Exbol

Leaflet accompanying the packaging: information for the user

Exbol, 37.5 mg + 325 mg, tablets

Tramadol hydrochloride + Paracetamol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Exbol and what is it used for
• 2. Important information before taking Exbol
• 3. How to take Exbol
• 4. Possible side effects
• 5. How to store Exbol
• 6. Contents of the packaging and other information

1. What is Exbol and what is it used for

Exbol contains two active substances with analgesic effects - tramadol and paracetamol. Exbol is used to treat moderate or severe pain, when the doctor recommends the combined use of tramadol and paracetamol.
Exbol is intended for adults, adolescents, and children over 12 years of age.

2. Important information before taking Exbol

When not to take Exbol

• if the patient is allergicto tramadol, paracetamolor any of the other ingredientsof this medicine (listed in section 6)
• in case of acute intoxication with alcohol, sleeping pills, painkillersor psychotropic drugs (affecting mood, emotions, and mental state)
• if the patient is taking monoamine oxidase inhibitors (MAOIs)at the same time or has taken MAOIs in the last 14 daysbefore starting Exbol. MAOIs are used to treat depression and Parkinson's disease
• if the patient has severe liver dysfunction
• if the patient has epilepsythat is not properly controlled with medication

Exbol is not recommended for children under 12 years of age.

Warnings and precautions

Before taking Exbol, you should consult a doctor or pharmacist.

• if the patient is taking other medicines containing paracetamol or tramadol
• if the patient has liver disease; for example, they have yellowing of the eyes and skin, which may indicate jaundice
• if the patient has kidney problems
• if the patient has severe breathing difficulties, such as those associated with asthma or severe lung disease
• if the patient has epilepsy or has had seizures in the past
• if the patient has recently had a head injury, was in shock, or had severe headaches with vomiting
• if the patient may be dependent on other painkillers, such as morphine
• if the patient is taking other painkillers that contain buprenorphine, nalbuphine, or pentazocine
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Exbol and other medicines")
• if the patient is scheduled for surgery under anesthesia (should inform the doctor or dentist about taking Exbol).

If any of the above situations occur during Exbol treatment or have occurred in the patient's past, they should inform their doctor.
During Exbol treatment, the patient should immediately inform their doctor if:
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If the patient experiences any symptoms of this serious condition, they should seek medical attention immediately (see section 4, "Possible side effects").
If the patient has severe illnesses, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic) at the same time. There have been reports of a serious condition called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a long time or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.
Respiratory disorders during sleep
Exbol may cause respiratory disorders during 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, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should contact their doctor. The doctor may recommend reducing the dose.
If the patient experiences any of the following symptoms while taking Exbol, they should tell their doctor: excessive tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact their doctor, who will decide whether the patient needs hormone replacement.
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid. Repeated use of opioids can lead to tolerance (the patient gets used to the medicine). Repeated use of Exbol can also lead to dependence, abuse, and addiction, which can result in life-threatening overdose. The risk of these side effects may increase with the dose and duration of treatment.
Dependence can make it difficult for the patient to control the dose they take or how often they take it.
The risk of dependence varies from person to person. The risk of dependence on Exbol may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illegal drugs ("addiction");
• the patient smokes;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If the patient experiences any of the following symptoms while taking Exbol, it may indicate dependence:

• the patient needs to take the medicine for longer than the doctor recommended
• the patient needs to take a higher dose than recommended
• the patient uses the medicine for reasons other than those recommended, such as "to calm down" or "to help fall asleep"
• the patient has made repeated, unsuccessful attempts to stop or control the use of the medicine
• after stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal symptoms").

If the patient experiences any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when to stop the medicine and how to do it safely (see section 3, "Stopping Exbol treatment").
Tramadol is converted in the liver by an enzyme. Some people have a variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, while in others, serious side effects are more likely to occur.
The patient should stop taking the medicine and contact their doctor immediately if they experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children with respiratory disorders
Tramadol is not recommended for children with respiratory disorders, as the symptoms of tramadol toxicity may be more severe in them.

Exbol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Exbol contains paracetamol and tramadol. The patient should inform their doctor about taking other medicines containing paracetamol or tramadol. The patient should not exceed the maximum daily dose of paracetamol or tramadol when taking this or other medicines.
Do not takeExbol with monoamine oxidase inhibitors (MAOIs) (see "When not to take Exbol").
Exbol is not recommended if the following medicines are taken at the same time:

• carbamazepine (a medicine used to treat epilepsy and various types of pain)
• buprenorphine, nalbuphine, and pentazocine (opioid painkillers). Their analgesic effect may be weakened.

The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic), due to the increased risk of a serious condition affecting blood and body fluids (called metabolic acidosis), which requires emergency treatment (see section 2).
• 2).

Exbol may increase the risk of side effects if taken with the following medicines:

• Certain antidepressants. Exbol may interact with these medicines and cause serotonin syndrome (see section 4, "Possible side effects").
• Sedatives, sleeping pills, other painkillers such as morphine and codeine (also in cough medicines), baclofen (a muscle relaxant), blood pressure-lowering medicines, antidepressants, or antihistamines. The patient should inform their doctor about drowsiness and fainting.
• Medicines that can cause seizures (epilepsy), such as antidepressants or antipsychotics. The risk of seizures may be increased when taking Exbol. The doctor will decide whether Exbol should be taken.
• Concomitant use of Exbol with sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if the doctor has prescribed Exbol with sedatives, the dose and duration of concomitant use should be limited by the doctor. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.
• Warfarin or acenocoumarol (blood-thinning medicines). The effectiveness of these medicines may change, and bleeding may occur (see section 4). The patient should inform their doctor about any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or nerve pain (neuropathic pain).

The effectiveness of Exbol may also be affected by concomitant use of the following medicines:

• metoclopramide, domperidone, or ondansetron (used to treat nausea and vomiting);
• cholestyramine (used to lower blood cholesterol levels);
• ketokonazole or erythromycin (used to treat infections).

Exbol with food, drink, and alcohol

The patient should not consume alcohol while taking Exbol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, the patient should not take Exbol more than once while breastfeeding, or if they have taken Exbol more than once, they should stop breastfeeding.

Driving and using machines

If the patient experiences drowsiness while taking Exbol, they should not drive vehicles, use tools, or operate machines.

Exbol contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Exbol

This medicine should always be taken exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Exbol, when and how long to take it, when to contact the doctor, and when to stop taking it (see also section 2).
The patient should take Exbol for as short a time as possible and no longer than the doctor has told them.
The dose will be adjusted according to the severity of the pain and the patient's sensitivity to pain. In general, the patient should take the lowest dose that provides pain relief.

Adults, adolescents, and children over 12 years of age:

The recommended initial dose is 2 tablets, unless the doctor has prescribed otherwise. If necessary, the patient can take additional doses, as recommended by the doctor.
The patient should leave at least a 6-hour gap between doses. The patient should not take more than 8 tablets in 24 hours.

Elderly patients

In patients over 75 years of age, the elimination of tramadol from the body may take longer. In these patients, the doctor may recommend prolonging the time interval between doses.

Patients with severe kidney or liver impairment, dialysis patients

The patient should not take Exbol in case of severe liver or kidney impairment. In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.
The patient should swallow the tablet with a drink of water.
If the effect of Exbol is too strong (the patient feels drowsy or has breathing difficulties) or too weak (the pain does not go away), the patient should consult their doctor.

Children under 12 years of age:

Exbol is not recommended for children under 12 years of age.

Taking a higher dose of Exbol than recommended

In case of overdose or accidental ingestion of this medicine by a child, the patient should immediately contact a doctor or the nearest hospital and provide the exact amount of the medicine taken. The patient should take any remaining tablets and this leaflet to the doctor. Overdose of paracetamol can cause serious consequences, including liver failure, which can be fatal.

Missing a dose of Exbol

If the patient forgets to take a dose, it is likely that the pain will return.
The patient should not take a double dose to make up for the missed dose; they should continue taking the medicine as scheduled.

Stopping Exbol treatment

The patient should not stop taking Exbol suddenly without their doctor's advice. If the patient wants to stop taking Exbol, they should discuss it with their doctor, especially if they have been taking the medicine for a long time.
The doctor will advise when and how to stop taking Exbol; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms).
If the patient stops taking Exbol, it is likely that the pain will return. If the patient wants to stop treatment due to unwanted side effects, they should consult their doctor.
Stopping Exbol treatment usually does not cause withdrawal symptoms. After stopping long-term treatment, some patients may experience symptoms such as restlessness, anxiety, nervousness, panic attacks, hallucinations, unusual sensations (itching, tingling, numbness), ringing in the ears, insomnia, tremors, or gastrointestinal symptoms. If the patient experiences any of these symptoms after stopping Exbol, they should contact their doctor.
If the patient has any further questions about taking Exbol, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Exbol can cause side effects, although not everybody gets them.

Some side effects can be serious. The patient should stop taking Exbol and contact their doctor immediately if they experience any of the following symptoms:

• swelling of the face, lips, or throat, difficulty swallowing or breathing, or a sudden drop in blood pressure and fainting. The patient may also experience a rash or itching. These symptoms can be a sign of a serious allergic reaction;
• prolonged or unexpected bleeding when taking Exbol with blood-thinning medicines (warfarin or acenocoumarol).

In addition, the following side effects may occur during Exbol treatment:

Very common side effects(occurring in more than 1 in 10 patients):

• nausea (feeling sick);
• dizziness, drowsiness.

Common side effects(occurring in 1 to 10 patients in 100):

• vomiting;
• digestive problems (constipation, bloating, diarrhea), stomach pain, dry mouth;
• itching, sweating;
• headache, tremors;
• disorientation, sleep disturbances, mood changes (anxiety, nervousness, elevated mood).

Uncommon side effects(occurring in 1 to 10 patients in 1,000):

• rapid heartbeat or increased blood pressure, irregular heartbeat or arrhythmia;
• urination problems or pain when urinating;
• skin reactions (e.g., rash, hives);
• tingling, numbness, or a feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle contractions;
• depression, nightmares, hallucinations (hearing, seeing, or feeling things that do not exist), memory lapses;
• difficulty swallowing, blood in the stool;
• chills, hot flashes, chest pain;
• breathing difficulties.

Rare side effects(occurring in less than 1 in 10,000 patients):

• seizures, uncoordinated movements;
• dependence;
• blurred vision. Frequency not known(cannot be estimated from the available data):
• low blood sugar (hypoglycemia);
• hiccups;
• serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2, "Important information before taking Exbol")
• a serious condition that can cause increased acidity of the blood (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

In addition, patients taking medicines containing only tramadol or only paracetamol have reported the following side effects:

• feeling faint when standing up from a lying or sitting position, slow heartbeat, fainting;
• changes in appetite;
• muscle weakness, decreased breathing rate or depth;
• changes in mood, activity, or perception;
• worsening of asthma symptoms;
• nosebleeds or gum bleeding, which may be caused by a decrease in platelet count;
• very rarely, serious skin reactions have been reported.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Exbol

There are no special precautions for storage of the medicinal product.
The medicine should be stored out of sight and reach of children.
The medicine should be stored in a safe place, where others cannot access it. It can cause serious harm and be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Exbol contains

• The active substances of Exbol are tramadol hydrochloride and paracetamol. Each tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other ingredients are: maize starch, povidone 25, croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Exbol looks like and contents of the pack

Exbol is a white, round tablet with a score line, 12 mm in diameter. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Exbol is available in blisters containing 10, 20, 30, 40, 50, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

CZ: Medracet 37,5 mg + 325 mg, tablets
HU: Tramcet 37,5 mg + 325 mg tablet
PL:
Exbol
SK: Tramcet 37,5 mg + 325 mg tablets
Date of last revision of the leaflet:June 2025