DILIBAN 75 mg/650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diliban 75 mg/650 mg Tablets

Tramadol Hydrochloride/Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

1. What Diliban is and what it is used for

Diliban is a combination of two painkillers, tramadol and paracetamol, which work together to relieve pain. Diliban is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that a combination of tramadol and paracetamol is necessary.

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

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

Do not take Diliban:

• If you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• In case of acute alcohol intoxication, if you are taking sleeping pills, strong painkillers, or other psychotropic medicines (medicines that can alter mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines 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 epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions:

Consult your doctor before starting to take Diliban:

• If you are taking other medicines 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 a sign of jaundice or problems with your bile ducts;
• If you have kidney problems;
• If you have severe breathing 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 severe headaches associated with vomiting;
• If you are dependent on any other medicine used for pain relief, for example, morphine;
• If you are taking other painkillers that contain buprenorphine, nalbuphine, or pentazocine;
• If you are going 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 can be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Using Diliban with other medicines").

During treatment with Diliban, inform your doctor immediately:

• If you have severe illnesses, 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 are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

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

Sleep-related breathing disorders

Diliban may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

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 alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Tolerance, dependence, and addiction

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

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

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

• You or someone in your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or 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 medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You use the medicine for reasons other than those prescribed, for example, "to calm down" or "to sleep"
• You have repeatedly tried to stop or control the use of the medicine without success
• When you stop taking the medicine, 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 so that he can indicate 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 is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Other medicines and Diliban:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Inform your doctor or pharmacist if you are taking:

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

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

Do not take Diliban with monoamine oxidase inhibitors (MAOIs) (see "Do not take Diliban").

Diliban is not recommended if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as intense pain attacks in the face called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). 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, uncontrolled muscle contractions, or diarrhea, you should call your doctor.

• Sedatives, sleeping pills, other painkillers such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used to help quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Diliban is suitable for you.
• Warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• Other medicines that can facilitate or cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Diliban at the same time as these medicines. Your doctor will tell you if Diliban is suitable for you.

-Medicines for the treatment of depression. Diliban can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• The concomitant use of Diliban and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

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

Please inform your doctor about all sedative medicines you are taking and closely follow your doctor's dose recommendation. It may be useful to inform friends or family members to be alert to the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

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

• Metoclopramide, domperidone, and ondansetron (medicines for the treatment of nausea and vomiting),
• Colestyramine (a medicine that reduces cholesterol in the blood),
• Ketoconazole and erythromycin (medicines used against infections).

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

Taking Diliban with food, drinks, and alcohol:

Do not drink alcoholic beverages if you are taking this medicine.

Pregnancy, breastfeeding, and fertility:

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.

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

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

Driving and using machines:

Ask your doctor if you can drive or use machines during treatment with this medicine. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it in combination with other medicines.

3. How to take Diliban

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, 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 stop it (see also section 2).

You should take Diliban for the shortest possible time.

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

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age 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 indicated by your doctor.

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.

Elderly patients

In elderly 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.

Patient with liver or kidney failure/patients on dialysis

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

Use in children and adolescents:

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

Method of administration:

The tablets can be taken whole or broken in half with the help of a glass of liquid, preferably water. The score line on the tablet is to break the tablet if you find it difficult to swallow whole or if you need to take half a dose.

If you think the effect of Diliban is too strong (i.e., you feel very drowsy or have difficulty breathing) or too weak (i.e., you do not have adequate pain relief), tell 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 that liver damage may occur, which may 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 medicine and the amount taken.

If you forget to take Diliban:

If you forget to take the tablets, it is possible that the pain will return. Do not take a double dose to make up for the forgotten doses, simply continue taking the tablets as usual.

If you stop taking Diliban:

Generally, no unwanted effects occur after stopping treatment with Diliban. However, it may be the case that patients who have been taking Diliban for a long time and have stopped treatment abruptly feel unwell (see section 4 "Possible side effects"). You should not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

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

4. Possible Adverse Effects

Like all medicines, Diliban can have adverse effects, although not all people suffer from them.

Very frequent: can affect more than 1 in 10 patients;

• nausea.
• dizziness, drowsiness.

Frequent: can affect between 1 and 10 out of 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 of being "high-spirited" all the time-).

Infrequent: can affect between 1 and 10 out of 1,000 patients;

• tachycardia, hypertension, cardiac rhythm and frequency disorders.
• difficulty or pain when urinating.
• skin reactions (e.g., rashes, urticarial edema).
• tingling sensation, numbness, or sensation of pins and needles in the limbs, ringing in the ears, muscle spasms, involuntary muscle contractions.
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss.
• difficulty swallowing, blood in stools.
• chills, hot flashes, chest pain.
• difficulty breathing.

Rare: can affect between 1 and 10 out of 10,000 patients;

• seizures, difficulties in carrying out coordinated movements.
• addiction
• blurred vision.
• pupil constriction (miosis) - excessive dilation of the pupils (midriasis) - speech disorders.

Frequency not known: cannot be estimated from the available data;

• decrease in blood sugar levels.
• hypoglycemia.
• serotonin syndrome, which can 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, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Diliban").
• a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

• Feeling of dizziness when standing up after being 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 rashes, indicating allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness.

If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.

Using a medicine 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 trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling sensation, and numbness, and ringing in the ears (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 result in nosebleeds or bleeding gums.

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

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

Reporting of Adverse Effects:

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

5. Storage of Diliban

Keep out of the reach and sight of children.

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who have not been prescribed it.

This medicine does not require special storage conditions.

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

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

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Diliban:

The active ingredients are tramadol hydrochloride and paracetamol.

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

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

Appearance of the Product and Package Contents:

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

Marketing Authorization Holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona

Manufacturer:

GEBRO PHARMA GmbH

A-6391 Fieberbrunn (Austria)

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

Sant Cugat del Vallès (Barcelona)

This prospectus was revised in February 2025.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es