Diliban 75 mg/650 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diliban 75 mg/650 mg Effervescent tablets

Tramadol hydrochloride / Paracetamol

Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

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 whenever 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 ingredients of this medicine (listed in section 6).
• In cases of acute alcohol intoxication, if you are taking sleeping medications, 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, pharmacist, or nurse 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 indicate 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;
• If you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• If you are dependent on any other pain-relief medicine, for example morphine;
• If you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anaesthetized. Inform 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 of them may interact with tramadol (see “Use of Diliban with other medicines”).

During treatment with Diliban, inform your doctor immediately:

• If you have serious conditions 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 under these circumstances when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 breathlessness, 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 slight risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol used alone. Consult a doctor immediately if you experience any 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, which may affect individuals differently. In some people, adequate 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 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 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 could result in a 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.

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 indicate 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 to determine the best treatment approach for you, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, "If you stop taking Diliban").

Children and adolescents

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Diliban contains sodium

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

Other medicines and Diliban:

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

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an 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”).

The use of Diliban is contraindicated if you are undergoing treatment with:

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

The risk of adverse effects increases if you take:

• 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 limb or eye movements, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

• Sedatives, sleeping medicines, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• Antidepressants, anesthetics, medicines affecting mood, or bupropion (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 (used to prevent blood clots). The effectiveness of these medicines may be altered, leading to bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.

• Antidepressants. 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, breathing difficulties (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 treating nausea and vomiting),
• Cholestyramine (a medicine that lowers 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

Diliban may make you feel drowsy. Alcohol may increase drowsiness; therefore, 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Because Diliban contains tramadol, the use of this medicine during pregnancy is not recommended. If you become pregnant while being treated with Diliban, consult your doctor before taking the next tablet.

Breastfeeding

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 must stop breastfeeding.

Driving and using machines Ask your doctor whether you can drive or operate machinery while being treated with Diliban. 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.

3. How to take Diliban

Follow exactly the instructions for use of this medicine 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 the use of 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 time possible.

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

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

If necessary, the dose may be increased as advised 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 directed by your doctor. Your doctor may increase the interval between doses:

• If you are over 75 years of age.
• If you have kidney problems.
• If you have liver problems.

Method of administration:

The effervescent tablets are administered orally.

The effervescent tablets should be taken dissolved in a glass of water.

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

If you stop taking Diliban

Generally, no undesirable effects occur after discontinuation of treatment with Diliban. However, it may happen that patients who have been taking Diliban for some time and have stopped treatment abruptly may feel unwell (see section 4 "Possible side effects"). You should not suddenly stop taking this medicine unless instructed by your doctor. If you wish to stop taking your 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 reduce the likelihood of 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 may have adverse effects, although not everyone will experience them.

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

• nausea
• dizziness, drowsiness

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

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth
• itching, increased sweating
• headache, restlessness
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of continuously being “on a high”)

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

• tachycardia, hypertension, disturbances in heart rhythm and heart rate
• difficulty or pain when urinating
• skin reactions (e.g., rashes, urticaria)
• tingling sensation, numbness, or prickling sensations in the extremities, ringing in the ears, involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not actually exist), 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
• transient loss of consciousness (syncope)
• 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, diarrhea) (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 who use paracetamol (see section 2)

The following recognized adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. 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, 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, shortness of breath, or drop in blood pressure and dizziness

If this happens to you, 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 treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky.

They may become hyperactive, have difficulty sleeping, and experience digestive and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, 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 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.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diliban

Keep this medicine out of the sight and reach of children.

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

Do not use Diliban effervescent tablets after the expiry date stated on the carton or on the bottom of the tablet container (after EXP). The expiry date refers to the last day of the month indicated.

Tablets in tablet containers:

Store below 30°C.

Keep in the original container to protect from moisture.

Shelf life after first opening: 12 months, not exceeding the expiry date.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Diliban effervescent tablets

• The active substances 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 flavouring, anhydrous citric acid, anhydrous monosodium citrate, sodium bicarbonate, copovidone, acesulfame potassium, macrogol 6000.

Description of the product and package contents:

Diliban effervescent tablets are presented as effervescent tablets that are white or almost white in colour.

The effervescent tablets are packed in tablet containers.

Tablet containers: packs containing 20 and 60 effervescent tablets.

Only certain pack 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 most recent revision of this leaflet: 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/