DILIBAN 75 MG/650 MG EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Diliban 75 mg/650 mg Effervescent 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 or pharmacist.
• 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 or pharmacist, even if you have read it in this leaflet. See section 4.

Contents of the package leaflet

1. What is Diliban and what is it 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 is Diliban and what is it used for

Diliban is a combination of two pain relievers, 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 take 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, potent pain relievers, 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, pharmacist, or nurse before starting treatment with 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;
• If you have recently had a head injury, shock, severe headaches associated with vomiting;
• If you have dependence on any other medicine used for pain relief, for example, morphine;
• If you are taking other pain relievers 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 indicators 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/she 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 notices 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 alone. Consult your doctor immediately if you experience any of the symptoms related to this serious 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 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 your 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 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 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 and failed to stop or control the use of the medicine
• When you stop taking the medicine, you feel unwell, and you feel better when you take it again ("withdrawal effect")

If you notice any of these signs, talk to your doctor so that he/she can indicate the best 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 in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Diliban contains sodium

This medicine contains 356.22 mg of sodium (the main component of table/cooking salt) in each dose unit. This is approximately 18% of the maximum daily intake of sodium recommended for an adult. Consult your doctor or pharmacist if you need to take one or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt diet (sodium).

Other medicines and Diliban:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an 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.Tell 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 nottake Diliban with monoamine oxidase inhibitors (MAOIs) (see section "do not take Diliban").

The use of Diliban is contraindicated 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 pain relievers). Pain relief may be reduced.

The risk of side effects increases if you take:

-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 pain relievers such as morphine and codeine (also when used to treat cough), baclofen (a 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, medicines that affect mood, or bupropion (used to help quit smoking). The risk of having a fit may increase. Your doctor will tell you if Diliban is suitable for you.

• Warfarin or phenprocoumon (used to prevent blood clots). The effectiveness of these medicines may be altered, and bleeding may occur. You should inform your doctor immediately of any prolonged or unexpected bleeding.

• Antidepressants. Diliban may 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 lowers 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

Diliban can make you feel drowsy. Alcohol can make you feel even drowsier, so it is recommended not to drink alcohol while taking Diliban.

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.

Pregnancy

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.

Breastfeeding

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 machinesAsk your doctor if you can drive or use machines during treatment with Diliban. 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.

3. How to take Diliban

Follow exactly the administration instructions of this medicine given by your doctor. In case of 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 time necessary.

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

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age is 2 effervescent tablets.

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.

Method of administration:

The effervescent tablets are administered orally.

The effervescent tablets are taken dissolved in a glass of water.

If you think the action 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 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 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 appear 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: may affect more than 1 in 10 patients;

• nausea.
• dizziness, drowsiness.

Frequent: may 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: may 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, hives).
• tingling sensation, numbness, or pinching sensation in the limbs, ringing in the ears, 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: may affect between 1 and 10 out of 10,000 patients;

• seizures, difficulties in carrying out coordinated movements.
• addiction
• blurred vision.
• transient loss of consciousness (syncope)
• pupil contraction (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 using paracetamol (see section 2).

The following recognized adverse effects 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:

• 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 as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness.

If this happens, stop treatment and consult your doctor immediately. You should 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 suddenly stop treatment. They may feel agitated, anxious, nervous, or trembly.

They may be hyperactive, have difficulty sleeping, and experience 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 with anticoagulants (e.g., femprocumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

Reporting of Adverse Effects

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

5. Conservation of Diliban

Keep this medication out of sight and reach of children.

Store this medication 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.

Do not use Diliban effervescent tablets after the expiration date shown on the carton or on the bottom of the tablet container (after CAD). The expiration date is the last day of the month indicated.

Box of tablets in tablet containers:

Store below 30°C

Store in the original container to protect it from moisture.

Validity period once opened: 12 months, without exceeding the expiration date.

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

6. Package Contents and Information

Composition of Diliban Effervescent Tablets

• The active ingredients are tramadol hydrochloride and paracetamol.

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

• The other components are: povidone (PVK-90), maltodextrin, sodium saccharin dihydrate, orange flavor, anhydrous citric acid, anhydrous sodium citrate, sodium bicarbonate, copovidone, potassium acesulfame, macrogol 6000.

Appearance of the Product and Package Contents:

Diliban effervescent tablets are presented in the form of white or almost white effervescent tablets.

The effervescent tablets are packaged in tablet containers.

Tablet containers: containers with 20 and 60 effervescent tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Manufacturer:

Laboratorios Medicamentos Internacionales S.A (Medinsa)

C/ Solana Nº 26

28850 Torrejón de Ardoz, Madrid

Spain

Date of the Last Revision of this Prospectus: February 2025

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/