Diliban 75 mg/650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diliban 75 mg/650 mg Tablets

Tramadol hydrochloride/Paracetamol

Read the entire leaflet carefully before starting to take 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, inform your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

1. What Diliban is 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. How to store 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 analgesics, 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 the 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 taking Diliban

Do not take Diliban:

• If you are allergic to tramadol, paracetamol, or any of the other components 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 may 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 within the last 14 days before starting 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:

Talk to your doctor before starting to take Diliban:

• If you are taking other medicines containing 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 serious lung conditions;
• If you have epilepsy or have had seizures or fits;
• If you have recently suffered head trauma, shock, or severe headaches associated with vomiting;
• If you are dependent on any other pain-relieving medicine, for example morphine;
• If you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• If you are going 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 signs of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need hormonal supplements.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Use of Diliban with other medicines”).

During treatment with Diliban, inform your doctor immediately:

• If you have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

If you develop or have previously experienced any of these problems while taking Diliban, inform your doctor. Your doctor will decide whether 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 levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night 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 low risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact a doctor immediately if you experience any 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, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact 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 may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of Diliban may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much 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 a family member 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 prescribed, for example, "to stay calm" 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 feel better when you take it again ("withdrawal effect")

If you notice any of these signs, talk to your doctor so they can advise you on the best treatment approach, including when it is appropriate to stop taking it and how to do so safely (see section 3, "If you stop taking Diliban").

Children and adolescents

Use in children with respiratory problems

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may 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 abnormality (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 containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Do not take Diliban together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Diliban”).

Diliban is not recommended if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain attacks called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

• Triptans (for the treatment of migraine) or selective serotonin reuptake inhibitors “SSRIs” (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

• Sedatives, sleeping pills, other painkillers such as morphine and codeine (also when used for cough treatment), 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 occurs, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will tell you whether Diliban is suitable for you.
• Warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• Other medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Diliban simultaneously with these medicines. Your doctor will tell you whether Diliban is suitable for you.

• Medicines for the treatment of depression. Diliban may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).

• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).
• Concomitant use of Diliban and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Diliban together 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 dosage recommendations. It may be helpful to inform friends or family members to be alert for the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

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

• Metoclopramide, domperidone, and ondansetron (medicines for the treatment of nausea and vomiting),
• Colestipol or cholestyramine (medicines that lower blood cholesterol),
• Ketoconazole and erythromycin (medicines used to treat 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 while taking this medicine.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because Diliban contains tramadol, the use of this medicine during pregnancy is not recommended. 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 while breastfeeding, or if you take Diliban more than once, you must stop breastfeeding.

Driving and using machines:

Ask your doctor whether you can drive or operate machinery while being treated with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

3. How to take Diliban

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

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from using Diliban, when and for how long you should take it, when you should contact your doctor, and when you should discontinue it (see also section 2).

You should take Diliban for the shortest possible duration.

The dose should be adjusted according to the intensity of your pain and your individual sensitivity to pain. Normally, the lowest effective dose that provides pain relief should be used.

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents over 12 years of age is 1 tablet.

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 4 Diliban tablets per day.

Do not take Diliban more frequently than instructed by your doctor.

Your doctor may increase the dosing interval:

• 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 of age), elimination of tramadol may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

Treatment with Diliban is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Use in children and adolescents:

Use of this medicine is not recommended in children under 12 years of age.

Method of administration:

The tablets may be taken whole or split in half with a glass of liquid, preferably water. The tablet's score line is intended to facilitate splitting if you have difficulty swallowing the tablet whole or if you need to take a half dose.

If you feel that the effect of Diliban is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, you do not get 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 may only become apparent later.

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

If you forget to take Diliban:

If you forget to take your tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue taking the tablets as usual.

If you stop taking Diliban:

Generally, no undesirable effects occur after discontinuation of Diliban treatment. However, in some cases, patients who have taken Diliban for a prolonged period and stopped treatment abruptly may feel unwell (see section 4, "Possible adverse effects"). You should not suddenly stop taking this medicine unless instructed by your doctor. If you wish to stop taking the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to discontinue it, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further 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 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 every 100 patients:

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth
• itching, increased sweating
• headache, agitation
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being constantly “high-spirited”)

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

• tachycardia, hypertension, disturbances in heart rhythm and rate
• difficulty or pain when urinating
• skin reactions (e.g. rashes, urticaria)
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss
• difficulty swallowing, blood in stools
• chills, hot flushes, chest pain
• difficulty breathing

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

• seizures, difficulty performing coordinated movements
• addiction
• blurred vision
• pupil constriction (miosis), excessive pupil dilation (mydriasis), speech disorders

Frequency not known: cannot be estimated from available data:

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you need to know before taking Diliban”)
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2)

The following adverse effects have been reported in individuals taking medicines containing tramadol only or paracetamol only. However, if you experience any of these symptoms while taking Diliban, you must inform your doctor:

• Dizziness upon standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity levels, changes in perception, worsening of asthma.

• In rare cases, skin rashes indicating allergic reactions, which may manifest as sudden swelling of the face and neck, breathlessness, drop in blood pressure, and dizziness.

If you experience any of these, stop treatment immediately and consult your doctor without delay. You must not take this medicine again.

Using a medicine such as tramadol may lead to dependence, making it difficult for you 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 become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping Diliban, please consult your doctor.

In exceptional cases, blood tests may reveal abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

The use of Diliban together with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You must 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 adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diliban

Keep out of the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

This medicine does not require any special storage conditions.

Do not use Diliban after the expiry date stated on the packaging (after EXP).

The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Return unused containers and medicines to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diliban:

The active substances 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, colloidal anhydrous silica, sodium carboxymethylstarch (Type A) from potato and pregelatinized corn starch.

Nature of the product and contents of the container:

Diliban is presented as tablets for oral administration, in packs 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 leaflet has been reviewed in February 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):

http://www.aemps.gob.es