Patient Information Leaflet

Edunix 16 mg prolonged-release tablets

Hidrochloride of Hidromorphone

For use in adults and adolescents 12 years and older

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Edunix is and what it is used for

2. What you need to know before you start taking Edunix

3. How to take Edunix

4. Possible side effects

5. Storage of Edunix

6. Contents of the pack and additional information

Edunix is a strong analgesic in the group of medications called opioid analgesics.Tablets are indicated for treating intense pain.

Do not take Edunix:

• if you areallergicto hydrochloride of hydromorphone or to any of the other components of this medication (listed in section 6);
• if you haverespiratory problems(depression or chronic obstructive pulmonary disease);
• if you have a severe and persistent airway disorder with narrowing of the respiratory tract (e.g. severe asthma);
• in case of loss of consciousness (coma);
• if you havestomach problems or unexpected abdominal pain (acute abdomen);
• if you have anintestinal problemwithabsence ofmotility(paralytic ileus);
• if you are takingmonoamine oxidase inhibitors(MAOIs -medications for depression), orif you have taken this type of medication in the last 2 weeks.
  

Warnings and precautions

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

• you or a family member has a history of alcohol abuse, prescription medication abuse, or illicit substance abuse (“addiction”);
• if you smoke;
• if you have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental illnesses;
• increased intracranial pressure or head injury;

• alcohol addiction or severe reaction to stopping alcohol consumption (delirium tremens);
• increased intracranial pressure or head injury;
• condition that causes seizures, such as epilepsy;
• mental disorder called toxic psychosis;
• low blood pressure (hypotension) with low blood volume (hypovolemia);
• decreased consciousness, with dizziness or fainting;
• gallbladder problems, biliary attack, or kidney attack (colic);
• pancreatitis (inflammation of the pancreas);
• intestinal problems, including inflammation, constriction, or obstruction of the intestine
• prostate enlargement, causing difficulty urinating (prostatic hypertrophy);
• reduced function of the adrenal gland (e.g. Addison's disease). Your doctor will need to monitor your blood cortisol levels;
• low thyroid activity (hypothyroidism);
• difficulty breathing normally (e.g. chronic obstructive pulmonary disease or reduced lung capacity such as asthma);
• elderly or debilitated patients;
• severe kidney or liver problems.

If you have or have had any of the above conditions or symptoms, consult your doctor as you may need a lower dose of the medication.

Abuse and dependence

Hydromorphone - like other strong analgesics - has a profile of abuse. Repeated use of this medication may lead to the development of psychological or physical dependence and abuse, which may result in a potentially fatal overdose. It is essential to inform your doctor if you think you may have developed dependence on this medication. Therefore, patients with current or past histories of alcohol or drug abuse should use Edunix with special caution.

The abrupt interruption of therapy may cause withdrawal syndrome. If you no longer need treatment with hydromorphone, it may be advisable to gradually reduce the daily dose to avoid withdrawal symptoms.

Tolerance
This medication contains hydromorphone, which is an opioid. Repeated use of opioid analgesics may reduce the efficacy of the medication (your body becomes accustomed to the medication). This leads to the use of higher doses 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 accustomed to that opioid.

Increased sensitivity to pain
With high doses, rare sensitivity to pain (hyperalgesia) may occur, which will not respond to an additional increase in the dose of hydromorphone. In this case, your doctor will modify the treatment individually.

Respiratory disorders related to sleep

Edunix may cause respiratory disorders 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 interruptions in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. 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 should not be used in situations where it may cause paralysis of intestinal motility (paralytic ileus). If you suspect or experience paralytic ileus during use, treatment with hydromorphone should be interrupted immediately.

Additional pain therapy
If you are to undergo additional pain therapy (e.g. surgery, nerve block), do not take hydromorphone during the 24 hours prior to surgery. After that, the dose will be adjusted as needed by your doctor.

Switching to another opioid

You should be aware that once an effective dose of a specific opioid (group of potent analgesics to which Edunix belongs) is applied, you should not switch to another opioid without a medical evaluation and a new careful assessment based on your needs. Otherwise, you will not ensure continuous pain relief.

Adrenal cortex insufficiency

If your adrenal cortex does not function as it should (adrenocortical insufficiency), your doctor may want to monitor your plasma cortisol levels and prescribe appropriate medications (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 occur especially after taking high doses for long periods of time.

Note
Extended-release tablets should never be crushed and injected as this could lead to severe adverse effects, potentially fatal.

Use in athletes

This medication contains hydromorphone, which may produce a positive result in doping control tests.

Children

This medication is not recommended for use in children under 12 years of age. There have been no clinical studies on the use of hydromorphone in children.

Other medications and Edunix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The concomitant use of Edunix and sedatives such as benzodiazepines (which can 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 other treatment options are not possible. The concomitant use of opioids and medications 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 along with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

When taken with other central nervous system depressants or alcohol, they may increase the adverse effects of hydromorphone or the other medication, such as drowsiness or deterioration of respiratory function.

Such depressants are:

- medications for anxiety (e.g. tranquilizers);

- muscle relaxants that relax muscles (such as barbiturates);

- medications for psychiatric or mental disorders (neuroleptics);

- medications to help you sleep (such as hypnotics or sedatives);

- medications for depression (antidepressants);

- medications for allergies, dizziness, or nausea (antihistamines or antiemetics)

- other potent analgesics (opioids). There may be cross-tolerance with other opioids. If you also take other potent analgesics (opioids), you may develop tolerance to these analgesics.

You should not take Edunix if you are taking medications for depression called monoamine oxidase inhibitors (MAOIs) or within the last 2 weeks of stopping these medications (see section 2 “Do not take Edunix”).

The concomitant use of hydromorphone with certain muscle relaxants (called muscle relaxants, which are usually injected or taken orally in the form of tablets) may lead to increased difficulty breathing (respiratory depression).

Edunix and alcohol

Drinking alcohol while taking this medication may make you feel more drowsy or increasetherisk of severe reactions such as shallow breathing with the risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while taking Edunix.

Pregnancy and breastfeeding

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

Pregnancy

Edunix is not recommended during pregnancy unless your doctor specifically indicates it. There are no or insufficient data on the use of hydromorphone in pregnant women.

If you are given Edunix during pregnancy, it may affect uterine contractility. Additionally, there is a risk of respiratory difficulty (respiratory depression) in the newborn.

Newborns may suffer from withdrawal syndrome (e.g. loud crying, tremors, convulsions, loss of appetite, and diarrhea) if their mothers have taken hydromorphone for an extended period during pregnancy.

Breastfeeding

Hydromorphone may pass into breast milk. Therefore, Edunix should not be used if you are breastfeeding. If its use is necessary, you should stop breastfeeding.

Driving and operating machinery

Hydromorphone has a moderate effect on the ability to drive and operate machinery. These effects are more noticeable at the beginning of treatment with hydromorphone, after increasing the dose or changing medication. This is also likely if you combine Edunix with alcohol or other central nervous system depressants. If you are stabilized with a specific dose, you may not be influenced necessarily. Therefore, you should consult your doctor if you are allowed to drive or operate machinery.

Edunix contains saccharose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Edunix contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per extended-release tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated 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 needs for analgesics.

Adults and adolescents over 12 years old

Unless your doctor tells you otherwise, the initial dose in adults and adolescents over 12 years of age is 8 mgonce a day (every 24 hours).

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

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

Edunix 16 mg prolonged-release tablets are not suitable for initial treatment with opioids; they should only be used in cases where lower doses do not provide sufficient pain relief.

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

Once an effective dose of Edunix has been adjusted, it should not be changed to other strong analgesics (opioid analgesic preparations). Your doctor will need to evaluate and carefully adjust the dose. Otherwise, continuous pain relief is not guaranteed.

Older patients

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

Patients with liver or kidney insufficiency

If you have kidney or liver insufficiency, inform your doctor as you may need lower doses to achieve pain control. Therefore, your hydromorphone dose should be adjusted with special care. This medication is not recommended for patients with severe liver insufficiency.

Use in children

This medication is not recommended for use in children under 12 years old. No clinical studies have been conducted on the use of Edunix in children. Therefore, no recommended dose can be given for this patient population. The dose will depend on the intensity of the pain and their previous analgesic needs.

Administration form
Oral route.

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

How to open the child-resistant blister
1. Cut a single dose along the perforation line of the blister.

2. This way, the non-sealed area is more accessible, where the perforation lines are marked.

3. Pull the non-sealed part of the label to remove the aluminum cover.

Treatment duration

You should not take this medication for longer than necessary.

Your treatment should be regularly reevaluated regarding pain relief and other effects, in order to achieve optimal pain treatment and to monitor the appearance of side effects, as well as to consider continuing treatment.

If you take more Edunix than you should

If you have taken more prolonged-release tablets than prescribed, inform your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service; Teléfono 91 562 04 20, indicating the medication and the amount taken.

The following symptoms may occur: constricted pupils (miosis), slow heart rate (bradycardia), depressed respiration (respiratory depression), decreased blood pressure (hypotension), and increased drowsiness that progresses to rigidity (stupor) or loss of consciousness (coma). Patients may develop pneumonia (possible symptoms: difficulty breathing, cough, and fever) caused by inhalation of vomit or solids.

In severe cases of circulatory collapse or deep unconsciousness (coma), it may cause death. In no case should you expose yourself to situations that require high concentration, such as driving a car.

In case of overdose, the following measure may be recommended until the doctor arrives: stay awake, give breathing instructions, assist with breathing.

If you forget to take Edunix

Do not take a double dose to compensate for the missed doses.

If you take a lower dose than indicated or if you forget to take the prolonged-release tablet, the pain relief will be insufficient or will cease completely.

If you forget to take a tablet, you can compensate for the dose immediately and start a new 24-hour schedule. In principle,do not take more than 1 Edunix prolonged-release tablet every 24 hours.

If you interrupt treatment with Edunix

Do not stop taking this medication without consulting your doctor. If you stop taking Edunix after prolonged use, you may experience withdrawal symptoms (e.g. agitation, anxiety, nervousness, difficulty sleeping, involuntary movements, tremors, and gastrointestinal/intestinal discomfort). If therapy is no longer needed, treatment should be interrupted gradually by reducing the dose.

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

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

Side effects or signs to be aware of and measures to take when these side effects or signs occur:

• Severe, potentially life-threatening 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 eyelids, face, lips, mouth, or throat, skin rash or itching, especially those that cover your entire body.

If you have a severe allergic reaction, stop using Edunix prolonged-release tablets and seek medical attention immediately. You may need urgent medical treatment.

The slow and shallow breathing (respiratory depression) is the most serious side effect of opioid overdose.

Most patients become constipated if they take hydromorphone. If you have constipation or nausea (feeling unwell), your doctor will take the necessary measures. You can counteract the side effect of constipation by using preventive measures (e.g., increasing fluid intake, eating foods rich in fiber such as fruit, vegetables, and whole grain products). If you already had constipation before starting to take your prolonged-release tablets, you should take laxatives from the beginning. Please consult your doctor.

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

Other possible side effects:

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

• Constipation, nausea.
• Dizziness, drowsiness.

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

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

• Withdrawal symptoms such as agitation, anxiety, nervousness, difficulty sleeping, involuntary movements (e.g., tremors) or stomach/intestinal discomfort (when stopping Edunix).
• Indigestion, diarrhea, taste disturbances.

• Hyperexcitability, depression, mood changes (euphoria), hallucinations, nightmares.
• Tremors, muscle spasms, abnormal skin sensations (pinching and needles).
• Visual disturbances.
• Low blood pressure.
• Difficulty breathing.
• Changes in blood tests that show how your liver is functioning (elevated liver enzymes).
• Skin rash, urticaria.
• Difficulty urinating.
• Decreased libido, impotence.
• Fatigue, general feeling of being unwell, swelling of hands, ankles, or feet (fluid accumulation in tissue)

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

• Drowsiness to the point of somnolence (sedation), lack of energy.
• Increased heart rate.
• Abnormal heart rhythm, slow heart rate.
• Respiratory muscle convulsions, weakening and slowing of breathing (respiratory depression), difficulty breathing, and wheezing (bronchospasm).
• Changes in blood tests that show how your pancreas is functioning.
• Face redness.

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

• Exhaustion, involuntary muscle movements,increased sensitivity to pain (hyperalgesia, see section 2 "Warnings and precautions").
• Paralysis of the intestines (ileus).
• Biliary colic.
• Medication addiction, mood changes (dysphoria), restlessness.
• Pupil constriction (miosis).
• Sensation of heat.
• Skin rash with itching (urticaria).
• Need to take higher doses (called habituation or tolerance to drugs).
• Sleep apnea (interrupted breathing during sleep).

Drug withdrawal syndrome in newborns whose mothers took Edunix during pregnancy (see section "Pregnancy and breastfeeding")

If you experience any side effect, report it to your doctor or pharmacist. This includes side effects not mentioned in this leaflet.

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 notification system included in the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use. Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of that medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofEdunix

• The active principle is hydrochloride of hydromorphone.

Each prolonged-release tablet contains16mg of hydrochloride ofhydromorphone(equivalent to14.19mg of hydromorphone).

• The other components are:

Tablet core: Sugar spheres, hypromellose, ethylcellulose, hypromellose, triethylcitrate, talc, sodium carmellose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.

Tablet coating: Polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E171), iron (III) oxide + H2O (E172).

Appearance of the product and contents of the package

Edunix 16 mg prolonged-release tablets are yellow, oblong, biconvex, 14 x 6.5 mm with a notch on both sides.

The tablets can be divided into equal doses.

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

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

Only some package sizes may be commercially available.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Responsible for manufacturing

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

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

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Hydromorphon Aristo long 16 mg Retardtabletten

Spain:Edunix 16 mg prolonged-release tablets

Last review date of this leaflet: December 2022

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/