Edunix 1.3 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Edunix 1.3 mg hard capsules EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 adverse effects
5. How to store Edunix
6. Contents of the pack and other information

1. What Edunix is and what it is used for

This medicine is indicated for the relief of severe pain.

It contains the active substance hydromorphone, which is a strong analgesic ("opioid") belonging to a group of medicines called opioids.

This medicine is indicated for use in adults and adolescents over 12 years of age.

2. What you need to know before taking Edunix

Do not take hydromorphone:

• if you are allergic (hypersensitive) to hydromorphone or to any of the other components of this medicine (listed in section 6);
• if you have respiratory problems, such as severe chronic obstructive airway disease, respiratory depression, or severe asthma. Symptoms may include shortness of breath, cough, or slower and weaker breathing than expected;
• if you have severe and sudden abdominal pain (acute abdomen);
• if you have a condition in which the intestine does not function properly (paralytic ileus);
• if you are taking a type of medicine known as monoamine oxidase inhibitors (for example: tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken any of these medicines within the last two weeks.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have breathing problems, such as chronic obstructive pulmonary disease (COPD) or reduced respiratory capacity. Symptoms may include difficulty breathing and cough; or if you have difficulty sleeping (sleep apnea);
• if you have severe headache or are unwell due to a head injury or increased pressure inside the skull (for example, due to a brain disorder), as these capsules may worsen your symptoms or mask the extent of your head injury;
• if you suffer from seizures, epileptic fits, or convulsions;
• if you have a mental disorder resulting from poisoning (toxic psychosis);
• if you have low blood pressure (hypotension);
• if you feel dizzy or weak;
• if you have gallbladder or biliary tract problems;
• if you have abdominal colic or discomfort;
• if you have inflammation of the pancreas (which may cause severe pain in the abdomen and back);
• if you have intestinal obstruction or inflammatory disorder of the large intestine;
• if you have prostate enlargement (prostatic hypertrophy) causing difficulty in urinating (in men);
• if you have impaired adrenal gland function (for example, Addison's disease) (your adrenal gland does not function properly);
• if you have reduced thyroid gland function (hypothyroidism);
• if you have severe kidney or liver problems;
• 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;
• if you experience withdrawal symptoms such as restlessness, anxiety, tremors, or sweating when stopping alcohol or drug use;
• elderly or debilitated patients;
• if you suffer from constipation.

Tolerance, dependence, and addiction

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

This medicine contains hydromorphone, which is an opioid medicine. Repeated use of opioid analgesics may reduce their effectiveness (your body becomes 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. You may have a higher risk of developing dependence or addiction to hydromorphone 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 ever had mood problems (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 be a sign 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, for example, 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 again 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 Hidromorfona Aristo).

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 blood oxygen levels). Symptoms may include breathing interruptions during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

You may experience hormonal changes while taking hydromorphone. Your doctor may want to monitor these changes.

You may experience increased sensitivity to pain despite taking high doses of these capsules (hyperalgesia). Your doctor will decide whether you need a dose adjustment or a switch to another strong analgesic (“painkiller”).

If you are undergoing surgery, inform your doctor that you are taking hydromorphone.

The capsule contents must never be injected, as this may cause serious adverse effects, which could be fatal.

This medicine contains hydromorphone, which is an opioid. Repeated use of opioid analgesics may reduce the effectiveness of the drug (your body becomes accustomed to the drug).

Repeated use of hydromorphone may cause dependence and abuse, which may lead to potentially fatal overdose. It is important that you inform your doctor if you think you may have developed dependence on hydromorphone.

Children

Use of this medicine is not recommended in children under 12 years of age.

Other medicines and hydromorphone

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

If you take hydromorphone with another medicine, the effect of hydromorphone or the other medicine may be altered.

Hydromorphone must not be used simultaneously if you are taking a type of medicine called monoamine oxidase inhibitors (MAOIs), or if you have taken such a medicine within the last two weeks (see section 2. “Do not take hydromorphone”).

Tell your doctor or pharmacist if you are taking:

• medicines to help you sleep or stay calm (for example, tranquilizers, hypnotics, or sedatives, such as benzodiazepines);
• medicines known as barbiturates to treat seizures or help you sleep;
• medicines to prevent nausea or feeling unwell;
• medicines to prevent or relieve allergy symptoms (antihistamines);
• medicines to treat depression;
• medicines to treat mental or psychiatric disorders (antipsychotics such as phenothiazines);
• other strong analgesics (“painkillers”).

Also inform your doctor if you have recently been given an anaesthetic.

Concomitant use of hydromorphone and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Because of this, 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 hydromorphone together with sedative medicines, they will limit the dose and duration of concomitant treatment.

Please inform your doctor of all sedative medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform your friends or family members so they can watch for the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking hydromorphone with food and alcohol

You may take hydromorphone with or without food. You must not take this medicine with alcohol. Drinking alcohol during treatment with hydromorphone may cause drowsiness or negatively affect your breathing.

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

Use of hydromorphone during pregnancy and childbirth is not recommended unless specifically prescribed by your doctor.

Depending on the dose and duration of hydromorphone treatment, slow and shallow breathing (respiratory depression) or withdrawal symptoms may occur in the newborn. Newborns may experience withdrawal effects (such as high-pitched crying, restlessness, 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, hydromorphone should not be used during breastfeeding.

Driving and using machines

Hydromorphone may cause a number of adverse effects such as drowsiness, which could affect your ability to drive or operate machinery (see section 4 for a complete list of side effects). These effects are more noticeable when starting hydromorphone treatment or increasing the dose. If affected, you must not drive or operate machinery.

3. How to take Edunix

Follow exactly the instructions given by your doctor for the administration of this medicine.

Do not exceed the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents over 12 years of age

The usual initial dose is one capsule every 4 hours. However, your doctor will prescribe the dose necessary to relieve your pain. More intense pain may require an increase in the hydromorphone dose to achieve the desired relief; inform your doctor accordingly.

Children under 12 years of age

Children under 12 years of age must not take hydromorphone.

Elderly patients and patients with hepatic or renal impairment

Inform your doctor if you have kidney or liver problems. Your doctor may prescribe a lower dose if you are an elderly patient or have kidney or liver problems.

Method of administration
This medicine is for oral use.

Swallow the capsules whole with a glass of water. If you have difficulty swallowing the capsule,
you may open it and sprinkle the contents onto cold soft food such as yoghurt.

How to open the child-resistant blister
The aluminium foil can be opened normally and will show resistance before opening. This resistance is a feature of the child-resistant blister packaging.

If you take more Edunix than you should or if someone accidentally swallows the capsules

Contact your doctor immediately or go to the nearest hospital. In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service; Telephone 91 562 04 20, stating the name of the medicine and the amount taken.

People who have taken an overdose may feel drowsy, sick, or dizzy, and may also develop pinpoint pupils, breathing difficulties, a brain disorder (known as toxic leukoencephalopathy), low blood pressure, or pneumonia caused by inhalation of vomit or foreign bodies (symptoms may include shortness of breath, cough, and fever).

In severe cases, an overdose may lead to loss of consciousness or even death. When seeking medical attention, make sure to bring this leaflet and any remaining capsules to show the doctor.

If you have taken too many capsules, do not place yourself in any situation requiring high concentration, for example, driving a car.

If you forget to take Edunix

If you forget to take a dose, take it as soon as you remember and then continue as before. Do not take two doses within 4 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Edunix

You must not stop treatment with this medicine suddenly unless instructed by your doctor. If you wish to stop taking hydromorphone, discuss this first with your doctor. He/she will advise you on how to proceed, usually by gradually reducing the dose to avoid experiencing any unwanted adverse effects. Withdrawal symptoms such as restlessness, anxiety, nervousness, difficulty sleeping, unusual hyperactivity, tremors, or gastrointestinal disorders (e.g., stomach discomfort) may occur if you stop taking hydromorphone suddenly.

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 can cause adverse effects, although not everyone will experience them.

This medicine can cause allergic reactions (hypersensitivity), which may be severe (anaphylactic reactions). The frequency of these reactions is unknown. Inform your doctor immediately if you suddenly develop wheezing, difficulty breathing, swelling of the eyelids, face, lips, mouth or throat, or any rash or itching, especially if it spreads over your entire body.

The most serious adverse effect is when breathing becomes slower and weaker than expected (respiratory depression, a typical risk of opioid overdose).

Like all strong analgesics, hydromorphone carries a risk of developing dependence or addiction.

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

• Constipation (your doctor may prescribe a laxative for this problem)
• Nausea
• Dizziness, drowsiness

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

• Vomiting (these symptoms should normally disappear after a few days, but your doctor may prescribe an antiemetic if it remains a problem)
• Anxiety, confusion
• Difficulty sleeping
• Dry mouth, loss of appetite, abdominal pain or discomfort
• Headache
• Feeling weak
• Itching of the skin
• Sweating
• Sudden need to urinate

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

• Withdrawal symptoms (see section 3. "If you stop treatment with Edunix")
• Indigestion, diarrhoea, taste disturbances
• Depression, feeling of extreme happiness (euphoria), hallucinations, nightmares
• Blurred vision
• Restlessness
• Tremor, muscle spasms, tingling or numbness
• Low blood pressure
• Difficulty breathing
• Decreased sexual desire, impotence
• Skin rash
• Swelling of feet, ankles or hands
• Difficulty urinating
• General malaise
• Tiredness
• Worsening of liver function tests (in a blood test)

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

• Aggression
• Feeling more drowsy than usual
• Lack of energy
• Fast heartbeat, slow heartbeat, palpitations
• Wheezing or difficulty breathing
• Changes in pancreatic function (in a blood test)

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

• Sleep apnoea (interruptions in breathing during sleep)
• Seizures, fits or convulsions
• Mood changes or restlessness
• Increased sensitivity to pain
• Intestinal failure (paralytic ileus)
• Constriction of the pupils (miosis)
• Flushing
• Urticaria
• Need to take higher doses to achieve the same level of pain relief (tolerance)
• Drug withdrawal symptoms in newborns whose mothers have taken hydromorphone during pregnancy (see section "Pregnancy and breastfeeding")

Reporting of adverse effects

If you experience any adverse effect, consult 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 outer packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE 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 hard capsule contains 1.3 mg of hydromorphone hydrochloride (equivalent to 1.16 mg of hydromorphone).

• The other components are:

Capsule contents: microcrystalline cellulose, hypromellose, hydrochloric acid (2.61%) (to adjust pH), propyl gallate.

Capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

Printing ink: shellac glaze, propylene glycol (E 1520), titanium dioxide (E 171).

Nature and contents of the container

Hard gelatin capsules, orange-colored, opaque, size 3, marked with "1.3".

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

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 hard capsules.

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 Internacionales, 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 European Economic Area member states under the following names:

Germany: Hydromorphon Aristo akut 1.3 mg Hartkapseln

Spain: Edunix 1.3 mg hard capsules EFG

Portugal: Hidromorfona Aristo 1.3 mg capsules

Date of the most recent review 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/