Leaflet: information for the user

Diliban 75 mg/650 mg Effervescent Tablets

Tramadol hydrochloride/ Paracetamol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Diliban is and for what it is used

2. What you need to know before starting to take 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, that act together to relieve pain.

Diliban is indicated for the 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 ingredients of this medicine (listed in section 6).

- In case of acute alcohol intoxication, if you are taking sleeping pills, strong analgesics, or other psychotropic medications (medicines 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, pharmacist or nurse 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;

- If you have recently had a head injury, shock, severe 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 anaesthetized. 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 chronic malnutrition, alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious 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/she will decide if you should continue taking this medication.

Respiratory disorders related to sleep

Diliban may cause respiratory disorders 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 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 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 experience any of the following side effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of 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 a higher dose and longer duration of 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 experience 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 of the recommended dose
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep"
• You have repeatedly and unsuccessfully tried 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.

Diliban contains sodium

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

Other medications and Diliban:

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

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

It is contraindicated to use Diliban if you are being treated with:

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

- Buprenorphine, nalbuphine or pentazocine (opioid analgesics). 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, involuntary muscle contractions or diarrhea, you should call your doctor.

- Sedatives, sleeping pills, 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, medications that affect mood, or bupropion (used to help quit smoking). The risk of adjustment may increase. Your doctor will tell you if Diliban is suitable for you.

- Warfarin or phenprocoumon (used to prevent blood clots). It is possible that the effectiveness of these medications 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 medications and you 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 concomitant use of Diliban and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, 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 alert to 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 (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

Diliban may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to take alcohol while taking Diliban.

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.

Pregnancy

Due to the fact that 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.

Breastfeeding

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

Driving and operating machineryAsk your doctor if you can drive or operate machinery during treatment with Diliban. 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.

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.

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

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

Administration form:

Effervescent tablets are administered orally.

Effervescent tablets are taken dissolved in a glass of water.

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 the 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 probability of unnecessary adverse effects (withdrawal symptoms).

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

Like all medicines, Diliban may cause 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, urticaria).

- 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.

- transient loss of consciousness (syncope)

- 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, 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. 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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach 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.

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

Tablet container in tablet containers:

Store below 30º

Store in the original container to protect it from moisture.

Shelf life once opened: 12 months, not exceeding the expiration date.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diliban effervescent tablets

- The active principles are hydrochloride of tramadol and paracetamol.

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

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

Appearance of the product and content of the packaging:

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

The effervescent tablets are packaged in tablet containers.

Tablet containers: containers with 20 and 60 effervescent tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization:

Gebro Pharma, S.A. Laboratories

Av. Tibidabo, 29

08022 Barcelona

Spain

Responsible for Manufacturing:

Medicamentos Internacionales S.A (Medinsa) Laboratories

C/ Solana Nº 26

28850 Torrejón de Ardoz, Madrid

Spain

Last review date of this leaflet: February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/