HIDROMORFONA ARISTO 2.6 mg HARD CAPSULES

2. What you need to know before you take Hidromorfona Aristo

Do not take hydromorphone:

• if you are allergic to hydromorphone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have respiratory problems, such as severe chronic obstructive pulmonary disease or respiratory depression. Symptoms may include shortness of breath, cough, or slower and weaker breathing than expected;
• in case of loss of consciousness (coma)
• if you have severe and sudden abdominal pain (acute abdomen)
• if you have a disease in which the intestine does not function properly (paralytic ileus)
• if you are taking a type of medicine known as monoamine oxidase inhibitors (e.g., tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken this type of medicine in the last 2 weeks.

Warnings and precautions

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

• if you have severe headaches or are ill due to a head injury or increased pressure in the skull (e.g., due to a brain disease), as these capsules may worsen the symptoms of your disease or hide the extent of your head injury;
• if you suffer from seizures or convulsions;
• if you have a mental disorder as a result of poisoning (toxic psychosis);
• if you have low blood pressure (hypotension);
• if you suffer from dizziness or fainting;
• if you have gallbladder or biliary tract problems (biliary colic);
• if you have abdominal colic pain or discomfort;
• if you have pancreatitis (which can cause severe abdominal and back pain);
• if you have intestinal obstruction or inflammatory bowel disease;
• if you have prostate inflammation (prostatic hyperplasia) that causes difficulty urinating (in men);
• if you have adrenal gland insufficiency (e.g., Addison's disease) (your adrenal gland does not function properly);
• if you have low thyroid function (hypothyroidism);
• if you have respiratory problems such as chronic obstructive pulmonary disease or have reduced respiratory capacity. Symptoms may include difficulty breathing and cough;
• if you have severe kidney or liver problems;
• if you or a family member have a history of abuse or dependence on alcohol, prescription medications, or illicit substances ("addiction").
• if you smoke
• if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.
• if you experience withdrawal symptoms such as agitation, anxiety, tremors, or sweating when you stop drinking alcohol or taking drugs.

Respiratory disorders related to sleep

Hidromorfona Aristo may cause sleep-related respiratory disorders 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, 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.

This medicine contains hydromorphone, which is an opioid. Repeated use of opioid analgesics can reduce the effectiveness of the drug (your body gets used to the drug).

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

You may experience hormonal changes while taking hydromorphone. These changes should be monitored by a doctor.

You may experience increased sensitivity to pain despite taking higher doses of these capsules (hyperalgesia). Your doctor will decide if you need a dose change or a change to a more potent analgesic.

If you are going to undergo surgery, inform your doctor that you are taking hydromorphone.

The contents of the capsule should never be injected, as this can cause severe adverse effects, which can be fatal.

Children

This medicine is not recommended for use in children under 12 years of age.

Other medicines and hydromorphone

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

When you are taking other medicines, the effect of hydromorphone or the other medicines may be altered.

Hydromorphone should not be used at the same time as a type of medicine called monoamine oxidase inhibitors (MAOIs) or within 2 weeks after stopping the use of these medicines (see section 2. "Do not take hydromorphone").

Inform your doctor or pharmacist if you are taking:

• medicines to help you sleep or stay calm (e.g., tranquilizers, hypnotics, or sedatives, such as benzodiazepines);
• medicines known as barbiturates to treat seizures or to help you sleep;
• medicines to prevent or relieve nausea and vomiting
• medicines to prevent or relieve allergy symptoms (antihistamines);
• medicines to treat depression;
• medicines to treat mental or psychiatric disorders (neuroleptics such as phenothiazine);
• other strong analgesics.

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

The concomitant use of hydromorphone and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. The concomitant use of opioids and drugs used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, and can be potentially fatal.

However, if your doctor prescribes hydromorphone with sedative medicines, you should limit the dose and duration of concomitant treatment.

Please inform your doctor of all sedative medicines you are taking and follow the dose recommended by your doctor to the letter. It may be useful to inform your friends or family to be aware of the signs and symptoms indicated above. Contact your doctor when you experience such symptoms.

Taking hydromorphone with food and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

This medicine is not recommended during pregnancy unless your doctor has specifically indicated it.

Depending on the dose and duration of treatment with hydromorphone, the newborn may experience slow or shallow breathing (respiratory depression) or withdrawal symptoms. Newborn babies may suffer from withdrawal symptoms (such as loud crying, tremors, convulsions, lack of appetite, 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. If its use is necessary, you should stop breastfeeding.

Driving and using machines

Hydromorphone may cause a number of side effects such as drowsiness, which could affect your ability to drive or use machines (see section 4. "Possible side effects" for a complete list of side effects). These effects are more noticeable at the start of treatment with hydromorphone or when increasing the dose. If they affect you, do not drive or use machines.

3. How to take Hidromorfona Aristo

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not take more than the dose recommended by your doctor.

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 severe pain will require an increase in the dose of hydromorphone to achieve the desired relief; inform your doctor.

Children under 12 years of age

Children under 12 years of age should not take hydromorphone.

Elderly patients and patients with liver or kidney 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 liver or kidney problems.

Method of administration: Oral.

Swallow the capsules whole with a glass of water. If you have difficulty swallowing the capsule, you can open it and sprinkle the contents over soft, cold foods, such as yogurt.

How to open the child-resistant blisterThe aluminum foil can be opened normally and will show resistance before opening. This resistance is a protection against child-resistant blisters.

If you take more Hidromorfona Aristo than you should or someone accidentally swallows the capsules

Inform your doctor immediately or go to the nearest hospital. In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service; Telephone 91 562 04 20, indicating 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 problems, or low blood pressure. It can cause pneumonia (possible symptoms: shortness of breath, cough, and fever), which occurs due to the inhalation of vomit or solid food components. In severe cases, an overdose can cause loss of consciousness or even death. When seeking medical attention, make sure to bring this leaflet and the remaining capsules to show them to the doctor.

If you have taken too many capsules, do not under any circumstances put yourself in a situation that requires your attention, for example, driving a car.

If you forget to take Hidromorfona Aristo

If you have forgotten to take a dose, you should take it as soon as you remember and continue as before. Do not take two doses within a 4-hour period. Do not take a double dose to make up for the forgotten dose.

If you stop taking Hidromorfona Aristo

You should not stop treatment with this medicine suddenly unless your doctor tells you to. If you want to stop taking hydromorphone, discuss it with your doctor first. He will explain how to act, usually by gradually reducing the dose so that you do not experience any undesirable side effects. Withdrawal symptoms such as agitation, anxiety, nervousness, difficulty sleeping, unusual hyperactivity, tremors, or gastrointestinal disorders (e.g., stomach upset) may appear if you stop taking hydromorphone suddenly.

If you have any other questions 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.

This medicine can very rarely cause allergic reactions (hypersensitivity reactions) that can be severe (anaphylactic reactions). The frequency of these reactions is unknown. Inform your doctor immediately if you suddenly experience one or more of the following symptoms: difficulty breathing, swelling of the eyelids, face, lips, mouth, or throat, or any rash or itching, especially those that cover your entire body.

The most serious side effect is a situation in which breathing is slower and weaker than expected (respiratory depression, a typical risk of opioid overdose).

Like all strong analgesics, hydromorphone has 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 (should normally disappear after a few days, but your doctor may prescribe a medicine against vomiting if it continues to be a problem);
• 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 (see section 3. "If you stop taking Hidromorfona Aristo”);
• Indigestion, diarrhea, taste disorders;
• Hyperexcitability, depression, mood changes (euphoria), hallucinations, nightmares.
• Tremors, muscle spasms, tingling or numbness;
• Blurred vision;
• Decreased blood pressure;
• Breathing difficulties;
• Changes in blood tests that show how your liver is working (increased liver enzymes);
• Rash;
• Urinary retention;
• Decreased sexual desire, impotence,
• Fatigue, generally feeling unwell, swelling of hands, ankles, or feet (fluid accumulation in the tissue).

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

• Aggression;
• Drowsiness up to sedation (sedation), lack of energy;
• Increased heart rate, slow heart rate, palpitations;
• Spasms of the respiratory muscles, failure, i.e., clearly flattened and slow breathing (respiratory depression);
• Biliary colic, worsening of pancreatic function values (determined by a blood test);

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

• Exhaustion, uncontrolled muscle movements, increased sensitivity to pain (hyperalgesia, see section 2 "Warnings and precautions");
• Loss of intestinal movement (paralytic ileus);
• Drug addiction, mood changes (dysphoria), restlessness;
• Pupil constriction (miosis);
• Feeling of heat;
• Rash with itching (urticaria);
• Need to take higher doses (called habituation or drug tolerance);
• Withdrawal symptoms in newborns whose mothers have taken hydromorphone during pregnancy (see "Pregnancy and breastfeeding").
• Sleep apnea (interruptions in breathing during sleep).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storing Hidromorfona Aristo

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 outer packaging and on the blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

6. Container Content and Additional Information

Composition ofHydromorphone Aristo

• The active ingredient is hydromorphone hydrochloride.

Each hard capsule contains 2.6 mg of hydromorphone hydrochloride (equivalent to 2.32 mg of hydromorphone).

• The other components are:

Capsule content: microcrystalline cellulose, hypromellose, hydrochloric acid (2.61%) (for pH adjustment), propyl gallate

Capsule coating: gelatin, titanium dioxide (E 171), red iron oxide (E 172)

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

Product Appearance and Container Content

Hard gelatin capsules, red, opaque, size 3, and marked with "2.6".

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

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

Only some container 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

You can request more information about this medication 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 medication is authorized in the member states of the European Economic Area under the following names:

Germany: Hydromorphon Aristo akut 2,6 mg Hartkapseln

Spain: Hidromorfona Aristo 2,6 mg hard capsules EFG

Portugal: Hidromorfona Aristo 2,6 mg hard capsules

Date of the last revision of this prospectus: December 2022

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