• extreme drowsiness that leads to stupor or coma
• constriction of the pupils (miosis)
• cold and clammy skin
• muscle flaccidity
• slowed heartbeat (bradycardia)
• low blood pressure (hypotension)

It may cause low blood sugar.
In severe overdose, especially intravenously, the following may occur:

• cessation of breathing (apnea)
• circulatory collapse
• cardiac arrest
• death.

If you forget to take Eptadone
Do not take a double dose to make up for a missed dose.

If you stop taking Eptadone
Abruptly stopping treatment with this medicine can cause undesirable, even serious, effects.
Carefully follow your doctor's instructions on how to gradually reduce the use of this medicine.
If you have any doubts 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.
Below are listed the side effects that may occur. Sufficient data are not available to establish the frequency of the individual effects listed.
The main risks of methadone are represented by:

• serious breathing problems (respiratory depression and respiratory arrest);
• serious problems with circulation (circulatory depression);
• serious problems with the heart (shock and cardiac arrest);
• heart diseases that can alter the heart rate (prolongation of the QT interval and torsade de pointes).

Other observed side effects are:

• feeling of emptiness in the head, dizziness and drowsiness;
• nausea, vomiting, sweating;
• feeling of dizziness when getting up due to a drop in pressure (orthostatic hypotension);
• mood disorders (euphoria, dysphoria);
• weakness, headache, insomnia, agitation;
• disorientation and visual disturbances;
• dry mouth, loss of appetite (anorexia), weight gain, constipation and gallbladder problems;
• facial flushing, slowing of the heartbeat (bradycardia), perception of the heartbeat (palpitations);
• feeling of fainting and loss of consciousness (syncope);
• urinary retention or difficulty urinating, fluid retention;
• loss of sexual desire (libido) and/or sexual impotence, absence of menstruation (amenorrhea);
• itching, hives (also of a hemorrhagic type), other skin reactions even transient (transient skin rash);
• swelling due to fluid accumulation (edema). Frequency not known: low blood sugar

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Eptadone

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 packaging after “Scad”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain or in household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eptadone contains
The active ingredient is methadone hydrochloride.
The other ingredients are: glycerol, ethanol 96%, sodium methyl parahydroxybenzoate, ethyl
sodium parahydroxybenzoate, propyl sodium parahydroxybenzoate, tolu balsam hydroglyceric extract,
vanillin, sucrose, purified water.

Description of the appearance of Eptadone and contents of the pack
EPTADONE 5 mg/20 ml syrup: single-dose container of 20 ml
EPTADONE 10 mg/20 ml syrup: single-dose container of 20 ml
EPTADONE 20 mg/20 ml syrup: single-dose container of 20 ml
EPTADONE 1 mg/ml syrup: 40 ml bottle
EPTADONE 1 mg/ml syrup: 80 ml bottle

Marketing authorisation holder and manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., S.S. 67, Fraz. Granatieri, Scandicci (FI).

EPTADONE 10 mg/1 ml injectable solution

Methadone hydrochloride

Read this leaflet carefully before you start to use 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 nurse.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Eptadone and what is it used for?

Eptadone contains the active ingredient methadone hydrochloride, which belongs to a group of medicines that
act on the Nervous System, opioid analgesics.
This medicine is used for the treatment of severe pain, especially in cases of:

• tumors (neoplastic pain)
• surgical interventions (post-operative pain)

2. What you need to know before using Eptadone

Do not use Eptadone

• if you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe constipation;
• if you have heart problems (organic heart disease);
• if you have serious problems with the liver and kidneys;
• if you suffer from fluctuations in blood glucose levels (uncontrolled diabetes);
• if you are affected by porphyria (a rare blood disease);
• if you have low blood pressure (hypotension);
• if you have high pressure inside the skull (intracranial hypertension);
• if you have head injuries (cranioencephalic trauma);
• if you suffer from acute asthma attacks or other lung diseases (chronic obstructive bronchopneumopathies);
• if you have breathing problems (respiratory failure);
• if you have an enlarged heart due to lung disease (cor pulmonale);
• if you have a low blood volume (hypovolemia).

The use of methadone is not indicated during pregnancy, during breastfeeding and in the treatment of labor pains
because its long duration of action increases the probability of respiratory problems in the newborn.
Furthermore, the use of this medicine is not indicated in children.

Warnings and precautions
Talk to your doctor or nurse before you are given Eptadone.
Therapy with methadone can cause physical and mental dependence, and tolerance to the drug. This
means that the dose taken will be less effective. Therefore, it must be prescribed and taken with the same
caution as morphine.
Tell your doctor if:

• you are taking medicines that act on the central nervous system (narcotic analgesics, phenothiazines, other tranquilizers, hypnotic sedatives, tricyclic antidepressants), or even substances such as alcohol because they can cause breathing problems (respiratory depression), lowering of blood pressure (hypotension), deep sedation or coma;
• anxiety states appear during treatment. This medicine has no anti-anxiety action, so higher doses should not be used;
• you have acute abdominal problems;
• you have a low blood volume (hypovolemia) or are being treated with phenothiazine or anesthetics because it may have a severe drop in blood pressure;
• you feel dizzy when you get up, due to a rapid drop in pressure (orthostatic hypotension);
• you are elderly or debilitated;
• you have a thyroid malfunction (hypothyroidism);
• you have a disease of the adrenal glands (Addison's disease);
• you have an enlarged prostate (prostatic hypertrophy);
• you have difficulty urinating due to a narrowing of the urethra;
• you suffer or have suffered from heart rhythm disturbances (arrhythmias), serious heart disease, a lowered concentration of potassium and magnesium in the blood (hypokalemia and hypomagnesemia), have a family history of sudden death in young age, are being treated with sotalol, amiodarone, flecainide (antiarrhythmics), thioridazine, haloperidol, sertindole (antipsychotics) or erythromycin and clarithromycin (antibiotics), because they can alter the heart rate (prolongation of the QT interval).

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 symptom
that the adrenal glands are producing too little of the hormone cortisol and a hormonal supplement may be
necessary.
Long-term use can cause a decrease in sex hormone levels and an increase in prolactin hormone levels. Contact your doctor if you experience symptoms such as decreased libido, impotence or
absence of menstruation (amenorrhea).
If you have a physical dependence on narcotics, the administration of antagonists must be done with caution
because it can trigger withdrawal symptoms.
If you are an athlete, taking Eptadone may give a positive result to doping tests.

Children
The use of this medicine is contraindicated in children.

Other medicines and Eptadone
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including over-the-counter medicines, because Eptadone can affect how some medicines
work or because other medicines can affect how Eptadone works.
The concomitant use of Eptadone and sedatives such as benzodiazepines or related medicines
increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be
life-threatening. For this reason, concomitant use should only be considered when other
treatment options are not possible.
However, if your doctor prescribes Eptadone together with sedatives, the dose and duration of concomitant treatment
must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow your
doctor's dosage recommendations. It may be helpful to inform friends or family to watch out for
the above signs and symptoms. See your doctor if you experience these symptoms.
The risk of side effects increases if methadone is used in conjunction with antidepressants (such as
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine,
amitriptyline, clomipramine, imipramine, nortriptyline).
Contact your doctor if you experience symptoms such as:

• changes in mental status (e.g., agitation, hallucinations, coma)
• tachycardia, instability of blood pressure, fever
• exaggerated reflexes, impaired coordination, muscle rigidity
• gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)

Your doctor may decide to increase the dose of methadone to avoid withdrawal symptoms if you are
taking other medicines such as:

• medicines for epilepsy such as barbiturates, carbamazepine, phenytoin, phenobarbital;
• medicines for the treatment of AIDS such as nevirapine and efavirenz;
• medicines for tuberculosis such as rifampicin;
• medicines used to acidify the urine such as ammonium chloride;
• medicines used for the treatment of inflammation and allergies such as dexamethasone;
• medicines for the treatment of depression such as hypericum perforatum (St. John's wort);
• metamizole, a medicine used to treat pain and fever.

Your doctor may decide to decrease the dose of methadone if you are taking:

• medicines used to regulate the heartbeat (quinidine);
• medicines to lower blood pressure (verapamil);
• cannabinoids;
• antibacterial medicines such as clarithromycin, erythromycin and telithromycin;
• medicines for the treatment of AIDS such as delavirdine and ritonavir;
• antidepressants such as nefazodone, desipramine and selective serotonin reuptake inhibitors such as fluoxetine, fluvoxamine, paroxetine and sertraline;
• medicines used for the treatment of fungal infections, such as itraconazole, ketoconazole and fluconazole.

Methadone can interfere with the activity of other medicines: tell your doctor if you are taking:

• medicines for AIDS therapy such as didanosine, stavudine, zidovudine, amprenavir, nelfinavir, lopinavir/ritonavir and ritonavir /saquinavir;
• medicines that affect cardiac conduction or drugs that can affect the concentration of salts;
• opioid antagonists, naloxone and naltrexone, used for drug and alcohol dependence;
• medicines used in pain therapy such as butorphanol, nalbuphine, pentazocine;
• medicines that have a depressive effect on the CNS such as analgesics, tranquilizers;
• medicines used in the treatment of diarrhea such as diphenoxylate, loperamide and octreotide;
• antimuscarinic medicines;
• medicines used for depression such as monoamine oxidase inhibitors (MAO).
• medicines used to control heart rhythm such as sotalol, amiodarone, flecainide;
• medicines used for mental disorders (thioridazine, haloperidol, sertindole).

Eptadone with drinks and alcohol
During treatment with methadone, do not drink alcoholic beverages, which can cause drowsiness, and
avoid taking grapefruit juice, which interacts with the activity of this medicine.

Pregnancy and breastfeeding
Methadone is contraindicated in pregnancy, for possible effects on fetal development, and during
breastfeeding.
Talk to your doctor if you are breastfeeding or are planning to breastfeed while taking methadone
as this may harm the baby. Monitor your baby for signs and symptoms such as
increased drowsiness (more than usual), difficulty breathing or weakness. Consult your
doctor immediately if you notice any of these symptoms.

Driving and using machines
Eptadone can impair the ability to drive and operate machinery.

3. How to use Eptadone

This medicine will be administered to you in hospital by trained personnel. If you have any doubts, consult your
doctor or nurse.
The dosage will be appropriately adjusted by the doctor depending on the severity of the pain and your response
to therapy.

Adults
The recommended dose is 2.5-10 mg per injection into the muscle (intramuscular route) or under the skin (subcutaneous)
every 3-4 hours, depending on your needs.
Subcutaneous injection (subcutaneous administration) of Eptadone is suitable for occasional use, while
injection into a muscle (intramuscular) is recommended if repeated doses are necessary.
Sometimes, in cases of exceptionally intense pain or in cases where the usual dose proves to be ineffective, the
doctor may decide to administer you a higher dose.

If you use more Eptadone than you should
This medicine will be administered by trained personnel, so an overdose is unlikely.
In case of accidental ingestion/intake of an excessive dose of Eptadone, immediately inform your
doctor or go to the nearest hospital.
Overdose manifests with the following symptoms:

• difficulty breathing (irregular and shallow breathing, bluish discoloration of the skin due to lack of oxygen)
• extreme drowsiness progressing to stupor or coma
• constriction of the pupils (miosis)
• cold and clammy skin
• muscle flaccidity
• slowed heartbeat (bradycardia)
• low blood pressure (hypotension).

It may cause low blood sugar.
In severe overdose, especially by intravenous route, the following may occur:

• cessation of breathing (apnea)
• circulatory collapse
• cardiac arrest
• death

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the side effects that may occur. Sufficient data are not available to establish the frequency of the individual effects listed.
The main risks of methadone are represented by:

• serious breathing problems (respiratory depression and respiratory arrest);
• serious problems with circulation (circulatory depression);
• serious problems with the heart (shock and cardiac arrest);
• heart diseases that can alter the heart rate (prolongation of the QT interval and torsade de pointes).

Other observed side effects are:

• feeling of emptiness in the head, dizziness and drowsiness;
• nausea, vomiting, sweating;
• feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension);
• mood disorders (euphoria, dysphoria);
• weakness, headache, insomnia, agitation;
• disorientation and visual disturbances;
• dry mouth, loss of appetite (anorexia), weight gain, constipation and gallbladder problems;
• facial flushing, slowing of the heartbeat (bradycardia), perception of the heartbeat (palpitations);
• feeling of fainting and loss of consciousness (syncope);
• urinary retention or difficulty urinating, fluid retention;
• loss of sexual desire (libido) and/or sexual impotence, absence of menstruation (amenorrhea);
• itching, hives (also hemorrhagic), other skin reactions even transient (transient skin rash);
• swelling due to fluid accumulation (edema).

Frequency not known: low blood sugar

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Eptadone

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 packaging after “Scad”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eptadone contains
The active ingredient is methadone hydrochloride. One 1 ml vial contains 10 mg of methadone hydrochloride.
The other ingredient is: water for injectable preparations.

Description of the appearance of Eptadone and contents of the pack
Vials of 1 ml. Pack of 5 vials.

Marketing authorisation holder and manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., S.S. 67, Fraz. Granatieri, Scandicci (FI).