Exbol

Leaflet accompanying the packaging: patient information

Exbol, 75 mg + 650 mg, tablets

Tramadol hydrochloride + Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Exbol is and what it is 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 pack and other information

1. What Exbol is and what it is 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 and adolescents aged 12 and over.

2. Important information before taking Exbol

When not to take Exbol

• if the patient is allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6)
• in case of acute alcohol intoxication, sleeping pills, painkillers, or 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 days before starting Exbol. MAOIs are used to treat depression and Parkinson's disease
• if the patient has severe liver dysfunction
• if the patient has epilepsy that is not adequately controlled by medication
• if the patient is pregnant or breastfeeding.

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

Warnings and precautions

Before taking Exbol, consult your doctor or pharmacist:

• if the patient is taking other medicines containing paracetamol or tramadol
• if the patient has liver disease; for example, if 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 is taking antidepressants, as some of these may interact with tramadol (see "Exbol and other medicines")
• if the patient is scheduled for surgery (inform your doctor or dentist that you are taking Exbol).

If any of the above situations occur during Exbol treatment or have occurred in the past, inform your doctor.
During Exbol treatment, immediately inform your doctor if:
After taking tramadol in combination with certain antidepressants or tramadol alone
there is a small risk of 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 in the blood, leading to organ damage), or malnutrition,
chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
There have been reports of a serious condition called metabolic acidosis (a blood and fluid disorder) in patients taking paracetamol regularly for a long time or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include:
severe breathing difficulties, including rapid deep breathing, drowsiness,
nausea (feeling sick) and vomiting.
Breathing difficulties during sleep
Exbol may cause breathing difficulties during sleep, such as sleep apnea (pauses in breathing during sleep) and 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 someone else 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 becomes accustomed to the medicine). Repeated use of Exbol can also lead to dependence 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 or frequency of the medicine.
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 ("dependence");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses. If any of the following symptoms occur 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 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 effects").

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.
The patient should stop taking the medicine and immediately contact their doctor if they experience any of the following side effects: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children with breathing difficulties
Tramadol is not recommended for children with breathing difficulties, as the symptoms of tramadol toxicity may be exacerbated in them.

Exbol and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
Exbol contains paracetamol and tramadol. The patient should inform their doctor about taking other medicines containing paracetamol or tramadol.
Do not exceed the maximum daily dose of paracetamol or tramadol when taking this medicine or other medicines.
Do not take Exbol 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.

Tell your doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (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.
• Taking 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, concurrent 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 concurrent 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.
• Gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain (nerve pain).
• Warfarin or acenocoumarol (blood thinners). 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.

The effectiveness of Exbol may also be affected by the concurrent 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

Do not drink alcohol while taking Exbol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Do not take Exbol during pregnancy and breastfeeding (see "When not to take Exbol").
Tramadol is excreted into breast milk. Therefore, the patient should not take Exbol more than once while breastfeeding, or if they have taken it more than once, they should stop breastfeeding.
No studies have been conducted on the effect of the combination of tramadol and paracetamol on fertility.

Driving and using machines

If drowsiness occurs while taking Exbol, the patient should not drive, use tools, or operate machinery.

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 it (see also section 2).
Take Exbol for as short a time as possible and no longer than the doctor has told the patient.
The dose will be adjusted according to the severity of the pain and the patient's sensitivity to pain. In general, the lowest dose that provides pain relief should be taken.

Adults and adolescents aged 12 and over

Initially, one tablet is recommended, unless the doctor has prescribed otherwise. If necessary, the patient can take additional doses, as recommended by the doctor.
There should be at least a 6-hour interval between doses.

Do not take more than 4 tablets per day.

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

Do 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.

Method of administration

Take the tablets orally.
The tablet can be divided into equal doses. The tablet should be swallowed, washed down with a sufficient amount of liquid (e.g., a glass of water). The tablets can be taken with or without food.
If the effect of Exbol is too strong (the patient feels drowsy or has breathing difficulties) or too weak (the pain does not subside), 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 their doctor or the nearest hospital and provide the exact amount of the medicine taken. The patient should take the 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.
Do not take a double dose to make up for the missed dose; instead, continue taking the medicine as scheduled.

Stopping Exbol treatment

Do not stop taking this medicine suddenly without the doctor's advice. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if they have been taking it for a long time.
The doctor will advise when and how to stop taking the medicine; 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 unfavorable 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 anxiety, fear, nervousness, panic attacks, hallucinations, unusual sensations (itching, tingling, numbness), ringing in the ears, insomnia, or tremors. If the patient experiences any of these symptoms after stopping Exbol, they should consult their doctor.
If the patient has any further doubts about taking the medicine, they should consult 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. A rash or itching may also occur. These symptoms may be a sign of a serious allergic reaction;
• prolonged or unexpected bleeding when taking Exbol with blood thinners (warfarin or acenocoumarol).

In addition to the above, the following side effects may occur when taking Exbol:
Very common(occurring in more than 1 in 10 patients):

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

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

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

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

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

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

• seizures, uncoordinated movements;
• dependence, confusion;
• blurred vision, pinpoint pupils;
• transient loss of consciousness (fainting).

Very rare(occurring in less than 1 in 10,000 patients):

• abuse.

Frequency not known(cannot be estimated from the available data):

• speech disorders;
• marked dilation of the pupils;
• low blood sugar (hypoglycemia);
• hiccups;
• serotonin syndrome, whose symptoms may include changes in mental status (e.g., agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, loss 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 an increase in blood acidity (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

In addition to the above, 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 heart rate, fainting, changes in appetite, muscle weakness, decreased or shallow breathing, mood changes, changes in activity, changes in perception, worsening of asthma.

In rare cases, taking tramadol may lead to dependence and difficulties in stopping the medicine. In rare cases, patients taking tramadol for some time may experience a feeling of being unwell after sudden withdrawal. They may experience: agitation, anxiety, nervousness, or tremors. Patients may be overactive, have sleep problems, and gastrointestinal disturbances. A very small number of patients may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, or ringing in the ears. If any of the above symptoms occur in the patient after stopping Exbol, they should contact their doctor. In exceptional cases, blood test results may show abnormalities, such as a low platelet count, which can lead to nosebleeds or bleeding gums.
Severe skin reactions have been reported very rarely during paracetamol treatment.
Depression of breathing has been rarely reported during tramadol treatment.

Reporting side effects

If the patient experiences any side effects, including any 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,
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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 storing the medicinal product.
Keep the medicine out of the sight and reach of children.
Store the medicine in a safe place where others cannot access it. It can cause serious harm and be fatal to people it was not prescribed for.
Do not use this medicine after the expiry date (EXP) 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 pack and other information

What Exbol contains

• The active substances of Exbol are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• The other ingredients are: maize starch, povidone 25, sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Exbol looks like and contents of the pack

Exbol is a white or almost white, elongated, biconvex tablet with a break line. The tablet can be divided into equal doses.
The approximate dimensions of the tablet are 19 mm x 8.8 mm.
Exbol is available in blisters containing 10, 30, 60, or 90 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Date of last revision of the leaflet:June 2025