Leaflet: information for the user

Diliban 75 mg/650 mg Tablets

Tramadol hydrochloride/ Paracetamol

1. What is Diliban and what it is used for

2. What you need to know before taking Diliban

3. How to take Diliban

4. Possible side effects.

5. Storage of Diliban

6. Contents of the pack and additional information

Diliban is a combination of two analgesics, tramadol and paracetamol, which act together to relieve pain. Diliban is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Diliban should only be used by adults and children over 12 years old.

Do not take Diliban:

- If you are allergic to tramadol, paracetamol, or any of the other components of this medication (listed in section 6).

- In case of acute alcohol intoxication, if you are taking sleeping medications, potent analgesics, or other psychotropic medications (medications that can alter mood and emotions).

- If you are taking MAO inhibitors (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Diliban.

- If you have severe liver disease.

- If you have uncontrolled epilepsy.

Warnings and precautions:

Consult your doctor before starting to take Diliban:

- If you are taking other medications that contain paracetamol or tramadol;

- If you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;

- If you have kidney problems;

- If you have severe respiratory difficulties, for example asthma or severe lung problems;

- If you have epilepsy or have had seizures or convulsions;

- If you have recently had a head injury, shock, or intense headaches associated with vomiting;

- If you have dependence on any other pain-relieving medication, for example morphine;

- If you are taking other pain-relieving medications that contain buprenorphine, nalbuphine, or pentazocine;

- If you are to be anesthetized. Tell your doctor or dentist that you are using Diliban.

- Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

- If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Use of Diliban with other medications").

Inform your doctor immediately during treatment with Diliban:

- If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

If you experience or have experienced any of these problems while taking Diliban, inform your doctor. He will decide if you should continue taking this medication.

Respiratory problems related to sleep

Diliban may cause respiratory problems 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 pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, known as tolerance). Repeated use of Diliban can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer use.

Dependence or addiction can make you feel like you no longer control the amount of medication you need to take or how often you need to take it.

The risk of becoming dependent or addicted to Diliban varies from person to person. You may be at a higher risk of becoming dependent or addicted to Diliban if:

• You or a family member has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Diliban, it could be a sign that you have become dependent or addicted:

• You need to take the medication for a longer period than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep".
• You have repeatedly tried and failed to stop or control the use of the medication.
• When you stop taking the medication, you feel unwell, and you feel better when you take it again ("withdrawal effect").

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

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medications and Diliban:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Important:This medication contains paracetamol and tramadol. Inform your doctor if you are taking any other medication that contains paracetamol or tramadol, so as not to exceed the maximum daily dose.

You should not take Diliban with MAO inhibitors (see "Do not take Diliban").

Do not use Diliban if you are being treated with:

- Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as intense facial pain called trigeminal neuralgia).

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of side effects increases if you also use:

- Triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions, or diarrhea, you should call your doctor.

- Sedatives, sleeping medications, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

- Antidepressants, anesthetics, neuroleptics (medications that affect mood), or bupropion (a medication used as a smoking cessation aid). The risk of seizures may increase. Your doctor will tell you if Diliban is suitable for you.

- Warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

- Other medications that may facilitate or cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Diliban simultaneously with these medications. Your doctor will tell you if Diliban is suitable for you.

- Medications for the treatment of depression. Diliban may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible side effects").

- Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

-The use of Diliban and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Diliban with sedatives, your doctor should limit the dose and duration of concomitant treatment.

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

The effectiveness of Diliban may be altered if you also use:

- Metoclopramide, domperidone, and ondansetron (medications for nausea and vomiting),

- Cholestyramine (a medication that reduces cholesterol in the blood),

- Ketoconazole and erythromycin (medications used to treat infections).

Your doctor will know which medications are safe to use with Diliban.

Taking Diliban with food, drinks, and alcohol:

You should not take alcoholic beverages while taking this medication.

Pregnancy, breastfeeding, and fertility:

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

Because Diliban contains tramadol, it is not recommended to use this medication during pregnancy. If you become pregnant during treatment with Diliban, consult your doctor before taking the next tablet.

Tramadol is excreted in breast milk. Therefore, you should not take Diliban more than once during breastfeeding, or if you take Diliban more than once, you should interrupt breastfeeding.

Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the beginning of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, your doctor will explain what you can expect from the use of Diliban, when and for how long you should take it, when you should contact your doctor and when you should interrupt it (see also section 2).

You should take Diliban for the shortest time possible.

The dose should be adjusted to the intensity of your pain and your individual sensitivity to pain. Normally, you should take the lowest dose possible that produces pain relief.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years old is 1 tablet.

If necessary, you can increase the dose as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 4 Diliban tablets per day.

Do not take Diliban more frequently than your doctor has indicated.

Your doctor may increase the interval between doses:

- If you are over 75 years old.

- If you have kidney problems.

- If you have liver problems.

Older patients

In older patients (over 75 years old), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney disease/patients on dialysis

If you have severe liver or kidney disease, treatment with Diliban is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Use in children and adolescents:

This medication is not recommended for use in children under 12 years old.

Administration form:

The tablets can be taken whole or split in half with the help of a liquid, preferably water. The groove in the tablet serves to split the tablet if it is difficult to swallow whole or if you need to take half a dose.

If you estimate that the action of Diliban is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., you do not have adequate pain relief), inform your doctor.

If you take more Diliban than you should:

You should consult your doctor or pharmacist even if you feel well. There is a risk of liver damage that will only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Diliban:

If you forgot to take the tablets, it is possible that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Diliban:

Generally, no adverse effects occur after interrupting treatment with Diliban. However, it may be the case that patients who have been taking Diliban for a while and have interrupted treatment abruptly feel unwell (see section 4. "Possible adverse effects").You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

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

Like all medicines, Diliban can have side effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 patients;

- nausea.

- dizziness, drowsiness.

Common: may affect between 1 and 10 in 100 patients;

- vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth.

- itching, increased sweating.

- headache, agitation.

- confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling "high" all the time).

Uncommon: may affect between 1 and 10 in 1,000 patients;

- tachycardia, hypertension, cardiac rhythm and frequency disorders.

- difficulty or pain urinating.

- skin reactions (e.g. rashes, urticarial hives).

- numbness, tingling, or pins and needles sensation in the extremities, ear noises, spasms, involuntary muscle contractions.

- depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss.

- difficulty swallowing, blood in stool.

- chills, hot flashes, chest pain.

- difficulty breathing.

Rare: may affect between 1 and 10 in 10,000 patients;

- convulsions, difficulties with coordinated movements.

- addiction

- blurred vision.

- pupil constriction (miosis)
- excessive pupil dilation (mydriasis)
- speech disorders.

Frequency not known: cannot be estimated from available data;

- decreased blood sugar levels.

- hypotension.

- serotonin syndrome, which may manifest as changes in mental state (e.g. agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting to take Diliban").

- a severe disease that can make the blood more acidic (metabolic acidosis) in seriously ill patients using paracetamol (see section 2).

The following adverse effects recognized have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Diliban, you should tell your doctor:

- Dizziness when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.

- In rare cases, skin eruptions, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness.

If this happens, interrupt treatment and consult your doctor immediately. Do not take this medication again.

Using a medication like tramadol can create dependence, making it difficult to stop taking it.

People who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Diliban, please consult your doctor.

In exceptional cases, blood tests reveal abnormalities, such as low platelet count, which can cause nasal or gum bleeding.

The use of Diliban with anticoagulants (e.g. femprocumona, warfarin) may increase the risk of bleeding. You should immediately inform your doctor about any prolonged or unexpected bleeding.

In very rare cases, severe skin reactions have been reported.

Reporting of adverse effects:

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Store this medication in a safe and protected place where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

This medication does not require special storage conditions.

Do not use Diliban after the expiration date shown on the packaging (after CAD).

The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

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. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Diliban:

The active principles are hydrochloride of tramadol and paracetamol.

One tablet contains 75 mg of hydrochloride of tramadol and 650 mg of paracetamol.

The other components are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium carboxymethylcellulose (Type A) from potato and pregelatinized cornstarch.

Appearance of the product and content of the container:

Diliban is presented in the form of oral tablets, in containers of 20 and 60 tablets.

Holder of the marketing authorization:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona

Responsible for manufacturing:

GEBRO PHARMA GmbH

A-6391 Fieberbrunn (Austria)

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

Sant Cugat del Vallès (Barcelona)

This leaflet has been reviewed in February 2025.

The detailed and updated information of this medicine is available on the Web page

of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es