Edunix 8 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Edunix 8 mg prolonged-release tablets

Hydrochloride of Hydromorphone

For use in adults and adolescents from 12 years of age

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Edunix is and what it is used for

Edunix is a strong painkiller belonging to the group of medicines known as opioid analgesics.

The tablets are indicated for the treatment of severe pain.

2. What you need to know before taking Edunix

Do not take Edunix:

• if you are allergic to hydrochloride hydromorphone or to any of the other ingredients of this medicine (listed in section 6);
• if you have breathing problems (respiratory depression or severe chronic obstructive pulmonary disease);
• if you have a severe and persistent airway disorder with narrowing of the airways (e.g. severe asthma);
• in case of loss of consciousness (coma);
• if you have stomach problems or unexpected abdominal pain (acute abdomen);
• if you have an intestinal disorder with absence of intestinal motility (paralytic ileus);
• if you are taking monoamine oxidase inhibitors (MAOIs — medicines used to treat depression), or if you have taken such medicines within the last 2 weeks.

Warnings and precautions

Talk to your doctor or pharmacist before starting Edunix if any of the following apply to you:

• if you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction");
• if you smoke;
• if you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses;
• alcohol addiction or severe reaction to stopping alcohol consumption (delirium tremens);
• increased intracranial pressure or head injury;
• a condition causing seizures, such as epilepsy;
• a mental disorder called toxic psychosis;
• low blood pressure (hypotension) with low blood volume (hypovolemia);
• decreased consciousness, with dizziness or fainting;
• gallbladder problems, gallstone attack, or kidney attack (colic);
• inflammation of the pancreas (pancreatitis);
• intestinal problems, including inflammation, narrowing, or obstruction of the intestine;
• enlarged prostate, causing difficulty urinating (prostatic hypertrophy);
• reduced adrenal gland function (e.g. Addison’s disease). Your doctor will need to monitor your blood cortisone levels;
• underactive thyroid (hypothyroidism);
• breathing difficulties (such as chronic obstructive pulmonary disease or reduced respiratory capacity like asthma);
• elderly or debilitated patients;
• severe kidney or liver problems.

If you currently have or have previously had any of the above conditions or symptoms, consult your doctor, as you may require a lower dose of the medicine.

Tolerance, dependence, and addiction

This medicine contains hydromorphone, which is an opioid. It may cause dependence and/or addiction.

This medicine contains hydromorphone, an opioid medicine. Repeated use of opioid analgesics may reduce their effectiveness (you become accustomed to their effects, known as tolerance). Repeated use of hydromorphone may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much medicine you need to take or how often you need to take it.

The risk of developing dependence or addiction varies from person to person. Your risk may be higher if:

• You or a family member has abused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction").
• You are a smoker.
• You have previously 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 hydromorphone, it could indicate that you have become dependent or addicted:

• You need to take the medicine for longer than prescribed by your doctor.
• You need to take a higher dose than recommended.
• You may feel the need to keep taking the medicine, even if it does not help relieve your pain.
• You are using the medicine for reasons other than prescribed, e.g., to stay calm or to sleep.
• You have repeatedly tried, without success, to stop or control your use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better when you take it again ("withdrawal syndrome").

If you notice any of these signs, talk to your doctor to discuss the best treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking Edunix).

This leads to the use of higher doses in order to achieve the desired pain relief. There may be cross-tolerance to other opioids; this means that when taking another opioid, you may also become tolerant to that opioid.

Increased sensitivity to pain Rarely, with high-dose use, increased sensitivity to pain (hyperalgesia) may occur, which will not respond to further increases in hydromorphone dose. In such cases, your doctor will individually adjust your treatment.

Sleep-related breathing disorders

Edunix may 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 breathing interruptions during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Surgery

The use of Edunix is not recommended before or during the first 24 hours after surgery. After this time, Edunix should be used with caution, especially after abdominal surgery.

Paralysis of intestinal motility

Edunix must not be used in situations where paralysis of intestinal motility (paralytic ileus) may occur. If paralytic ileus is suspected or occurs during treatment, hydromorphone therapy must be stopped immediately.

Additional pain therapy

If you are undergoing additional pain therapy (e.g., surgery, plexus block), you must not take hydromorphone during the 24 hours prior to surgery. After that, the dose will be readjusted as necessary by your doctor.

Switching to another opioid

You should be aware that once an effective dose of a specific opioid (the group of strong analgesics to which Edunix belongs) has been established, switching to another opioid should not be done without medical evaluation and careful reassessment based on your individual needs. Otherwise, continuous pain relief cannot be guaranteed.

Adrenal cortex insufficiency

If your adrenal cortex is not functioning properly (adrenocortical insufficiency), your doctor may wish to monitor your plasma cortisol levels and prescribe appropriate medication (corticosteroids).

Interference with normal hormone production

Edunix may interfere with the normal production of hormones produced by your body (such as cortisol or sex hormones). This may especially occur after taking high doses for prolonged periods.

Note Prolonged-release tablets must never be crushed and injected, as this could lead to serious adverse effects, potentially fatal.

Use in athletes

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

Children

The use of this medicine is not recommended in children under 12 years of age. Clinical studies on the use of hydromorphone in children have not been conducted.

Other medicines and Edunix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use of Edunix and sedative medicines such as benzodiazepines (which may help reduce anxiety and seizures, relax muscles, and induce sleep) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible. Concomitant use of opioids and medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, and may be potentially fatal.

However, if your doctor prescribes Edunix 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 carefully follow the dose recommended by your doctor. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

When taken together with other medicines that depress brain function or with alcohol, the adverse effects of hydromorphone or the other medicine may increase, for example, drowsiness or impaired breathing.

Such depressant medicines include:

• medicines used to treat anxiety (e.g., tranquilizers);
• muscle-relaxing anesthetics (such as barbiturates);
• medicines used to treat psychiatric or mental disorders (neuroleptics);
• medicines to help you sleep (such as hypnotics or sedatives);
• medicines used to treat depression (antidepressants);
• medicines used to treat allergy, dizziness, or nausea (antihistamines or antiemetics);
• other strong analgesics (opioids). Cross-tolerance with other opioids may occur. If you also take other strong analgesics (opioids), you may develop tolerance to these analgesics.

Do not take Edunix if you are taking medicines for depression called monoamine oxidase inhibitors (MAOIs) or during the two weeks after stopping these medicines (see section 2 “Do not take Edunix”).

Simultaneous use of hydromorphone with certain muscle relaxants (called muscle relaxants, usually injected or taken orally as tablets) may lead to increased difficulty in breathing (respiratory depression).

Taking Edunix with alcohol

Drinking alcohol while taking this medicine may make you feel more drowsy or increase the risk of serious adverse reactions such as shallow breathing with risk of respiratory arrest, and loss of consciousness. It is recommended not to drink alcohol while taking Edunix.

Pregnancy and breastfeeding

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

The use of Edunix during pregnancy is not recommended unless specifically prescribed by your doctor. There are no or insufficient data on the use of hydromorphone in pregnant women. If Edunix is administered during pregnancy, uterine contractility may be affected. In addition, there is a risk of breathing difficulties (respiratory depression) in the newborn.

Newborns may experience withdrawal syndrome (such as high-pitched crying, tremors, seizures, poor feeding, and diarrhea) if their mothers have taken hydromorphone for a prolonged period during pregnancy.

Breastfeeding

Hydromorphone may pass into breast milk. Therefore, Edunix must not be used during breastfeeding. If its use is necessary, breastfeeding must be discontinued.

Driving and using machines

Hydromorphone has a moderate influence on the ability to drive and use machines. These effects are most noticeable at the beginning of hydromorphone treatment, after increasing the dose, or when switching medicines. This is also likely if Edunix is combined with alcohol or other central nervous system depressants. If you are stabilized on a specific dose, you may not necessarily be affected. Therefore, you should consult your doctor to determine whether driving or operating machinery is permitted for you.

Edunix contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Edunix contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per prolonged-release tablet; hence, it is essentially "sodium-free".

3. How to take Edunix

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

The dose depends on the severity of your pain and your previous analgesic requirements.

Adults and adolescents over 12 years of age

Unless otherwise directed by your doctor, the initial dose for adults and adolescents over 12 years of age is 8 mg once daily (every 24 hours).

Important note: The daily dose of Edunix must not be administered more than once every 24 hours and should be taken at approximately the same time each day. The dose should not be increased at intervals of less than 2 days.

If adequate pain relief is not achieved, your doctor will increase your dose. In general, the lowest effective dose required to relieve pain will be selected for each individual case.

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

Once an effective dose of Edunix has been established, switching to other strong analgesics (opioid analgesic preparations) is not recommended. Clinical evaluation and careful dose adjustment by your doctor will be necessary. Otherwise, continuous pain relief cannot be guaranteed.

Elderly patients

Elderly patients may require a lower dose to achieve adequate analgesia.

Patients with hepatic or renal impairment

If you have renal or hepatic impairment, inform your doctor, as you may require lower doses to achieve adequate pain control. Therefore, your dose of hydromorphone must be carefully adjusted. Administration of this medicine is not recommended in patients with severe hepatic impairment.

Use in children

The use of this medicine is not recommended in children under 12 years of age. Clinical studies on the use of Edunix in children have not been conducted. Therefore, no recommended dose can be provided for this patient population. The dose will depend on the intensity of pain and previous analgesic requirements.

Method of administration: Oral use.

Swallow the prolonged-release tablets with sufficient liquid (half a glass of water). The prolonged-release tablets may be divided into equal doses using the score lines. The prolonged-release tablets must not be chewed or crushed, as this may lead to rapid release of hydromorphone and cause symptoms of overdose (see below "If you take more Edunix than you should").

How to open the child-resistant blister pack

1. Cut a single dose along the perforation line of the blister.

1. This makes the unsealed area more accessible, where the perforation lines are marked.

1. Pull the unsealed part of the label to detach the aluminum backing.

Duration of treatment

You should not take this medicine longer than necessary.

Your treatment should be regularly re-evaluated regarding pain relief and other effects, in order to achieve optimal pain management and monitor for the emergence of side effects, as well as to consider whether continued treatment is appropriate.

If you take more Edunix than you should

If you have taken more prolonged-release tablets than prescribed, you must inform your doctor immediately. In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service; Telephone 91 562 04 20, stating the medicine and the amount taken.

The following symptoms may occur: constricted pupils (miosis), slow heart rate (bradycardia), depressed breathing (respiratory depression), low blood pressure (hypotension), and increasing drowsiness (somnolence) progressing to stupor or loss of consciousness (coma). Patients may develop pneumonia (possible symptoms: difficulty breathing, cough, and fever) caused by aspiration of vomit or solids.

In severe cases, circulatory collapse or deep unconsciousness (coma) may occur, which can result in death. You must under no circumstances expose yourself to situations requiring high concentration, such as driving a car.

In case of overdose, the following measures may be advisable until medical help arrives: keep the person awake, give breathing instructions, provide respiratory support.

If you forget to take Edunix

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

If you take a lower dose than prescribed or miss a prolonged-release tablet, pain relief may be insufficient or cease completely. If you forget to take a tablet, you may take the missed dose immediately and start a new 24-hour dosing schedule. In principle, you must not take more than 1 prolonged-release tablet of Edunix once every 24 hours.

If you stop taking Edunix

Do not stop taking this medicine without consulting your doctor. If you stop taking Edunix after prolonged use, you may experience withdrawal symptoms (e.g., restlessness, anxiety, nervousness, difficulty sleeping, involuntary movements, tremor, and gastrointestinal discomfort). If treatment is no longer necessary, therapy should be discontinued gradually by reducing the 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 may cause adverse effects, although not everyone experiences them.

Adverse effects or signs to watch for, and actions to take if these adverse effects or signs occur:

• Severe, potentially life-threatening sudden allergic reactions:
  • hypersensitivity reactions (frequency cannot be estimated from available data);
  • anaphylactic reactions (frequency cannot be estimated from available data).

Contact your doctor immediately if you notice any of the following symptoms: difficulty breathing, swelling of the eyelids, face, lips, mouth or throat, skin rash or itching, especially if widespread across your body.

If you experience a severe allergic reaction, stop using Edunix prolonged-release tablets and seek medical help immediately. You may require urgent medical treatment.

Slow and weak breathing (respiratory depression) is the most serious adverse effect of opioid overdose.

Most patients become constipated when taking hydromorphone. If you experience constipation or nausea (feeling unwell), your doctor will take appropriate measures. You can counteract the constipation side effect by preventive measures (e.g., increasing fluid intake, eating fiber-rich foods such as fruit, vegetables, and whole grains). If you already had constipation problems before starting your prolonged-release tablets, you should take laxatives from the beginning. Please consult your doctor.

If you experience dizziness or vomiting (which frequently occurs especially at the beginning of treatment), your doctor may prescribe appropriate medication.

Other possible adverse effects:

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

• Constipation, nausea.
• Dizziness, drowsiness.

Common (may affect up to 1 in 10 people):

• Malaise.
• Decreased appetite, loss of appetite.
• Anxiety, confusion, insomnia.
• Headache.
• Dry mouth, abdominal pain or discomfort.
• Itching, sweating.
• Sudden need to urinate.
• Feeling of weakness.

Uncommon (may affect up to 1 in 100 people):

• Withdrawal symptoms such as restlessness, anxiety, nervousness, difficulty sleeping, involuntary movements (e.g., tremor), or stomach/intestinal discomfort (when stopping Edunix).

• Indigestion, diarrhea, taste disturbances.

• Hyperexcitability, depression, mood changes (euphoria), hallucinations, nightmares.

• Tremors, muscle spasms, abnormal skin sensations (pins and needles).

• Visual disturbances.

• Low blood pressure.

• Difficulty breathing.

• Changes in blood tests indicating liver function (increased liver enzymes).

• Skin rash, hives.

• Difficulty urinating.

• Decreased sex drive, impotence.

• Tiredness, general malaise, swelling of hands, ankles or feet (fluid accumulation in tissues).

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

• Drowsiness progressing to sedation, lack of energy.
• Increased heart rate.
• Slow heart rate, irregular heartbeat.
• Respiratory muscle spasms, weakening and slowing of breathing (respiratory depression), difficulty breathing and wheezing (bronchospasm).
• Changes in blood tests indicating pancreatic function.
• Flushing of the face.

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

• Exhaustion, uncontrolled muscle movements, increased sensitivity to pain (hyperalgesia, see section 2 "Warnings and precautions").
• Loss of intestinal movement (paralytic ileus).
• Biliary colic.
• Medication dependence, mood changes (dysphoria), restlessness.
• Constriction of the pupils (miosis).
• Feeling of warmth.
• Itchy skin rash (urticaria).
• Need to take higher doses (known as habituation or drug tolerance).
• Sleep apnea (interruptions in breathing during sleep).

Neonatal withdrawal syndrome in newborns whose mothers took hydromorphone during pregnancy (see section "Pregnancy and breastfeeding").

If you experience any adverse effect, inform your doctor or pharmacist. This includes adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the reporting system included in the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Edunix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister, after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Edunix

• The active substance is hydromorphone hydrochloride.

Each prolonged-release tablet contains 8 mg of hydromorphone hydrochloride (equivalent to 7.09 mg of hydromorphone).

• The other components are:

Tablet core: Sugar spheres, hypromellose, ethylcellulose, hydroxypropyl cellulose, triethyl citrate, talc, sodium carboxymethylcellulose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.

Tablet coating: Polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E171).

Appearance of the product and contents of the pack

Edunix 8 mg prolonged-release tablets are white, oblong, biconvex tablets measuring 11 x 5 mm, with a score line on both sides.

The tablets may be divided into equal doses.

They are presented in child-resistant aluminum/PVC-PE-PVDC blisters.

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

Manufacturer

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

Or

Laboratorios Medicamentos Internationales, S.A.
C/Solana, 26
Torrejón de Ardoz
28850 Madrid
Spain

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

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850, Torrejón de Ardoz
Madrid – Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Hydromorphon Aristo long 8 mg Retardtabletten
Spain: Edunix 8 mg prolonged-release tablets

Date of the most recent revision of this leaflet: December 2025

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